VRC 605: A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered Intravenously or Subcutaneously to Healthy Adults
Phase: PHASE1
Conditions: HIV Prevention
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Official Title: A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of a Human 
Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered 
Intravenously or Subcutaneously to Healthy Adults 
 
 
ClinicalTrials.gov Identifier: NCT03015181 
 
 
Document Type: 
 
• Redacted Study Protocol (Statistical Analysis Considerations located in Section 6 of the 
Protocol 4.0) 
• Redacted IRB-approved Informed Consent (final version) 
 
Document/Date: 
• 
Protocol Version 4.0: October 11, 2017 
• 
IRB-approved Informed Consent Version 3.0: August 15, 2017 
 

 
 
Version 4.0 
October 11, 2017  
 
 
VACCINE RESEARCH CENTER 
 
Protocol VRC 605 
(NIH 17-I-0030) 
 
A PHASE 1 DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS 
OF A HUMAN MONOCLONAL ANTIBODY, VRC-HIVMAB075-00-AB  
(VRC07-523LS), ADMINISTERED INTRAVENOUSLY OR SUBCUTANEOUSLY TO 
HEALTHY ADULTS 
 
Study Product Provided by 
Vaccine Research Center/NIAID/NIH, Bethesda, MD 
Clinical Trial Sponsored by: 
National Institute of Allergy and Infectious Diseases (NIAID) 
Vaccine Research Center (VRC) 
Bethesda, Maryland 
IND Sponsored by: 
National Institute of Allergy and Infectious Diseases 
Vaccine Research Center (VRC) 
Bethesda, Maryland 
IND 133,027 
Principal Investigator: 
Martin Gaudinski, M.D. 
Vaccine Research Center, National Institute of Allergy and Infectious Diseases (NIAID) 
National Institutes of Health (NIH) 
Bethesda, MD 20892 
 
IRB Initial Review Date:  November 21, 2016 
 

PRODUCT: VRC-HIVMAB075-00-AB                                                                          PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 2 of 62 
TABLE OF CONTENTS 
 
Page 
PRÉCIS .......................................................................................................................................... 7 
 
INTRODUCTION............................................................................................................. 8 
 Rationale for the Study ....................................................................................................... 8 
 VRC07-523LS Specific Laboratory Assessments ............................................................ 10 
 Previous human experience .............................................................................................. 10 
1.3.1 
VRC01 Safety Data ............................................................................................... 10 
1.3.2 
VRC01LS Safety Data ........................................................................................... 11 
1.3.3 
VRC07-523LS Safety Data .................................................................................... 11 
 Pharmacokinetic Parameters ............................................................................................. 12 
 
STUDY PRODUCT ........................................................................................................ 12 
 VRC-HIVMAB075-00-AB............................................................................................... 12 
 Preclinical Toxicology Study ............................................................................................ 13 
 In Vitro Safety Studies ...................................................................................................... 13 
 In Vivo Preclinical Pharmacology Studies ....................................................................... 14 
 
STUDY OBJECTIVES ................................................................................................... 16 
 Primary Objectives............................................................................................................ 16 
 Secondary Objectives........................................................................................................ 16 
 Exploratory Objectives ..................................................................................................... 16 
 
STUDY DESIGN ............................................................................................................. 16 
 Study Population ............................................................................................................... 17 
4.1.1 
Inclusion Criteria .................................................................................................. 17 
4.1.2 
Exclusion Criteria ................................................................................................. 18 
 Clinical Procedures and Laboratory Assays ..................................................................... 18 
4.2.1 
Screening............................................................................................................... 18 
4.2.2 
Enrollment, Study Days and Visit Numbers .......................................................... 19 
4.2.3 
Administration of VRC07-523LS .......................................................................... 19 
4.2.4 
Solicited Adverse Events and Clinical Follow-up ................................................ 19 
4.2.5 
Pharmacokinetics .................................................................................................. 20 
4.2.6 
Oral Mucosa Samples ........................................................................................... 20 
4.2.7 
Schedule of Evaluations ........................................................................................ 20 
4.2.8 
Concomitant Medications ..................................................................................... 21 
 Criteria for Dose and Route Escalation ............................................................................ 21 
 Criteria for Discontinuation of VRC07-523LS Administration ....................................... 22 
 Criteria for Pausing the Study and Resuming the Study .................................................. 22 
 
SAFETY AND ADVERSE EVENT REPORTING ..................................................... 23 
 Adverse Events ................................................................................................................. 23 
 Serious Adverse Events .................................................................................................... 23 
 Adverse Event Reporting to the IND Sponsor .................................................................. 24 
5.3.1 
IND Sponsor Reporting to the FDA ...................................................................... 24 
 Reporting to the Institutional Review Board .................................................................... 24 

PRODUCT: VRC-HIVMAB075-00-AB                                                                          PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 3 of 62 
5.4.1 
Unanticipated Problem (UP) Definition ............................................................... 24 
5.4.2 
Protocol Deviation Definition............................................................................... 25 
5.4.3 
Non-Compliance Definition .................................................................................. 25 
5.4.4 
Expedited Reporting to the NIAID IRB ................................................................. 25 
5.4.5 
Annual Reporting to the NIAID IRB ..................................................................... 26 
 
STATISTICAL CONSIDERATIONS .......................................................................... 26 
 Overview ........................................................................................................................... 26 
 Objectives ......................................................................................................................... 26 
 Size and Accrual ............................................................................................................... 27 
6.3.1 
Treatment Assignments ......................................................................................... 27 
6.3.2 
Sample Size Considerations .................................................................................. 27 
 Statistical Analysis ............................................................................................................ 28 
6.4.1 
Analysis Variables ................................................................................................ 28 
6.4.2 
Baseline Demographics ........................................................................................ 28 
6.4.3 
Safety Analysis ...................................................................................................... 29 
6.4.4 
Tolerability Evaluation ......................................................................................... 29 
6.4.5 
Pharmacokinetics Analysis ................................................................................... 29 
6.4.6 
Interim Analyses.................................................................................................... 30 
 
PHARMACY PROCEDURES ...................................................................................... 30 
 Study Product and Administration Regimen .................................................................... 30 
 VRC HIVMAB075-00-AB (VRC07-523LS) Vialed Product .......................................... 31 
 Temperature Excursions ................................................................................................... 31 
 Preparation of Study Product for Administration ............................................................. 31 
7.4.1 
VRC-HIVMAB075-00-AB: Preparation for Administration Intravenously .......... 32 
7.4.2 
VRC-HIVMAB075-00-AB: Preparation for Administration Subcutaneously ....... 32 
7.4.3 
VRC -HIVMAB075-00-AB (VRC07-523LS) Prepared Product (IV Bag and 
Syringe) ................................................................................................................. 33 
 Risks .................................................................................................................................. 33 
 Benefits ............................................................................................................................. 34 
 Institutional Review Board ............................................................................................... 34 
 Subject Confidentiality ..................................................................................................... 34 
 Plan for Use and Storage of Biological Samples .............................................................. 34 
7.9.1 
Use of Samples, Specimens and Data ................................................................... 35 
7.9.2 
Storage and Tracking of Blood Samples and Other Specimens ........................... 35 
7.9.3 
Disposition of Samples, Specimens and Data at Completion of the Protocol ...... 35 
7.9.4 
Loss or Destruction of Samples, Specimens or Data ............................................ 35 
 Subject Identification and Enrollment .............................................................................. 35 
7.10.1 
Participation of Children ...................................................................................... 36 
7.10.2 
Participation of NIH Employees ........................................................................... 36 
 Compensation ................................................................................................................... 36 
 Safety Monitoring ............................................................................................................. 36 
 
ADMINISTRATIVE AND LEGAL OBLIGATIONS ................................................ 36 
 Protocol Amendments and Study Termination ................................................................. 36 
 Study Documentation and Storage .................................................................................... 37 

PRODUCT: VRC-HIVMAB075-00-AB                                                                          PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 4 of 62 
 Study Monitoring, Data Collection and Data Sharing ...................................................... 37 
8.3.1 
Protocol Monitoring Plan ..................................................................................... 37 
8.3.2 
Data Collection ..................................................................................................... 37 
8.3.3 
Source Documents ................................................................................................ 38 
8.3.4 
Data Sharing ......................................................................................................... 38 
 Language ........................................................................................................................... 38 
 Policy Regarding Research-Related Injuries .................................................................... 38 
 
REFERENCES ................................................................................................................ 39 
 
LIST OF TABLES 
Table 1: 
In Vitro Preclinical Safety Studies ........................................................................ 14 
Table 2: 
In Vivo Preclinical Pharmacology/Proof-of-Concept Studies............................... 15 
Table 3: 
VRC 605 Study Schema ....................................................................................... 16 
Table 4: 
Probability of Event for Different Scenarios ........................................................ 28 
Table 5: 
95% Confidence Intervals of the True Rate for All Possible Number of Observed 
Events within a Group .................................................................................................................. 28 
 
APPENDICES 
Appendix I: Study Informed Consent Form ................................................................................. 41 
Appendix II: Contact Information ................................................................................................ 52 
Appendix III: Schedule of Evaluations ......................................................................................... 54 
Appendix IV: Table for Grading Severity of Adverse Events ...................................................... 61 

PRODUCT: VRC-HIVMAB075-00-AB                                                                          PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 5 of 62 
ABBREVIATIONS 
 
Abbreviation 
Term 
ADA 
anti-drug antibody 
AE 
adverse event 
AIDS 
Acquired Immunodeficiency Syndrome 
ALP 
alkaline phosphatase 
ALT 
alanine aminotransferase 
AoU 
Assessment of Understanding 
ART 
antiretroviral therapy 
AST 
aspartate aminotransferase 
AUC 
area under the curve 
β-HCG 
human chorionic gonadotropin 
BMI 
body mass index 
BUN 
blood urea nitrogen 
CBC 
complete blood count 
Cmax 
maximum concentration 
CRS 
cytokine release syndrome  
cGMP 
current Good Manufacturing Practice 
DAIDS 
Division of AIDS 
EDTA 
Ethylenediaminetetraacetate 
ELISA 
enzyme-linked immunosorbent assay 
Env 
Envelope 
EOI 
end of infusion 
F 
Bioavailability 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practice 
GLT 
(green) lithium heparin tube 
HIV 
human immunodeficiency virus 
HLA 
human leukocyte antigen 
HRPP 
Human Research Protections Program 
IB 
Investigator’s Brochure 
ICF 
informed consent form 
IgG1 
Immunoglobulin G1 
IND 
investigational new drug application 
IRB 
Institutional Review Board 
IV 
Intravenous 
kg 
Kilogram 
L 
Liter 
LIMS 
Laboratory Information Management System 
λz 
terminal slope of concentration vs time profile 
MAb 
monoclonal antibody 
mcg 
Microgram 

PRODUCT: VRC-HIVMAB075-00-AB                                                                          PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 6 of 62 
Abbreviation 
Term 
mg 
Milligram 
mL 
Milliliter 
mM, mmol 
Millimole 
MSD 
Meso Scale Discovery 
MTCT 
mother-to-child transmission 
NIAID 
National Institute of Allergy and Infectious Diseases 
NIH 
National Institutes of Health 
NIH CC 
National Institutes of Health Clinical Center 
NHP 
Non-human primate 
NVITAL 
NIAID Vaccine Immune T-Cell and Antibody Laboratory  
OHRP 
Office for Human Research Protections 
PBMC 
peripheral blood mononuclear cells 
PCR 
polymerase chain reaction 
PI 
Principal Investigator 
PK 
Pharmacokinetic 
PSRT 
Protocol Safety Review Team 
Q 
Inter-compartmental clearance 
QA 
quality assurance 
RSC 
Regulatory Support Center 
SAE 
serious adverse event 
SC 
Subcutaneous 
SHIV 
simian-human immunodeficiency virus 
SST 
serum separator tube 
TCR 
tissue cross reactivity 
T½ 
half-life 
Tmax 
time of maximal concentration (Cmax) 
UNAIDS 
Joint United Nations Programme on HIV/AIDS 
UP 
unanticipated problem 
USP 
United States Pharmacopeia 
Vd 
volume of distribution 
VRC 
Vaccine Research Center 
WBC 
white blood cell 
 
 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 7 of 62 
PRÉCIS 
VRC 605: 
A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of a Human 
Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered 
Intravenously or Subcutaneously to Healthy Adults 
Study  
Design:   
This is the first study in healthy adults of the VRC-HIVMAB075-00-AB (VRC07-
523LS) monoclonal antibody (MAb). It is a dose-escalation study to examine safety, 
tolerability, dose, and pharmacokinetics of VRC07-523LS. The hypothesis is that 
VRC07-523LS administration to healthy adults will be safe by the intravenous (IV) and 
subcutaneous (SC) routes.  A secondary hypothesis is that VRC07-523LS will be 
detectable in human sera with a definable half-life. 
Product 
Description: VRC-HIVMAB075-00-AB (VRC07-523LS) is a human MAb targeted to the HIV-1 
CD4 binding site. It was developed by the VRC/NIAID/NIH and manufactured under 
current Good Manufacturing Practice regulations at the VRC Pilot Plant operated under 
contract by the Vaccine Clinical Materials Program, Leidos Biomedical Research, Inc., 
Frederick, MD. Product is provided at 100 ± 10 mg/mL in a volume of 6.25 ± 0.10 mL 
filled into 10 mL glass vials. 
Subjects: 
Healthy adults, 18-50 years of age. 
Study Plan: This study includes 4 open-label, dose escalations of VRC07-523LS from 1 mg/kg IV to 
40 mg/kg IV, 1 route escalation from IV to SC, and 2 open-label groups to assess repeat 
dosing of VRC07-523LS.  Groups will be enrolled per the dose and route escalation and 
safety evaluation plan. 
VRC 605 Study Schema 
Group 
Subjects 
Administration Schedule 
Day 0 
Week 12 
Week 24 
1 
3 
1 mg/kg IV 
 
 
2 
3 
5 mg/kg IV 
 
 
3 
3 
5 mg/kg SC 
 
 
4 
3 
20 mg/kg IV 
 
 
5 
3 
40 mg/kg IV 
 
 
6 
5 
5 mg/kg SC 
5 mg/kg SC 
5 mg/kg SC 
7 
5 
20 mg/kg IV 
20 mg/kg IV 
20 mg/kg IV 
Total* 
25 
*The expected enrollment is 25 subjects.  Enrollment up to a total of 
40 subjects is permitted if additional subjects are necessary for 
safety or PK evaluations. 
Study Duration: Subjects will be followed for 24 weeks after the last study product administration. 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 8 of 62 
 INTRODUCTION 
The global incidence of new human immunodeficiency virus (HIV) infection peaked in the mid-
1990s.  The incidence of new infections in 2014 is reported by Joint United Nations Programme on 
HIV/AIDS (UNAIDS) as 2 million new cases, a reduction of 35% since 2000, with an estimated 
global total of 36.9 million people living with HIV [1].  The decrease in HIV incidence, due to 
multiple factors including prevention and treatment programs, is an encouraging trend but the scope 
and cost of the epidemic remains a global health threat.  
The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health 
(NIH) is committed to the development of safe, effective methods to prevent and treat HIV and 
AIDS worldwide.  In this regard, the Vaccine Research Center (VRC), NIAID and Division of 
AIDS (DAIDS), NIAID, are collaborating to evaluate the potential clinical uses of HIV-specific 
broadly neutralizing human monoclonal antibodies (MAb) [2-4].  
The VRC, NIAID, NIH has developed VRC07-523LS, a highly potent and broadly neutralizing 
HIV-1 human MAb targeted against the HIV-1 CD4 binding site.  A similar antibody, VRC01 
MAb, is currently in clinical trials under IND 113,611 [prevention indication] and IND 126,001 and 
IND 126,664 [therapeutic indication], was originally discovered in a subject infected with HIV-1 
for more than 15 years and whose immune system controlled the virus without anti-retroviral 
therapy [5]. Through advances in B-cell immunology, cloning and structure-guided optimization 
techniques, numerous HIV-1 neutralizing MAbs, including VRC07 (“07” denotes sequential 
numbering when discovered), VRC07-523 (“523” denotes sequential numbering when engineered 
variant generated), and later VRC07-523LS (“LS” denotes 2 amino acid mutations), were isolated 
with potency and breadth greater than those of early antibodies[3]. 
The VRC07 (wild-type) heavy chain was identified by 454 deep sequencing based on its similarity 
to the VRC01 MAb and paired with the VRC01 (wild-type) light chain.  The mutations that together 
define the 523 designations are a glycine to histidine mutation at residue 54 of the heavy chain, a 
deletion of the first two amino acids, glutamate and isoleucine, from the light chain, and a valine to 
serine mutation at the third amino acid residue of the light chain.  The LS designation specifies 
methionine to leucine (L) and asparagine to serine (S) (M428L/N434S, referred to as LS) changes 
within the C-terminus of the heavy chain constant region.  The LS mutation was introduced by site-
directed mutagenesis to increase the binding affinity for the neonatal Fc-receptor (FcRn), resulting 
in increased recirculation of functional IgG [6, 7], thus increasing plasma half-life.   
VRC-HIVMAB075-00-AB (VRC07-523LS) is an investigational drug that has not been 
administered to humans prior to this study. VRC07-523LS is intended for the prevention of HIV-1 
infection in healthy adults initially. VRC07-523LS may also be evaluated for prevention of mother-
to-child transmission and for treatment of HIV-1 infected subjects. 
 RATIONALE FOR THE STUDY  
VRC’s clinical development plans for neutralizing MAbs include potential uses in three broad 
areas: 1) prevention of mother-to-child transmission (MTCT) of HIV, 2) prevention of sexual 
transmission of HIV, and 3) therapeutic application in HIV-1 infected individuals.  The initial 
development plan focused on clinical research to lead to an efficacy evaluation of VRC01 for 
MTCT of HIV.  To evaluate the safety of administering VRC01 to infants who may be HIV-
infected at birth, studies in infants were preceded by Phase 1 trials in HIV-infected adults (VRC 
601) and HIV-uninfected adults (VRC 602) that began in 2013 and 2014, respectively.  

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 9 of 62 
VRC01 has been assessed as safe and well tolerated at the 5-40 mg/kg doses administered 
intravenously (IV) and at 5 mg/kg subcutaneously (SC) in both HIV-infected and HIV-uninfected 
adult populations.  The pharmacokinetic (PK) parameters of passively administered VRC01 were 
also evaluated.  For healthy adults who received VRC01 at the 5-40 mg/kg doses administered IV 
(n=18), the clearance was 0.016±0.003 L/h and an overall mean value for the elimination half-life 
was 15.4±3.9 days for IV administration.  At 5 mg/kg SC (n=5), the clearance was 0.029±0.007 L/h, 
and the mean elimination half-life was 16.6 ± 2.9 days.  Work is ongoing to further describe the PK 
and biological activity of VRC01 after repeat dosing in HIV-infected and -uninfected adults. 
VRC07-523LS, an engineered variant of VRC07 that was discovered in the same HIV-1 infected 
subject as VRC01, neutralizes more HIV envelope strains than VRC01 at lower concentrations.   
VRC07-523LS was found to be 5-to 8-fold more potent than VRC01, with an inhibitory 
concentration IC50 <50 mcg/mL against 96% of HIV-1 pseudoviruses representing the major 
circulating HIV-1 clades and IC50 <1 mcg/mL against 92% of HIV-1 viruses tested and displayed 
minimal levels of autoreactivity.  VRC07-523LS was shown to have a prolonged half-life over 
VRC07 by about 2-fold [3].   
In vivo proof-of-concept studies showed that VRC07-523LS is about 5-fold more potent than 
VRC01LS in Rhesus macaques and displays a longer half-life (9.8 days) than VRC07 (4.9 days) 
after a single dose of MAb at 10 mg/kg administered IV [3]. 
When administered IV at a single dose of 10 mg/kg in cynomolgus macaques, the half-life of 
VRC07-523LS was about 12 days, and persisted at least 28 days (last collection point) in rectal and 
vaginal secretions and tissues. When administered SC at a single dose of 10 mg/kg in rhesus 
macaques, the half-life of VRC07-523LS was about 14 days and it persisted at least 49 days (last 
collection point) in rectal, vaginal and nasal secretions. Complete protection from SHIV-SF162P3 
challenge was demonstrated with a single dose of VRC07-523LS at 20 mg/kg administered IV.   
A repeat dose IV and SC toxicity study with VRC07-523LS was performed in male and female 
Sprague-Dawley rats in accordance with “Good Laboratory Practice (GLP) for Nonclinical 
Laboratory Studies.”  Treatment with VRC07-523LS at doses up to 400 mg/kg/dose IV or 40 
mg/kg/dose SC with three doses at 10 days intervals was generally well tolerated as most findings 
were reversible and no longer seen at the end of the recovery period.  Additionally, histologic 
changes were not observed in the GLP repeat dose toxicology study in the cell types with staining 
observed in the GLP tissue cross reactivity (TCR) study. 
Increased neutralization potency in vitro and prolonged half-life of VRC07-523LS correlate with 
improved protection against SHIV infection in vivo in animal studies, suggesting a potential clinical 
application against HIV-1 infection in humans in preventive and/or therapeutic settings. 
The proposed VRC07-523LS doses are based on human studies of VRC01, preclinical studies of 
VRC07-523LS and the requirements to assess PK at a range of doses that will allow for full PK 
analysis and predictive modeling.  This range of doses allows for informative PK modeling to be 
performed with the study data obtained here.  Preclinical studies with VRC07-523LS to date also 
support the proposed human doses and intervals between doses to achieve passive immunity as 
described in Section 2 and in the Investigator’s Brochure (IB). 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 10 of 62 
 VRC07-523LS SPECIFIC LABORATORY ASSESSMENTS 
Laboratory assessments in this Phase 1 study of VRC07-523LS include PK parameters, 
development of anti-VRC07-523LS antibody following exposure to the product, and functional 
capacity (neutralization) of the MAb following infusion. 
VRC07-523LS concentration for the PK analysis in this Phase 1 study will be measured by an 
ELISA on a Beckman Biomek based automation platform. The monoclonal antibody 5C9 is coated 
onto Immulon-4HXB microtiter plates overnight at 4° C at a concentration of 3.5 mg/mL.  Plates 
are washed and blocked (10% FBS in PBS) for 2 hours at room temperature.  Duplicate serial 3-fold 
dilutions covering the range of 100 - 24300 of the test sample are incubated 2 hours at 37° C 
followed by Horseradish Peroxidase - labeled goat anti-human antibody (1hour, 37° C), and TMB 
substrate (15 minutes, room temperature).  Color development is stopped by addition of sulfuric 
acid and plates are read within 30 minutes at 450 nm via the Molecular Devices Paradigm plate 
reader.  Four parameter logistic curve regression of a standard curve of VRC07-523LS covering the 
range from 0.98 to 1000 ng/mL is utilized to quantitate the sample concentrations based upon the 
average of sample dilutions within the range of the assay. 
Assessment for development of anti-VRC07-523LS antibodies in subjects will be performed using 
the Meso Scale Discovery (MSD) platform based on electrochemiluminescence.  The developed 
ADA assay uses the biotin-labeled VRC07 immobilized on a streptavidin-coated MSD plate as the 
capture molecule, and the SULFO-TAG labeled VRC07 as the reporter molecule.  This assay is 
independent of the anti-VRC07-523LS antibody isotype, and permits the detection of both high and 
low affinity antibodies. Evaluation for anti-VRC07-523LS antibodies will be conducted in batches, 
on samples collected at 4 weeks after each antibody administration. Samples collected at other visits 
could be tested if there is a clinical indication or a decrease in PK values observed. 
Depending upon the concentrations measured in collected specimens, further evaluation of the 
research samples to assess for functional capacity to neutralize HIV may be conducted by an in 
vitro cell-based virus neutralization assay using the pseudotyped viruses [8-10]. 
As an exploratory evaluation, subjects may be evaluated for their IgG1 allotypes to determine the 
potential for theoretical allotype-specific effects on the VRC07-523LS pharmacokinetics such as 
reduced half-life or anti-drug antibody response [11-13].  Coded stored samples will be used for 
evaluation of the genetic sequence of the immunoglobulin heavy chain constant region allotype. 
 PREVIOUS HUMAN EXPERIENCE 
There is no previous human experience with VRC07-523LS administration. VRC01 and its variant 
VRC01LS are similar products and previous human experience related to VRC01 and VRC01LS is 
described here.   
1.3.1 VRC01 Safety Data  
Evaluation of VRC01 as an investigational drug began in humans in September 2013.  Initial 
development of VRC01 was based on an intended indication for the prevention of HIV-1 infection 
in infants at risk for HIV-1 infection through maternal transmission at birth or during breastfeeding. 
Further evaluation of VRC01 in adults and infants for preventative and therapeutic indication is 
ongoing in phase 1 and phase 2 trials.   
 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 11 of 62 
Overall, as of January 10, 2017, VRC01 administration in the dose range from 1 to 40 mg/kg IV and 
at 5 and 40 mg/kg SC have been assessed as well-tolerated in adults and infants and safe for further 
evaluation. Cumulatively, across all studies, VRC01 has been administered to over 840 HIV-
uninfected and HIV-infected adults and 33 HIV uninfected infants. There have been no SAEs 
related to VRC01 that required expedited reporting to the FDA or other regulatory authorities and 
no study safety pauses for adverse events. A non-serious AE of urticaria was submitted to 
regulatory authorities as a safety report because urticaria, at the grade 3 severity, was not reported in 
the IB (Version 6.0 dated October 5, 2016) 
 
