VRC 608: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-EBOMAB092-00-AB (MAb114), Administered Intravenously to Healthy Adults
Phase: PHASE1
Conditions: Healthy Adult Immune Responses to Vaccine
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Official Title: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics 
of a Human Monoclonal Antibody, VRC-EBOMAB092-00-AB (MAb114), Administered 
Intravenously to Healthy Adults 
 
 
ClinicalTrials.gov Identifier: NCT03478891 
 
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 Amendment Version 4.0: January 14, 2019 
• 
IRB-approved Informed Consent Version 3.0: October 24, 2018 
 
 

 
 
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY 
   MEDICAL RECORD 
               •AdultPatientor•Parent,forMinorPatient 
 
 
INSTITUTE: 
National Institute of Allergy and Infectious Diseases 
 
 
STUDY NUMBER: 
18-I-0069 
PRINCIPAL INVESTIGATOR:  Martin Gaudinski, MD 
 
 
STUDY TITLE: 
VRC 608: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of 
a Human Monoclonal Antibody, VRC-EBOMAB092-00-AB (MAb114), Administered Intravenously 
to Healthy Adults 
 
 
Initial Review Approved by the IRB on 02/22/18  
Amendment Approved by the IRB on 10/16/18 (B) 
 
 
Date Posted to Web: 
10/24/18 
Study Consent, Version 3.0 
 
PATIENT IDENTIFICATION 
CONSENT TO PARTICIPATE IN A CLINICAL 
 
RESEARCH STUDY 
 
•AdultPatientor•Parent,forMinorPatient 
 
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 
Ebola is a virus that has infected and killed people mostly in West Africa.  There is no approved, effective treatment or 
prevention for Ebola, but several drugs are being studied for this purpose.  
In this study, we are testing an experimental drug called “MAb114”.ExperimentalmeansthatMAb114hasnotbeen
approved by the United States (U.S.) Food and Drug Administration (FDA), but the FDA gave us permission to test it in 
research studies.  It is not known if MAb114 works to prevent or treat Ebola infection, so the FDA only allows it to be 
used for research.   
The main purpose of this study is to see if MAb114 is safe and how your body will respond to it.  We will give you 
MAb114 and measure how much stays in your body over time.  We will also check to see if your immune system makes 

 
  
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: 
18-I-0069 
CONTINUATION:  Page 2 of 8 pages  
 
 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
 
NIH-2514-1 (10-84) 
 
NIH-2514-2 (10-84) 
 
P.A.: 09-25-0099 
antibodies to MAb114 that prevent it from working.
We are testing 3 different doses of MAb114 in this study.  
The Study Groups are shown in the following table:  
Group 
Subjects 
Schedule 
Day 0 
1 
3 
5 mg/kg IV 
2 
5 
25 mg/kg IV 
3 
10 
50 mg/kg IV 
Total 
18 
More people may be enrolled, if needed, to reach the study goals. 
The study will start by giving the smallest dose of MAb114 to people in Group 1. After the first person in a group gets a 
dose of MAb114, we will wait 3 days before giving the dose to the second person. We will wait 7 days after the last 
person in Group 1 gets a dose and review the safety data for all people in Group 1.  If no safety concerns are identified 
with the dose in Group 1, then Group 2 will open.  Likewise, if no safety concerns are identified with the dose in Group 2 
after the safety data review, then Group 3 will open. The exact amount of MAb114 that you get will be based on the 
group you are in and how much you weigh. 
About 18 to 30 people will take part in this study at the NIH Clinical Center in Bethesda, Maryland. 
ELIGIBILITY 
You are eligible to take part in this study because you have completed the screening process and: 

18 to 60 years old 

In good general health  

Willing to get MAb114 

Willing to donate blood samples for future research 

Willing to use birth control for the whole study 

Have not received a licensed or investigational monoclonal antibody or Ebola vaccine in the past 

Weigh less than 220 pounds 
STUDY DRUG 
MAb114isamonoclonalantibodyor“MAb”thattargetstheEbolavirus.Antibodiesaremadebytheimmunesystemto
fight infection by blocking germs (bacteria and viruses) like Ebola.  Monoclonal means that all the antibodies in MAb114 
are exactly the same. 
MAb114 was developed at the Vaccine Research Center (VRC) at NIH.  It is made in a laboratory and looks like an 
antibody your own body could make.  It has shown promise as an Ebola treatment in laboratory and animal studies, but it 
has not yet been studied in humans.  This is the first study to give MAb114 to humans. 
MAb114 will not protect you from Ebola infection.  You cannot get Ebola from MAb114 because there is no Ebola virus in 
it.  
 
