Immunogenicity of Nonavalent HPV Vaccine Administered Prior to Renal Transplantation in Adults: A Prospective, Single-Arm, Multi-Center Clinical Trial
Phase: PHASE2
Conditions: Human Papillomavirus Infection, Human Papillomavirus-Related Carcinoma
Sponsor: National Cancer Institute (NCI)

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COVER PAGE 
 
DCP Protocol #: 
NWU2015-06-02 
 
Local Protocol #: NCI 2015-06-02 
 
Immunogenicity of Nonavalent HPV Vaccine Administered Prior To Renal Transplantation in 
Adults: A Prospective, Single-Arm, Multi-Center Clinical Trial 
 
 
Consortium Name: 
Northwestern Cancer Prevention Consortium 
Name of Consortium Principal 
Seema A. Khan, M.D. 
Investigator: 
Bluhm Family Professor of Cancer Research 
Professor of Surgery 
Feinberg School of Medicine 
303 E. Superior, Suite 4-111 
Chicago, IL 60611 
Telephone: (312) 503-4236 
Fax: (312) 503-2555 
E-mail address: skhan@nm.org 
 
 
Organization Name: 
Cedars-Sinai Medical Center 
Protocol Principal Investigator: 
Marc T. Goodman, Ph.D., M.P.H. 
Director, Cancer Prevention and Control 
Samuel Oschin Comprehensive Cancer Institute 
Director, Community and Population Health Research Institute 
Department of Biomedical Sciences 
Professor of Medicine 
Cedars-Sinai Medical Center 
8700 Beverly Boulevard, SCCT 1S37 
Los Angeles, CA 90048 
Telephone: (310) 423-6188 
Fax: (310) 423-7182 
E-mail address: marc.goodman@cshs.org 
 
Organization Name: 
Cedars-Sinai Medical Center 
Clinical Co-Principal Investigator:   Irene Kim, M.D. 
Transplant Surgeon 
Director, Fellowship in Abdominal Transplant Surgery 
Director, Kidney Paired Exchange Program 
Comprehensive Transplant Center 
Cedars-Sinai Medical Center 
8900 Beverly Boulevard, 590W 
Los Angeles, CA 90048 
Telephone: (310) 423-2641 
Fax: (310) 423-0234 
E-mail address: Irene.Kim@cshs.org 
 
 
Organization Name: 
Cedars-Sinai Medical Center 
Investigator: 
Alice Peng, M.D. 
Director, Nephrology Fellowship Program 

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Medicine/Nephrology 
Comprehensive Transplant Center 
Cedars-Sinai Medical Center 
8900 Beverly Boulevard 
Los Angeles, CA 90048 
Telephone: (310) 423-3422 
Fax: (310) 423-8208 
E-mail address: Alice.Peng@cshs.org 
 
Organization Name: 
University of California, Davis  
Protocol Co-Principal Investigator: Shehnaz K. Hussain, Ph.D., Sc.M. 
Professor 
Department of Public Health Sciences 
School of Medicine  
University of California, Davis 
4610 X Street 
Sacramento, CA 95817 
Telephone: (310) 429-9859 
E-mail address: skhussain@ucdavis.edu 
 
Organization Name: 
Northwestern University 
Investigator: 
 Seema A. Khan, M.D. 
 
Bluhm Family Professor of Cancer Research 
 
Professor of Surgery 
 
 Feinberg School of Medicine 
 
 
 
 
 
303 E. Superior, Suite 4-111 
 
 
 
 
 
Chicago, IL 60611 
 
 
 
 
 
Tel: (312) 503-4236 
 
 
 
 
 
Fax: (312) 503-2555 
 
 
 
 
 
E-mail: skhan@nm.org  
 
Organization Name: 
University of California, San Francisco 
Investigator: 
Garrett R. Roll, M.D. 
Assistant Professor 
Department of Surgery, Division of Transplant Surgery 
UCSF School of Medicine 
505 Parnassus Avenue 
San Francisco, CA  94143 
Telephone: (415) 353-1551 
Fax: (415) 353-8708 
E-mail address: garrett.roll@ucsf.edu 
 
Organization Name: 
University of California, San Francisco 
Co-Investigator: 
Rajalingam Raja, Ph.D., D(ABHI) 
Professor 
Department of Surgery 
Director, UCSF Immunogenetics and Transplantation Laboratory 
UCSF School of Medicine 
3333 California Street, Suite 150 
San Francisco, CA 94118 
Telephone: (415) 476-0647 
Fax: (415) 476-0379 

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E-mail address: Rajalingam.Raja@ucsf.edu 
 
Organization Name: 
University of Alabama at Birmingham 
Investigator:  
 
 
Paul Goepfert, MD 
Professor of Medicine 
Edward W. Hook III Endowed Professorship in Infectious Diseases 
Department of Medicine 
845 19th Street South, BBRB 256G 
Birmingham AL 35294 
Telephone: (205) 975-5667 
Fax: (205) 975-6027 
E-mail address: pgoepfert@uabmc.edu  
 
Organization Name: 
University of Alabama at Birmingham 
Co-Investigator: 
Graham Towns, M.D. 
Assistant Professor, Department of Medicine 
Division of Nephrology 
University of Alabama at Birmingham School of Medicine 
1720 2nd Avenue South, ZRB 627 
Birmingham, AL 35294-2050 
Telephone: (205) 934-9045 
Fax: (205) 934-7742 
E-mail address: gtowns@uabmc.edu 
 
Organization Name: 
University of North Carolina at Chapel Hill 
Investigator: 
Lisa Rahangdale, MD, MPH 
Associate Professor of Obstetrics & Gynecology 
Associate Dean for Admissions 
UNC School of Medicine 
3031 Old Clinic Bldg., CB #7570 
Chapel Hill, NC 27599 
Telephone: (919) 843-7851 
Fax: (919) 966-6001 
Email address: lisa_rahangdale@med.unc.edu 
 
Organization Name: 
University of North Carolina at Chapel Hill 
Investigator: 
Randal Detwiler, MD 
Allan Brewster Distinguished Professor of Medicine 
Medical Director, Kidney and Pancreas Transplantation 
UNC School of Medicine 
7024 Burnett-Womack, CB # 7155 
Chapel Hill, NC 27599 
Telephone: (919) 445-2674 
Fax: (984) 974-5751 
E-Mail address: randy_detwiler@med.unc.edu 
 
Organization Name: 
Northwestern University 
Statistician: 
Masha Kocherginsky, Ph.D. 
680 North Lake Shore Drive, Suite 1400 
Chicago, IL 60611 
Telephone: (312) 503-4224 
Fax: (312) 908-9588 

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E-mail address:mkocherg@northwestern.edu 
 
Organization Name: 
National Cancer Institute Division of Cancer Prevention 
Scientific Monitor: 
Vikrant Sahasrabuddhe, M.B.B.S., M.P.H., Dr.P.H. 
Program Director, Breast and Gynecologic Cancer Research Group 
9609 Medical Center Drive 
Rockville, MD 20850 
Telephone: (240) 276-7332 
Fax: (240) 276 7828 
E-mail address: sahasrabuddhevv@mail.nih.gov 
 