1.3.2 VRC01LS Safety Data 
VRC01LS began evaluation in HIV-uninfected adults in the VRC 606 study in November 2015. 
Evaluation of VRC01LS in HIV-infected adults in the VRC 607 study was initiated in April 2017. 
There have been no SAEs reported in VRC 606 as of July 17, 2017. Overall 29 of 39 (74.4%) 
subjects who began product administrations have had one or more unsolicited AEs, with a 
maximum severity being Grade 1 for 18 subjects and Grade 2 for 11 subjects.  
VRC01LS administrations have been generally well tolerated. Overall, 3 of 21 subjects (14.3%) 
who received VRC01LS IV and 14 of 18 subjects (77.8%) who received VRC01LS SC reported 
solicited local reactions in the week after product administration. The most frequent local reaction 
was pain/tenderness at injection site reported by 14 subjects (2 for IV and 12 for SC administration) 
at a maximum severity being mild, and being moderate by 1 subject for SC product administration. 
Other local reactogenicity symptoms included mild bruising (n=1), swelling (n=2), and redness 
(n=2).  
With regard to solicited systemic adverse events, 13 of 39 subjects (33.3 %) had one or more mild 
systemic signs or symptoms reported in the 3 days after product administration. This included mild 
malaise (n=10), myalgia (n=6), headache (n=4), and nausea (n=4).  
 
Observations during product administration included brief reactions of local pain and/or stinging 
sensations at SC administration sites (15 of 18 subjects, 83.3%) that resolved within 2-5 minutes 
after injection. These reactions were consistent with known risks of injections and did not meet 
criteria for reporting as AEs as defined by the Table for Grading Severity of Adverse Events. No 
systemic symptoms were reported during product administration.  
 
As of 7/17/2017, no local or systemic reactogenicity were reported during VRC01LS 
administrations in VRC 607 study in HIV-infected adults; all infusions were completed as per 
protocol. All 4 subjects reported maximal solicited local reactogenicity as “none” on a 3-day diary 
card. As to systemic solicited reactogenicity, one subject reported mild symptoms of headache, 
chills, and nausea that resolved within 7-11 days after product administration. No SAEs were 
reported; all unsolicited AEs were Grade 1 (mild) or Grade 2 (moderate), and assessed as unrelated 
to study product. 
1.3.3 VRC07-523LS Safety Data 
As of July 17, 2017, 9 out of 10 subjects enrolled in VRC 605 have received at least one dose of 
VRC07-523LS (7 IV administrations and 1 SC administration). One subject withdrew from the 
study due to time commitment and did not receive study product. There have been no SAEs and no 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 12 of 62 
study safety pauses for adverse events (AEs), with maximum severity being Grade 1 for 3 subjects 
and Grade 2 for 1 subject. None of the AEs were related to study product.  
 
For solicited local reactions in the week after VRC07-523LS IV administrations, one subject 
reported mild bruising. There were no local reactions reported by the one subject that received 
VRC07-523LS subcutaneously. With regard to solicited systemic events, one subject who received 
VRC07-523L via IV route reported mild myalgia.  
 
The final PSRT review occurred on August 9, 2017(Section 4.3).  After each review, the PSRT 
concluded that product administrations were well tolerated and to proceed with the next dose and/or 
route escalation.  Repeat dosing was recommended for subjects enrolled in Groups 6 and 7.   
 PHARMACOKINETIC PARAMETERS 
The PK parameters of the passively administered, similar MAb VRC01 have been evaluated in 
healthy and HIV-infected adults and can be found in published studies [14, 15] and the IB.  Work is 
ongoing to further describe the PK of VRC01 by the IV and SC routes of administration after a 
single dose and a repeat dosing in adults.  The PK parameters of VRC07-523LS in humans will be 
evaluated in this study. 
 STUDY PRODUCT 
The study product, VRC-HIVMAB075-00-AB (VRC07-523LS) was produced under current Good 
Manufacturing Practice (cGMP) by VRC/NIAID/NIH at the VRC Pilot Plant operated under 
contract by the Vaccine Clinical Materials Program, Leidos Biomedical Research, Inc., Frederick, 
MD.  Specific manufacturing information is included on the product vial label and in the IB.  
Quality Assurance (QA) lot release testing by the manufacturer and ongoing stability programs 
verify conformance to product specifications throughout use in clinical trials.  
 VRC-HIVMAB075-00-AB 
VRC-HIVMAB075-00-AB (VRC07-523LS) is a broadly neutralizing human MAb targeted against 
the HIV-1 CD4 binding site.  It was developed by VRC/NIAID/NIH.  Generation and testing of 
VRC07-523LS is briefly described.  The VRC07 (wild-type) heavy chain was identified by 454 
deep sequencing based on its similarity to the VRC01 MAb and paired with the VRC01 (wild-type) 
light chain.  The mutations that together define the 523 designations are a glycine to histidine 
mutation at residue 54 of the heavy chain, a deletion of the first two amino acids, glutamate and 
isoleucine, from the light chain, and a valine to serine mutation at the third amino acid residue of 
the light chain.  The LS designation specifies methionine to leucine (L) and asparagine to serine (S) 
(M428L/N434S, referred to as LS) changes within the C-terminus of the heavy chain constant 
region.  The LS mutation was introduced by site-directed mutagenesis to increase the binding 
affinity for the neonatal Fc-receptor (FcRn), resulting in increased recirculation of functional IgG, 
thus increasing plasma half-life. 
The bulk lot of the drug substance was manufactured under cGMP using a stably transfected 
Chinese Hamster Ovary (CHO) DG44 cell line and purified.  The drug product was filled into glass 
vials and labeled at the VRC Pilot Plant.  Each 10 mL glass vial contains 6.25 ± 0.10 mL at a 
concentration of 100 mg/mL ± 10 mg/mL of VRC07-523LS in formulation buffer consisting of 50 
mM Histidine, 50 mM Sodium Chloride, 5% Sucrose, and 2.5% Sorbitol at pH 6.8.   

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 13 of 62 
More details on VRC-HIVMAB075-00-AB composition and manufacturing are found in the IB.  
 PRECLINICAL TOXICOLOGY STUDY 
A repeat dose IV and SC toxicity and pharmacokinetic study of clinical-grade VRC-HIVMAB075-
00-AB (VRC07-523LS) in male and female Sprague-Dawley rats was performed by IITRI, 
Chicago, IL in accordance with Good Laboratory Practice (GLP) regulations.  Treatment with VRC-
HIVMAB075-00-AB (VRC07-523LS), at doses up to 400 mg/kg/dose IV or 40 mg/kg/dose SC 
with three doses at 10-day intervals, was well-tolerated as most findings were reversible and no 
longer seen at the end of the recovery period.  Refer to the IB for more information about this study. 
 IN VITRO SAFETY STUDIES 
The list of in vitro preclinical safety studies performed to assess potential off target binding are 
summarized in Table 1.  Refer to the IB for more information about these studies. 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 14 of 62 
Table 1: 
In Vitro Preclinical Safety Studies 
Study Purpose 
Study Outcome 
Assessment of anti-phospholipid 
reactivity 
VRC07-523LS has slight reactivity to phospholipids [3] 
Assessment of anti-nuclear 
antigen reactivity 
VRC07-523LS does reacts with a small subset of nuclear 
antigens 
Assessment of anti-phospholipid 
characteristics by impact on 
activated partial thromboplastin 
time (aPTT) 
VRC07-523LS does not impact aPTT by binding 
phospholipids 
Assessment of binding to a 
human epithelial cell line (HEp-
2) by Immunohistochemistry 
VRC07-523LS has minimal reactivity with HEp-2 cells [3] 
Assessment of potential “off 
target” binding in a GLP tissue 
cross-reactivity study with 
normal adult human and rat 
(Sprague Dawley) tissues 
VRC07-523LS staining that was observed in both human 
and Sprague-Dawley rat tissues included cytoplasm, 
cytoplasmic granules, perinuclear, and/or apical cytoplasm 
of endothelium, epithelial cells, spindle cells, mononuclear 
cells, granulosa lutein cells, and neural cell processes.  
VRC07-523LS staining that was observed in human tissues 
only included cytoplasmic elements of hematopoietic cells, 
cells/processes associated with peripheral nerve, glial cell 
processes, reticular cells, mesothelial cells, interstitial cells, 
and adipocytes, and extracellular proteinaceous material in 
connective tissue of the sclera.  VRC07-523LS staining that 
was observed in rat tissues only included the cytoplasm of 
rare decidual cells and lens protein.  According to ICH 
S6(R1) and other references [17, 18], monoclonal antibody 
binding to cytoplasmic sites generally is considered of little 
to no toxicologic significance.  The specific staining of 
extracellular proteinaceous material in eye (human tissue) 
and staining for lens protein in eye (rat tissue) further 
support the rat as a relevant species to assess safety. 
Additionally, histologic changes were not observed in the 
GLP repeat dose toxicology study in the cell types with 
staining observed in the GLP TCR study. 
 IN VIVO PRECLINICAL PHARMACOLOGY STUDIES 
A summary of the in vivo pharmacology studies conducted with VRC07-523LS and similar 
monoclonal antibodies are presented in Table 2.  Refer to the IB for more information about these 
studies. 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 15 of 62 
Table 2: 
In Vivo Preclinical Pharmacology/Proof-of-Concept Studies 
Study Purpose 
Study Outcome 
Determine if VRC07-523LS, an antibody 
with increased neutralization potency in 
vitro, would confer greater in vivo protection 
compared to VRC01LS when administered 
as a single dose IV to male rhesus macaques 
challenged intrarectally with SHIV-BaLP4 
7/12 animals were protected after receiving VRC01LS at 
0.3 mg/kg IV, 3/4 animals were protected after receiving 
VRC07-523LS at 0.2 mg/kg IV and 0/4 were protected 
after receiving VRC07-523LS at 0.05 mg/kg IV.  VRC07-
523LS showed >5-fold increase in potency compared to 
VRC01LS, consistent with its ability to better neutralize 
viruses in vitro [3]. 
Demonstrate SHIV-SF162P3 challenge 
protection in male and female rhesus 
macaques administered a single dose of 
VRC07-523LS at 20 mg/kg IV 
6/6 animals were protected after receiving a single dose of 
VRC07-523LS at 20 mg/kg IV.  The average plasma 
concentration of VRC07-523LS on the day of the challenge 
(Day 5) was 114.2 µg/mL. 
Determine plasma and rectal secretion 
concentrations in male rhesus macaques 
administered 10 mg/kg of VRC07-523LS IV 
When administered IV at a single dose of 10 mg/kg in 
rhesus macaques (n=4), the half-life of VRC07-523LS was 
about 10 days, a 2-fold increase compared to VRC07.  
Plasma concentrations of VRC07-523LS exceeded 10 
µg/mL at day 14 and were greater than 2 µg/mL at day 28 
[3].  Detectable concentrations (>10 ng/mL) of VRC07-
523LS were measured in rectal secretions for at least 14 
days (last collection point) in the 2 animals tested. 
Determine plasma, mucosal secretions and 
tissue concentrations in male and female 
cynomolgus macaques administered 10 
mg/kg of VRC07-523LS IV  
When administered IV at a single dose of 10 mg/kg in 
cynomolgus macaques, the half-life of VRC07-523LS was 
about 12 days.  In all 4 animals, plasma concentrations of 
VRC07-523LS exceeded 10 µg/mL at day 14 and were 
greater than 3 µg/mL at day 28.  Detectable concentrations 
of VRC07-523LS were found in rectal and vaginal 
secretions and tissues for at least 28 days (last collection 
point). 
Determine plasma, rectal, vaginal and nasal 
secretions concentrations in male and female 
rhesus macaques administered 10 mg/kg of 
VRC07-523LS SC 
When administered SC at a single dose of 10 mg/kg in 
rhesus macaques, the half-life of VRC07-523LS was about 
14 days.  In all 6 animals, detectable concentrations of 
VRC07-523LS were found in rectal, vaginal and nasal 
secretions for at least 49 days (last collection point). 
 
 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 16 of 62 
 
STUDY OBJECTIVES 
 PRIMARY OBJECTIVES 
• To evaluate the safety and tolerability of VRC-HIVMAB075-00-AB administered as a 
single dose at 1 mg/kg IV, 5 mg/kg IV, 20 mg/kg IV, 40 mg/kg IV, and 5 mg/kg SC to 
healthy adults. 
• To evaluate the safety and tolerability of VRC-HIVMAB075-00-AB administered at 20 
mg/kg IV by repeat dosing every 12 weeks for a total of 3 infusions to healthy adults. 
• To evaluate the safety and tolerability of VRC-HIVMAB075-00-AB administered at 5 
mg/kg SC by repeat dosing every 12 weeks for a total of 3 injections to healthy adults. 
 SECONDARY OBJECTIVES 
• To evaluate the pharmacokinetics of VRC-HIVMAB075-00-AB at each dose level through 
24 weeks after the last dose. 
• To determine whether anti-drug antibody (ADA) to VRC07-523LS can be detected in 
recipients of VRC-HIVMAB075-00-AB. 
 EXPLORATORY OBJECTIVES 
• To determine if measurable levels of VRC-HIVMAB075-00-AB can be found in oral 
secretions of subjects. 
• To evaluate for evidence of functional activity of VRC-HIVMAB075-00-AB in samples 
collected at representative timepoints throughout the study. 
• To test subjects for the IgG1 allotypes in order to evaluate allotype-specific effects on the 
VRC07-523LS pharmacokinetics. 
 STUDY DESIGN 
This is an open-label, dose-escalation study to examine the safety, tolerability, dose, and PK of 
VRC07-523LS in healthy adults.  The hypothesis is that VRC07-523LS administration will be safe 
by the IV and SC routes.  The secondary hypothesis is that VRC07-523LS will be detectable in 
human sera with a definable half-life.  The study schema is shown in Table 3.  
Table 3: 
VRC 605 Study Schema 
Group 
Subjects 
Administration Schedule 
Day 0 
Week 12 
Week 24 
1 
3 
1 mg/kg IV 
 