 

 
  
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: 
18-I-0069 
CONTINUATION:  Page 3 of 8 pages  
 
 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
 
NIH-2514-1 (10-84) 
 
NIH-2514-2 (10-84) 
 
P.A.: 09-25-0099 
STUDY SCHEDULE AND PROCEDURES 
First study visit:  If you agree to take part in this study, you will get one dose of MAb114 at your first study visit after 
enrolling in the study.  You cannot choose the dose of MAb114 you get.  The dose you get will depend on when you join 
the study and how much you weigh.  This visit will be at the Clinical Center and will take about 8-10 hours.   
If you are female and able to become pregnant, you must use an effective method of birth control for the entire study.  A 
pregnancy test will be done before you get MAb114.  If you are pregnant, we will not give you MAb114.  
You will get MAb114 by intravenous (IV) infusion.  This means we will place a thin tube or IV line in a vein in your arm. 
TheIVlinewillbeattachedtoabagthatcontainsMAb114mixedwithaliquidcalled“normalsaline”orsaltwater.Itwill 
flow into your vein for about 30 minutes.  If you have side effects during the infusion, it may be slowed down or stopped 
as needed.  At the end of your infusion, we will monitor you for any side effects for at least 4 hours.  
If possible, we will also place an IV line in your other arm for blood collection during this visit.  We will draw your blood 
before and right after the infusion, and then 3 more times during the 4-6 hours after the infusion.  Blood draw volumes 
will be within NIH Clinical Center limits. You will be allowed to go home about 4-6 hours after the infusion, as long as you 
do not have concerning side effects. 
We will give you a thermometer and ask you to check your temperature every day for 3 days after you get MAb114.  You 
will need to record your highest temperature and any symptoms you may have.  Even if you do not feel sick, it is still very 
important that you record this information.  We will give you a password to a secure website to record this information on 
an electronic form or diary.  If you do not have a computer, you may use a paper diary instead.   
If you have any side effects after you get MAb114, you should tell a VRC nurse or doctor as soon as possible.  You can 
reach the clinic 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.  
Follow-up visits:  You will return to the Clinical Center for about 14 more study visits over a 6-month period.  These 
visits will take about 1-2 hours.  We will discuss the exact schedule of these visits with you.  At each follow-up visit, we 
will draw your blood and check you for any health changes or problems.  We will ask you how you are feeling and if you 
have taken any medications.  You will have about 2-8 tubes of blood drawn at each visit for safety and research tests.  
Blood draw volumes will be within NIH Clinical Center limits.  We will tell you right away if any of your test results show a 
health problem.  You might need to have extra clinic visits and laboratory tests if you have health changes that need to 
be checked.  We will use some of the blood to see how long MAb114 remains in your body.  We will also use some of the 
blood to see if your immune system makes antibodies to MAb114.  These tests are for research purposes only and are not 
for checking on your health.  We will not give you these results.   
When you complete this study after about 6 months, we may invite you to take part in another study for follow-up 
sample collection. 
Clinical studies follow a set schedule.  This helps us answer the research questions.  The visit schedule is a little flexible, 
but it is important that you follow the schedule as closely as possible.  You should try to not miss any visits. You should 
contact the clinic staff as soon as possible if you need to change the date or time of any study visit. 
 