Organization Name: 
National Cancer Institute Division of Cancer Prevention 
Medical Monitor: 
Eva Szabo, M.D. 
Chief, Lung & Upper Aerodigestive Cancer Research Group 
9609 Medical Center Drive 
Rockville, MD 20850 
Telephone: (240) 276-7011 
Fax: (240) 276-7848 
Email address: szaboe@mail.nih.gov 
IND Sponsor: 
NCI DCP 
IND# 
(Exempt) 
Agent(s)/Supplier: 
Gardasil® 9 Nonavalent HPV vaccine / Merck / NCI, DCP 
NCI Contract # 
HHSN261201200035I 
Protocol Version Date: 
April 20, 2023 
Protocol Revision or 
Amendment # 
Version 3.11 

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SCHEMA 
Immunogenicity of Nonavalent HPV Vaccine Administered Prior To Renal Transplantation in Adults: A Prospective, 
Single-Arm, Multi-Center Clinical Trial 
 
 
 
 
 
** [NOTE: For COVID-19 Contingency Plan, please see Appendix G and Appendix H] 

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TABLE OF CONTENTS 
COVER PAGE ............................................................................................................................................................................................. 1 
SCHEMA ..................................................................................................................................................................................................... 5 
TABLE OF CONTENTS ............................................................................................................................................................................. 6 
1. 
OBJECTIVES .................................................................................................................................................................................... 8 
1.1 
Primary Objectives ......................................................................................................................................................................... 8 
1.2 
Secondary Objectives ..................................................................................................................................................................... 8 
1.3 
Exploratory Objectives ................................................................................................................................................................... 8 
2. 
BACKGROUND ............................................................................................................................................................................... 8 
2.1 
Study Disease ................................................................................................................................................................................. 8 
2.2 
Study Agent .................................................................................................................................................................................... 9 
2.3 
Rationale ......................................................................................................................................................................................... 9 
3. 
SUMMARY OF STUDY PLAN ..................................................................................................................................................... 11 
4. 
PARTICIPANT SELECTION ......................................................................................................................................................... 14 
4.1 
Inclusion Criteria .......................................................................................................................................................................... 14 
4.2 
Exclusion Criteria ......................................................................................................................................................................... 15 
4.3   Inclusion of Women and Minorities ................................................................................................................................................ 16 
4.4 
Recruitment and Retention Plan ................................................................................................................................................... 17 
5. 
AGENT ADMINISTRATION ........................................................................................................................................................ 19 
5.1 
Dose Regimen and Dose Groups .................................................................................................................................................. 20 
5.2 
Study Agent Administration ......................................................................................................................................................... 20 
5.3 
Run-in Procedures ........................................................................................................................................................................ 21 
5.4 
Contraindications .......................................................................................................................................................................... 21 
5.5 
Concomitant Medications ............................................................................................................................................................. 21 
5.6 
Dose Modification ........................................................................................................................................................................ 22 
5.7 
Adherence/Compliance ................................................................................................................................................................. 22 
6. 
PHARMACEUTICAL INFORMATION ........................................................................................................................................ 22 
6.1 
Study Agent (IND #
 (Exempt), IND Sponsor: NCI/DCP) .................................................................................................. 22 
6.2 
Reported Adverse Events and Potential Risks .............................................................................................................................. 22 
6.3 
Availability ................................................................................................................................................................................... 24 
6.4 
Agent Distribution ........................................................................................................................................................................ 24 
6.5 
Agent Accountability .................................................................................................................................................................... 24 
6.6 
Packaging and Labeling ................................................................................................................................................................ 24 
6.7 
Storage .......................................................................................................................................................................................... 25 
6.8 
Registration/Randomization ......................................................................................................................................................... 25 
6.9 
Blinding and Unblinding Methods ................................................................................................................................................ 25 
6.10 Agent Destruction/Disposal .......................................................................................................................................................... 25 
7. 
CLINICAL EVALUATIONS AND PROCEDURES ..................................................................................................................... 25 
7.1 
Schedule of Events ....................................................................................................................................................................... 25 
7.2 
Pre-Study Evaluation Consent and Screening Visit ...................................................................................................................... 27 
7.3 
Baseline Testing and Evaluation During Study Intervention Pre-Transplant Vaccine Visit 1 ..................................................... 28 
7.3.4 Transplant Surgery........................................................................................................................................................................ 29 
7.4 
Evaluation at Completion of Study Intervention 6 Month Post-Transplant Visit ......................................................................... 29 
7.5 
Post-intervention Follow-up Period 13 Month Post-Transplant Visit ........................................................................................... 30 
7.6 
Additional Study Visit(s) .............................................................................................................................................................. 30 
7.7 
Methods for Clinical Procedures .................................................................................................................................................. 31 
8. 
CRITERIA FOR EVALUATION AND ENDPOINT DEFINITION .............................................................................................. 32 
8.1 
Primary Endpoint .......................................................................................................................................................................... 32 
8.2 
Secondary and Exploratory Endpoints ........................................................................................................................................... 32 
8.3 
Off-Agent Criteria ........................................................................................................................................................................ 32 
8.4 
Off-Study Criteria ......................................................................................................................................................................... 32 
8.5 
Study Termination ........................................................................................................................................................................ 33 
9. 
CORRELATIVE/SPECIAL STUDIES ........................................................................................................................................... 33 
9.1 
Rationale for Methodology Selection ........................................................................................................................................... 33 
9.2 
Comparable Methods .................................................................................................................................................................... 34 

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10. 
SPECIMEN MANAGEMENT ........................................................................................................................................................ 34 
10.1 Laboratories .................................................................................................................................................................................. 34 
10.2 Collection and Handling Procedures ............................................................................................................................................. 34 
10.3 Shipping Instructions .................................................................................................................................................................... 35 
10.4 Tissue Banking ............................................................................................................................................................................. 35 
11. 
REPORTING ADVERSE EVENTS................................................................................................................................................ 35 
11.1 Adverse Events ............................................................................................................................................................................. 36 
11.2 Serious Adverse Events ................................................................................................................................................................ 38 
12. 
STUDY MONITORING ................................................................................................................................................................. 40 
12.1 Data Management ......................................................................................................................................................................... 40 
12.2 Case Report Forms ....................................................................................................................................................................... 40 
12.3 Source Documents ........................................................................................................................................................................ 40 
12.4 Data and Safety Monitoring Plan .................................................................................................................................................. 41 
12.5 Sponsor or FDA Monitoring ......................................................................................................................................................... 41 
12.6 Record Retention .......................................................................................................................................................................... 41 
12.7 Cooperative Research and Development Agreement (CRADA)/Clinical Trials Agreement (CTA) ............................................ 41 
13. 
STATISTICAL CONSIDERATIONS ............................................................................................................................................. 41 
13.1 Study Design/Description ............................................................................................................................................................. 41 
13.2 Randomization/Stratification ........................................................................................................................................................ 42 
13.3 Accrual and Feasibility ................................................................................................................................................................. 42 
13.4 Primary Objective, Endpoint(s), Analysis Plan ............................................................................................................................ 42 
13.5 Secondary and Exploratory Objectives, Endpoints, Analysis Plans ............................................................................................. 43 
13.6 Reporting and Exclusions ............................................................................................................................................................. 44 
13.7 Evaluation of Toxicity .................................................................................................................................................................. 44 
13.8 Evaluation of Response ................................................................................................................................................................ 44 
13.9 Interim Analysis ........................................................................................................................................................................... 44 
13.10 Ancillary Studies .......................................................................................................................................................................... 44 
14. 
ETHICAL AND REGULATORY CONSIDERATIONS ............................................................................................................... 44 
14.1 Form FDA 1572 ............................................................................................................................................................................ 44 
14.2 Other Required Documents .......................................................................................................................................................... 44 
14.3 Institutional Review Board Approval ........................................................................................................................................... 45 
14.4 Informed Consent ......................................................................................................................................................................... 45 
14.5 Submission of Regulatory Documents .......................................................................................................................................... 45 
14.6 Other ............................................................................................................................................................................................. 46 
15. 
FINANCING, EXPENSES, AND/OR INSURANCE ..................................................................................................................... 46 
REFERENCES ....................................................................................................................................................................................... 47 
CONSENT FORM ............................................................................................................................................................... 50 
APPENDIX A ................................................................................................................................................................................. 67 
APPENDIX B .................................................................................................................................................................................. 68 
APPENDIX C .................................................................................................................................................................................. 69 
APPENDIX D ................................................................................................................................................................................. 70 
APPENDIX E .................................................................................................................................................................................. 71 
APPENDIX F .................................................................................................................................................................................. 79 
APPENDIX G ................................................................................................................................................................................. 86 
APPENDIX H ............................................................................................................................................................... 88 
 