 
2 
3 
5 mg/kg IV 
 
 
3 
3 
5 mg/kg SC 
 
 
4 
3 
20 mg/kg IV 
 
 
5 
3 
40 mg/kg IV 
 
 
6 
5 
5 mg/kg SC 
5 mg/kg SC 
5 mg/kg SC 
7 
5 
20 mg/kg IV 
20 mg/kg IV 
20 mg/kg IV 
Total* 
25 
*The expected enrollment is 25 subjects.  Enrollment up to a 
total of 40 subjects is permitted if additional subjects are 
necessary for safety or PK evaluations (Section 4.3). 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 17 of 62 
Enrollment will begin in the 1 mg/kg IV dose group (Group 1).  Enrollments into the subsequent 
dose and route groups may proceed after dose and route escalation reviews (Section 4.3).  
Subjects in Groups 1 through 5 will be expected to be available for follow-up visits during 24 
weeks of study participation; subjects in Groups 6 and 7 will be expected to be available for 
follow-up visits during 48 weeks of study participation  
For each new dose level (1 mg/kg, 5 mg/kg, 20 mg/kg and 40 mg/kg) and for the initial SC group, 
following the first product administration, the study team will wait at least 2 days before 
administering VRC07-523LS to a second subject within the same group.  Safety review decisions 
and the status of the enrollment process will be transparent to the Protocol Safety Review Team 
(PSRT) throughout the trial and discussed during the weekly safety review.  
Safety laboratory samples will be collected throughout the study as per the Schedule of 
Evaluations.  Subjects will keep a daily diary of solicited systemic symptoms for 3 days after each 
product administration.  PK samples will be collected at specified intervals through 24 weeks after 
a subject’s last product administration. 
When the subject agrees, optional oral samples will be collected at specified intervals for the 
purpose of detecting if measurable levels of VRC07-523LS can be found in oral mucosa.  
The study will be conducted by the VRC Clinical Trials Program at the NIH Clinical Center (NIH 
CC).   
 STUDY POPULATION 
All inclusion and exclusion criteria must be met for eligibility. 
4.1.1 Inclusion Criteria 
A volunteer must meet all of the following criteria: 
1. Able and willing to complete the informed consent process. 
2. 18 to 50 years of age. 
3. Based on history and examination, must be in good general health and without history of 
any of the conditions listed in the exclusion criteria. 
4. Willing to have blood samples collected, stored indefinitely, and used for research purposes.  
5. Able to provide proof of identity to the satisfaction of the study clinician completing the 
enrollment process. 
6. Willing to adhere to reduced risk sexual behavior during study participation. 
7. Screening laboratory values within 84 days prior to enrollment must meet the following 
criteria: 
• WBC 2,500-12,000/mm3. 
• WBC differential either within institutional normal range or accompanied by the 
PI or designee approval. 
• Platelets = 125,000 – 400,000/mm3. 
• Hemoglobin within institutional normal range. 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 18 of 62 
• Creatinine ≤ 1.1 x ULN. 
• ALT ≤1.25 x ULN. 
• Negative for HIV infection by the FDA approved method of detection.  
Female-Specific Criteria: 
8. If a woman is of reproductive potential and sexually active with a male partner, then she 
agrees to use an effective means of birth control from the time of study enrollment until the 
last study visit, or to be monogamous with a partner who has had a vasectomy. 
9. Negative β-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of 
enrollment for women presumed to be of reproductive potential. 
4.1.2 Exclusion Criteria 
A volunteer will be excluded if one or more of the following conditions apply: 
1. Previous receipt of licensed or investigational monoclonal antibody. 
2. Weight >115 kg. 
3. Any history of a severe allergic reaction with generalized urticaria, angioedema or 
anaphylaxis prior to enrollment that has a reasonable risk of recurrence during the study. 
4. Hypertension that is not well controlled. 
5. Woman who is breast-feeding, or planning to become pregnant during the study 
participation.  
6. Receipt of any investigational study agent within 28 days prior to enrollment. 
7. Any other chronic or clinically significant medical condition that in the opinion of the 
investigator would jeopardize the safety or rights of the volunteer, including but not limited 
to:  diabetes mellitus type I, chronic hepatitis; OR clinically significant forms of: drug or 
alcohol abuse, asthma, autoimmune disease, psychiatric disorders, heart disease, or cancer. 
 CLINICAL PROCEDURES AND LABORATORY ASSAYS 
Evaluation of safety for this study will include laboratory studies, medical history, and physical 
assessment by clinicians.  The study schedule is provided in Appendix III.  Total blood volume 
drawn from each subject will comply with the NIH CC Guidelines, which is available on the NIH 
intranet at the following link: http://cc-internal.cc.nih.gov/policies/PDF/M95-9.pdf.  
4.2.1 Screening 
Screening for this study will be completed through the Vaccine Research Center’s screening 
protocol, VRC 500 (NIH 11-I-0164).  Volunteers will be recruited through Institutional Review 
Board (IRB)-approved advertising.  The evaluations and sample collection that will be included in 
screening are a medical history, physical exam, any laboratory tests needed to confirm eligibility, 
and pregnancy test for females of reproductive potential.  Additional assessments of health will be 
conducted at screening based on clinical judgment.  Storage samples of PBMCs, plasma and serum 
will also be collected.  Informed consent documents will be reviewed.  Counseling related to 
potential risks of the study product, pregnancy prevention and HIV prevention will be performed.  
An Assessment of Understanding (AoU) will be completed in association with enrollment into VRC 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 19 of 62 
605.  Screening records will be kept to document the reason why an individual was screened but not 
enrolled.  
4.2.2 Enrollment, Study Days and Visit Numbers  
In this study, enrollment is defined as the assignment of a study identification number and study 
group schedule (Section 6.3.1) in the clinical database.  A clinician will discuss the target dates and 
timing of the study product administration(s) and sample collections before completing an 
enrollment to help ensure that the subject can comply with the projected schedule.  
Day 0 is defined as the day of first VRC07-523LS administration.  Day 0 may occur on the same 
day as enrollment or up to 6 weeks after.  This period may be increased with PI approval.  If Day 0 
does not coincide with enrollment, then the enrollment day may be referred to by a negative number 
of days (i.e., Day -1 to Day -42).  For calculating elapsed days following Day 0, each subsequent 
calendar date is labeled by the next sequential “Study Day” as shown in the Schedule of 
Evaluations, Appendix III.  Since there may be more than one research sampling timepoint of 
interest per study day, each sample collection timepoint has its own “Visit Number.”  For this 
reason, there may be more than one visit number recorded on the same calendar date. 
Medical history and Day 0 evaluations prior to the first study product administration are the 
baseline for subsequent safety assessments.   
4.2.3 Administration of VRC07-523LS 
All study product administrations will be completed according to the assigned group.  For women 
of childbearing potential, product administration may not proceed unless a negative pregnancy test 
has been obtained within the previous 24 hours.  Prior to each product administration, temperature, 
blood pressure, heart rate (pulse) and weight will be collected and a targeted physical examination 
(based on signs, reported symptoms or interim medical history) may be conducted.  In all study 
groups, the subject will be observed for at least 4 hours following each product administration.   
If a subject is assigned to an IV administration group, the IV access will be placed in an arm vein in 
an aseptic manner.  A different site may be used for collection of PK blood samples; however, the 
same site may be used after flushing the line if another site is not available.  VRC07-523LS will be 
administered with approximately 100 mL normal saline IV over about 30 minutes or longer.  If the 
subject experiences side effects during the infusion, the rate of infusion may be slowed or stopped 
to alleviate the symptoms.   
If a subject is assigned to a SC administration group, the SC administration site(s) to be used will be 
discussed with the subject and must be assessed as acceptable by the clinician and the subject.  The 
preferred SC administration site is the abdomen, but the upper arm or thigh may be used.  Given the 
weight criterion in this study, the maximum volume needed to administer a 5 mg/kg SC dose is not 
expected to exceed 5.75 mL.  The SC dose will be administered by standard needle and syringe SC 
injection methods with about 2.5 mL per injection site.  Up to 4 SC injection sites may be used if 
deemed necessary by the clinician.  SC administration sites should be at least 2 inches apart. 
Procedures for VRC07-523LS preparation and administration are described in Section 7. 
4.2.4 Solicited Adverse Events and Clinical Follow-up   
Subjects will be asked to record temperature and systemic symptoms daily for 3 days after each 
product administration.  Subjects will be trained and encouraged to use the electronic database to 
record reactogenicity but will have the option to use the paper diary card.  When the 3-day diary 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 20 of 62 
card parameters are recorded directly by the subject into the database, the subject’s electronic record 
will be available to clinicians in real time, and will be the source for these data.  If concerns arise 
based on the electronic data, or if a subject uses a paper diary card, clinicians may follow up with 
additional phone calls during reactogenicity period as needed.  The paper diary may be the source 
document, if used by the subject.  When neither a written nor electronic diary is available from the 
subject, the clinician will note the source of reactogenicity information recorded in the study 
database.  
For this study, solicited systemic parameters occurring during the 3 days after receipt of study 
product will include: unusually tired/feeling unwell, muscles aches, headache, chills, nausea and 
joint pain. Subjects will also record highest measured temperature daily.  Subject diaries are 
reviewed for accuracy and completeness at follow-up visits and reactogenicity is recorded without 
an attribution assessment.  Clinicians will follow and collect resolution information for any 
reactogenicity symptoms that are not resolved within 3 days. 
Local symptoms will be assessed and recorded by the clinicians.  Local reactogenicity parameters 
will include pain/tenderness, swelling, redness, bruising, and pruritus (itchiness) at the product 
administration site. Clinicians will assess the product administration site(s) for local reactogenicity 
on the day of product administration and during the scheduled follow-up timepoints for all groups.   
Events that may require a clinic visit include rash, urticaria, fever of 38.6˚C (Grade 2) or higher 
lasting greater than 24 hours or significant impairment in the activities of daily living (such as those 
consistent with Grade 2 or higher impairment). Additionally, arthralgia or other clinical concerns 
may prompt a study visit based on the judgment of a study clinician.  
Clinical laboratory assays and clinical evaluations will assess safety and tolerability at specified 
intervals after each administration.  Throughout the study, clinicians will also assess subjects for 
any changes in symptoms to include vision changes.  Any new or concerning symptoms will be 
fully assessed to include specialty consultation at the NIH Clinical Center as indicated clinically. 
4.2.5 Pharmacokinetics 
PK samples will be collected as close as reasonably possible to the target timepoints.  However, 
actual time of collection is critical for PK analysis and will be recorded for all samples.  The PK 
timepoints are shown in the Schedule of Evaluations. 
4.2.6 Oral Mucosa Samples 
To understand tissue distribution of VRC07-523LS and how long after administration it may be 
detectable, this protocol includes exploratory collection of oral mucosa samples. Subjects will be 
offered the option of participating in the oral sampling schedule, but it will not be mandatory.  
Samples will be collected using small ophthalmic sponges designed for clinical use.  
Oral swabs for research may be collected per the Schedule of Evaluations, Appendix III.  
4.2.7 Schedule of Evaluations  
The Schedule of Evaluations, Appendix III, provides details on the study schedule and the permitted 
visit windows.  Schedule 1 is for the IV dose escalation groups receiving one injection (Groups 1, 2, 
4, and 5), Schedule 2 is for the SC dose group receiving one injection (Group 3).  Schedule 3 and 
Schedule 4 are for the groups receiving repeat dosing; Group 6 (5 mg/kg SC) and Group 7 (20 
mg/kg IV).  The schedules also include instructions for evaluations of subjects who discontinue 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 21 of 62 
product administration.  After enrollment, deviations from the visit windows are discouraged but 
will be permitted at the discretion of the PI or designee and will be recorded as protocol deviations.  
Additional visits and blood draws may be scheduled during the study if needed to assess subject 
safety or for sample collection for immunological testing.  After study completion, subjects may be 
invited to participate in one of the VRC sample collection protocols (VRC 200 or VRC 900) for 
follow-up sample collection. 
Any evaluation for an AE or possible exacerbation of a pre-existing condition may be evaluated at 
study team discretion as a “protocol related” evaluation. 
4.2.8 Concomitant Medications 
Only routine prescription medications will be entered in the database at the time of enrollment.  
Subsequently, concomitant medications associated with an AE that requires expedited reporting or 
the development of a new chronic condition requiring ongoing medical management will be 
recorded in the database.  Receipt of a FDA-approved vaccine at any time during the study will be 
recorded in the database (clinicians should work with subjects regarding the timing of licensed 
vaccines relative to study product administration).  Otherwise, concomitant medications taken 
throughout the study will be recorded in the subject’s chart as needed for general medical 
documentation but will not be recorded in the database.   
 CRITERIA FOR DOSE AND ROUTE ESCALATION 
There are three dose escalation reviews in this study and one route escalation review.  The Protocol 
Safety Review Team (PSRT, Section 8.9) will conduct an interim safety data review before dose 
escalation and repeat dosing may occur.  The PSRT must assess the data as showing no significant 
safety concerns before proceeding with enrollment of the next groups.  
• The first dose escalation review (from 1 mg/kg IV to 5 mg/kg IV) will occur when at least 3 
subjects who received the 1 mg/kg IV dose have completed 2 weeks of safety follow-up 
visits.  The PSRT review will determine if enrollments in Group 2 may begin. 
• The only route escalation review and the second dose escalation review (from 5 mg/kg IV to 
5 mg/kg SC and 20 mg/kg IV, respectively) will occur when at least 3 subjects who received 
the 5 mg/kg IV dose have completed 2 weeks of safety follow-up visits.  The PSRT review 
will determine if enrollments in Group 3 (5 mg/kg SC), Group 6 (5 mg/kg SC by repeat 
dosing), Group 4 (20 mg/kg IV) and Group 7 (20 mg/kg IV by repeat dosing) may begin.  
• The third dose escalation review (from 20 mg/kg IV to 40 mg/kg IV) will occur when at 
least 3 subjects who received the 20 mg/kg IV dose have completed 2 weeks of safety 
follow-up visits.  This review will determine if enrollments in Group 5 (40 mg/kg IV) may 
begin.  
• Additionally, the second and third doses can be administered in Groups 6 and 7 once the 
initial dose is assessed as safe for further evaluation. 
If the first product administration is not completed or there are discontinuations from the study 
before there are sufficient data to conduct the dose escalation review for a group, then extra subjects 
may be enrolled into that group in order to have the requisite data on at least 3 subjects. 
Additionally, AEs assessed as related to the study product at the time of a dose escalation review 
may be judged by the PSRT to warrant adding additional subjects at a given dose group. 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 22 of 62 
The IRB will be provided with documentation of the safety review process and notification of the 
dose escalation.  Consultation with the IRB and FDA, if needed, as per study pause criteria (Section 
4.5) will occur if indicated by the review.  One outcome of a dose escalation review may be to 
recommend evaluation of additional subjects at the current dose and reassess for safety before 
proceeding to a higher dose.  
 CRITERIA FOR DISCONTINUATION OF VRC07-523LS ADMINISTRATION 
Under certain circumstances, a subject may be terminated from participating in study product 
administrations.  Subjects who receive at least one VRC07-523LS administration will continue 
follow-up according to the protocol Schedule of Evaluations, except that the research sample 
collections will be discontinued for pregnant women or others in which it is contraindicated.  The 
study team will notify the antiretroviral pregnancy registry (http://www.apregistry.com) of any 
pregnancies that occur after receiving VRC07-523LS for any subject still on study. Specific events 
that will require discontinuing a subject from receiving the study product include: 
1. 
Pregnancy; 
2. 
Grade 3 AE assessed as related to the study product (with the exception that self-limited 
Grade 3 solicited reactogenicity does not require discontinuation of product administration); 
3. 
Grade 4 AE assessed as related to the study product;  
4. 
Immediate hypersensitivity reaction associated with the study product; 
5. 
Intercurrent illness that is not expected to resolve prior to the next scheduled study product 
administration which is assessed by the PI (or designee) to require withdrawal from the 
product administration;  
6. 
Repeated failure to comply with protocol requirements;  
7. 
Co-enrollment into a study in which other investigational research agents will be 
administered before the subject has completed the follow-up after the last VRC07-523LS 
administration; 
8. 
The IND sponsor or the study PI decide to stop or cancel the study; 
9. 
The IRB, Office for Human Research Protections (OHRP) or the FDA halt the study.  
 CRITERIA FOR PAUSING THE STUDY AND RESUMING THE STUDY 
Administration of the study product and new enrollments will be paused by the PI according to the 
criteria noted below. In the event of a pause, the IND Sponsor Medical Officer (MO) and the PSRT 
will be promptly notified. Pause criteria are as follows:  
One (or more) subject experiences a Serious Adverse Event (SAE) that is assessed as related to 
study product, or 
Two (or more) subjects experience the same Grade 3 or higher AEs assessed as related to study 
product (other than self-limited Grade 3 solicited reactogenicity AEs).  
Plan for Review of Pauses and Resuming Rules:   

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
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Study product administration and enrollments would resume only if review of the AEs that caused 
the pause results in a recommendation to permit further study product administrations and study 
enrollments.  The reviews to make this decision will occur as follows: 
Pauses for related SAEs: The IND Sponsor, with participation by the PI, will consult with the 
FDA to conduct the review and make the decision to resume, amend or close the study and will 
notify the IRB accordingly. 
Pauses for Grade 3 or higher related AEs: The IND Sponsor MO, in consultation with the PI, 
will conduct the review and make the decision to resume, amend or close the study for the Grade 3 
or higher AEs that meet criteria for pausing the study.  As part of the pause review, the reviewers 
will also advise on whether the study needs to be paused again for any subsequent events of the 
same type.  The FDA and the IRB will be notified of Grade 3 or higher pause reviews and of the 
IND Sponsor’s decisions. 
 SAFETY AND ADVERSE EVENT REPORTING 
 ADVERSE EVENTS 
An adverse event (AE) is any untoward or unfavorable medical occurrence in a human subject, 
including any abnormal sign (e.g., abnormal physical exam or laboratory finding), symptom, or 
disease temporally associated with the use of study treatment, whether or not considered related to 
the study treatment.   
Severity of AEs will be assessed using the Version 2.0 of the DAIDS Table for Grading the Severity 
of Adult and Pediatric Adverse Events [November 2014]. The table is available at: http://rsc.tech-
res.com/Document/safetyandpharmacovigilance/DAIDS_AE_GRADING_TABLE_v2_NOV2014.
pdf.  Additional information can be found in Appendix IV.   
Reporting of all AEs will occur during the period from first study product administration through 56 
days after each study product administration.  After this through completion of study participation 
only serious adverse events (SAEs) and new chronic medical conditions that require ongoing 
medical management will be recorded as AEs in the study database.   
 SERIOUS ADVERSE EVENTS 
The term “Serious Adverse Event” (SAE) is defined in 21 CFR 312.32 as follows:  “An adverse 
event or suspected adverse reaction is considered serious if, in the view of either the investigator or 
the sponsor, it results in any of the following outcomes:  Death, a life-threatening adverse event, 
inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant 
incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital 
anomaly/birth defect.  Important medical events that may not result in death, be life-threatening, or 
require hospitalization may be considered serious when, based upon appropriate medical judgment, 
they may jeopardize the patient or subject and may require medical or surgical intervention to 
prevent one of the outcomes listed in this definition.  Examples of such medical events include 
allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood 
dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug 
dependency or drug abuse.” 
“Life-threatening” refers to an AE that at occurrence represents an immediate risk of death to a 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 24 of 62 
subject. An event that may cause death if it occurs in a more severe form is not considered life-
threatening.  Similarly, a hospital admission for an elective procedure is not considered a SAE. 
 ADVERSE EVENT REPORTING TO THE IND SPONSOR 
AEs that meet Serious Adverse Event (SAE) Reporting Requirements must be reported and 
submitted by the clinical site on an expedited basis to the IND Sponsor, VRC/NIAID/NIH, 
according to Sponsor guidelines as follows:  
• results in death 
• is life threatening 
• results in persistent or significant disability/incapacity 
• requires unplanned inpatient hospitalization or prolongation of existing hospitalization 
• is a congenital anomaly/birth defect in the offspring of a study subject 
• is an important medical event that may jeopardize the subject or may require 
intervention to prevent one of the other outcomes listed above.  
In addition, any event, regardless of severity, which in the judgment of an investigator represents a 
SAE, may be reported on an expedited basis. 
An investigator will communicate an initial SAE report within 24 hours of site awareness of 
occurrence to the IND sponsor by email to the VRC Protocol Operations Office (see Appendix II).  
A written report by the investigator should be submitted to the IND Sponsor within 3 working days.  
In order for the IND Sponsor to comply with regulations mandating sponsor notification of 
specified SAEs to the FDA within 7 and/or 15 calendar days, the investigator must submit 
additional information as soon as it is available. 
5.3.1 IND Sponsor Reporting to the FDA 
It is the responsibility of the IND Sponsor to make the determination of which SAEs are “serious 
and unexpected suspected adverse reactions” (SUSARs) as defined in 21 CFR 312.32. 
• Suspected adverse reaction means any AE for which there is a reasonable possibility that 
the drug caused the AE. 
• Unexpected Adverse Event means an AE that is not listed in the IB or is not listed at the 
specificity or severity that has been observed.   
All SUSARs, as determined by the IND Sponsor, will be reported to the FDA as IND Safety 
Reports and IND Safety Reports will be provided to the IRB. 
The IND Sponsor will also submit an IND Annual Report of the progress of the investigation to the 
FDA as defined in 21 CFR 312.33. 
 REPORTING TO THE INSTITUTIONAL REVIEW BOARD 
5.4.1 Unanticipated Problem (UP) Definition 
A serious “Unanticipated Problem (UP)” is defined as any incident, experience, or outcome that 
meets all three of the following criteria: 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 25 of 62 
• unexpected in nature, severity, or frequency in relation to the research risks that are 
described in the protocol, informed consent, IB, other study documents or in consideration 
of the characteristics of the subject population being studied; and 
• related to participation in the research; and 
• suggests that the research places subjects or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or 
recognized. 
Non-serious UP: An UP that is not an Adverse Event (UPnonAE) is an unanticipated problem that 
does not fit the definition of an AE, but which may, in the opinion of the investigator, involve risk 
to the subject, affect others in the research study, or significantly impact the integrity of research 
data.  Such events would be considered a non-serious UP. For example, we will report occurrences 
of breaches of confidentiality, accidental destruction of study records or samples, or unaccounted-
for study drug. 
5.4.2 Protocol Deviation Definition 
A Protocol Deviation is defined as any change, divergence, or departure from the IRB-approved 
study procedures in a research protocol. Protocol deviations are designated as serious or non-serious 
and further characterized as follows: 
• Those that occur because a member of the research team deviates from the protocol. 
• Those that are identified before they occur, but cannot be prevented. 
• Those that are discovered after they occur. 
Serious Protocol Deviation: A deviation that meets the definition of a SAE or compromises the 
safety, integrity of the data, welfare or rights of subjects or others. 
5.4.3  Non-Compliance Definition 
Non-compliance is the failure to comply with applicable NIH Human Research Protections Program 
(HRPP) policies, IRB requirements, or regulatory requirements for the protection of human 
subjects. Non-compliance is further characterized as serious, continuing or minor. 
“Serious non-compliance” is defined as non-compliance that: 
• Increases risks, or causes harm, to participants 
• Decreases potential benefits to participants 
• Compromises the integrity of the NIH-HRPP 
• Invalidates the study data 
“Continuing non-compliance” is non-compliance that is recurring. 
“Minor non-compliance” is non-compliance that is neither serious nor continuing. 
5.4.4 Expedited Reporting to the NIAID IRB 
The following will be reported within 7 calendar days of investigator awareness: 
• Serious and non-serious UP 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 26 of 62 
• Deaths 
• Serious protocol deviations 
• Serious or continuing non-compliance  
• SAEs that are possibly, probably, or definitely related to the research regardless of 
expectedness 
The following waiver applies to reporting anticipated protocol deviations and expected UPnonAEs:  
Anticipated deviations in the conduct of the protocol will not be reported to the IRB unless they 
occur at a rate greater than anticipated by the study team. Expected AEs will not be reported to the 
IRB unless they occur at a rate greater than that known to occur in healthy adults. If the rate of these 
events exceeds the rate expected by the study team, the events will be classified and reported as 
though they are unanticipated problems.  
5.4.5 Annual Reporting to the NIAID IRB 
The following will be reported to the NIAID IRB in summary at the time of Continuing Review: 
• Serious and non-serious UPs  
• Expected SAEs that are possibly, probably, or definitely related to the research 
• SAEs that are not related to the research 
• All AEs, except expected AEs granted a waiver of reporting  
• Serious and non-serious Protocol Deviations  
• Serious, continuing, and minor non-compliance  
• Any trends or events which in the opinion of the investigator should be reported 
 STATISTICAL CONSIDERATIONS 
 OVERVIEW 
This is a Phase I dose-escalation study of the safety and pharmacokinetics of VRC-HIVMAB075-
00-AB (VRC07-523LS), a human monoclonal antibody with broad HIV-1 neutralizing activity, 
administered to healthy adults. 
 OBJECTIVES 
The primary objective is to evaluate the safety and tolerability of VRC07-523LS administered at 1 
mg/kg IV, 5 mg/kg IV, 5 mg/kg SC, 20 mg/kg IV and 40 mg/kg IV as a single dose, and 
administered at 20 mg/kg IV and 5 mg/kg SC by repeat dosing every 12 weeks for a total of 3 
product administrations to healthy adults.  Secondary objectives include evaluation of the PKs at 
each dose level through 24 weeks after the last dose and testing for the presence of ADA against 
VRC07-523LS.  Exploratory objectives include determining if measurable levels of VRC07-523LS 
can be found in oral secretions, evaluation for evidence of functional activity of VRC07-523LS in 
collected samples, and evaluation of allotype-specific effects on the VRC07-523LS 
pharmacokinetics.  

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
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 SIZE AND ACCRUAL 
Recruitment will target about 25 healthy adults of age 18-50 with 3 subjects in each dose escalation 
group (Groups 1-5), and 5 subjects in each repeat dosing group (Groups 6 and 7).  The permitted 
accrual is 40 subjects to allow for additional enrollments in the event that an enrolled subject does 
not complete the minimum evaluations needed to meet the protocol criteria for the group dose 
safety or dose escalation evaluation. 
6.3.1 Treatment Assignments 
In this dose-escalation study, subjects will be assigned to the dose group that is open to accrual at 
the time of enrollment.  
When a subject is enrolled into a group but does not begin product administrations, a new eligible 
subject may be enrolled into the same group.  If any replacement is needed in case of subject 
withdrawal, the replacement subject will be assigned to the same treatment as the dropout subject in 
order to complete the safety dataset as planned.   
Dose escalation rules are described in Section 4.3. 
6.3.2 Sample Size Considerations 
This study is primarily descriptive.  For safety analysis, the goal is to identify safety concerns 
associated with different VRC07-523LS doses.  There may be as few as 3 to 5 subjects in a group at 
the time of a dose escalation; therefore, this section considers group sizes of both n=3 and n=5. 
The ability to identify serious adverse experiences is best expressed by the maximum true rate of 
SAE that would unlikely be observed and the minimum true SAE rate that would very likely be 
observed. Within a group of size n=3, there is a 90% chance of observing at least 1 event if the true 
rate is no less than 0.536 and a 90% chance of observing no event if the true rate is no bigger than 
0.034. Within a group of size n=5, there is a 90% chance of observing at least 1 event if the true rate 
is no less than 0.37 and a 90% chance of observing no event if the true rate is no bigger than 0.02. 
Probabilities of observing 0 or more than 1 event are presented in Table 4 for a range of possible 
true event rates.  These calculations provide a complete picture of the sensitivity of this study design 
to identify potential safety problems with the study product.  For example, within the group of size 
n=3, if the true event rate is 0.01, then there is a probability of 0.97 to observe no event and a 
probability of <0.001 to observe more than 1 event; while, within the group of size n=5, if the true 
event rate is 0.01, then there is a probability of 0.951 to observe no event and a probability of 0.001 
to observe more than 1 event.  
 