 

 
  
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: 
18-I-0069 
CONTINUATION:  Page 4 of 8 pages  
 
 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
 
NIH-2514-1 (10-84) 
 
NIH-2514-2 (10-84) 
 
P.A.: 09-25-0099 
MONITORING OF THE STUDY 
A group of physicians and scientists at NIH will monitor safety in this study.  This group will review the information from 
the study and will pay close attention to possible harmful reactions.   
GENETIC TESTING 
Some of the blood drawn from you as part of this study will be used for genetic tests.  Some genetic tests may be done 
to see if genetic differences in people cause different types of immune responses.  Genetic tests that are done in our 
research lab using your research blood sample 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 Human Leukocyte Antigen (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 blood samples 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 get payment for such products. 
 
 

 
  
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: 
18-I-0069 
CONTINUATION:  Page 5 of 8 pages  
 
 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
 
NIH-2514-1 (10-84) 
 
NIH-2514-2 (10-84) 
 
P.A.: 09-25-0099 
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.
HUMAN DATA SHARING 
To advance science, it is helpful for researchers to share information they get from studying humans by putting it into 
shared scientific databases.  Researchers can then study the information combined from many studies to learn even more 
about health and diseases.  
If you agree to take part in this study, some of your data will be placed into one or more scientific databases.  We will 
remove identifying information like your name, address, and birth date.  The data may then be used for future research 
and shared broadly for research purposes. Only researchers who are approved to access the database may be able to see 
and use your information.  You will not get any direct benefits from future research that uses your data and information.  
You may stop participating in this study at any time and withdraw permission for your individual data, specimens, and 
health information to be used for additional or future research.  You may ask to have your research data destroyed.  
However, it may not be possible to withdraw or delete data once they have been shared with other researchers.  
POSSIBLE STUDY RISKS 
Risks of MAb114 and similar antibodies: This study is the first time that MAb114 is given to people.  As of July 24, 
2018, 13 subjects in this study have received a single dose of MAb114 administered IV.  Product administrations appear 
to be safe and well tolerated, without safety concerns identified.  Some people who received MAb114 reported mild 
symptoms including headache, feeling unwell, muscle aches, chills, and joint pain.  There may be risks and side 
effectsthatwedon’tknowabout yet. 
We do have data from other monoclonal antibodies that are approved for use in people and are also given by IV.  Like 
other drugs, monoclonal antibodies can cause side effects, some of which can be serious.  Most side effects occur within 
the first 24 hours. These 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.  
We are giving MAb114 at a controlled rate.  If you have symptoms while getting MAb114, tell the nurse.  Slowing or 
stopping the infusion may help improve the symptoms.    
Some antibody products have a risk of more serious reactions or side effects.   

Anaphylaxis is one type of serious allergic reaction that may happen soon after an antibody is given.  This 
reaction can include difficulty breathing, low blood pressure, hives or rash, and swelling in the mouth and face. 
This reaction is rare but can be life threatening. 

Serum sickness is a type of allergic reaction that may happen several days to three weeks after a monoclonal 
antibody is given.  This reaction can include hives or rash, fever, enlarged lymph nodes, muscle pains, joint pains, 
chest discomfort and shortness of breath.   

Some antibody products that contain larger amounts of an additive called sucrose may cause temporary damage 
to the kidneys.  MAb114 contains a relatively smaller amount of sucrose but we will still monitor your kidney 
function closely by a blood test during this trial.   
The study team will monitor you closely for side effects during the infusion, and will have medicine and equipment 
available to treat side effects, including severe effects, if necessary. 

 
  
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: 
18-I-0069 
CONTINUATION:  Page 6 of 8 pages  
 
 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
 
NIH-2514-1 (10-84) 
 
NIH-2514-2 (10-84) 
 