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1. 
OBJECTIVES 
 
The objective of this prospective single-arm trial is to evaluate if the Gardasil® 9 HPV vaccine induces 
and sustains an adequate immune response at 12-months post-transplantation among 18-49 year old 
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1.1 
Primary Objectives 
 
To assess HPV vaccine-type-specific seroconversion rates at 12-months post-transplantation among 
NLGQH\WUDQVSODQWUHFLSLHQWVZKRUHFHLYHGRVHVRIWKH*DUGDVLO® +39YDFFLQHGD\VSULRUWR
transplantation. 
 
1.2 
Secondary Objectives 
 
To assess HPV vaccine-type-specific seroconversion rates at 6- and 12-months post-transplantation 
stratified by number of doses (1, 2, or 3) of the vaccine given pre-transplant among kidney transplant 
UHFLSLHQWVZKRUHFHLYHGRVHVRIWKH*DUGDVLO® 9 HPV vaccine prior to transplantation: 
 
1.3 
Exploratory Objectives 
 
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+39YDFFLQHGD\VSULRUWRWUDQVSODQWDWLRQ 
 
1) HPV vaccine-type-specific seroconversion rates at 12-months post-transplantation stratified by: 
a) time elapsed between last vaccine dose and the transplant procedure; 
b) variations in dosing and types of post-transplant immunosuppressant medications; and 
interactions with type of transplant surgery (living donor/deceased donor); 
c) differences in Human Leukocyte Antigen (HLA) histocompatibility between donor and 
recipient; 
d) differences in biological sex (i.e. male vs. female) of the transplant recipient. 
 
2) Stability of HPV vaccine-type-specific geometric mean titers (GMT) at 6 and 12-months post-
transplantation and rise in HPV vaccine-type-specific GMT at the 13-month post-transplant visit. 
 
3) Vaccine safety profile and allograft rejection/opportunistic infections stratified by number of 
vaccine doses and time between the last vaccine dose and the transplant procedure. 
 
4) HPV detection in samples from the cervix/vagina and oral cavity at baseline (pre-vaccination) 
and at 6- and 12-months post-vaccination, overall and by number of vaccine doses (1, 2, or 3), 
sexual behavior, type-specific seroconversion rates, and time elapsed between the last vaccine 
dose and the transplant procedure. 
 
2. 
BACKGROUND 
 
2.1 
Study Disease 
 
Adult solid organ transplant recipients are at increased risk of developing several types of malignant 
tumors related to the use of immunosuppression to prevent transplant rejection [1]. Cancers causally 
linked to infections with carcinogenic human papillomavirus (HPV) genotypes, including squamous cell 
carcinomas of the anogenital region and oropharynx, are among the higher incidence cancers in this group 

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and potentially the most preventable [2-4]. The number of solid organ transplant recipients has increased 
along with their post-transplant lifespan. As such, the need for prevention of HPV-associated cancers is 
projected to increase [5]. 
 
2.2 
Study Agent 
 
Gardasil® 9 Human Papillomavirus vaccine is a non-infectious recombinant 9-valent vaccine prepared 
from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, 18, 
31, 33, 45, 52, and 58. The L1 proteins are produced by separate fermentations using recombinant 
Saccharomyces cerevisiae and self-assembled into VLPs. The fermentation process involves growth of S. 
cerevisiae on chemically-defined fermentation media which include vitamins, amino acids, mineral salts, 
and carbohydrates. The VLPs are released from the yeast cells by cell disruption and purified by a series 
of chemical and physical methods. The purified VLPs are adsorbed on preformed aluminum-containing 
adjuvant (Amorphous Aluminum Hydroxyphosphate Sulfate or AAHS). The 9-valent HPV VLP vaccine 
is a sterile liquid suspension that is prepared by combining the adsorbed VLPs of each HPV type and 
additional amounts of the aluminum-containing adjuvant and the final purification buffer [6]. 
 
Gardasil® 9 is indicated for prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 
16, 18, 31, 33, 45, 52 and 58; and for the prevention of genital warts caused by HPV types 6 or 11; in 
females 9-26 years of age. Gardasil® 9 also adds protection against precancerous or dysplastic cervical, 
vulvar, vaginal, and anal lesions caused by the covered HPV types. 
 
The safety of Gardasil® 9 was evaluated in six clinical studies that included 13,234 individuals who 
received at least one dose and had safety follow-XS7KHPRVWFRPPRQORFDODQGV\VWHPLF
adverse reactions of the Gardasil® 9 HPV vaccine in females and males 16 through 26 years of age were 
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DQGKHDGDFKH3\UH[LDPD\EHH[SHULHQFHGE\RIIHPDOHYDFFLQHUHFLSLHQWVDQGIRU
male vaccine recipients. Contraindications include hypersensitivity, including severe allergic reactions to 
yeast (a vaccine component), or after a previous Gardasil® dose [6]. Individuals who develop symptoms 
indicative of hypersensitivity after the first dose should not receive additional doses. Syncope, sometimes 
associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV 
vaccination. Participants must be monitored for 30 minutes following vaccination for syncope/convulsive 
syncope and allergic reactions. There have been no adequate and well-controlled studies of Gardasil® 9 in 
pregnant women. The Gardasil® 9 HPV vaccine is not recommended for pregnant women. 
 