 
 
 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 28 of 62 
Table 4: 
Probability of Event for Different Scenarios  
True event rate 
Within a group 
(n=3) 
Within a group 
(n=5) 
Pr(0 event 
observed) 
Pr(more than 1 
event observed) 
Pr(0 event 
observed) 
Pr(more than 1 
event observed) 
0.01 
0.97 
0 
0.951 
0.001 
0.03 
0.913 
0.003 
0.859 
0.008 
0.05 
0.857 
0.007 
0.774 
0.023 
0.1 
0.729 
0.028 
0.59 
0.081 
0.2 
0.512 
0.104 
0.328 
0.263 
0.3 
0.343 
0.216 
0.168 
0.472 
0.4 
0.216 
0.352 
0.078 
0.663 
 
Table 5 gives the upper and lower bounds for 95% exact binomial confidence intervals for all 
possible number of observed events within a group.  Within the group of size n=3, if no subjects 
experience the event, the 95% exact 2-sided confidence interval for the true rate has upper bound as 
0.708; if all subjects experience the event, the 95% exact 2-sided confidence interval for the true 
rate has lower bound as 0.292.  Within the group of size n=5, if no subjects experience the event, 
the 95% exact 2-sided confidence interval for the true rate has upper bound as 0.522; if all subjects 
experience the event, the 95% exact 2-sided confidence interval for the true rate has lower bound as 
0.478. 
Table 5: 
95% Confidence Intervals of the True Rate for All Possible Number of 
Observed Events within a Group 
Within a group (n=3) 
95% confidence interval 
Within a group (n=5) 
95% confidence interval 
Observed rate Lower bound Upper bound Observed rate Lower bound Upper Bound 
0/3 
0 
0.708 
0/5 
0 
0.522 
1/3 
0.008 
0.906 
1/5 
0.005 
0.716 
2/3 
0.094 
0.992 
2/5 
0.053 
0.853 
3/3 
0.292 
1 
3/5 
0.147 
0.947 
 
 
 
4/5 
0.284 
0.995 
 
 
 
5/5 
0.478 
1 
 
Tables 4 and 5 apply to the secondary and exploratory endpoints as well.  
 STATISTICAL ANALYSIS  
6.4.1 Analysis Variables 
The analysis variables consist of baseline variables, pharmacokinetics and safety variables for 
primary and secondary objective analyses. 
6.4.2 Baseline Demographics 
Baseline characteristics including demographics and laboratory measurements will be summarized 
using descriptive statistics. 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
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6.4.3 Safety Analysis 
Summaries of the number and percentage of subjects experiencing any AE or reactogenicity will be 
tallied by subgroup, and presented along with exact 95% confidence intervals for the proportion. 
Solicited AEs:  Solicited AE data is collected after each dose administered in this study.  The 
number and percentage of subjects experiencing each type of solicited sign or symptom will be 
tabulated by severity.  For a given sign or symptom, each subject’s solicited AEs will be counted 
once under the maximum severity for all assessments. 
Unsolicited AEs:  Unsolicited AEs are coded into MedDRA preferred terms.  The number and 
percentages of participants experiencing each specific AE will be tabulated by severity and 
relationship to treatment.  For the calculations in these tables, each participant’s adverse experience 
will be counted once under the maximum severity or strongest recorded causal relationship to 
treatment. 
A complete listing of adverse experiences for each participant will provide details including 
severity, relationship to treatment type, onset, duration and outcome. 
Local Laboratory Values:  Boxplots of local laboratory values will be generated for baseline values 
and for values measured during the course of the study.  Each boxplot will show the 1st quartile, the 
median, and the 3rd quartile.  Outliers, or values outside the boxplot, will also be plotted.  If 
appropriate, horizontal lines representing boundaries for abnormal values will be plotted. 
6.4.4 Tolerability Evaluation  
The tolerability of the medical product represents the degree to which overt adverse effects can be 
tolerated by the subject [19].  VRC 605 is the first trial of VRC07-523LS in healthy adults.  The 
tolerability evaluation will be mostly descriptive by nature and consist of solicited AEs that occur 
during the 3 days following each VRC07-523LS administration and reasons for any withdrawal or 
discontinuation based upon subject discomfort.  This early assessment of tolerability of VRC07-
523LS will inform which parameters should be solicited or routinely assessed to further characterize 
the tolerability profile in a larger number of subjects.  
6.4.5 Pharmacokinetics Analysis 
Blood samples for PK evaluations will be collected at timepoints per the Schedule of Evaluations.  
Individual Subject Pharmacokinetic Analysis:  A non-compartmental PK analysis will be 
performed using Phoenix (Centara) or a similar program on the VRC07-523LS concentration data 
generated from each subject.  Calculated PK parameters for IV Groups 1, 2, 4, 5, and 7 will include: 
area-under-the-curve (AUC), maximum concentration (Cmax), time to Cmax (Tmax), clearance 
(CL), volume of distribution (Vdz), terminal elimination rate constant (λz) and the terminal half-life 
(T1/2).  For Groups 3 and 6, the PK parameters will include AUC, Cmax, Tmax, apparent clearance 
(CL/F), apparent volume of distribution (Vdz/F), λz and T1/2.  Cmax and Tmax will be taken 
directly from the observed concentration-time data.  The terminal slope, λz, will be determined 
from the log-linear portion of the curve and the T1/2 calculated as 0.693/λz.  AUC0-Clast will be 
determined using the linear trapezoidal method, where Clast is the concentration at 12 weeks after 
the first two doses in Groups 6 and 7 and the concentration at 24 weeks after dose in Groups 1, 2, 4 
and 5 and final dose in Groups 6 and 7.  If the final sample (Clast) has measurable VRC07-523LS 
concentrations, the remaining AUC after the final concentration (AUCClast-inf) will be estimated as 
Clast/λz.  Data will be summarized based by each dose group and overall for IV administration 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 30 of 62 
groups for CL, Vd and T1/2.  For Groups 6 and 7, potential accumulation will be assessed as the 
ratios of the AUC0-inf and Cmax for the first and the last doses.  The potential for non-linearity PKs 
among IV groups will be determined by comparing the dose-adjusted ratios for Cmax and AUC 
between IV groups.  Additional compartmental analysis will be performed as warranted by the data. 
Population Pharmacokinetic Analyses:  Population PK analyses will be performed on the 
VRC07-523LS PK data following IV and SQ administration to determine compartmental PK 
parameters with the program NONMEM.  One and two compartment PK models will be assessed.  
Based on prior PK studies of antibodies, including VRC01, it is anticipated that a two compartment 
model will adequately characterize the data.  The population analysis will generate estimates for 
initial and final volumes of distribution (Vd1 and Vd2), inter-compartmental clearance (Q), CL and 
bioavailability (F).  Given the small subject numbers, the population PK analysis will not include an 
exploratory covariate analysis to assess clinical factors as fixed effects associated with VRC07-
523LS PK parameters with the exception of dose (5 vs 20 vs 40 mg/kg), and first vs subsequent 
doses as a fixed effects on CL, Vd1, and Vd2.  The terminal half-life, t1/2β will be determined from 
CL. Vd1, Vd2 and Q.  Final model selection will be based on changes in the objective function and 
graphically by goodness of fit plots.  The final population model will be assessed using bootstrap 
analysis and dose normalized visual posterior predictive check. VRC07-523LS dosing strategies 
and their ability to achieve and maintain target VRC07-523LS concentrations will be performed 
using the final population PK model and Monte Carlo simulations with at least 5000 replicates. 
6.4.6 Interim Analyses 
Preliminary analyses of PKs may be done once per dose level as the data for each dose level is 
obtained.  This will be used to inform decisions about the dose levels to be administered in studies 
that may begin while VRC 605 is still in progress.  
 
PHARMACY PROCEDURES 
The study groups and study product dosing schedule are shown in Table 3.  Refer to the IB for 
further information about the investigational study product.   
 STUDY PRODUCT AND ADMINISTRATION REGIMEN 
VRC-HIVMAB075-00-AB (VRC07-523LS) is supplied at a concentration of 100 mg/mL ± 10 
mg/mL in an isotonic, sterile solution; two fill volumes are available: 2.5 ± 0.1 mL in a 3 mL glass 
vial and 6.25 ± 0.1 mL in a 10 mL glass vial. Vials contain a clear, colorless to yellow liquid 
essentially free of visible particles; some opaque or translucent particles may be present.  The 
formulation buffer is composed of 50 mM Histidine, 50 mM Sodium Chloride, 5% Sucrose, and 
2.5% Sorbitol at pH 6.8.  Vials are intended for single-use only and thus do not contain a 
preservative.  
In this trial, dose is limited or established based on subject weight.  In calculating the dose to 
administer and number of vials to thaw, it should be assumed that the concentration is 100 mg/mL 
and that a volume of at least 6 mL can be withdrawn from a vial.  Preparation of VRC07-523LS for 
IV administration will require a 100 mL bag of 0.9% sodium chloride, USP (normal saline).  Note 
that the normal saline bags referred to as “100 mL bags” in the IV administration instructions will 
typically have 103 mL volume before any VRC07-523LS is added and this is acceptable in the 
context of the instructions below.  Preparation of VRC07-523LS for SC administration will not 
require any diluent. 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
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There are 7 different schedules in the study described in Section 4. 
 VRC HIVMAB075-00-AB (VRC07-523LS) VIALED PRODUCT 
The VRC07-523LS product label designates the long-term storage temperature as -35°C to -
15°C.  Clinical site storage in a qualified, continuously monitored, temperature-controlled freezer 
with temperature excursions -45°C to -10°C is acceptable.   
Following thaw, VRC07-523LS vials may be stored for up to 24 hours at controlled room 
temperature (maximum 27°C) and/or up to 2 weeks at 2oC to 8oC.  Product may not be stored in 
direct sunlight. If stored at 2-8°C, vials must be equilibrated at controlled room temperature 
(maximum 27oC) for a minimum of 30 minutes and may be held at room temperature for up to 8 
hours prior to product preparation.  
 TEMPERATURE EXCURSIONS 
The site pharmacist must promptly report any storage temperature excursions outside of the normal 
allowance for the storage device to the IND Sponsor (Appendix II).  The affected product must be 
quarantined in a separate area.  The IND Sponsor will notify the site pharmacist if continued clinical 
use of the product is acceptable. 
 PREPARATION OF STUDY PRODUCT FOR ADMINISTRATION  
This section describes how the site pharmacist will prepare the study product for administration and 
how the clinician will administer the product.  Clinician instructions on how to select an 
administration site are in Section 4.2.3.   
VRC07-523LS is a highly concentrated protein solution and may develop white, opaque to 
translucent particles after thawing. When particles are observed, they may disappear after a few 
hours at room temperature or storage at 2oC to 8oC.  
The following instructions apply to thawing VRC07-523LS: 
1. Thaw vial(s) for a minimum of 1 hour at controlled room temperature (maximum 27°C) 
after removing from the freezer.   
2. Keep the material at room temperature during the entire preparation period until use, up 
to the maximum storage times described in Section 7.2. 
3. Prior to preparation for administration, vials should be swirled for 30 seconds with 
sufficient force to resuspend any visible particles, yet avoiding foaming. DO NOT 
SHAKE THE VIALS. If particles are observed, return the vials to 2°C to 8°C storage. If 
the particles redissolve within the maximum storage times described in Section 7.2, the 
vials may be used for product preparation. If particles continue to be observed, do not 
use the vialed product for SC or IV administration.  Refrigerated product must be 
equilibrated at controlled room temperature (maximum 27oC) for a minimum of 30 
minutes before preparation and must be used within 8 hours of any subsequent return to 
room temperature.   
4. If the thawed material is not administered within 24 hours of thaw, follow the storage 
information provided in Section 7.2.  

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 32 of 62 
Preparation is to be done using aseptic technique, in a laminar flow biosafety cabinet.  Assure that 
only the required vials are present in the preparation unit during dilution, and medication labels are 
strictly segregated to avoid mix-ups.  More information on product preparation can be found in the 
IB. 
7.4.1 VRC-HIVMAB075-00-AB: Preparation for Administration Intravenously 
For each IV infusion order, the subject’s weight and dose level or randomization code will be 
included in the pharmacy order.  To prepare an IV infusion, the pharmacist will calculate the total 
milligrams needed, retrieve the minimum number of thawed, particle free vials needed to prepare  
the full dose and add the calculated total mg needed to a 100 mL bag of normal saline using good 
pharmacy practices to maintain sterility.  Prior to preparation for administration,  vials should be 
gently swirled for 30 seconds avoiding foaming.  DO NOT SHAKE THE VIAL.  Typically, 50 to 
100 of additional volume may be added to a 100 mL bag of normal saline. Each pharmacist should 
test the capacity of the brand of saline bags that will be used at the site to confirm the capacity to 
add additional volume.    
An in-line filter infusion set must be used for IV product administrations.  In-line filters must 
comply with the following specifications: 1.2 micron PES (polyethersulfone) filter membrane, 
DEHP-free, latex-free (equivalent to Braun #473994 filter extension set). When the in-line 
filter is added to the tubing, prime the administration set. Flush the administration set with 
about 30 mL or appropriate volume of normal saline at the end of product administration 
The  study product solution will typically be administered IV over about 15 to 30 minutes or 
more as needed  using a volumetric pump.  The total time needed to administer the dose may 
be longer based on factors such as subject tolerance. The rate of infusion may range from 
10-20 mg/kg/hr with the lowest dose group to 80-160 mg/kg/hr with the highest dose group.  
The mL/hr infusion rate may vary based on the total volume needed to administer a full 
dose.   
7.4.2 VRC-HIVMAB075-00-AB: Preparation for Administration Subcutaneously 
For each SC administration order, the subject’s weight and dose level or randomization code will be 
included in the pharmacy order.  To prepare a SC administration dose, the pharmacist will calculate 
the total mg needed and retrieve the minimum number of thawed, particle free vials needed to 
prepare  the full dose.   Prior to preparation for administration, vials should be gently swirled for 30 
seconds  avoiding foaming.  DO NOT SHAKE THE VIALS. If particles are observed, follow 
instructions in Section 7.4.  
The needed volume of VRC07-523LS must be withdrawn from the vial into 1 to 4 syringes 
(BD Luer-Lok mL syringe; REF # 309657) using a 5 micron filter needle (BD Blunt Fill 
Needle – Filter , 18G 1 ½ inch; REF# 305211).  A new filter needle must be used for each 
syringe. The filter needle must be discarded prior to dispensing and replaced with a needle 
suitable for SC injection at the time of administration. 
The product may be administered by direct SC injection with needle and syringe or using a SC 
infusion pump at a rate of 15 mL/hr. The clinician will use proper SC technique to ensure 
administration into SC fatty layer and a slow push to minimize discomfort or the excessive 
distention of overlying skin. The length of time to complete the infusion will vary depending on the 
subject’s weight and tolerance of the infusion rate.  

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 33 of 62 
7.4.3 VRC -HIVMAB075-00-AB (VRC07-523LS) Prepared Product (IV Bag and 
Syringe) 
After product preparation in IV bags, the prepared VRC07-523LS may be stored at 2oC to 8oC up 
to 24 hours or at room temperature (maximum 30oC) for a maximum of 8 hours total including the 
infusion time. Product may not be stored in direct sunlight. If stored at 2oC to 8oC, prepared 
product must be equilibrated at room temperature (maximum 30oC) for a minimum of 30 minutes 
prior to product administration.  
After preparation in syringes for SC administration, the prepared VRC07-523LS may be stored at 
2oC to 8oC up to 24 hours or at room temperature (maximum 30oC) up to 4 hours. Product may not 
be stored in direct sunlight.  
 
Each institution will need to follow their policies for expiration dates if shorter than the timeframes 
specified here or in the IB.  
 RISKS  
Risks of Administration of MAbs: Administration of MAbs may have a risk of immune reactions 
such as acute anaphylaxis, serum sickness and the generation of antibodies.  However, these 
reactions are rare and more often associated with MAbs targeted to human proteins or with the use 
of murine MAbs that would have a risk of human anti-mouse antibodies [20].  In this regard, 
because VRC07-523LS is targeted to a viral antigen and is a human MAb, it is expected to have a 
low risk of such side effects.  
Typically, the side effects of MAbs are mild and may include reactions at injection site (pain, 
redness, bruising swelling), fever, chills, rigors, nausea, vomiting, pain, headache, dizziness, 
shortness of breath, bronchospasm, hypotension, hypertension, pruritus, rash, urticaria, angioedema, 
diarrhea, tachycardia or chest pain.  Clinical use of MAbs that are targeted to cytokines or antigens 
associated with human cells may be associated with an increased risk of infections [20]; however, 
this is not expected to be a risk for a MAb targeted to a viral antigen. 
It is known from published experience with human MAbs directed against the cell surface targets on 
lymphocytes that infusion of a MAb may be associated with cytokine release, causing a reaction 
known as “cytokine release syndrome” (CRS) [21].  Most infusion-related events occur within the 
first 24 hours after beginning administration.  Severe reactions, such as anaphylaxis, angioedema, 
bronchospasm, hypotension and hypoxia, are infrequent and more often associated with MAbs 
targeted to human proteins or with non-human MAb, such as a murine MAb [20].  CRS reactions 
most commonly occur within the first few hours of beginning infusion and with the first MAb 
infusion received.  This is because the cytokine release is associated with lysis of the cells targeted 
by the MAb and the burden of target cells is greatest at the time of the first MAb treatment.  With 
licensed therapeutic MAbs, CRS is managed by temporarily stopping the infusion, administering 
histamine blockers and restarting the infusion at a slower rate [22]. 
Delayed allergic reactions to a MAb may include a serum sickness type of reaction, which is 
characterized by urticaria, fever, lymph node enlargement, and joint pains.  Symptoms may not 
appear until several days after the exposure to the Mab.  This type of reaction is noted to be more 
common with chimeric types of MAb [20]. 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 34 of 62 
There are several FDA-licensed MAbs for which reactions related to the rate of IV infusion have 
been described.  Some symptoms may be treated by slowing or stopping the infusion.  Supportive 
treatment may also be indicated for some signs and symptoms. 
Participation in this study may limit a subject’s eligibility for future MAb studies. 
Risks of Blood Drawing:  Blood drawing may cause pain and bruising and, infrequently, may cause 
a feeling of lightheadedness or fainting. Rarely, it may cause infection at the site where blood is 
taken.  In this study, an IV line that can be used for blood collection may be placed and left in place 
for several hours on the days when there are frequent PK blood draws.  Problems from use of an IV 
for blood drawing are generally mild and may include pain, bruising, minor swelling or bleeding at 
the IV site and rarely, infection, vein irritation (called phlebitis), or blood clot.  
Risks of Oral Mucosa Sample Collection: Collection of samples by swabs and wicks rubbed over 
the mucosal surfaces may cause momentary discomfort and, in some cases, minor bleeding.   
 
 BENEFITS 
There are no direct benefits to subjects from study participation.  Others may benefit from 
knowledge gained in this study that may aid in the development of HIV prevention or therapeutic 
methods. 
 INSTITUTIONAL REVIEW BOARD 
A copy of the protocol, ICF, other written subject information, and any advertising material will be 
submitted to the IRB for written approval prior to implementation. 
The investigator must submit and, where necessary, obtain approval from the IRB for all subsequent 
protocol amendments and changes to the informed consent document. The investigator will notify 
the IRB of unanticipated problems, non-compliance, deviations from the protocol, and serious AEs 
per IRB policy. 
The investigator will be responsible for obtaining IRB approval of the annual Continuing Review 
throughout the duration of the study. 
 SUBJECT CONFIDENTIALITY 
The investigator must ensure that no information identifying the subject will be released to any 
unauthorized party.  Individual identifying information will not be included in any reports.  Subjects 
will be identified only by coded numbers.  All records will be kept confidential to the extent 
provided by federal, state and local law.  Medical records are made available for review when 
required by the FDA or other authorized users, such as the study product manufacturer, only under 
the guidelines set by the Federal Privacy Act.  Direct access includes examining, analyzing, 
verifying, and reproducing any records and reports that are important to the evaluation of the study.  
The investigator is obligated to inform the subjects that the above named representatives will review 
their study-related records without violating the confidentiality of the subjects.  
 PLAN FOR USE AND STORAGE OF BIOLOGICAL SAMPLES 
The plan for use and storage of biological samples from this protocol is as outlined as follows. 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 35 of 62 
7.9.1 Use of Samples, Specimens and Data 
Samples, specimens and data collected under this protocol may be used to conduct protocol-related 
safety and immunology evaluations, exploratory laboratory evaluations related to the biological 
target of the study product, exploratory laboratory evaluations related to vaccine or infectious 
disease research in general and for research assay validation.  Genetic testing may be performed in 
accordance with the genetic testing information that is included in the study informed consent. 
7.9.2 Storage and Tracking of Blood Samples and Other Specimens 
All of the stored study research samples are labeled by a code that only the VRC Clinic can link to 
the subject.  Samples are stored at the NIAID Vaccine Immune T-Cell and Antibody Laboratory 
(NVITAL), Gaithersburg, MD or VRC Laboratories in Building 40, which are both secure facilities 
with limited access.  Data will be kept in password-protected computers.  Only investigators or their 
designees will have access to the samples and data.  Samples will be tracked in the Laboratory 
Information Management System (LIMS) database or using another software designed for this 
purpose (e.g., Freezerworks). 
7.9.3 Disposition of Samples, Specimens and Data at Completion of the Protocol  
In the future, other investigators (both at NIH and outside) may wish to study these samples and/or 
data.  IRB approval must be sought prior to any sharing of samples.  Any clinical information 
shared about those samples would similarly require prior IRB approval.  The research use of stored, 
unlinked or unidentified samples may be exempt from the need for prospective IRB review and 
approval.  Exemption requests will be submitted in writing to the NIH Office of Human Subjects 
Research, which is authorized to determine whether a research activity is exempt. 
At the time of protocol termination, samples will remain in the NVITAL facility or VRC 
laboratories or, after IRB approval, transferred to another repository.  Regulatory oversight of the 
stored samples and data may be transferred to a stored samples protocol as part of the IRB-approved 
termination plan.  Data will be archived by the VRC in compliance with requirements for retention 
of research records, or after IRB and study sponsor approval, it may be either destroyed or 
transferred to another repository. 
7.9.4 Loss or Destruction of Samples, Specimens or Data 
The NIH Intramural Protocol Deviation definition related to loss of or destruction of samples or 
data will be followed.  Any loss or unanticipated destruction of samples (for example, due to freezer 
malfunction) or data (for example, misplacing a printout of data with identifiers) that compromises 
the scientific integrity of the study will be reported to the IRB in accordance with institutional 
policies. The PI will also notify the IRB if the decision is made to destroy the remaining samples. 
 
SUBJECT IDENTIFICATION AND ENROLLMENT  
All study activities will be carried out at the NIH CC.  Study subjects will be recruited through on-
site and off-site advertising done for the screening protocol, VRC 500 (NCT 01375530) 
(https://clinicaltrials.gov/ct2/show/NCT01375530?term=VRC+500&rank=1).  Effort will be made 
to include women and minorities in proportions similar to that of the community from which they 
are recruited and will be limited to persons at least 18 years of age and no older than 50 years of age 
at enrollment. 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 36 of 62 
7.10.1 Participation of Children 
Children are not eligible to participate in this clinical trial because the study product has not been 
previously evaluated in adults.  If the product is assessed as safe for further study other protocols 
specifically designed for children may be conducted. 
7.10.2 Participation of NIH Employees 
NIH employees and members of their immediate families may participate in this protocol.  The site 
will follow the NIH Guidelines for the Inclusion of Employees in NIH Research Studies. 
The NIH information sheet “NIH Information Sheet on Employee Research Participation.” 
regarding employee research participation will be distributed to all potential subjects who are NIH 
employees.  The employee subject’s privacy and confidentiality will be preserved in accordance 
with NIH CC and NIAID policies.  Neither participation nor refusal to participate will have an 
effect, either beneficial or adverse, on the participant’s employment or work situation.  For NIH 
employee subjects, consent will be obtained by an individual who is independent of the employee’s 
team.  If the individual obtaining consent is a co-worker to the subject, independent monitoring of 
the consent process will be provided through the Bioethics Consultation Service.  Protocol study 
staff will be trained on obtaining potentially sensitive and private information from co-workers or 
subordinates.  
 
COMPENSATION 
Subjects will be compensated for time and inconvenience in accordance with the standards for 
compensation of the Clinical Research Volunteer Program.  Study product administration 
accompanied by the same day PK blood draws combined will be $375; product administration visits 
without PK blood draws will be $325.  The compensation will be $175 for scheduled visits that 
include oral swabs and blood drawing, $75 for clinic visits that do not include a blood draw or 
procedure, and $25 for completion of each electronic diary.  
 