P.A.: 09-25-0099 
 
Some antibodies that attack human proteins can increase the risk of serious infections.  MAb114 is not expected to 
increase the risk of serious infections because it attacks a virus and not a human protein. 
Taking part in this study may affect your eligibility for future monoclonal antibody studies.   
Risks of Blood Drawing and IV Insertion:  The risks of drawing blood from a vein and having an IV include pain, 
bruising, bleeding, lightheadedness and fainting. Rarely, infection or inflammation can occur in the skin or vein.   
Risks during Pregnancy and Breastfeeding: We do not know what effects MAb114 may have on a fetus or nursing 
infant.  Therefore, if you are pregnant or nursing you cannot be in this study.  Women of childbearing potential must 
agree to not get pregnant during this study by using an effective method of birth control for the entire study.  We will 
discuss effective birth control methods with you.  
You must tell the clinic staff right away if you get pregnant during this study or think that you might be pregnant. If you 
get pregnant, we may not collect any more blood for research.  However, we will still want you to continue with study 
follow-up visits to check on your health and to tell us the outcome of the pregnancy.  
POSSIBLE BENEFITS 
This study will not give you any direct health benefit. The information we obtain in this study will help us learn more 
about the use of MAb114 in humans. 
COSTS TO YOU FOR PARTICIPATION 
There are no costs to you for taking part 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 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 $375 for the study visit that includes the MAb114 infusion.  You will get $25 total for the timely 
completion of all 3 days of an electronic diary.  You will get $175 for each scheduled follow-up visit that includes a 
research blood draw.  You will get $75 for all other clinic visits that do not include research blood draws.  
Total compensation for completion of all study visits is about $3,000 and is based on the number and type of study visits 
you complete. Your compensation may need to be reported to the internal revenue service (IRS) as taxable income.
REASONS FOR STOPPING STUDY PARTICIPATION 
You may choose to stop taking part in the study at any time.  If you get MAb114, you will be asked to keep follow-up 
visits so we can check your health.  Collection of samples that are only for research purposes may be stopped. 
You may be removed from the study without your consent if the study doctor feels it is in your best interest or if the 
study is cancelled or stopped early.  You may be withdrawn from the study if you cannot continue to attend study visits 
according to the schedule discussed. 
 
 

 
  
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: 
18-I-0069 
CONTINUATION:  Page 7 of 8 pages  
 
 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
 
NIH-2514-1 (10-84) 
 
NIH-2514-2 (10-84) 
 
P.A.: 09-25-0099 
ALTERNATIVES 
This study is not designed to treat or prevent any disease. You may choose to not take part in this study. You may be 
eligible for other studies.  
NEW FINDINGS 
We will give you any new information about risks or other information that becomes available that may affect your 
decision to stay in the study. 
CONFLICT OF INTEREST  
The NIH reviews NIH research staff associated with this study at least yearly for conflicts of interest.  You may ask the 
research team for more information or for a copy of the NIH Guide to Avoiding Financial on Non-Financial Conflicts or 
Perceived Conflicts of Interest in Clinical Research.  This study may have investigators who are not NIH employees.  
Non-NIH investigators are expected to follow the principles of this 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 MAb114.  The results of this study could play a 
role in whether the FDA approves MAb114 for sale at some time in the future.  If approved, the future sale of MAb114 
could lead to payments to NIH and some NIH scientists.  By U.S. law, government scientists are required to get such 
payments for their inventions.  You will not get any money from the development or sale of MAb114. 
CLINICALTRIALS.GOV 
A description of this clinical trial will be available on 
, as required by U.S. law.  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.  
 
 
 
 

 
  
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY 
   MEDICAL RECORD 
•  Adult Patient or    •  Parent, for Minor Patient 
 
STUDY NUMBER: 
18-I-0069 
CONTINUATION:  Page 8 of 8 pages (v3)  
 
PATIENT IDENTIFICATION 
CONSENT TO PARTICIPATE IN A CLINICAL 
 
RESEARCH STUDY (Continuation Sheet) 
 
•AdultPatientor•Parent,forMinorPatient 
 
NIH-2514-1 (07-09) 
 
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, MD 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: 
A. 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/Legal Representative    Date 
 
 
   __________________________________ 
Print Name 
 
 
THIS CONSENT DOCUMENT HAS BEEN APPROVED FOR USE  
FROM FEBRUARY 22, 2018 THROUGH FEBRUARY 21, 2019. 
 
 
  
 
 
_______ 
 
______   
Signature of Investigator/ 
Date 
Person Obtaining Consent 
 
 
   __________________________________ 
Print Name 
Signature of Witness 
Date 
 
 
 
   __________________________________ 
Print Name