2.3 
Rationale 
 
The nonavalent Gardasil® SURSK\ODFWLF+39YDFFLQHLVQHDUO\HIILFDFLRXV in preventing infection 
with the seven carcinogenic (HPV 16, 18, 31, 33, 45, 52, 58) and two condyloma-inducing viruses (HPV 
6, 11) when given to individuals who have not been exposed to these specific HPV types. The body of 
evidence [41-45] that has influenced the current approval of Gardasil® 9 by the US Food and Drug 
Administration (FDA) for ages 9-45 years in both females and males include: 
(i) 
clinical trial data about clinical efficacy of Gardasil® 9 (endpoints such as persistent infection, 
genital warts, and precancerous lesions related to HPV types covered by the vaccine) in 16-26 
years old women and men; 
(ii) 
inferential data from clinical trial data about clinical efficacy of quadrivalent Gardasil® 
prophylactic HPV vaccine (the forerunner to Gardasil® 9 with a similar manufacturing 
process) in 27-45 years old women for the four key HPV types (HPV 16, 18, 6 & 11) covered 
by both the quadrivalent and nonvalent vaccines 
(iii) 
immunogenicity and immunobridging data (i.e., inferring efficacy based on similar or higher 
vaccine-induced serologic immune titers in age-groups where efficacy has not been directly 
studied, e.g., individuals <16 years at vaccination, or men 27-45 years) 

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The protective effect of Gardasil® 9 among older immunosuppressed adults is unknown. Given the 
continued HPV-related risk in the post-transplant years (evidenced by a high proportion of women and 
men testing positive for cervical/anogenital HPV DNA [7], even with no additional sexual acquisition risk 
of new HPV infections, it is speculated that this represents a consequence of activation of latent HPV 
infections. Empirical studies to demonstrate the phenomenon of reactivation of HPV infection and the 
effect of HPV vaccination on this purported phenomenon are lacking. 
 
Guidelines from both the Centers for Disease Control and prevention (CDC) and American Society of 
Transplantation recommend that immunosuppressed individuals, including transplant candidates, receive 
the same HPV vaccines according to the same schedule as individuals in the general population [8,9]. 
Only two small observational immunogenicity studies have evaluated post-transplantation serologic 
responses to the quadrivalent Gardasil® vaccine [10,11]. Although the safety of the virus-like particle 
(VLP)-based subunit HPV vaccines has not been a major concern, the strength of the immunologic 
responses (and consequent efficacy) among immunosuppressed transplant recipients remains uncertain 
[5,12]. Research questions related to the efficacy of the prophylactic HPV vaccination among adult solid 
organ transplant candidates and recipients include the levels and inter-person variability of peak and 
plateau antibody titers and avidity of antibody responses, as well as the optimal timing of vaccine 
administration either pre- or post-transplant. The possibility that reactivation or latent HPV infection may 
occur with immunosuppression is supported by descriptive clinical studies, but the potential of 
vaccination to suppress this reactivation is untested. The relationship between HPV vaccine response and 
post-transplantation immune status measurements – both non-specific immune monitoring assays, as well 
as opportunistic pathogen-specific response assays – is unclear and merits further exploration [13]. Renal 
transplant candidates represent an ideal population in which to evaluate prophylactic vaccine efficacy in 
organ transplant recipients because many such transplants are planned months in advance, and patients 
have frequent medical contacts, facilitating recruitment and required visits. 
 
Given the strong biological rationale, a recently convened International Agency for Research on 
Cancer/National Cancer Institute workshop has recommended seroconversion, and specifically 
immunological non-inferiority, as sufficient for a presumption of efficacy for the HPV vaccine in 
immunobridging studies focused on the expansion of vaccine indications [14]. Thus, the endpoint for this 
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achieving seroconversion. The definition for positivity, or seroconversion, will be based on results of the 
HPV-9 cLIA (Merck) or, alternatively, a validated 9-valent HPV multiplex assay developed at the NCI 
Frederick National Laboratory for Cancer Research (FNLCR), which measures HPV type-specific 
antibodies to neutralizing epitopes on VLPs from a patient’s serum sample. Seropositivity is not part of 
the eligibility criteria for enrollment. 
 
Vaccine Doses and Timing in relation to Transplant Surgery and Immunosuppression. 
Current (2018) CDC recommendations suggest that Gardasil® 9 be given in a 3-dose schedule at 0, 2, and 
6 months for immunocompromised individuals (such as transplant recipients) between the ages of 16 and 
45 years. (There are no recommendations for vaccination for individuals over 45 years of age, and such 
use is considered off-label.) Furthermore, there are no recommendations on the optimal number and 
timing of doses in relation to the transplant surgery. This trial will seek to enroll both living-donor and 
deceased-donor transplant recipients, and the number and timing of vaccine doses will be dependent on 
two factors: 
i. 
The time remaining between enrollment date and transplant surgery. 
ii. Need for avoiding administering any vaccine doses for at least 12 months in the post-transplant 
period when the strongest regimens of immunosuppressive medications to prevent transplant 
rejection are being administered. 
Due to these caveats, participants may receive one, two, or three doses of vaccines prior to transplant. If 
all three doses are not administered before transplant then the rest of the doses in the three dose vaccine 

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series will be administered at or after 12-months after transplant. An abbreviated schedule of vaccination 
(permitted by current vaccine label/CDC recommendations) may also be utilized to allow administration 
of as many vaccine doses prior to transplantation as possible. If participants do not undergo transplant 
surgery within 12 months of study enrollment and have not received the recommended three dose series 
in the intervening 12 months, the remaining doses will be offered via Additional Study Visit(s) at 12 
months and, if necessary, at 15 months after the first vaccine dose. 
Desensitization. Both vaccines and infections are known to cause both humoral and cellular immune 
activation, which is of particular interest in transplant populations because alloreactive T-cells and the 
development of anti-HLA antibodies mediate transplant allograft injury. Transplant recipients who are 
already highly sensitized to alloantigens are at higher risk for rebound immune activation through a 
process called heterologous immunity, potentially leading to allograft injury. Furthermore, the potential 
for a ‘shared epitope’ between viral products and Human Leukocyte Antigen (HLA) proteins suggests 
that vaccination can produce de novo HLA antibody formation [15]. Desensitization procedures vary 
somewhat among the five participating transplant centers, which does not permit proposing uniform 
criteria across all study sites for determining exclusion due to desensitization . In general, adults who have 
received a prior transplant, have unsuitable scores on Calculated Panel Reactive Antibody (PRA) 
percentage (institution-specific thresholds), or an ABO incompatible donor are likely to undergo 
desensitization at one or more of the study centers. These factors, among others, will be used by the study 
clinician to determine exclusion due to anticipated desensitization in the study. 
 
HPV Vaccination and Risk of Allograft Rejection. Current recommendations allow for HPV vaccine 
administration before or after transplantation, and that it is safe to do so because it is not a live vaccine 
[16]. Studies that have examined safety of the vaccine in the post-transplant setting have reported no 
elevation in rejection episodes attributed to the vaccine [10,11]. 
 