SAFETY MONITORING 
Close cooperation between the designated members of the Protocol Team will occur to evaluate and 
respond to individual AEs in a timely manner.  The VRC designated Safety Officer for the day 
conducts a daily safety review of clinical data per VRC Standard Operating Procedures.  The PSRT, 
comprised of the PI, Associate Investigators, Study Coordinator, Protocol Specialists, other Study 
Clinicians, and MO will review the summary study safety data reports on a weekly basis through 4 
weeks after the last subject receives the last product administration and will continue to monitor the 
safety data reports on a monthly basis through completion of the last study visit.   
 ADMINISTRATIVE AND LEGAL OBLIGATIONS 
 PROTOCOL AMENDMENTS AND STUDY TERMINATION 
Protocol amendments may be made only with the prior approval from the IND Sponsor.  Agreement 
from the PI and MO must be obtained for all amendments to the protocol and the informed consent 
document.  All study amendments will be submitted to the IRB for approval. 
The IND Sponsor, NIAID IRB, Office of Human Research Protections, study PI, and FDA reserve 
the right to terminate the study.  The PI will notify the IRB in writing of the study’s completion or 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 37 of 62 
early termination. 
 STUDY DOCUMENTATION AND STORAGE 
The PI will maintain a list of appropriately qualified persons to whom trial duties have been 
delegated. 
Source documents are original documents, data, and records from which the subject’s data are 
obtained.  These include but are not limited to hospital records, clinical and office charts, laboratory 
and pharmacy records, microfiches, radiographs, and correspondence. Long-term storage of source 
documents may be in the form of electronic files.  
The PI and staff are responsible for maintaining a comprehensive and centralized filing system of 
all study-related (essential) documentation, suitable for inspection at any time by representatives 
from the VRC, IRB, FDA, and/or applicable regulatory authorities. Elements include: 
• Subject files containing completed informed consent forms, and supporting copies of source 
documentation (if kept) 
• Study files containing the protocol with all amendments, IBs, copies of all correspondence 
with the IRB and the VRC 
In addition, all original source documentation must be maintained and be readily available. 
All essential documentation should be retained by the institution for the same period of time 
required for medical records retention. The FDA requires study records to be retained for up to two 
years after marketing approval or refusal (21 CFR 312.62).  No study document should be destroyed 
without prior written agreement between the VRC and the investigator.  Should the investigator 
wish to assign the study records to another party or move them to another location, they must notify 
the VRC in writing of the new responsible person and/or the new location. 
 STUDY MONITORING, DATA COLLECTION AND DATA SHARING 
8.3.1 Protocol Monitoring Plan 
The IND Sponsor or their authorized representatives are responsible for ensuring integrity of study 
data and compliance with the protocol. The PI will allow the study monitors, the IRB and the FDA 
to inspect study documents (e.g., consent forms, drug distribution forms, and case report forms) and 
pertinent hospital or clinic records for confirmation of the study data. Site visits by study monitors 
will be made to monitor the following: study operations, quality of data collected in the research 
records, the accuracy and timeliness of data entered in the database, and to determine that all 
process and regulatory requirements are met. Study monitoring visits will occur as defined by the 
IND Sponsor approved monitoring plan.  
8.3.2 Data Collection 
Clinical research data will be collected in a secure electronic web-based clinical data management 
system (CDMS) through a contract research organization, EMMES (Rockville, MD).  Extracted 
data without patient identifiers will be sent to the PSRT for safety review and to Protocol 
Statistician for statistical analysis. 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 38 of 62 
8.3.3 Source Documents 
The site will maintain appropriate medical and research records for this trial, in compliance with 
ICH GCP, regulatory and institutional requirements for the protection of confidentiality of subjects.  
Source data are all information, original records of clinical findings, observations, or other activities 
in a clinical trial necessary for the reconstruction and evaluation of the trial. Examples of these 
original documents and data records include, but are not limited to, medical records, laboratory 
reports, pharmacy records and other research records maintained for the clinical trial.  
8.3.4 Data Sharing 
Data generated in this study will be shared as de-identified data in the government-funded public 
repository, www.ClinicalTrials.gov. Data may be shared prior to publication at approved public 
presentations or for collaborative development and will be shared at the time of publication or 
within 1 year of the primary completion date. 
 LANGUAGE 
All written information and other material to be used by subjects and investigative staff must use 
vocabulary and language that are clearly understood.  
 POLICY REGARDING RESEARCH-RELATED INJURIES 
The NIH CC will provide short-term medical care for any injury resulting from participation in this 
research.  In general, the National Institutes of Health, the NIH CC, or the U.S. Federal Government 
will provide no long-term medical care or financial compensation for research-related injuries. 
 
 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 39 of 62 
 REFERENCES 
 
1. 
UNAIDS, Fact sheet: 2015 statistics. 2015. 
 
2. 
Wu, X., Z.Y. Yang, Y. Li, C.M. Hogerkorp, W.R. Schief, et al., Rational design of envelope 
identifies broadly neutralizing human monoclonal antibodies to HIV-1. Science, 2010. 
329(5993): p. 856-61. 
 
3. 
Rudicell, R.S., Y.D. Kwon, S.Y. Ko, A. Pegu, M.K. Louder, et al., Enhanced Potency of a 
Broadly Neutralizing HIV-1 Antibody In Vitro Improves Protection against Lentiviral 
Infection In Vivo. J Virol, 2014. 88(21): p. 12669-82. 
 
4. 
Kwon, Y., I. Georgiev, S. O'Dell, W. Shi, G. Chuang, et al., Structure-guided modification 
and optimization of antibody VRC07. Retrovirology, 2012. 9(Suppl 2): p. O34. 
 
5. 
Wu, X., C. Wang, S. O'Dell, Y. Li, B.F. Keele, et al., Selection pressure on HIV-1 envelope 
by broadly neutralizing antibodies to the conserved CD4-binding site. J Virol, 2012. 86(10): 
p. 5844-56. 
 
6. 
Ko, S.-Y., A. Pegu, R.S. Rudicell, Z.-y. Yang, M.G. Joyce, et al., Enhanced neonatal Fc 
receptor function improves protection against primate SHIV infection. Nature, 2014. 
advance online publication. 
 
7. 
Zalevsky, J., A.K. Chamberlain, H.M. Horton, S. Karki, I.W. Leung, et al., Enhanced 
antibody half-life improves in vivo activity. Nat Biotechnol, 2010. 28(2): p. 157-9. 
 
8. 
Montefeori, D.C., Measuring HIV Neutralization in a Luciferase Reporter Gene Assay, in 
HIV Protocols, Second Edition, Vol. 485, V.R. Prasad, and Kalpana, G.V., Editor. 2009, 
Humana Press: New York, NY. p. 395-405. 
 
9. 
Ozaki, D.A., H. Gao, C.A. Todd, K.M. Greene, D.C. Montefiori, et al., International 
technology transfer of a GCLP-compliant HIV-1 neutralizing antibody assay for human 
clinical trials. PLoS One, 2012. 7(1): p. e30963. 
 
10. 
Todd, C.A., K.M. Greene, X. Yu, D.A. Ozaki, H. Gao, et al., Development and 
implementation of an international proficiency testing program for a neutralizing antibody 
assay for HIV-1 in TZM-bl cells. J Immunol Methods, 2012. 375(1-2): p. 57-67. 
 
11. 
Allen, J.C. and H.G. Kunkel, Antibodies to genetic types of gamma globulin after multiple 
transfusions. Science, 1963. 139(3553): p. 418-9. 
 
12. 
Jefferis, R. and M.P. Lefranc, Human immunoglobulin allotypes: possible implications for 
immunogenicity. MAbs, 2009. 1(4): p. 332-8. 
 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 40 of 62 
13. 
Kickler, T.S., P.M. Ness, H.G. Braine, L. Richardson, and M. Farkosh, The expression of 
IgG allotypes on platelets and immunization to IgG allotypes in multitransfused 
thrombocytopenic patients. Blood, 1990. 76(4): p. 849-52. 
 
14. 
Lynch, R.M., E. Boritz, E.E. Coates, A. DeZure, P. Madden, et al., Virologic effects of 
broadly neutralizing antibody VRC01 administration during chronic HIV-1 infection. Sci 
Transl Med, 2015. 7(319): p. 319ra206. 
 
15. 
Ledgerwood, J.E., E.E. Coates, G. Yamshchikov, J.G. Saunders, L. Holman, et al., Safety, 
pharmacokinetics and neutralization of the broadly neutralizing HIV-1 human monoclonal 
antibody VRC01 in healthy adults. Clin Exp Immunol, 2015. 
 
16. 
DHHS. Panel On Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the 
use of antiretroviral agents in HIV-1-infected adults and adolescents.  
https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf. Assessed 
February 16, 2016. 
 
17. 
Hall, W.C., S.A. Price-Schiavi, J. Wicks, and J.L. Rojko, Tissue Cross-Reactivity Studies for 
Monoclonal Antibodies: Predictive Value and Use for Selection of Relevant Animal Species 
for Toxicity Testing, in Preclinical Safety Evaluation of Biopharmaceuticals: A Science-
Based Approach to Facilitating Clinical Trials (ed J. A. Cavagnaro). 2008, John Wiley & 
Sons, Inc.: Hoboken, NJ, USA. p. 208-40. 
 
18. 
Leach, M.W., W.G. Halpern, C.W. Johnson, J.L. Rojko, T.K. MacLachlan, et al., Use of 
tissue cross-reactivity studies in the development of antibody-based biopharmaceuticals: 
history, experience, methodology, and future directions. Toxicol Pathol, 2010. 38(7): p. 
1138-66. 
 
19. 
FDA, Guidance for Industry: E9 Statistical Principles for Clinical Trials. 1998, U. S. 
DHHS, FDA, CDER, CBER. 
 
20. 
Hansel, T.T., H. Kropshofer, T. Singer, J.A. Mitchell, and A.J. George, The safety and side 
effects of monoclonal antibodies. Nature reviews. Drug discovery, 2010. 9(4): p. 325-38. 
 
21. 
Bugelski, P.J., R. Achuthanandam, R.J. Capocasale, G. Treacy, and E. Bouman-Thio, 
Monoclonal antibody-induced cytokine-release syndrome. Expert review of clinical 
immunology, 2009. 5(5): p. 499-521. 
 
22. 
Vogel, W.H., Infusion reactions: diagnosis, assessment, and management. Clin J Oncol 
Nurs, 2010. 14(2): p. E10-21. 
 
 

PRODUCT: VRC-HIVMAB075-00-AB                                                                          PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 41 of 62 
Appendix I: Study Informed Consent Form 
Text to be included in the NIH Clinical Center Informed Consent Template 
 

PRODUCT: VRC-HIVMAB075-00-AB                                                                          PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 42 of 62 
TITLE:  VRC 605: A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of a 
Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered 
Intravenously or Subcutaneously to Healthy Adults 
 
INTRODUCTION 
We invite you to take part in a research study at the National Institutes of Health (NIH). First, 
we want you to know that: 
 
Taking part in NIH research is entirely voluntary. 
 
You may choose not to take part, or you may withdraw from the study at any time.  In 
either case, you will not lose any benefits to which you are otherwise entitled.  
However, to receive care at the NIH, you must be taking part in a study or be under 
evaluation for study participation. 
 
You may receive no benefit from taking part.  The research may give us knowledge that 
may help people in the future. 
Second, some people have personal, religious or ethical beliefs that may limit the kinds of 
medical or research treatments they would want to receive (such as blood transfusions).  If you 
have such beliefs, please discuss them with your NIH doctors or research team before you 
agree to the study. 
Now we will describe this research study.  Before you decide to take part, please take as much 
time as you need to ask any questions and discuss this study with anyone at NIH, or with family, 
friends or your personal physician or other health professional.
PURPOSE AND PLAN OF THE STUDY 
This is the study of an experimental product called “VRC07-523LS.”  The U.S. Food and Drug 
Administration (FDA) allows it to be used for research only.  VRC07-523LS is an antibody 
directed against HIV virus.  The human body uses antibodies as one way to help fight infection.  
There is currently no cure for HIV or vaccine to prevent it.   
The main purpose of this study is to see if the experimental product is safe and well-tolerated.  
We will study the amount of VRC07-523LS in the body and how it changes over time.  We will 
check to see if people who get VRC07-523LS make an immune response (antibody) to it. 
About 25 to 40 people will participate in this study at the NIH Clinical Center in Bethesda, 
Maryland.  The study will have about 13-27 clinic visits over 24-48 weeks for each person, 
depending on the study group. 
STUDY PRODUCT 
VRC07-523LS is a monoclonal antibody or “MAb.”  An antibody is a protein that is used by the 
immune system to find and block bacteria and viruses, like HIV.  Monoclonal means that all the 
antibodies in the product are the same.  The formal name for the product is VRC-HIVMAB075-
00-AB.   
VRC07-523LS is a human antibody but it is a genetically modified synthetic product.  It was 
made based on an antibody that was first found in an HIV-infected person.  Although the 
antibody was found in a human, the product is not made by collecting it from a human.  VRC07-
523LS was developed by the Vaccine Research Center (VRC) at NIH.  This product was made in 

PRODUCT: VRC-HIVMAB075-00-AB                                                                          PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 43 of 62 
a drug manufacturing laboratory.  This is the first study to give VRC07-523LS to humans. 
VRC07-523LS is similar to the monoclonal antibody VRC01 and was manufactured in a similar 
way.  VRC01 has been given to over 150 healthy and HIV-infected adults and has been found to 
be safe and well-tolerated.   
VRC07-523LS will not protect you from HIV infection.  Because we have never tested this 
product in humans, we assume that it cannot protect against HIV infection.  You cannot get HIV 
from VRC07-523LS because there are no parts of HIV in it.  
In laboratory and animal studies, VRC07-523LS was shown to attach to and inactivate many 
types of HIV viruses. We do not know if the product will act the same way when given to 
humans.  It will take many studies to learn if the product will be useful for preventing or treating 
HIV.  This study alone will not answer this question.  
ELIGIBILITY 
You are eligible to participate in this study because you have completed the screening process 
and are known to be the following: 
• 18 to 50 years old 
• In general good health without significant medical problems as determined at screening 
• Willing to get VRC07-523LS 
• Willing to donate blood samples for future research 
• Willing to be tested for HIV infection 
• If female and able to get pregnant: willing to use birth control for the whole study. 
STUDY PROCEDURES 
The study will have 7 groups.  Each group will have about 3-5 people in it.  The groups are 
defined by the dose of VRC07-523LS and how it is given.  Most people will get VRC07-523LS 
by the intravenous (IV) route, meaning into a vein.  Some people will get VRC07-523LS by the 
subcutaneous (SC) route, meaning into the fatty tissue under the skin.  Both methods use a 
needle.  The product administration visit(s) will last about 8 hours.  Other clinic visits will take 
about 2 hours.   
The study will last about 24 weeks for people in Groups 1-5 because they will only get the study 
product one time.  The study will last for about 48 weeks for people in Groups 6 and 7 because 
they will get the study product three times.   
People in Groups 1-5 will get different doses of the study product 1 time so we can see how long 
it lasts in the body and if higher doses are safe. 
People in Groups 6 and 7 will get the study product 3 times instead of 1 time so we can see if 
repeat doses are better.  We also want to see if it is better to give the study product by the IV or 
SC routes.  This information will be helpful for future uses of the product.  
If you agree to take part in this study, you will get 1 or 3 doses of VRC07-523LS, depending on 
the group.  You will know how many doses you will get once you enroll.  The amount of study 
product you will get is calculated based on your body weight.  We will measure your weight on 
the day the study product is given to calculate the dose.  
The Study Groups are shown in the following table:  

PRODUCT: VRC-HIVMAB075-00-AB                                                                          PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 44 of 62 
Group 
Subjects 
Schedule 
Day 0 
Week 12 
Week 24 
1 
3 
1 mg/kg  IV 
 
 
2 
3 
5 mg/kg  IV 
 
 
3 
3 
5 mg/kg  SC 
 
 
4 
3 
20 mg/kg  IV 
 
 
5 
3 
40 mg/kg  IV 
 
 
6 
5 
5 mg/kg  SC 
5 mg/kg  SC 
5 mg/kg  SC 
7 
5 
20 mg/kg  IV 
20 mg/kg  IV 
20 mg/kg  IV 
Total 
25 
More people may be enrolled, if needed, to reach the study goals. 
The study will start by assigning subjects to get the lowest dose of VRC07-523LS in Group 1.  If 
people in the lower dose groups tolerate the study product, the next dose groups may enroll.  
This pattern will continue until we reach the highest dose.  People who are available for 24 
weeks of study participation may enroll into Groups 1 to 5.  People who are available for 48 
weeks of study participation may enroll into Group 6 or Group 7.  For Groups 6 and 7 who will 
get 3 doses of VRC07-523LS, the second and third doses can be given once the first dose is 
determined to be safe.  
If you are female and able to become pregnant, a pregnancy test will be done before each product 
administration.  The result of the test must be negative for you to get study product.  You must 
use an effective method of birth control for the entire study.  
• Intravenous (IV) Route Dose Groups:  
If you are in a group getting VRC07-523LS by IV infusion, we will place a thin tube or IV 
line in a vein on your arm on the day you get the study product.  If needed, we will place a 
second IV line in a vein on your other arm for blood sample collection.  VRC07-523LS will 
be mixed into a bag of liquid called “normal saline” or salt water.  The mix of normal saline 
and VRC07-523LS will be given directly into your vein.  A pump will control how fast the 
study product goes into the vein.  The goal is to give it over about 30 minutes or longer.  If 
you have side effects, the rate of the infusion may be slowed down or stopped.  At the end of 
each infusion, we will monitor you for at least four hours and collect blood samples. 
o Blood sample collections for IV Groups:  
On the day of your first IV infusion of VRC07-523LS, we will collect blood samples from 
you before and right after the infusion, and about 1 hour, 3 hours, and 6 hours after the 
infusion.  You will also be asked to come back to the clinic 1 to 3 times during that first 
week for sample collection.  If you are in Group 7, for the second and third doses of 
VRC07-523LS, we will collect blood samples from you before and right after the infusion, 
and then again about 1 hour after the infusion.  You will also be asked to come back to the 
clinic 4-5 times after each repeat dose. 
• 
Subcutaneous (SC) Route Dose Groups: 
If you are in a group getting VRC07-523LS by SC injection, we will put a small needle into 
the fatty tissue under your skin.  The abdominal area is usually where the needle will be 
inserted in your body.  It is possible we may use your arm or thigh area instead.  VRC07-
523LS will not be mixed with any other liquid.  You will get the SC doses by injection with a 

PRODUCT: VRC-HIVMAB075-00-AB                                                                          PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 45 of 62 
standard needle and syringe in 1 to 4 SC sites on your body. After all of the injections are 
given each time, we will monitor you for at least four hours.   
o Blood sample collections for SC Groups: 
On the day of your first SC injection of VRC07-523LS, we will collect blood samples 
from you before the injection.  You will also be asked to come back to the clinic 1 to 3 
times during that first week for sample collection.  If you are in Group 6, for the second 
and third doses of VRC07-523LS, we will collect blood samples from you before each 
injection.  You will also be asked to come back to the clinic 4-5 times after each repeat 
dose. 
We will give you a thermometer and ask you to check your temperature every day for 3 days 
after you get the study product.  We will also ask you to record your temperature and any 
symptoms you may have. You will get a password to a secure website to record this information 
on an electronic form or “diary.”  If you prefer, you can use a paper diary instead.   
If you have any side effects, you should tell a VRC nurse or doctor as soon as possible.  You can 
reach the staff by phone 24 hours a day.  If you have symptoms, you may be asked to come into 
the clinic for an examination before your next scheduled visit.  It is very important that you 
follow the instructions from the clinic staff.  
At each visit, we will check you for any health changes or problems.  We will ask you how you 
are feeling and if you have taken any medications.  We will draw your blood at scheduled study 
visits, taking about 1 to 9 tubes of blood depending on the visit.  We may ask you to come into 
the clinic for additional blood collection.  We will request urine samples at 2 to 6 visits during 
the study, depending on your group if you are willing.  We will tell you right away if any of your 
test results show a health problem.   
We will use some blood samples to study if your body develops an immune response 
(antibodies) to the study product.  These tests are for research purposes only and are not for 
checking on your health.  We will not give you these results.  After completing this study, we 
may invite you to take part in another study for follow-up sample collection. 
Experimental studies follow a set schedule.  This helps us answer the research questions. 
Scheduling for your visits allows some flexibility, but it is important that you work with the staff 
to follow the schedule.  You should try to not miss any visits.  You might need to have extra 
clinic visits and laboratory tests if you have health changes that need to be checked.  
Collection of Oral Secretion Samples for Research 
If you are willing, we will collect samples of the mouth (oral/saliva) for research during 3-6 
study visits, depending on your study group.  Collection of these samples is encouraged but not 
required.  If you choose to provide such samples, you may change your mind at any time 
throughout the study.  You may choose not to donate these samples but still take part in the 
study.  
Oral samples will be collected with small disposable sponges, similar to a “Q-tip,” which are 
made for this purpose.  Each sponge is new and sterile, and is safe for use in sensitive areas of 
the body.  
These samples are collected to see how VRC07-523LS is distributed in your body.  They will not 
be for checking your health and do not replace routine health care.  

PRODUCT: VRC-HIVMAB075-00-AB                                                                          PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 46 of 62 
HIV TESTING AND COUNSELING 
As part of your participation in this study, we will provide you with HIV counseling and testing. 
We will test you for HIV infection and possibly for other infections if needed to check your 
eligibility for the study.  We will tell you how to remain HIV-uninfected and give you prevention 
resources.  If you are infected with HIV, you will not be able to participate in this study.  We will 
tell you what the results mean, how to find care, how to avoid infecting others, how we report 
HIV infection, and the importance of informing your partners that may be at risk because of your 
HIV infection. 
If you have questions regarding the HIV testing, you are encouraged to discuss them with the 
study nurse or doctor, or you may call a NIH Clinical Center HIV counselor at 301-496-2381. 
MONITORING OF THE STUDY 
A group of physicians and scientists at NIH will monitor this study.  This group will review the 
information from the study and will pay close attention to possible harmful reactions.  If serious 
side effects occur, VRC07-523LS administrations may be delayed or canceled. 
GENETIC TESTING 
Some of the blood drawn from you as part of this study will be used for genetic tests.  Some 
genetic tests are done in research studies to see if genetic differences in people cause different 
types of immune responses.  Your blood sample used in these genetic tests will not have your 
name on it and the results will not be in your medical record.  These tests are not used to check 
your health and we will not tell you the results.  
A special genetic test, called HLA typing, is done by the NIH Clinical Center medical laboratory.    
These results will be in your medical record but they will not be used to check your health.  Any 
genetic testing, including HLA testing, is for research purposes only. Any genetic information 
collected or learned about you will be kept confidential.  Medical records, including HLA test 
results, are kept securely.  We will not give any genetic information that is in your medical 
record to anyone without your permission. 
STORED SAMPLES 
We will collect samples (including blood and possibly oral secretions) from you during the 
study.  We will keep these samples for future research to learn more about monoclonal 
antibodies, vaccines, the immune system, and/or other medical conditions.  Results from research 
with your samples will not be in your medical record or reported to you.  
Labeling of Stored Samples: We will label your stored samples by a special code or number.  
Only the study team can link this code to you.  Any identifying information about you (like name 
or date of birth) will be kept as confidential as allowable by law.  Despite protections, there is a 
small chance that information identifying you will be given to someone who should not get it. 
Risks from Stored Samples: There is a risk of unplanned release of information from your 
medical records.  The chance that this information will be given to an unauthorized person 
without your permission is very small.  Possible problems with the unplanned release of 
information include discrimination when applying for insurance and employment.  Similar 
problems may occur if you give information about yourself or agree to have your medical 
records released. 