Sexual Behavior, Detectable HPV Infection, and Vaccine-Induced Seroconversion. The possibility 
that reactivation of latent HPV infection may occur with immunosuppression is supported by descriptive 
clinical studies, but the potential of vaccination to suppress this reactivation is untested. Only a few 
studies have examined the prevalence of oral/anal/genital HPV in renal transplant recipients, generally 
following transplant [17]. The first longitudinal study of cervical-vaginal HPV prevalence before and 
DIWHUUHQDOWUDQVSODQWIRXQGDQLQFUHDVHIURP pre-WUDQVSODQWWRSRVW-transplant [18]. This 
increase occurred in the absence of reported changes in sexual behavior, suggesting re-activation of latent 
viral infection. Although the clinical impact of these findings are presently uncertain, an increased 
prevalence of cervical-vaginal HPV in the absence of person-to-person transmission has implications for 
patient management [19]. This will be the first study among renal transplant recipients to show whether 
there is a difference in Gardasil® 9-associated seroconversion between individuals with detectable versus 
undetectable HPV infections (cervical-vaginal and oral) that cannot be explained by sexual behavior. 
 
Hypothesis: The Gardasil® 9 nonavalent vaccine given before the solid organ transplant procedure will 
induce and maintain adequate immunogenicity in the post-transplant period despite immunosuppression. 
 
3. 
SUMMARY OF STUDY PLAN 
 
Design Overview. This will be a prospective single-arm trial to evaluate if the Gardasil® 9 HPV vaccine 
induces and sustains an adequate immune response at 12-months post-transplantation among 18-49 years 
old kidney transplant recipients when  1 doses of the vaccine are administered prior to transplantation (see 
Schema). The study population will include candidates who are scheduled to undergo kidney transplant 
within 12 months of enrollment at five transplant centers in the United States: Cedars-Sinai Medical Center 
(CSMC); the University of California, San Francisco Medical Center (UCSF); Northwestern University 
Feinberg School of Medicine (NW); University of Alabama at Birmingham (UAB); and the University of 
North Carolina at Chapel Hill (UNC). The local study teams at the clinical sites, which include transplant 
infectious disease specialists, transplant nephrologists, and transplant surgeons, will determine each 

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12 Month Post-Transplant Visit: This visit will entail specimen collection at 12-months (+/- 2 weeks) 
after the transplant surgery. If all three doses of the vaccine have been administered prior to transplant, 
this visit will involve specimen collection and no vaccination. If only one vaccine dose was administered 
prior to transplant, this visit will also entail administering the second vaccine dose. If two vaccine doses 
were administered prior to transplant, this visit will also entail administering the third vaccine dose. 
 
13 Month Post-Transplant Visit will be completed when the second/third vaccine dose is administered at 
the 12-months Post-Transplant Visit. This visit is for the purpose of collecting study-related specimens. 
 
Additional Study Visit(s) for completing vaccine series: 
Additional Study Visits will be offered to participants whose medical schedules did not permit them to 
complete their vaccine series earlier in the study. 
 
Study Measurements. All visits discussed above, except the 13 Month Post-Transplant Visit and 
Additional Study Visits will, include the following study measurements. The 13 Month Post-Transplant 
Visit will include a blood draw only, and Additional Study Visits will only include administering the 
remaining vaccine doses to complete the series. 
x 
History and physical exam 
x 
Blood specimen for measurement of the primary and secondary endpoints 
x 
Collection of cervical/vaginal and oral samples for HPV DNA testing 
x 
Optional collection of urine for HPV DNA testing. 
x 
Optional collection of eyebrow hair samples for future viral DNA testing. 
x 
Optional collection of male genital samples for future HPV DNA testing. 
x 
Baseline and follow-up questionnaires. 
 
4. 
PARTICIPANT SELECTION 
 
4.1 
Inclusion Criteria 
 
4.1.1 
&DQGLGDWHIRUUHQDOWUDQVSODQWH[SHFWHGWRXQGHUJRWUDQVSODQWVXUJHU\GD\VDQGPRQWKV
after enrollment. 
a. For potential participants on the institutional waiting list for deceased donor transplant, a study 
clinician confirms the candidate is likely to receive a transplant within the next 12 months, taking into 
account the candidate’s priority on the waiting list, age, medical status, institutional policies, and scores 
like the Estimated Post-Transplant Survival (EPTS) Score and Calculated Panel Reactive Antibody 
(CPRA) percentage, etc. 
b. For potential participants expected to undergo a living donor transplant, one or more donor(s) 
have been identified and is/are in work-up (even though all work-up status may or may not be complete). 
A study clinician confirms the living donor transplant is likely to be scheduled within the next twelve 
months after taking into account donor work-up progress, age and medical status, and institutional 
policies. 
*Notes: 
i) Living and Deceased Donor Transplant Recipients: The study was originally restricted to 
participants who were expecting to receive only living donor renal transplants. However, less than a 
third of kidney transplants in the United States occur with kidneys from living donors. A majority of 
transplants are in the setting of donation of kidneys from deceased donors. To permit efficiencies in 
accrual, the study is amended (from version 3.5) to also open enrollment to recipients of deceased 
donor kidneys. 
ii) Transplant recipients of both genders: The study was originally designed to be conducted only 

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among women. However, in October 2018, the FDA approved an age expansion indication for the 
Gardasil 9 HPV vaccine for both women and men up to 45 years (from the originally approved upper 
age limit of 26 years), thus opening a new clinical cancer preventative option for middle-age adults of 
both genders [38]. The primary endpoint for the study is HPV-vaccine-type-specific seroconversion 
rates, which are not expected to be differential by gender, based on extrapolating from the uniformly 
KLJK!VHURFRQversion rates observed regardless of gender in studies among immunocompetent 
individuals. However, HPV vaccine-type-specific titer levels (GMT) differences by gender will be 
analyzed as a secondary endpoint, given variability in immune response titer levels observed between 
males and females in immunocompetent individuals (related to the differences in body mass index or 
hitherto unproven factors related to hormone-immune interactions [20,21]). Another advantage of 
expanding this study to males will be to facilitate efficiencies in accrual, since men constitute the 
PDMRULW\-RIDOONLGQH\WUDQVSODQWUHFLSLHQWVLQWKH8QLWed States. Although a majority of 
current HPV-associated cancers among solid organ transplant recipients occur among women, [2] 
there is increasing evidence of the link between HPV infection and oropharyngeal cancers that 
disproportionately affect men [39]. HPV-related oropharyngeal cancers are now the most common 
HPV-related cancers in the United States, surpassing even the incidence of cervical cancer. [39] The 
expansion of enrollment to men will also allow this study to look at the effect of HPV vaccination on 
persistence of oral HPV infection as a secondary/exploratory endpoint in the context of transplant- 
related immunosuppression. 
 
4.1.2 
Age 18-49 years. We have chosen to focus on adults aged 18-49 for this initial study in transplant 
recipients for a few reasons. Prior data for HPV vaccine response exists for adults up to 49 years of age, 
providing an important external comparison group for our study. Immune response and exposure wane as 
age increases and we want to minimize the potential for age-related confounding of our study outcome. 
For this initial trial, we thought it best to maintain homogeneity in the study population to the extent 
possible. Finally, given that about half of renal transplant recipients in the U.S. are between the ages of 
18-49 years, selecting this age range permits efficiency in study accrual. 
 
4.1.3 
(&2*SHUIRUPDQFHVWDWXV.DUQRIVN\VHH$SSHQGL[ A) 
 
4.1.4 
The effects of the Gardasil® 9 HPV vaccine on the developing human fetus at the recommended 
therapeutic dose are unknown. For this reason and because there have been no adequate and well- 
controlled studies of Gardasil® 9 in pregnant women, women who are able to become pregnant must have 
a confirmed negative pregnancy test result within the past 28 days prior to enrollment and must agree to 
use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry 
and for the duration of study participation. Women who have had a both ovaries removed or a tubal 
ligation will not be required to have a pregnancy test. Should a woman become pregnant or suspect she is 
pregnant while participating in this study, she should inform her study physician immediately. 
 
4.1.5 
Ability to understand and the willingness to sign a written informed consent document and 
medical release form 
 
4.1.6 
Willing and able to comply with trial protocol and follow-up 
 
4.2 
Exclusion Criteria 
 
4.2.1 
Previous prophylactic HPV vaccination 
 
4.2.2 
Prior organ transplant 

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4.2.3 
Anticipated desensitization treatment. This decision to exclude a participant who may need 
desensitization will be based on the site clinician’s judgement. Desensitization procedures vary somewhat 
among the five participating transplant centers, which does not permit proposing uniform criteria across 
all study sites for determining exclusion due to desensitization. In general, women who have received a 
prior transplant, have unsuitable scores on Calculated Panel Reactive Antibody (PRA) percentage 
(institution-specific thresholds), or an ABO incompatible donor are likely to undergo desensitization at 
one or more of the study centers. These factors, among others, will be used by the study clinician to 
determine if exclusion due to anticipated desensitization is warranted for a particular participant in the 
study. 
 
4.2.4 
Current use of any other investigational agents 
 
4.2.5 
History of allergic reactions to yeast or attributed to compounds of similar chemical or biologic 
composition to Gardasil® 9 HPV vaccine 
 
4.2.6 
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, 
symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric 
illness/social situations that would limit compliance with study requirements 
 
4.2.7 
For female participants: Pregnant or intention to get pregnant, or breastfeeding. Pregnant women 
are excluded from this study because the safety and effectiveness of Gardasil® 9 HPV vaccine have not 
been established in pregnant women. It is not known whether Gardasil® 9 is excreted in human milk. 
Because many drugs are excreted in human milk, caution should be exercised when Gardasil® 9 is 
administered to a nursing woman. Because there is an unknown but potential risk for adverse events in 
nursing infants secondary to treatment of the mother with Gardasil® 9, women who are breastfeeding will 
be excluded. 
 
4.2.8 
History of cervical cancer or anal cancer. 
 
4.2.9 
History of active malignancy, including basal/squamous cell skin cancer 
 
4.2.10 Concurrent illness, such as known psychiatric disorders or substance abuse (i.e., average alcohol 
consumption of more than 3 drinks per day), which in the opinion of the investigators would compromise 
either the patient or the integrity of the data 
 
4.2.11 Patients on anticoagulation or with bleeding disorders should be evaluated by a physician for 
risk/benefit of bleeding disorders with intramuscular injections prior to study enrollment. Patients 
determined to be at high risk for bleeding with intramuscular injections will be excluded. 
 
4.3 
Inclusion of Women and Minorities 
 
Adult females and males of all races and ethnic groups are eligible for this trial. HPV-related 
malignancies are unequally distributed among men and women, Gardasil® 9 protects women against 
cervical, vaginal, vulvar, and anal cancers; and men against anal cancer caused by the seven oncogenic 
HPV types covered by the vaccine. 
 
The study was originally designed to be conducted only among women 18-49 years of age. However, as 
noted in Section 4.1.1 above, with version 3.6, the study is also expanded to men 18-49 years of age. 

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4.4 
Recruitment and Retention Plan 
 
Recruitment 
A waiver of consent to access patient records to allow for the identification of potential study participants 
for recruitment has been obtained from the CIRB. Potential participants will be identified for study 
recruitment by physicians or study staff: 
1. Before or during clinical encounters 
2. By review of medical charts 
3. By review of institutional databases 
4. By review of the deceased donor transplant waitlist 
5. Through consultation with the institution’s transplant coordinator(s) 
6. By referral from other physicians 
7. By reviewing upcoming donor workup evaluations 
8. By reviewing upcoming living donor surgery lists 
9. By other site-specific methods 
 
Medical charts of potential transplant recipients will be reviewed for eligibility, including sex, age, prior 
organ transplant, laboratory results, previous malignancies, and medical contraindications. The physician 
will review the eligibility information and assess the likelihood of undergoing surgery within 12 months 
of enrollment, and notify research staff whether the patient may be considered for participation. The 
research staff may approach potential participants through any of the following methods: 
1. Preparing and mailing a study information packet that introduces the study to potentially eligible 
patients. The packet may include materials such as the study consent form (ICF), HIPAA 
authorization, and IRB-approved recruitment materials (e.g., introductory letter, leaflet; each 
participating site will choose what materials to include). 
2. Contacting potential participants by phone. 
3. Approaching potential participants at their clinic visits. 
 
Patients will be encouraged to review the consent documents with family, friends, and/or other 
physicians. The patient will be told that the decision to join or not join the study will not affect the 
medical treatment that patients receive, and that patients can withdraw from the study at any time. If the 
participant is approached at the clinic, and wishes to review the consent form at home, research staff may 
follow-up with a phone call to the patient a few days later to evaluate interest in study participation and 
answer additional questions. If the potential participant is still interested, research staff may schedule a 
return visit to discuss the study further with the research staff and sign the consent form. 
 
Because this protocol has many possible schedules depending on the occurrence and the timing of each 
participants’ transplant surgery, and in order to limit the length of the Consent Form, Appendix C (Study 
Procedures for Potential Participants) and Appendix D (Study Schedule for Potential Participants) are 
provided. Study teams may optionally use these materials with potential participants. 
 
In an effort to minimize participant burden and increase the likelihood of enrollment and follow-up, we 
will schedule study visits to coincide with usual care appointments, whenever possible. A packet of 
material, including a map and parking instructions may be provided to the study participant prior to the 
scheduled study visit. At the completion of all study visits except the Additional Study Visits, participants 
will receive compensation for their time, transportation, parking, and other expenses related to the study. 

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Figure 2. Recruitment
Feasibility
According to the 2017 Organ Procurement Transplantation Network data reports [22], a total of 467 first- 
time kidney transplants in adults aged 18-49 were performed at these five sites (Table 1). First-time renal 
transplant recipients in adults aged 18-DWWKHVHLQVWLWXWLRQVLQFOXGHGZKLWH$IULFDQ
$PHULFDQ+LVSDQLF$VLDQ3DFLILF,VODQGHUDQG0XOWLUDFLDO– a larger 
percentage of non-white living doQRUWUDQVSODQWUHFLSLHQWVWKDQWKHQDWLRQDODYHUDJH
Recruitment of pre-renal transplant recipients will occur over a period of 18 months. Investigators will 
review all listed individuals undergoing evaluation for transplantation on a weekly basis.
We project that 815 adults, ages 18-49 years, will receive a first-time kidney transplant during an 18- 
month period based on the 543 adult first-time kidney transplant recipients aged 18-49 in 2017 by the 
participating transplant centers (Table 1), suggesting that our recruitment goal is highly feasible. The final 
analytic sample for follow-up will include an estimated 64 adults (which are projected to include 23 
white, 17 African-American, 17 Hispanic, 7 Asian based on current racial/ethnic composition of kidney 
transplant recipients) who have received two doses of the Gardasil® 9 HPV vaccine and have undergone a 
NLGQH\WUDQVSODQWGD\VDIWHUWKHILUVWYDFFLQHGRVH7RPHHWWKLVJRDOZHHVWLPDWHWKDWZHQHHGWR
recruit and consent 180 participants.