PRODUCT: VRC-HIVMAB075-00-AB                                                                          PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 47 of 62 
Future Studies: In the future, other investigators (at NIH or outside of NIH) may wish to study 
your stored samples.  When your stored samples are shared, they will be marked with a code.  
Your samples will not have any identifying information on them.  Some information about you, 
such as your gender, age, health history, or ethnicity may also be shared with other researchers. 
Any future research studies using your samples will be conducted in a way that protects the 
rights and privacy of study participants. 
Your stored samples will be used only for research and will not be sold.  The research done with 
your materials may be used to develop new products in the future but you will not receive 
payment for such products. 
Making your Choice: You cannot take part in this study if you do not want us to collect or store 
your blood samples.  If you agree to take part in this study, you must also agree to let us keep 
any of your samples for future research.  If you decide not to take part in this study, you may still 
take part in other studies at NIH. 
POSSIBLE STUDY RISKS 
Risks from IV infusions or SC injections: It is possible that you may have some side effects.  
General risks of methods that use a needle include stinging, discomfort, pain, soreness, redness, 
bruising, swelling or a tiny cut at the needle insertion site. 
Risks of VRC07-523LS: This study is the first time that VRC07-523LS is being given to people. 
VRC07-523LS is similar to the VRC monoclonal antibody, VRC01.  More than 150 adults have 
received one or more doses of VRC01 by IV or SC routes.  There were no safety concerns and 
no concerning reactions to the product.  However, VRC07-523LS may have additional unknown 
risks and side effects. 
There are several antibody products that are permitted for use in people.  Other antibody 
products have been given safely by both the IV and the SC route.  Local reactions at the site of 
the SC injections are common, but these reactions are usually mild and resolve in a few days.  
Most side effects tend to occur within the first 24 hours. 
Side effects to study product infusions may include fever, chills, shaking, nausea, vomiting, pain, 
headache, dizziness, trouble breathing, high or low blood pressure, itchiness, rash, hives, lip or 
face swelling, diarrhea, racing heart or chest pain. These reactions may be related to how fast the 
antibody product is given.  However, we rarely saw these reactions when VRC01 was given. 
When reactions were reported, they were usually mild.  VRC01 given by the SC route has 
sometimes caused mild itchiness, redness and/or swelling at site of injection. These symptoms 
usually cleared within a few minutes to hours after the product was given. In an ongoing study, 
additional product injections were discontinued for one subject who developed mild chest 
discomfort and for one subject who developed mild rash that were associated with study product 
administration (VRC01 or placebo).  
We are giving VRC07-523LS at a controlled rate.  If symptoms occur while VRC07-523LS is 
being given, tell the nurse.  Slowing or stopping the flow rate may help improve the symptoms.    
Some antibody products have a risk of serious allergic reactions that can be life-threatening.   

PRODUCT: VRC-HIVMAB075-00-AB                                                                          PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 48 of 62 
• Anaphylaxis is one type of allergic reaction that may happen soon after an antibody 
product is given.  This reaction can include difficulty breathing, low blood pressure, hives 
or rash, swelling in the mouth and face.  
• Serum sickness is a delayed type of allergic reaction that may happen several days to 
three weeks after an antibody product is given.  This reaction can include hives or rash, 
fever, enlarged lymph nodes, muscle pains, joint pains, chest discomfort and shortness of 
breath.   
Some antibodies of the type that attack human proteins can increase the risk of serious infections.  
VRC07-523LS is not expected to increase the risk of serious infections because it attacks a virus 
and not a human protein. 
In addition to the possible risks that are listed above, VRC07-523LS may have other side effects 
that we do not know about yet.  Participation in this study may affect your eligibility for future 
monoclonal antibody studies.  We will give you any new information about risks or other 
information that becomes available that may affect your decision to continue in the study. 
Risks of Blood Drawing: Blood drawing may cause pain and bruising and rarely, may cause a 
feeling of lightheadedness or fainting.  Rarely, it may cause infection at the site where the blood 
is taken.  In this study on the day of an infusion, an IV line may be placed in your vein and left 
for a few hours.  Problems at the IV site are usually mild and may include pain, bruising, minor 
swelling or bleeding.  Rarely, there may be an infection, vein irritation, or a blood clot.   
Risks of Oral Mucosa Sample Collection: Collection of samples by swabs and wicks by rubbing 
them over the mucosal surfaces in the mouth can cause brief discomfort and, rarely, a little 
bleeding.  
Risk of a False Positive HIV Antibody Test Caused by VRC07-523LS: An HIV antibody test is 
the usual way to test for HIV infection.  VRC01 and VRC07-523LS are antibodies against HIV. 
Based on laboratory testing, VRC01 does not cause a positive HIV antibody test in standard 
diagnostic tests.  Since VRC07-523LS is similar to VRC01, we expect that VRC07-523LS does 
not cause a positive HIV antibody test.  However, we do not know yet if it will cause a positive 
HIV antibody test or not.  We will test for HIV antibodies at some visits.  If you ever need or 
want an HIV test while you are on the study, please ask the VRC Clinic to do the test.  We will 
tell you the results of your HIV test. 
Risks during Pregnancy: We do not know what effects VRC07-523LS may have on a fetus or 
nursing infant.  Women who are able to have children must agree to not get pregnant during 
study participation.  We will discuss effective birth control methods with you.  
You must notify the clinic staff right away if you get pregnant during this study or think that you 
might be pregnant. If you get pregnant, you will not get any more VRC07-523LS administrations 
and we will not collect any more blood for research.  However, you will be asked to continue 
with study follow-up visits to check on your health and to report the outcome of the pregnancy to 
us, which will be reported to the antiretroviral pregnancy registry (http://www.apregistry.com).  
POSSIBLE BENEFITS 
This study will not provide you with any direct health benefit. You and others may benefit in the 
future from the information that we learn from the study. 
COSTS TO YOU FOR PARTICIPATION 

PRODUCT: VRC-HIVMAB075-00-AB                                                                          PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 49 of 62 
There are no costs to you for participating in this study.  You or your health insurance will have 
to pay for all medical costs for medical care that you get outside this study. 
COMPENSATION TO YOU FOR YOUR PARTICIPATION 
You will be compensated for your time and inconvenience by the NIH Clinical Research 
Volunteer Program.  It is possible that you may have some expenses that are not covered by the 
compensation provided. 
The compensation is $175 for scheduled visits with blood drawing and oral swabs; $375 for IV 
product administration visit(s) that includes follow-up blood sample collections on the same day, 
and $325 for SC product administration visit(s) without follow-up sample collections on the 
same day.  Compensation for timely completion of all 3 days of an electronic diary will be $25 
total.  Additional compensation for clinic visits that do not include research blood sample 
collection will be $75.  Total compensation for completion of the study is estimated to range 
from $2475 to $5425 and is based on the number and type of study visits you complete.   
You will get your compensation about 2 weeks after each completed visit by direct deposit into a 
bank account that you specify to the volunteer payment office.  Your compensation may need to 
be reported to the internal revenue service (IRS) as taxable income. 
REASONS FOR DISCONTINUING STUDY PRODUCT ADMINISTRATION OR 
REMOVING YOU FROM THE STUDY 
You may be stopped from getting VRC07-523LS for several different reasons, including: 
• You don't keep appointments or follow study procedures. 
• You get a serious illness that needs ongoing medical care. 
• You have a serious side effect thought to be due to VRC07-523LS. 
• You enroll in another research study at the same time you are in this study. 
• You become pregnant. 
• The study is stopped or canceled. 
A study may be stopped or canceled by a study sponsor, a regulatory agency or by the study 
investigators.  If this happens, we will tell you the reason why the study was stopped. 
You may choose to stop participating in the study at any time.  If you got any doses of VRC07-
523LS, you will be asked to keep follow-up visits so we can monitor your health.  We may stop 
collecting samples that are for research purposes only. 
ALTERNATIVES 
This study is not designed to treat or prevent any disease.  You may choose to not participate in 
this study.  You may be eligible for other studies.  
CONFLICT OF INTEREST 
The NIH research staff is checked yearly for conflicts of interest.  You may ask the research 
team for more information.  This study may have investigators who are not NIH employees.  
Non-NIH investigators are expected to follow the principles of the Protocol Review Guide but 
are not required to report their personal financial holdings to the NIH. 
The NIH, including some members of the VRC scientific staff, developed the investigational 
product being used in this research study.  The results of this study could play a role in whether 

PRODUCT: VRC-HIVMAB075-00-AB                                                                          PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 50 of 62 
the FDA will approve the study product for sale at some time in the future.  If approved, the 
future sale of the study product could lead to payments to NIH and some NIH scientists.  By U.S. 
law, government scientists are required to receive such payments for their inventions.  You will 
not receive any money from the development or sale of the product. 
Manufacturing process of the investigational product used in this trial is currently not available 
as a stock option by any commercial entity.  
CLINICALTRIALS.GOV 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov.  This 
website will not include information that can identify you. At most, the website will include a 
summary of the results.  You can search this website at any time.  

PRODUCT: VRC-HIVMAB075-00-AB                                                                          PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 51 of 62 
OTHER PERTINENT INFORMATION 
1. Confidentiality.  When results of an NIH research study are reported in medical journals or at 
scientific meetings, the people who take part are not named and identified.  In most cases, the NIH will 
not release any information about your research involvement without your written permission.  However, 
if you sign a release of information form, for example, for an insurance company, the NIH will give the 
insurance company information from your medical record.  This information might affect (either 
favorably or unfavorably) the willingness of the insurance company to sell you insurance. 
The Federal Privacy Act protects the confidentiality of your NIH medical records.  However, you should 
know that the Act allows release of some information from your medical record without your permission, 
for example, if it is required by the Food and Drug Administration (FDA), members of Congress, law 
enforcement officials, or other authorized people.  
2. Policy Regarding Research-Related Injuries.  The Clinical Center will provide short-term medical 
care for any injury resulting from your participation in research here.  In general, no long-term medical 
care or financial compensation for research-related injuries will be provided by the NIH, the Clinical 
Center, or the Federal Government.  However, you have the right to pursue legal remedy if you believe 
that your injury justifies such action. 
3. Payments.  The amount of payment to research volunteers is guided by the NIH policies.  In general, 
patients are not paid for taking part in research studies at the NIH.  Reimbursement of travel and 
subsistence will be offered consistent with NIH guidelines. 
4.    Problems or Questions.  If you have any problems or questions about this study or about any 
research-related injury, contact the Principal Investigator, Martin Gaudinski, M.D., or the Study 
Coordinator, 
, at 
. 
If you have any questions about your rights as a research subject, you may call the Clinical Center 
Patient Representative at 
. 
5. Consent Document.  Please keep a copy of this document in case you want to read it again. 
 
COMPLETE APPROPRIATE ITEM(S) BELOW: 
Adult Study Participant’s Consent 
 
I have read the explanation about this study and have been given the opportunity to discuss it and to ask questions.  I 
hereby consent to take part in this study. 
 
 
 
 
 
 
 
                                      Time 
 
 
  
 
Signature of Adult Participant                                   Date 
 
 
 
Print Name 
 
 
THIS CONSENT DOCUMENT HAS BEEN APPROVED FOR USE  
FROM XXXXXX THROUGH XXXXXX. 
 
 
 
 
 
  
Signature of Investigator/                               Date 
Person Obtaining Consent                              
 
 
 
Print Name 
Signature of Witness                                      Date 
 
 
 
 
Print Name 
 

PRODUCT: VRC-HIVMAB075-00-AB                                                                          PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 52 of 62 
Appendix II: Contact Information 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 53 of 62 
 
 
 
 
 
 
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PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 54 of 62 
Appendix III: Schedule of Evaluations 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 55 of 62 
Schedule 1: Groups 1 (1 mg/kg IV), 2 (5 mg/kg IV), 4 (20 mg/kg IV), and 5 (40 mg/kg IV) 
Visit Number 
01R 
02 
02A 
02B 
02C 
02D 
03 
04 
06 
07 
08 
09 
10 
11 
15 
16 
17 
Time After Infusion 
 
Pre 
EOI 
1hr 
3h 
6h 
24hr 
48hr 
Wk1 
Wk2 
Wk3 
Wk4 
Wk8 Wk12 Wk16 Wk20 Wk24 
1Day of Study 
-42 to -1 
D0 
D0 
D0 
D0 
D0 
D1 
D2 
D7 
D14 
D21 
D28 
D56 
D84 
D112 D140 D168 
Clinical 
Tube 
Screen 
Enroll 
Day of infusion 
 
 
 
 
 
 
 
 
 
 
 
VRC 500 Screening Consent 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
VRC 605 AoU; Consent 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 Screen: Physical exam, ht, wt; 
Other: targeted exam, BP, pulse, 
temp; also wt at visit 02 
 
X 
X 
X 
X 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Complete med history at screen; 
then interim med history 
 
X 
X 
X 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
3VRC07-523LS Administration 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Begin 3-day Diary Card 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CBC / differential 
EDTA 
3 
 
3 
 
 
 
 
3 
 
3 
3 
 
3 
 
 
 
 
 
4ALT, AST, ALP, creatinine (total 
bili, BUN, albumin, protein, 
calcium, Na, K, Cl, CO2, glucose) 
GLT 
4 
 
4 
 
 
 
 
4 
 
4 
4 
 
4 
 
 
 
 
 
Urine protein 
 
X 
 
X 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
5Pregnancy test: urine or serum 
 
X 
X 
X 
 
 
 
 
 
 
 
X 
 
 
 
 
X 
 
X 
5Pregnancy prevention counseling/ 
Reproductive Information Form 
 
X 
X 
X 
 
 
 
 
 
 
 
X 
 
 
 
 
X 
 
X 
HIV EIA (other tests, if needed) 
SST 
4 
 
 
 
 
 
 
 
 
4 
 
 
 
 
 
 
 
 
HIV prevention counseling 
 
X 
 
X 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
 
6HLA type 
EDTA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
20 
 
 
 
Research Samples 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Timed PK samples 
SST 
 
 
4 
4 
4 
4 
4 
4 
4 
4 
4 
4 
4 
4 
4 
4 
4 
4 
7Oral sample 
 
 
[X] 
 
 
 
 
 
 
 
[X] 
 
 
 
 
[X] 
 
 
 
PBMC and plasma 
EDTA 
20 
20 
 
 
 
 
 
 
 
 
 
 
20 
 
 
 
 
 
Serum 
SST 
24 
24 
16 
 
 
 
 
 
16 
16 
16 
16 
16 
16 
16 
16 
16 
16 
Daily Volume (mL) 
 
55 
44 
27 
4 
4 
4 
4 
11 
20 
31 
27 
20 
47 
20 
40 
20 
20 
20 
Cumulative Volume (mL) 
 
55 
99 
126 
130 
134 
138 
142 
153 
173 
204 
231 
251 
298 
318 
358 
378 
398 
418 
1 Day 0=day of first product administration.  Day 0 is preferably scheduled within 14 days after enrollment, but may be scheduled up to 42 days after enrollment to allow for the possibility of 
study pauses or scheduling difficulty with the approval of the PI. Day 0 evaluations prior to product administration are the baseline for assessing subsequent AEs.   
2 Screening includes physical exam with vital signs, height (ht) and weight (wt).  At other visits, if medically indicated, a targeted exam is performed. Otherwise only blood pressure (BP), 
pulse, and temperature are required, except at Visit 02 when the current weight is also obtained to use for ordering the study product, dosed based on “mg/kg”. 
3 The PK blood draw “visits,” defined by hours after an infusion, are relative to the exact time of the end of infusion (EOI).  The exact start and end times of product administration and the 
time of PK blood draw(s) are recorded to ensure accurate PK analysis.  All subjects will be observed for 4 hours after each product administration.  
4 ALT, AST, ALP and creatinine will be collected at all scheduled timepoints. Comprehensive metabolic panel (CMP) will be collected at screening, baseline, and 2 weeks after each product 
administration and as needed at additional timepoints.   
5 Pregnancy test results must be negative for women of reproductive potential before each product administration. Complete a Reproductive Information Form when pregnancy test is given.   
6 HLA type blood sample is collected once at any timepoint in the study and is shown as a Visit 11 evaluation for convenience; however, if HLA type is already available in the medical 
record it does not need to be repeated.  HLA type may also be obtained from a frozen sample.  
7 Oral mucosa sample collection is encouraged but not mandatory. Oral samples will not be collected for Group 1.  [X] indicates optional, as needed. 
Visit windows: Visits 02A, 02B and 02C (±10 min); Visit 02D (-2 hrs), Visits 03, 04 (± 6 hrs); Visits 06, 07, 08, 09 (±2 days), and Visits 10, 11, 15, 16 and 17 (±7 days).  
Visits 05, 12, 13 and 14 are not applicable to Schedule 1. 
 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 56 of 62 
Schedule 2: Group 3 (5 mg/kg SC) 
Visit Number 
01R 
02 
02A 
03 
04 
05 
06 
07 
08 
09 
10 
11 
15 
16 
17 
Time After Infusion 
 
Pre 
EOI 
24hr 
48hr 
72hr 
Wk1 
Wk2 
Wk3 
Wk4 
Wk8 
Wk12 
Wk16 
Wk20 
Wk24 
1Day of Study -42 to -1 
D0 
D0 
D1 
D2 
D3 
D7 
D14 
D21 
D28 
D56 
D84 
D112 
D140 
D168 
Clinical 
Tube 
Screen 
Enroll 
Day of injection 
 
 
 
 
 
 
 
 
 
 
 
 
VRC 500 Screening Consent 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
VRC 605 AoU; Consent 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2Screen: Physical exam, ht, wt; Other: 
targeted exam, BP, pulse, temp; also 
wt at visit 02 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Complete med history at screen; then 
interim med history 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
3VRC07-523LS Administration 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Begin 3-day Diary Card 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
CBC / differential 
EDTA 
3 
 
3 
 
3 
 
 
3 
3 
 
3 
 
 
 
 
 
4ALT, AST, ALP, creatinine (total bili, 
BUN, albumin, protein, calcium, Na, 
K, Cl, CO2, glucose) 
GLT 
4 
 
4 
 
4 
 
 
4 
4 
 
4 
 
 
 
 
 
Urine protein 
 
X 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
 
5Pregnancy test: urine or serum 
 
X 
X 
X 
 
 
 
 
 
X 
 
 
 
 
X 
 
X 
5Pregnancy prevention counseling/ 
Reproductive Information Form 
 
X 
X 
X 
 
 
 
 
 
X 
 
 
 
 
X 
 
X 
HIV EIA (other tests, if needed) 
SST 
4 
 
 
 
 
 
4 
 
 
 
 
 
 
 
 
 
HIV prevention counseling 
 
X 
 
X 
 
 
 
X 
 
 
 
 
 
 
 
X 
 
6HLA type 
EDTA 
 
 
 
 
 
 
 
 
 
 
 
 
20 
 
 
 
Research Samples 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Timed PK samples 
SST 
 
 
4 
 
4 
4 
4 
4 
4 
4 
4 
4 
4 
4 
4 
4 
7Oral sample  
 
 
[X] 
 
 
 
 
 
[X] 
 
 
 
 
[X] 
 
 
 
PBMC and plasma 
EDTA 
20 
20 
 
 
 
 
 
 
 
 
20 
 
 
 
 
 
Serum 
SST 
24 
24 
16 
 
 
16 
16 
16 
16 
16 
16 
16 
16 
16 
16 
16 
Daily Volume (mL) 
 
55 
44 
27 
0 
11 
20 
24 
27 
27 
20 
47 
20 
40 
20 
20 
20 
Cumulative Volume (mL) 
 
55 
99 
126 
126 
137 
157 
181 
208 
235 
255 
302 
322 
362 
382 
402 
422 
1 Day 0=day of first product administration.  Day 0 is preferably scheduled within 14 days after enrollment, but may be scheduled up to 42 days after enrollment to allow for the possibility 
of study pauses or scheduling difficulty with the approval of the PI.  Day 0 evaluations prior to product administration are the baseline for assessing subsequent AEs.   
2 Screening includes physical exam with vital signs, height (ht) and weight (wt).  At other visits, if medically indicated, a targeted exam is performed. Otherwise only blood pressure (BP), 
pulse, and temperature are required, except at Visit 02 when the current weight is also obtained to use for ordering the study product, dosed based on “mg/kg”. 
3 The PK blood draw “visits,” defined by hours after an injection, are relative to the exact time of the end of injection (EOI).  The exact start and end times of product administration and the 
time of PK blood draw(s) are recorded to ensure accurate PK analysis.  All subjects will be observed for 4 hours after each product administration. 
4 ALT, AST, ALP and creatinine will be collected at all scheduled timepoints. Comprehensive metabolic panel (CMP) will be collected at screening, baseline, and 2 weeks after each 
product administration and as needed at additional timepoints.   
5 Pregnancy test results must be negative for women of reproductive potential before each product administration. Complete a Reproductive Information Form when pregnancy test is given.   
6 HLA type blood sample is collected once at any timepoint in the study and is shown as a Visit 11 evaluation for convenience; however, if HLA type is already available in the medical 
record it does not need to be repeated.  HLA type may also be obtained from a frozen sample.  
7 Oral mucosa sample collection is encouraged but not mandatory.  [X] indicates optional, as needed. 
 Visit windows: Visit 02A (±10 min); Visits 03, 04, 05 (± 6 hrs); Visits 06, 07, 08, 09 (±2 days); Visits 10, 11, 15, 16, 17 (±7 days). Visits 12-14 are not applicable to Schedule 2. 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 57 of 62 
Schedule 3: Group 6 (5 mg/kg SC by repeat dosing) 
Visit Number 
01R 
02 
02A 
03 
04 
05 
06 
07 
09 
10 
11 
11A 
11E 
12 
13 
14 
15 
16 
17 
17A 
17E 
Time After Infusion 
 
Pre 
D0 
EOI 
D0 
24hr 48h 72hr 1wk Wk2 Wk4 Wk8 
Pre 
Wk12 
EOI 
Wk12 24hr 72hr Wk13 Wk14 Wk16 Wk20 Pre 
Wk24 
EOI 
Wk24 24hr 
1Day of Study -42 to -1 
D0 
D0 
D1 
D2 
D3 
D7 D14 D28 D56 D84 
D84 D85 D87 D91 D98 D112 D140 D168 D168 D169 
Clinical 
Tube Screen Enroll 
Day of 
injection 
 
 
 
 
 
 
 
Day of 
injection 
 
 
 
 
 
 
Day of 
injection 
 
VRC 500 Screening Consent 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
VRC 605 AoU; Consent 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2Screen: Physical exam, ht, wt; 
Other: targeted exam, BP, pulse, 
temp; wt at visits 02, 11, and 17 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Complete med history at screen; 
then interim med hx 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
X 
X 
X 
X 
X 
X 
 
 
3VRC07-523LS Administration 
 
 
 
X 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
 
 
Begin 3-day Diary Card 
 
 
 
X 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
 
 
Phone contact; clinic visit if 
indicated 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
CBC / diff 
EDTA 
3 
 
3 
 
3 
 
 
3 
3 
 
3 
3 
 
 
3 
3 
3 
 
3 
3 
 
 
4ALT, AST, ALP, creatinine (total 
bili, BUN, albumin, protein, 
calcium, Na, K, Cl, CO2, glucose) 
GLT 
4 
 
4 
 
4 
 
 
4 
4 
 
4 
4 
 
 
4 
4 
4 
 
4 
4 
 
 
Urine protein 
 
X 
 
X 
 
 
 
 
 
X 
 
 
X 
 
 
 
 
X 
 
 
X 
 
 
5Pregnancy test: urine or serum 
 
X 
X 
X 
 
 
 
 
 
X 
 
 
X 
 
 
 
 
X 
 
 
X 
 
 
5Pregnancy prevention counseling/ 
Reproductive Information Form 
 
X 
X 
X 
 
 
 
 
 
X 
 
 
X 
 
 
 
 
X 
 
 
X 
 
 
HIV EIA (other tests, if needed) 
SST 
4 
 
 
 
 
 
4 
 
 
 
 
 
 
 
4 
 
 
 
 
 
 
 
HIV prevention counseling 
 
X 
 
X 
 
 
 
X 
 
 
 
 
X 
 
 
X 
 
 
 
 
X 
 
 
Research Samples 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Timed PK samples 
SST 
 
 
4 
 
4 
4 
4 
4 
4 
4 
4 
4 
 
 
4 
4 
4 
4 
4 
4 
 
 
6Oral sample  
 
 
[X] 
 
 
 
 
 
 
 
 
 
[X] 
 
 
 
 
 
 
 
[X] 
 
 
PBMC and plasma 
EDTA 
20 
20 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Serum 
SST 
24 
24 
16 
 
 
16 
16 
16 
16 
16 
16 
16 
 
 
 
16 
16 
16 
16 
16 
 
 
Daily Volume (mL) 
 
55 
44 
27 
0 
11 
20 
24 
27 
27 
20 
27 
27 
0 
0 
15 
27 
27 
20 
27 
27 
0 
0 
Cumulative Volume (mL) 
 
55 
99 
126 
126 
137 157 181 208 235 255 282 
309 
309 
309 
324 
351 
378 
398 
425 452 
452 
452 
1 Day 0=day of first product administration.  Day 0 is preferably scheduled within 14 days after enrollment, but may be scheduled up to 42 days after enrollment to allow for the possibility of study pauses 
or scheduling difficulty with the approval of the PI.  Day 0 evaluations prior to product administration are the baseline for assessing subsequent AEs.   
2 Screening includes physical exam with vital signs, height (ht) and weight (wt).  At other visits, if medically indicated, a targeted exam is performed. Otherwise only blood pressure (BP) and temperature 
are required, except at Visits 02, 11, and 17 when weight is also obtained to use for ordering the study product, dosed based on “mg/kg”. 
3 The PK blood draw “visits,” defined by hours after an injection, are relative to the exact time of the end of injection (EOI).  The exact start and end times of product administration and the time of PK 
blood draw(s) are recorded to ensure accurate PK analysis.  All subjects will be observed for 4 hours after each product administration. 
4 ALT, AST, ALP and creatinine will be collected at all scheduled timepoints. Comprehensive metabolic panel (CMP) will be collected at screening, baseline, and 2 weeks after each product 
administration and as needed at additional timepoints.   
5 Pregnancy test results must be negative before each study product administration.  Complete a Reproductive Information Form when pregnancy test is given.  
6 Oral mucosa sample collection is encouraged but not mandatory. [X] indicates optional, as needed. 
*Subjects who discontinue product administration may be followed weekly for 4 weeks, then monthly for 24 weeks after last administration, per Schedule 3 (continued). 
Visit windows: Visit A (±10 min); Visit E (+ 1 day); Visits 03, 04, 05, 12, and 18 (± 6 hrs); Visits 06, 07, 13, and 14 (±2 days); Visits 09, 10, 11, 15, 16 and 17 (±7 days, with not less than 21 days 
between injections). Visits 08, 11B, 11C, 17B, and 17C are not applicable to Schedule 3. 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 58 of 62 
 
 
 
Schedule 3 (continued): Group 6 (5 mg/kg SC by repeat dosing) 
Visit Number* 
18 
19 
20 
21 
22 
23 
24 
25 
26 
27 
Time After Infusion 
72hr 
Wk25 Wk26 Wk27 Wk28 Wk32 Wk36 Wk40 Wk44 Wk48 
Day of Study 
D171 
D175 
D182 
D189 
D196 
D224 
D252 
D280 
D308 
D336 
Clinical 
Tube 
 
 
 
 
 
 
 
 
 
 
 Targeted physical exam, BP, pulse, temp 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Complete med history at screen; then interim med hx 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
CBC / diff 
EDTA 
3 
3 
3 
 
3 
 
 
 
 
 
1ALT, AST, ALP, creatinine (total bili, BUN, albumin, 
protein, calcium, Na, K, Cl, CO2, glucose) 
GLT 
4 
4 
4 
 
4 
 
 
 
 
 
Urine protein 
 
 
 
X 
 
 
 
 
 
 
 
Pregnancy test: urine or serum 
 
 
 
X 
 
 
 
X 
 
 
X 
2Pregnancy prevention counseling / Reproductive 
Information Form 
 
 
 
X 
 
 
 
X 
 
 
X 
HIV EIA (other tests, if needed) 
SST 
4 
 
 
 
 
 
 
 
 
 
HIV prevention counseling 
 
X 
 
 
 
 
 
X 
 
 
 
3HLA type 
EDTA 
 
 
20 
 
 
 
 
 
 
 
Research Samples 
 
 
 
 
 
 
 
 
 
 
 
Timed PK samples 
SST 
4 
4 
4 
4 
4 
4 
4 
4 
4 
4 
4Oral sample  
 
 
 
 
 
[X] 
 
 
[X] 
 
[X] 
PBMC and plasma 
EDTA 
 
 
20 
 
 
 
 
 
 
 
Serum 
SST 
 
16 
16 
16 
16 
16 
16 
16 
16 
16 
Daily Volume (mL) 
 
15 
27 
67 
20 
27 
20 
20 
20 
20 
20 
Cumulative Volume (mL) 
 
467 
494 
561 
581 
608 
628 
648 
668 
688 
708 
 
1 ALT, AST, ALP and creatinine will be collected at all scheduled timepoints. Comprehensive metabolic panel (CMP) will be collected at screening, baseline, 
and 2 weeks after each product administration and as needed at additional timepoints 
2 Complete a Reproductive Information Form when pregnancy test is given. 
3 HLA type blood sample is collected once at any timepoint in the study and is shown as a Visit 20 evaluation for convenience; however, if HLA type is already 
available in the medical record it does not need to be repeated.  HLA type may also be obtained from a frozen sample. 
4 Oral mucosa sample collection is encouraged but not mandatory. [X] indicates optional, as needed. 
* Subjects who discontinue product administration may be followed weekly for 4 weeks, then monthly for 24 weeks after last injection, per Schedule 3 
(continued). 
Visit windows: Visit 18 (± 6 hrs), Visits 19-22 (±2 days), and Visits 23-27 (±7 days).  
 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 59 of 62 
Schedule 4: Group 7 (20 mg/kg IV by repeat dosing) 
Visit Number 
01R 
02 
02A 02B 02C 02D 03 
04 
06 
07 
09 
10 
11 
11A 11B 
11E 
12 
13 
14 
15 
16 
17 
17A 17B 
Time After Day 0 Infusion 
 
Pre 
D0 
EOI 
D0 
1hr 
3h 
6h 24hr 48h Wk1 Wk2 Wk4 Wk8 Pre 
Wk12 
EOI 
Wk12 1hr 
24hr 72hr Wk13 Wk14 Wk16 Wk20 Pre 
Wk24 
EOI 
Wk24 1hr 
1Day of Study -42 to -1 D0 
D0 
D0 
D0 
D0 
D1 
D2 
D7 D14 D28 D56 D84 D84 D84 D85 D87 D91 D98 D112 D140 D168 D168 D168 
Clinical 
Tube Screen Enroll 
Day of infusion 
 
 
 
 
 
 
Day of infusion 
 
 
 
 
 
 
Day of infusion 
VRC 500 Screening Consent 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
VRC 605 AoU; Consent 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2Screen: Physical exam, ht, wt; 
Other: targeted exam, BP, pulse, 
temp; also wt at visits 02, 11, 17 
 
X 
X 
X 
X 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
 
Complete med history at screen; 
then interim med hx 
 
X 
X 
X 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
 
 
 
X 
X 
X 
X 
X 
X 
 
 
3VRC07-523LS Administration 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
X 
 
 
Begin 3-day Diary Card 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
X 
 
 
Phone contact; clinic visit if 
indicated 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
CBC / diff 
EDTA 
3 
 
3 
 
 
 
 
3 
 
3 
3 
 
3 
3 
 
 
 
3 
3 
3 
 
3 
3 
 
 
4ALT, AST, ALP, creatinine (total 
bili, BUN, albumin, protein, 
calcium, Na, K, Cl, CO2, glucose) 
GLT 
4 
 
4 
 
 
 
 
4 
 
4 
4 
 
4 
4 
 
 
 
4 
4 
4 
 
4 
4 
 
 
Urine protein 
 
X 
 
X 
 
 
 
 
 
 
 
X 
 
 
X 
 
 
 
 
 
X 
 
 
X 
 
 
 5Pregnancy test: urine or serum 
 
X 
X 
X 
 
 
 
 
 
 
 
X 
 
 
X 
 
 
 
 
 
X 
 
 
X 
 
 
 5Pregnancy prevention counseling/   
Reproductive Information Form 
 
X 
X 
X 
 
 
 
 
 
 
 
X 
 
 
X 
 
 
 
 
 
X 
 
 
X 
 
 
HIV EIA (other tests, if needed) 
SST 
4 
 
 
 
 
 
 
 
 
4 
 
 
 
 
 
 
 
 
4 
 
 
 
 
 
 
HIV prevention counseling 
 
X 
 
X 
 
 
 
 
 
 
X 
 
 
 
X 
 
 
 
 
X 
 
 
 
X 
 
 
Research Samples 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Timed PK samples 
SST 
 
 
4 
4 
4 
4 
4 
4 
4 
4 
4 
4 
4 
4 
4 
4 
 
 
4 
4 
4 
4 
4 
4 
4 
6Oral sample (all participants) 
 
 
[X] 
 
 
 
 
 
 
 
 
 
 
 
[X] 
 
 
 
 
 
 
 
 
[X] 
 
 
PBMC and plasma 
EDTA 
20 
20 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Serum 
SST 
24 
24 
16 
 
 
 
 
 
16 
16 
16 
16 
16 
16 
 
 
 
 
16 
16 
16 
16 
16 
 
 
Daily Volume (mL) 
 
55 
44 
27 
4 
4 
4 
4 
11 
20 
31 
27 
20 
27 
27 
4 
4 
0 
7 
31 
27 
20 
27 
27 
4 
4 
Cumulative Volume (mL) 
 
55 
99 
126 130 134 138 142 153 173 204 231 251 278 305 
309 
313 
313 
320 
351 
378 
398 
425 
452 
456 
460 
1 Day 0=day of first product administration.  Day 0 is preferably scheduled within 14 days after enrollment, but may be scheduled up to 42 days after enrollment to allow for the possibility of study pauses or 
scheduling difficulty with the approval of the PI. Day 0 evaluations prior to product administration are the baseline for assessing subsequent AEs.   
2 Screening includes physical exam with vital signs, height (ht) and weight (wt).  At other visits, if medically indicated, a targeted exam is performed. Otherwise only blood pressure (BP), pulse, and 
temperature are required, except at Visits 02, 11, and 17 when the current weight is also obtained to use for ordering the study product, dosed based on “mg/kg”. 
3 The PK blood draw “visits,” defined by hours after an infusion, are relative to the exact time of the end of infusion.  Exact start and end times of product administration and the time of PK blood draw(s) are 
recorded to ensure accurate PK analysis.  All subjects will be observed for 4 hours after each product administration. 
4 ALT, AST, ALP and creatinine will be collected at all scheduled timepoints. Comprehensive metabolic panel (CMP) will be collected at screening, baseline, and 2 weeks after each product administration 
and as needed at additional timepoints.   
5 Pregnancy test results must be negative for women of reproductive potential before each product administration. Complete a Reproductive Information Form when pregnancy test given.  
6 Oral mucosa sample collection is encouraged but not mandatory. [X] indicates optional, as needed. 
*Subjects who discontinue product administration may be followed weekly for 4 weeks, then monthly for 24 weeks after last administration, per Schedule 4 (continued). 
Visit windows: Visits A, B, and C (±10 min); Visit 02D (-2 hrs); Visit E (+1 day); Visits 03, and 04 (±6 hrs); Visits 06, 07, 13, and 14 (±2 days); Visit 12 (+2 days), Visits 09, 10, 11, 15, 16 and 17 (±7 days, 
with not less than 21 days between infusions). Visits 05, 08, and 18 are not applicable to Schedule 4. 
 

PRODUCT: VRC-HIVMAB075-00-AB                                                                         
 PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 60 of 62 
Schedule 4 (continued): Group 7 (20 mg/kg IV by repeat dosing) 
Visit Number* 
17E 
18 
19 
20 
21 
22 
23 
24 
25 
26 
27 
Time After Infusion 
24hr 
72hr 
Wk25 
Wk26 Wk27 
Wk28 
Wk32 
Wk36 Wk40 
Wk44 
Wk48 
Day of Study 
D169 
D171 
D175 
D182 
D189 
D196 
D224 
D252 
D280 
D308 
D336 
Clinical 
Tube 
 
 
 
 
 
 
 
 
 
 
 
Targeted physical exam, BP, pulse, temp 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Complete med history at screen; then interim med hx 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Phone contact; clinic visit if indicated 
 
X 
 
 
 
 
 
 
 
 
 
 
CBC / diff 
EDTA 
 
3 
3 
3 
 
3 
3 
 
 
 
 
1ALT, AST, ALP, creatinine (total bili, BUN, albumin, protein, 
calcium, Na, K, Cl, CO2, glucose) 
GLT 
 
4 
4 
4 
 
4 
4 
 
 
 
 
Urine protein 
 
 
 
 
X 
 
 
 
 
 
 
 
Pregnancy test: urine or serum 
 
 
 
 
X 
 
 
 
X 
 
 
X 
2Pregnancy prevention counseling / Reproductive Information Form 
 
 
 
 
X 
 
 
 
X 
 
 
X 
HIV EIA (other tests, if needed) 
SST 
 
 
4 
 
 
 
 
 
 
 
 
HIV prevention counseling 
 
 
 
X 
 
 
 
 
X 
 
 
 
3HLA type 
EDTA 
 
 
 
20 
 
 
 
 
 
 
 
Research Samples 
 
 
 
 
 
 
 
 
 
 
 
 
Timed PK samples 
SST 
 
 
4 
4 
4 
4 
4 
4 
4 
4 
4 
4Oral sample 
 
 
 
 
 
 
[X] 
 
 
[X] 
 
[X] 
PBMC and plasma 
EDTA 
 
 
 
20 
 
 
 
 
 
 
 
Serum 
SST 
 
 
16 
16 
16 
16 
16 
16 
16 
16 
16 
Daily Volume (mL) 
 
0 
7 
31 
67 
20 
27 
27 
20 
20 
20 
20 
Cumulative Volume (mL) 
 
460 
467 
498 
565 
585 
612 
639 
659 
679 
699 
719 
 
1 ALT, AST, ALP and creatinine will be collected at all scheduled timepoints. Comprehensive metabolic panel (CMP) will be collected at screening, baseline, and 2 weeks 
after each product administration and as needed at additional timepoints.   
2 Complete a Reproductive Information Form when pregnancy test is given.   
3 HLA type blood sample is collected once at any timepoint in the study and is shown as a Visit 20 evaluation for convenience; however, if HLA type is already available in 
the medical record, it does not need to be repeated.  HLA type may also be obtained from a frozen sample. 
4 Oral mucosa sample collection is encouraged but not mandatory. [X] indicates optional, as needed. 
*Subjects who discontinue product administration may be followed weekly for 4 weeks, then monthly for 24 weeks after last infusion, per Schedule 4 (continued). 
Visit windows: Visit 17E (+1 day); Visit 18 (+2 days), Visits 19-22 (±2 days), and Visits 23-27 (±7 days).  

PRODUCT: VRC-HIVMAB075-00-AB                                                                          PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 61 of 62 
Appendix IV: Table for Grading Severity of Adverse Events

PRODUCT: VRC-HIVMAB075-00-AB                                                                          PROTOCOL: VRC 605, VERSION 4.0 
 
PROTOCOL DATE: OCTOBER 11, 2017    
Page 62 of 62 
The U.S. Department of Health and Human Services, National Institutes of Health, National 
Institute of Allergy and Infectious Diseases, Division of AIDS. Division of AIDS (DAIDS) 
Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0. [November 
2014] will be used in this study. The table is available at the following link: 
http://rsc.tech-res.com/docs/default-
source/safety/daids_ae_grading_table_v2_nov2014.pdf?sfvrsn=8 
 
The Table will be used as posted at the link above with the following exemptions: 
• Weight loss will be recorded as an AE only if it is considered deleterious to the 
participant’s health. 
• For severity grading of the solicited bruising parameter at the product administration site, 
the definitions based on size of the largest diameter and listed for the “Injection Site 
Erythema or Redness” will be used. The severity grade definition for “Bruising” provided 
under the Dermatologic Clinical Conditions will be used only for unsolicited AEs 
involving bruising at other body locations. 
 

 
 
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY 
   MEDICAL RECORD 
               •  Adult Patient or     •  Parent, for Minor Patient 
 
 
INSTITUTE: 
National Institute of Allergy and Infectious Diseases 
 
 
STUDY NUMBER: 
17-I-0030 
 
PRINCIPAL INVESTIGATOR:  Martin Gaudinski, M.D. 
 
 
STUDY TITLE: 
VRC 605: A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of a Human 
Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered Intravenously or 
Subcutaneously to Healthy Adults 
 
Initial Review Approved by the IRB on 12/13/16  
 
 
Amendment Approved by the IRB on 08/15/17 (E) 
 
 
 
Date Posted to Web: 08/22/17 
Study Consent, [Version 3.0] 
 
 
PATIENT IDENTIFICATION 
CONSENT TO PARTICIPATE IN A CLINICAL 
 
RESEARCH STUDY 
 
•   Adult Patient or    •   Parent, for Minor Patient 
 
NIH-2514-1 (07-09) 
 
P.A.: 09-25-0099 
 
File in Section 4:  Protocol Consent (1) 
 
INTRODUCTION 
We invite you to take part in a research study at the National Institutes of Health (NIH). 
First, we want you to know that: 
 
Taking part in NIH research is entirely voluntary. 
 
You may choose not to take part, or you may withdraw from the study at any time.  In either case, you will not 
lose any benefits to which you are otherwise entitled.  However, to receive care at the NIH, you must be taking 
part in a study or be under evaluation for study participation. 
 
You may receive no benefit from taking part.  The research may give us knowledge that may help people in the 
future. 
Second, some people have personal, religious or ethical beliefs that may limit the kinds of medical or research treatments 
they would want to receive (such as blood transfusions).  If you have such beliefs, please discuss them with your NIH 
doctors or research team before you agree to the study. 
Now we will describe this research study.  Before you decide to take part, please take as much time as you need to ask 
any questions and discuss this study with anyone at NIH, or with family, friends or your personal physician or other health 
professional. 
PURPOSE AND PLAN OF THE STUDY 
This is the study of an experimental product called “VRC07-523LS.”  The U.S. Food and Drug Administration (FDA) allows 
it to be used for research only. VRC07-523LS is an antibody directed against HIV virus.  The human body uses antibodies 
as one way to help fight infection.  There is currently no cure for HIV or vaccine to prevent it.   
The main purpose of this study is to see if the experimental product is safe and well-tolerated.  We will study the amount 
of VRC07-523LS in the body and how it changes over time.  We will check to see if people who get VRC07-523LS make an 
immune response (antibody) to it. 
About 25 to 40 people will participate in this study at the NIH Clinical Center in Bethesda, Maryland.  The study will have 
about 13-27 clinic visits over 24-48 weeks for each person, depending on the study group. 

 
  
CONTINUATION SHEET for either: 
  MEDICAL RECORD 
NIH 2514-1, Consent to Participate in A Clinical Research Study 
 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research Study 
STUDY NUMBER: 17-I-0030 
 
 
CONTINUATION: Page 2 of 9  pages 
 
 
 
 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
 
NIH-2514-1 (10-84) 
 
NIH-2514-2 (10-84) 
 
P.A.: 09-25-0099 
STUDY PRODUCT 
VRC07-523LS is a monoclonal antibody or “MAb.”  An antibody is a protein that is used by the immune system to find and 
block bacteria and viruses, like HIV.  Monoclonal means that all the antibodies in the product are the same.   
The formal name for the product is VRC-HIVMAB075-00-AB.  VRC07-523LS is a human antibody but it is a genetically 
modified synthetic product.  It was made based on an antibody that was first found in an HIV-infected person.  Although 
the antibody was found in a human, the product is not made by collecting it from a human.   
VRC07-523LS was developed by the Vaccine Research Center (VRC) at NIH.  This product was made in a drug 
manufacturing laboratory.  This is the first study to give VRC07-523LS to humans. 
VRC07-523LS is similar to the monoclonal antibody VRC01 and was manufactured in a similar way.  VRC01 has been given 
to over 150 healthy and HIV-infected adults and has been found to be safe and well-tolerated. 
VRC07-523LS will not protect you from HIV infection.  Because we have never tested this product in humans, we assume 
that it cannot protect against HIV infection.  You cannot get HIV from VRC07-523LS because there are no parts of HIV in 
it. 
In laboratory and animal studies, VRC07-523LS was shown to attach to and inactivate many types of HIV viruses.  We do 
not know if the product will act the same way when given to humans.  It will take many studies to learn if the product will 
be useful for preventing or treating HIV.  This study alone will not answer this question. 
ELIGIBILITY 
You are eligible to participate in this study because you have completed the screening process and are known to be the 
following: 
• 
18 to 50 years old 
• 
In general good health without significant medical problems as determined at screening 
• 
Willing to get VRC07-523LS 
• 
Willing to donate blood samples for future research 
• 
Willing to be tested for HIV infection 
• 
If female and able to get pregnant: willing to use birth control for the whole study. 
STUDY PROCEDURES 
The study will have 7 groups.  Each group will have about 3-5 people in it.  The groups are defined by the dose of VRC07-
523LS and how it is given.  Most people will get VRC07-523LS by the intravenous (IV) route, meaning into a vein.  Some 
people will get VRC07-523LS by the subcutaneous (SC) route, meaning into the fatty tissue under the skin.  Both methods 
use a needle.  The product administration visit(s) will last about 8 hours.  Other clinic visits will take about 2 hours.   
The study will last about 24 weeks for people in Groups 1-5 because they will only get the study product one time.  The 
study will last for about 48 weeks for people in Groups 6 and 7 because they will get the study product three times.   
People in Groups 1-5 will get different doses of the study product 1 time so we can see how long it lasts in the body and if 
higher doses are safe. 
People in Groups 6 and 7 will get the study product 3 times instead of 1 time so we can see if repeat doses are better.  
We also want to see if it is better to give the study product by the IV or SC routes.  This information will be helpful for 
future uses of the product.  
If you agree to take part in this study, you will get 1 or 3 doses of VRC07-523LS, depending on the group.  You will know 
how many doses you will get once you enroll.  The amount of study product you will get is calculated based on your body 
weight.  We will measure your weight on the day the study product is given to calculate the dose. 
 