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Table 1. Numbers of Kidney Transplants in 2017 by Center 
 
CSMC 
UCSF 
NW 
UAB 
UNC 
Total 
First-time living donor kidney 
transplants in women age 18-49, 
2017* 
 
10 
 
18 
 
16 
 
19 
 
4 
 
67 
First-time living donor kidney 
transplants in men age 18-49, 2017* 
10 
28 
40 
31 
4 
113 
First-time deceased donor kidney 
transplants in women age 18-49 
years, 2017* 
 
19 
 
30 
 
30 
 
31 
 
16 
 
126 
First-time deceased donor kidney 
transplants in men age 18-49 years, 
2017* 
 
32 
 
40 
 
21 
 
54 
 
14 
 
161 
Total first-time kidney transplants in 
women and men age 18-49, 2017 
71 
116 
107 
135 
38 
467 
*https://optn.transplant.hrsa.gov/data/view-data-reports/center-data accessed on 11/06/2018. 
 
Time for kidney transplants will vary significantly between those receiving a living donor transplant and 
those receiving a deceased donor transplant. Typically, living donor kidney transplants are performed 
within 90 days after approval of an acceptable living donor at each of the participating transplant centers. 
:HZLOOPDNHHYHU\HIIRUWWRFRPSOHWHWKHVFUHHQLQJHYDOXDWLRQVDQGVFKHGXOHWKHEDVHOLQHYLVLWGD\V
before the patient’s living donor kidney transplant procedure to maximize the number of eligible, 
consented participants who receive at least one dose of the Gardasil® 9 HPV vaccine prior to the 
transplant. Study participants who are expected to receive a kidney transplant from a deceased donor will 
be selected based on their likelihood of receiving the transplant within 12 months of enrollment, and 
depending on when the transplant actually gets scheduled (unpredictable time frame, given the knowledge 
of availability of a donor kidney and transplant surgery is usually a matter of <24 hours), the participants 
may be able to receive one, two or all three doses of the HPV vaccine prior to transplant. 
 
Over an 18-month period we expect that 180 kidney transplant candidates will be consented and pass the 
medical chart review and pre-transplant clinic evaluations; 120 will receive one or two doses of the 
Gardasil® 9 HPV vaccine prior to transplant; 96 women will complete the 12-month post-transplant 
follow-up visit and receive the booster vaccine dose; and 64 women who have received the first vaccine 
GRVHGD\VEHIRUHWKHLUWUDQVSODQWZLOOFRPSOHWHDOOIROORZ-up. 
 
Although all eligible, consented kidney transplant candidates will receive their first vaccine dose, we 
expect that a substantial fraction (perhaps one-third) of these candidates may not receive a transplant 
within the study period, largely because the identified donor will not pass through all the transplant 
eligibility screening testing in case of living donor transplant recipients, or no matching kidney from 
deceased donors becomes available in case of participants on the deceased donor transplant waiting list. 
Therefore, to meet the sample size requirement (N=64) for analysis of our primary endpoint, we enroll a 
higher number of participants than our expected target, expecting losses to follow-up at several stages in 
the study enrollment and follow-up cascade. 
 
5. 
AGENT ADMINISTRATION 
 
Intervention will be administered on an outpatient basis. Reported AEs and potential risks are described in 
Section 6.2. 

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permit for such inspection. Do not use the product if particulates are present or if it appears 
discolored. 
x 
Administer the entire dose as per standard protocol and instructions in the package insert. 
x 
Participants will be required to be afebrile (oral temperature < 37.8° C) for 24 hours before 
vaccination. 
x 
Participants must be monitored for 30 minutes following vaccination for syncope/convulsive 
syncope and allergic reactions. There will be an accessible crash cart during vaccine 
administration which will include medications for anaphylaxis. 
x 
The CDC discourages deviating from the recommended route and encourages that all 
vaccines be administered by the manufacturer’s recommended route [47,48]. The HPV 
vaccine should be administered intramuscularly if a physician familiar with the patient’s 
bleeding risk determines that the vaccine can be administered by this route with reasonable 
safety. A fine-gauge needle (23-gauge or smaller caliber) should be used for the vaccination, 
followed by firm pressure on the site, without rubbing, for at least 2 minutes. The patient or 
family should be given information on the risk for hematoma from the injection. In patients 
with clotting factor disorders receiving antihemophilia or similar therapy, the intramuscularly 
administered vaccination can be scheduled shortly after such therapy is administered. Patients 
receiving anticoagulation therapy (or aspirin) presumably have similar bleeding risk as 
patients with clotting factor disorders and should follow the same guidelines for 
intramuscular administration. If possible, vaccination could be scheduled prior to the use of 
these medications, so that the patients’ risk of bleeding is not increased by their therapeutic 
action. 
 
5.3 
Run-in Procedures 
 
None. 
 
5.4 
Contraindications 
 
Gardasil® 9 is contraindicated in individuals who are hypersensitive to the active substances or to any of 
the excipients of the vaccine, including severe allergic reactions to yeast (a vaccine component), or after a 
previous Gardasil® 9 dose. 
 
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, 
and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to 
Gardasil® 9. Immunosuppressive therapies are not prohibited concomitant medications for this study. 
 
5.5 
Concomitant Medications 
 
The regimen type, duration, and dosing of all concomitant medications which, in the judgment of the 
study clinician, are expected to modulate the immune system (including, but not limited to, 
immunosuppressive agents, anti-virals, and anabolic steroids) will be documented on the concomitant 
medication CRF. 
 
All medications (prescription and over-the-counter), vitamin and mineral supplements, and/or herbs taken 
by the participant during a Serious Adverse Event will be documented. Medications taken for the 
transplant procedure do not need to be included; however, if the patient’s transplant hospitalization is 
extended because of an adverse event, medications taken during the extended portion of the 
hospitalization will be included. 

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Other medications (prescription and over-the-counter), vitamin and mineral supplements, and/or herbs 
taken by the participant during the regular course of the study will be documented at the discretion of the 
study clinician. 
5.6 
Dose Modification 
1RGRVHPRGLILFDWLRQVDUHSODQQHG7KHVWXG\DJHQWZLOOEHVWRSSHGLQWKHHYHQWRIDQ$(JUDGH
considered possibly, probably, or definitely related to the study agent. The second or third dose of 
Gardasil® 9 will not be administered to participants who experienced symptoms indicative of 
hypersensitivity after the first and/or second dose(s). 
 