 
  
CONTINUATION SHEET for either: 
  MEDICAL RECORD 
NIH 2514-1, Consent to Participate in A Clinical Research Study 
 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research Study 
STUDY NUMBER: 17-I-0030 
 
 
CONTINUATION: Page 3 of 9  pages 
 
 
 
 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
 
NIH-2514-1 (10-84) 
 
NIH-2514-2 (10-84) 
 
P.A.: 09-25-0099 
The Study Groups are shown in the following table: 
Group 
Subjects 
Schedule 
Day 0 
Week 12 
Week 24 
1 
3 
1 mg/kg  IV 
 
 
2 
3 
5 mg/kg  IV 
 
 
3 
3 
5 mg/kg  SC 
 
 
4 
3 
20 mg/kg  IV 
 
 
5 
3 
40 mg/kg  IV 
 
 
6 
5 
5 mg/kg  SC 
5 mg/kg  SC 
5 mg/kg  SC 
7 
5 
20 mg/kg  IV 
20 mg/kg  IV 
20 mg/kg  IV 
Total 
25 
 More people may be enrolled, if needed, to reach the study goals. 
The study will start by assigning subjects to get the lowest dose of VRC07-523LS in Group 1.  If people in the lower dose 
groups tolerate the study product, the next dose groups may enroll.  This pattern will continue until we reach the highest 
dose.  People who are available for 24 weeks of study participation may enroll into Groups 1 to 5.  People who are 
available for 48 weeks of study participation may enroll into Group 6 or Group 7.  For Groups 6 and 7 who will get 3 doses 
of VRC07-523LS, the second and third doses can be given once the first dose is determined to be safe.  
If you are female and able to become pregnant, a pregnancy test will be done before each product administration.  The 
result of the test must be negative for you to get study product.  You must use an effective method of birth control for the 
entire study.  
• 
Intravenous (IV) Route Dose Groups:  
If you are in a group getting VRC07-523LS by IV infusion, we will place a thin tube or IV line in a vein on your arm on 
the day you get the study product.  If needed, we will place a second IV line in a vein on your other arm for blood 
sample collection.  VRC07-523LS will be mixed into a bag of liquid called “normal saline” or salt water.  The mix of 
normal saline and VRC07-523LS will be given directly into your vein.  A pump will control how fast the study product 
goes into the vein.  The goal is to give it over about 30 minutes or longer.  If you have side effects, the rate of the 
infusion may be slowed down or stopped.  At the end of each infusion, we will monitor you for at least four hours and 
collect blood samples. 
o 
Blood sample collections for IV Groups:  
On the day of your first IV infusion of VRC07-523LS, we will collect blood samples from you before and right after 
the infusion, and about 1 hour, 3 hours, and 6 hours after the infusion.  You will also be asked to come back to the 
clinic 1 to 3 times during that first week for sample collection.  If you are in Group 7, for the second and third 
doses of VRC07-523LS, we will collect blood samples from you before and right after the infusion, and then again 
about 1 hour after the infusion.  You will also be asked to come back to the clinic 4-5 times after each repeat dose. 
• 
Subcutaneous (SC) Route Dose Groups: 
If you are in a group getting VRC07-523LS by SC injection, we will put a small needle into the fatty tissue under your 
skin.  The abdominal area is usually where the needle will be inserted in your body.  It is possible we may use your 
arm or thigh area instead.  VRC07-523LS will not be mixed with any other liquid.  You will get the SC doses by 
injection with a standard needle and syringe in 1 to 4 SC sites on your body. After all of the injections are given each 
time, we will monitor you for at least four hours.   
o 
Blood sample collections for SC Groups: 
On the day of your first SC injection of VRC07-523LS, we will collect blood samples from you before the injection.  
You will also be asked to come back to the clinic 1 to 3 times during that first week for sample collection.  If you 
are in Group 6, for the second and third doses of VRC07-523LS, we will collect blood samples from you before 
each injection.  You will also be asked to come back to the clinic 4-5 times after each repeat dose. 

 
  
CONTINUATION SHEET for either: 
  MEDICAL RECORD 
NIH 2514-1, Consent to Participate in A Clinical Research Study 
 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research Study 
STUDY NUMBER: 17-I-0030 
 
 
CONTINUATION: Page 4 of 9  pages 
 
 
 
 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
 
NIH-2514-1 (10-84) 
 
NIH-2514-2 (10-84) 
 
P.A.: 09-25-0099 
 
We will give you a thermometer and ask you to check your temperature every day for 3 days after you get the study 
product.  We will also ask you to record your temperature and any symptoms you may have. You will get a password to a 
secure website to record this information on an electronic form or “diary.” If you prefer, you can use a paper diary instead.   
If you have any side effects, you should tell a VRC nurse or doctor as soon as possible.  You can reach the staff by phone 
24 hours a day.  If you have symptoms, you may be asked to come into the clinic for an examination before your next 
scheduled visit.  It is very important that you follow the instructions from the clinic staff.  
At each visit, we will check you for any health changes or problems.  We will ask you how you are feeling and if you have 
taken any medications.  We will draw your blood at scheduled study visits, taking about 1 to 9 tubes of blood depending 
on the visit.  We may ask you to come into the clinic for additional blood collection.  We will request urine samples at 2 to 
6 visits during the study, depending on your group if you are willing.  We will tell you right away if any of your test results 
show a health problem.   
We will use some blood samples to study if your body develops an immune response (antibodies) to the study product.  
These tests are for research purposes only and are not for checking on your health.  We will not give you these results.  
After completing this study, we may invite you to take part in another study for follow-up sample collection. 
Experimental studies follow a set schedule.  This helps us answer the research questions. Scheduling for your visits allows 
some flexibility, but it is important that you work with the staff to follow the schedule.  You should try to not miss any 
visits.  You might need to have extra clinic visits and laboratory tests if you have health changes that need to be checked.  
COLLECTION OF ORAL SECRETION SAMPLES FOR RESEARCH 
If you are willing, we will collect samples of the mouth (oral/saliva) for research during 3-6 study visits, depending on 
your study group.  Collection of these samples is encouraged but not required.  If you choose to provide such samples, 
you may change your mind at any time throughout the study.  You may choose not to donate these samples but still take 
part in the study.  
Oral samples will be collected with small disposable sponges, similar to a “Q-tip,” which are made for this purpose.  Each 
sponge is new and sterile, and is safe for use in sensitive areas of the body.  
These samples are collected to see how VRC07-523LS is distributed in your body.  They will not be for checking your 
health and do not replace routine health care.  
HIV TESTING AND COUNSELING 
As part of your participation in this study, we will provide you with HIV counseling and testing. We will test you for HIV 
infection and possibly for other infections if needed to check your eligibility for the study.  We will tell you how to remain 
HIV-uninfected and give you prevention resources.  If you are infected with HIV, you will not be able to participate in this 
study.  We will tell you what the results mean, how to find care, how to avoid infecting others, how we report HIV 
infection, and the importance of informing your partners that may be at risk because of your HIV infection. 
If you have questions regarding the HIV testing, you are encouraged to discuss them with the study nurse or doctor, or 
you may call a NIH Clinical Center HIV counselor at 
. 
MONITORING OF THE STUDY 
A group of physicians and scientists at NIH will monitor this study.  This group will review the information from the study 
and will pay close attention to possible harmful reactions.  If serious side effects occur, VRC07-523LS administrations may 
be delayed or canceled. 
 

 
  
CONTINUATION SHEET for either: 
  MEDICAL RECORD 
NIH 2514-1, Consent to Participate in A Clinical Research Study 
 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research Study 
STUDY NUMBER: 17-I-0030 
 
 
CONTINUATION: Page 5 of 9  pages 
 
 
 
 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
 
NIH-2514-1 (10-84) 
 
NIH-2514-2 (10-84) 
 
P.A.: 09-25-0099 
GENETIC TESTING 
Some of the blood drawn from you as part of this study will be used for genetic tests.  Some genetic tests are done in 
research studies to see if genetic differences in people cause different types of immune responses.  Your blood sample 
used in these genetic tests will not have your name on it and the results will not be in your medical record.  These tests 
are not used to check your health and we will not tell you the results.  
A special genetic test, called HLA typing, is done by the NIH Clinical Center medical laboratory.  These results will be in 
your medical record but they will not be used to check your health.  Any genetic testing, including HLA testing, is for 
research purposes only. Any genetic information collected or learned about you will be kept confidential.  Medical records, 
including HLA test results, are kept securely.  We will not give any genetic information that is in your medical record to 
anyone without your permission. 
STORED SAMPLES 
We will collect samples (including blood and possibly oral secretions) from you during the study.  We will keep these 
samples for future research to learn more about monoclonal antibodies, vaccines, the immune system, and/or other 
medical conditions.  Results from research with your samples will not be in your medical record or reported to you.  
Labeling of Stored Samples:  We will label your stored samples by a special code or number.  Only the study team can 
link this code to you.  Any identifying information about you (like name or date of birth) will be kept as confidential as 
allowable by law.  Despite protections, there is a small chance that information identifying you will be given to someone 
who should not get it. 
Risks from Stored Samples:  There is a risk of unplanned release of information from your medical records.  The 
chance that this information will be given to an unauthorized person without your permission is very small.  Possible 
problems with the unplanned release of information include discrimination when applying for insurance and employment.  
Similar problems may occur if you give information about yourself or agree to have your medical records released. 
Future Studies:  In the future, other investigators (at NIH or outside of NIH) may wish to study your stored samples.  
When your stored samples are shared, they will be marked with a code.  Your samples will not have any identifying 
information on them.  Some information about you, such as your gender, age, health history, or ethnicity may also be 
shared with other researchers. 
Any future research studies using your samples will be conducted in a way that protects the rights and privacy of study 
participants.  Your stored samples will be used only for research and will not be sold.  The research done with your 
materials may be used to develop new products in the future but you will not receive payment for such products. 
Making your Choice:  You cannot take part in this study if you do not want us to collect or store your blood samples.  If 
you agree to take part in this study, you must also agree to let us keep any of your samples for future research.  If you 
decide not to take part in this study, you may still take part in other studies at NIH. 
POSSIBLE STUDY RISKS 
Risks from IV infusions or SC injections:  It is possible that you may have some side effects.  General risks of methods 
that use a needle include stinging, discomfort, pain, soreness, redness, bruising, swelling or a tiny cut at the needle 
insertion site. 
Risks of VRC07-523LS:  This study is the first time that VRC07-523LS is being given to people.   
VRC07-523LS is similar to the VRC monoclonal antibody, VRC01.  More than 150 adults have received one or more doses 
of VRC01 by IV or SC routes.  There were no safety concerns and no concerning reactions to the product.  However, 
VRC07-523LS may have additional unknown risks and side effects. 
 
There are several antibody products that are permitted for use in people.  Other antibody products have been given safely 

 
  
CONTINUATION SHEET for either: 
  MEDICAL RECORD 
NIH 2514-1, Consent to Participate in A Clinical Research Study 
 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research Study 
STUDY NUMBER: 17-I-0030 
 
 
CONTINUATION: Page 6 of 9  pages 
 
 
 
 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
 
NIH-2514-1 (10-84) 
 
NIH-2514-2 (10-84) 
 
P.A.: 09-25-0099 
by both the IV and the SC route.  Local reactions at the site of the SC injections are common, but these reactions are 
usually mild and resolve in a few days.  Most side effects tend to occur within the first 24 hours. 
Side effects to study product infusions may include fever, chills, shaking, nausea, vomiting, pain, headache, dizziness, 
trouble breathing, high or low blood pressure, itchiness, rash, hives, lip or face swelling, diarrhea, racing heart or chest 
pain. These reactions may be related to how fast the antibody product is given.  However, we rarely saw these reactions 
when VRC01 was given. When reactions were reported, they were usually mild.  VRC01 given by the SC route has 
sometimes caused mild itchiness, redness and/or swelling at site of injection. These symptoms usually cleared within a 
few minutes to hours after the product was given. In an ongoing study, additional product injections were discontinued 
for one subject who developed mild chest discomfort and for one subject who developed mild rash that were associated 
with study product administration (VRC01 or placebo).  
We are giving VRC07-523LS at a controlled rate.  If symptoms occur while VRC07-523LS is being given, tell the nurse.  
Slowing or stopping the flow rate may help improve the symptoms.    
Some antibody products have a risk of serious allergic reactions that can be life-threatening.   
• 
Anaphylaxis is one type of allergic reaction that may happen soon after an antibody product is given.  This reaction 
can include difficulty breathing, low blood pressure, hives or rash, swelling in the mouth and face.  
• 
Serum sickness is a delayed type of allergic reaction that may happen several days to three weeks after an antibody 
product is given.  This reaction can include hives or rash, fever, enlarged lymph nodes, muscle pains, joint pains, 
chest discomfort and shortness of breath.   
Some antibodies of the type that attack human proteins can increase the risk of serious infections.  VRC07-523LS is not 
expected to increase the risk of serious infections because it attacks a virus and not a human protein. 
In addition to the possible risks that are listed above, VRC07-523LS may have other side effects that we do not know 
about yet.  Participation in this study may affect your eligibility for future monoclonal antibody studies.  We will give you 
any new information about risks or other information that becomes available that may affect your decision to continue in 
the study. 
Risks of Blood Drawing:  Blood drawing may cause pain and bruising and rarely, may cause a feeling of lightheadedness 
or fainting.  Rarely, it may cause infection at the site where the blood is taken.  In this study on the day of an infusion, an 
IV line may be placed in your vein and left for a few hours.  Problems at the IV site are usually mild and may include pain, 
bruising, minor swelling or bleeding.  Rarely, there may be an infection, vein irritation, or a blood clot.   
Risks of Oral Mucosa Sample Collection:  Collection of samples by swabs and wicks by rubbing them over the mucosal 
surfaces in the mouth can cause brief discomfort and, rarely, a little bleeding.  
Risk of a False Positive HIV Antibody Test Caused by VRC07-523LS:  An HIV antibody test is the usual way to test for HIV 
infection.  VRC01 and VRC07-523LS are antibodies against HIV.  Based on laboratory testing, VRC01 does not cause a 
positive HIV antibody test in standard diagnostic tests.  Since VRC07-523LS is similar to VRC01, we expect that VRC07-
523LS does not cause a positive HIV antibody test.  However, we do not know yet if it will cause a positive HIV antibody 
test or not.  We will test for HIV antibodies at some visits.  If you ever need or want an HIV test while you are on the 
study, please ask the VRC Clinic to do the test.  We will tell you the results of your HIV test. 
Risks during Pregnancy:  We do not know what effects VRC07-523LS may have on a fetus or nursing infant.  Women who 
are able to have children must agree to not get pregnant during study participation.  We will discuss effective birth control 
methods with you.  
You must notify the clinic staff right away if you get pregnant during this study or think that you might be pregnant. If 
you get pregnant, you will not get any more VRC07-523LS administrations and we will not collect any more blood for 
research.  However, you will be asked to continue with study follow-up visits to check on your health and to report the 
outcome of the pregnancy to us, which will be reported to the antiretroviral pregnancy registry (http://www.apregistry.com).  
 

 
  
CONTINUATION SHEET for either: 
  MEDICAL RECORD 
NIH 2514-1, Consent to Participate in A Clinical Research Study 
 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research Study 
STUDY NUMBER: 17-I-0030 
 
 
CONTINUATION: Page 7 of 9  pages 
 
 
 
 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
 
NIH-2514-1 (10-84) 
 
NIH-2514-2 (10-84) 
 
P.A.: 09-25-0099 
POSSIBLE BENEFITS 
This study will not provide you with any direct health benefit. You and others may benefit in the future from the 
information that we learn from the study. 
 
COSTS TO YOU FOR PARTICIPATION 
There are no costs to you for participating in this study.  You or your health insurance will have to pay for all medical 
costs for medical care that you get outside this study. 
COMPENSATION TO YOU FOR YOUR PARTICIPATION 
You will be compensated for your time and inconvenience by the NIH Clinical Research Volunteer Program.  It is possible 
that you may have some expenses that are not covered by the compensation provided. 
The compensation is $175 for scheduled visits with blood drawing and oral swabs; $375 for IV product administration 
visit(s) that includes follow-up blood sample collections on the same day, and $325 for SC product administration visit(s) 
without follow-up sample collections on the same day.  Compensation for timely completion of all 3 days of an electronic 
diary will be $25 total.  Additional compensation for clinic visits that do not include research blood sample collection will 
be $75.  Total compensation for completion of the study is estimated to range from $2475 to $5425 and is based on the 
number and type of study visits you complete.   
You will get your compensation about 2 weeks after each completed visit by direct deposit into a bank account that you 
specify to the volunteer payment office.  Your compensation may need to be reported to the internal revenue service 
(IRS) as taxable income. 
REASONS FOR DISCONTINUING STUDY PRODUCT ADMINISTRATION OR REMOVING YOU FROM THE 
STUDY 
You may be stopped from getting VRC07-523LS for several different reasons, including: 
• 
You don't keep appointments or follow study procedures. 
• 
You get a serious illness that needs ongoing medical care. 
• 
You have a serious side effect thought to be due to VRC07-523LS. 
• 
You enroll in another research study at the same time you are in this study. 
• 
You become pregnant. 
• 
The study is stopped or canceled. 
A study may be stopped or canceled by a study sponsor, a regulatory agency or by the study investigators.  If this 
happens, we will tell you the reason why the study was stopped. 
You may choose to stop participating in the study at any time. If you got any doses of VRC07-523LS, you will be asked to 
keep follow-up visits so we can monitor your health. We may stop collecting samples that are for research purposes only. 
ALTERNATIVES 
This study is not designed to treat or prevent any disease.  You may choose to not participate in this study.  You may be 
eligible for other studies.  

 
  
CONTINUATION SHEET for either: 
  MEDICAL RECORD 
NIH 2514-1, Consent to Participate in A Clinical Research Study 
 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research Study 
STUDY NUMBER: 17-I-0030 
 
 
CONTINUATION: Page 8 of 9  pages 
 
 
 
 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
 
NIH-2514-1 (10-84) 
 
NIH-2514-2 (10-84) 
 
P.A.: 09-25-0099 
CONFLICT OF INTEREST 
The NIH research staff is checked yearly for conflicts of interest.  You may ask the research team for more information.  
This study may have investigators who are not NIH employees.  Non-NIH investigators are expected to follow the 
principles of the Protocol Review Guide but are not required to report their personal financial holdings to the NIH. 
The NIH, including some members of the VRC scientific staff, developed the investigational product being used in this 
research study.  The results of this study could play a role in whether the FDA will approve the study product for sale at 
some time in the future.  If approved, the future sale of the study product could lead to payments to NIH and some NIH 
scientists.  By U.S. law, government scientists are required to receive such payments for their inventions.  You will not 
receive any money from the development or sale of the product.   
Manufacturing process of the investigational product used in this trial is currently not available as a stock option by any 
commercial entity.  
CLINICALTRIALS.GOV 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov.  This website will not include 
information that can identify you.  At most, the website will include a summary of the results. You can search this 
website at any time.  
 
 
 
 

 
 MEDICAL RECORD 
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY 
 
 
•  Adult Patient or    •  Parent, for Minor Patient 
STUDY NUMBER: 17-I-0030 
 
 
CONTINUATION: Page 9 of 9 pages  
 
 
 
 
PATIENT IDENTIFICATION 
CONSENT TO PARTICIPATE IN A CLINICAL 
 
RESEARCH STUDY (Continuation Sheet) 
 
•  Adult Patient or   •  Parent, for Minor Patient 
 
NIH-2514-1 (7-09) 
 
P.A.: 09-25-0099 
 
 
 
 
File in Section 4:  Protocol Consent 
 
OTHER PERTINENT INFORMATION 
 
1. Confidentiality.  When results of an NIH research study are reported in medical journals or at scientific meetings, 
the people who take part are not named and identified.  In most cases, the NIH will not release any information about 
your research involvement without your written permission.  However, if you sign a release of information form, for 
example, for an insurance company, the NIH will give the insurance company information from your medical record.  This 
information might affect (either favorably or unfavorably) the willingness of the insurance company to sell you insurance. 
 
The Federal Privacy Act protects the confidentiality of your NIH medical records.  However, you should know that the Act 
allows release of some information from your medical record without your permission, for example, if it is required by the 
Food and Drug Administration (FDA), members of Congress, law enforcement officials, or other authorized people. 
 
2. Policy Regarding Research-Related Injuries.  The Clinical Center will provide short-term medical care for any 
injury resulting from your participation in research here.  In general, no long-term medical care or financial compensation 
for research-related injuries will be provided by the NIH, the Clinical Center, or the Federal Government.  However, you 
have the right to pursue legal remedy if you believe that your injury justifies such action. 
 
3. Payments.  The amount of payment to research volunteers is guided by the NIH policies.  In general, patients are 
not paid for taking part in research studies at the NIH.  Reimbursement of travel and subsistence will be offered 
consistent with NIH guidelines. 
 
4. Problems or Questions.  If you have any problems or questions about this study or about any research-related 
injury, contact the Principal Investigator, Martin Gaudinski, M.D.., or the Study Coordinator, 
 at 
. 
 
If you have any questions about your rights as a research subject, you may call the Clinical Center Patient Representative 
at 
. 
 
5. Consent Document.  Please keep a copy of this document in case you want to read it again. 
 
 
COMPLETE APPROPRIATE ITEM(S) BELOW: 
 
Adult Study Participant’s Consent 
I have read the explanation about this study and have been given the opportunity to discuss it and to ask questions.  I 
hereby consent to take part in this study. 
 
 
 
                      
 
 
 
                                                     Time 
 
_ _        
          
Signature of Adult Participant                                   Date 
 
 
   __________________________________ 
Print Name 
 
 
THIS CONSENT DOCUMENT HAS BEEN APPROVED FOR USE  
FROM DECEMBER 13, 2016 THROUGH DECEMBER 12, 2017. 
 
 
  
 
 
  
  
  
 
Signature of Investigator/ 
Date 
Person Obtaining Consent 
 
 
   __________________________________ 
Print Name 
Signature of Witness 
Date 
 
 
 
   __________________________________ 
Print Name