5.7 
Adherence/Compliance 
 
Study visits will coincide with usual care appointments whenever possible to increase compliance with 
the study protocol/vaccine dosing schedule. Research staff will contact study participants by phone 24-72 
hours after receiving each vaccine dose to ask about potential side effects of the immunization. If the 
participant reports adverse symptoms there will be a follow-up call on day 7 ± 2 days to assess resolution. 
Participants will also be contacted 5-7 days before each study visit to confirm the appointment. Contact 
can be made using site standard procedures and/or mechanisms (i.e. automated or manual phone call, text 
message, or email). 
 
6. 
PHARMACEUTICAL INFORMATION 
 
6.1 
Study Agent (IND #
 (Exempt), IND Sponsor: NCI/DCP) 
 
This clinical study investigating the preventive efficacy of recombinant human papillomavirus (HPV) 
nonavalent vaccine, Gardasil® 9, is being conducted under an IND exemption sponsored by NCI/DCP. 
Gardasil® 9 is indicated for prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 
16, 18, 31, 33, 45, 52 and 58, and for the prevention of genital warts caused by HPV types 6 or 11 in 
females 9-45 years of age. Gardasil® 9 is indicated for prevention of anal cancer caused by HPV types 16, 
18, 31, 33, 45, 52 and 58, and for the prevention of genital warts caused by HPV types 6 or 11 in males 9- 
45 years of age. 
 
Gardasil® 9 is manufactured by Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc. 
(Whitehouse Station, New Jersey). It is supplied in 0.5 mL single-dose vials or pre-filled syringes as a 
sterile suspension for intramuscular administration. Each 0.5 mL dose contains approximately 30 μg HPV 
Type 6 L1 protein, 40 μg HPV Type 11 L1 protein, 60 μg HPV Type 16 L1 protein, 40 μg HPV Type 18 
L1 protein, 20 μg HPV Type 31 L1 protein, 20 μg HPV Type 33 L1 protein, 20 μg HPV Type 45 L1 
protein, 20 μg HPV Type 52 L1 protein, and 20 μg HPV Type 58 L1 protein. Each 0.5 mL dose of the 
vaccine also contains approximately 500 μg aluminum (provided as amorphous aluminum 
hydroxyphosphate sulfate [AAHS]), 9.56 mg sodium chloride, 0.78 mg L-histidine, 50 μg polysorbate 80, 
35 μg sodium borate, <7 μg yeast protein, and water for injection. The product does not contain a 
preservative or antibiotics. After thorough agitation, Gardasil® 9 is a white cloudy liquid. 
 
6.2 
Reported Adverse Events and Potential Risks 
 
The manufacturer evaluated the safety of Gardasil® 9 in six clinical studies that included 15,703 
individuals who received at least one dose and had safety follow-up. The vaccine was administered on the 
day of enrollment, with subsequent doses administered approximately two and six months thereafter. 
Safety was evaluated using vaccination report card (VRC)-aided surveillance for 14 days after each 
injection of Gardasil® 9. The individuals who were monitored using VRC-aided surveillance included 
9,097 girls and women 16-26 years of age, 1,394 boys and men 16-26 years of age, and 5,212 girls and 
boys 9-15 years of age (3,436 girls and 1,776 boys) at enrollment. 

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Injection site reactions (pain, swelling, and erythema) and oral temperature were solicited using VRC- 
aided surveillance for five days after each injection of Gardasil® 9 during the clinical studies. The rates 
of injection site pain were approximately equal across the three reporting time periods; the rates of 
injection site swelling and injection site erythema increased following each successive dose of Gardasil® 
9. 
Unsolicited injection site and systemic adverse reactions were assessed as vaccine-related by the 
investigator. Few individuals discontinued study participation due to adverse experiences after receiving 
the vaccine. 
 
7KHPRVWFRPPRQ) local and systemic adverse reactions in females 16-26 years of age who 
received Gardasil® ZHUHLQMHFWLRQVLWHSDLQLQMHFWLRQVLWHVZHOOLQJLQMHFWLRQVLWH
HU\WKHPDDQGKHDGDFKH7KHPRVWFRPPRQORFDODQGV\VWHPLc adverse 
reactions in males 16-26 years of age who received Gardasil® ZHUHLQMHFWLRQVLWHSDLQLQMHFWLRQ
VLWHVZHOOLQJLQMHFWLRQVLWHHU\WKHPDDQGKHDGDFKH7KHPRVWFRPPRQ
local and systemic reactions in girls 9-15 years of age who received Gardasil® 9 were injection site pain 
LQMHFWLRQVLWHVZHOOLQJLQMHFWLRQVLWHHU\WKHPDDQGKHDGDFKH7KH
PRVWFRPPRQORFDODQGV\VWHPLFUHDFWLRQVLQER\VDJHG-15 years who received Gardasil® 9 
ZHUHLQMHFWLRQVLWHSDLQLQMHFWLRQVLWHVZHOOLQJDQGLQMHFWLRQVLWHHU\WKHPD 
 
Serious adverse events (SAEs) were collected throughout the entire study period (range one to 48 months 
post-last dose) for the six integrated clinical studies with Gardasil® 9. Of the 13,236 individuals who were 
administered Gardasil® 9 and had safety follow-XSUHSRUWHGDQ6$(UHSUHVHQWLQJRIWKH
population. Five reported at least one SAE that was determined to be vaccine-related: pyrexia, allergy to 
vaccine, asthmatic crisis, headache, and tonsillitis. There were no vaccine-related deaths among 
individuals administered Gardasil® 9 in the clinical studies. 
 
In all of the clinical trials with Gardasil® 9, participants were evaluated for new medical conditions 
SRWHQWLDOO\LQGLFDWLYHRIDV\VWHPLFDXWRLPPXQHGLVRUGHU,QWRWDORI*DUGDVLO® 9 
recipients reported new medical conditions potentially indicative of systemic autoimmune disorders, 
which were similar to rates reported following Gardasil®, AAHS control, or saline placebo in historical 
clinical trials. 
 
The safety of Gardasil® 9 when administered concomitantly with Menactra (Meningococcal [Groups A, 
C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) and Adacel (Tetanus Toxoid, 
Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed [Tdap]) was evaluated in a 
randomized study of 1,241 boys (n = 620) and girls (n = 621) with a mean age of 12.2 years. Of the 1,237 
boys and girls vaccinated, 1,220 had safety follow-up for injection site adverse reactions. The rates of 
injection site adverse reactions were similar between the concomitant group and non-concomitant group 
(vaccination with Gardasil® 9 separated from vaccination with Menactra and Adacel by one month) with 
the exception of an increased rate of swelling reported at the injection site for Gardasil® 9 in the 
FRQFRPLWDQWJURXSFRPSDUHGWRWKHQRQ-FRQFRPLWDQWJURXS7KHPDMRULW\RILQMHFWLRn site 
swelling adverse reactions were reported as mild to moderate in intensity. 
 
Reproductive studies performed in female rats at a dose approximately 240 times the human dose on a 
mg/kg basis revealed no evidence of impaired female fertility or harm to the fetus due to Gardasil® 9. 
There are, however, no adequate and well-controlled studies in pregnant women. Because animal 
reproduction studies are not always predictive of human responses, Gardasil® 9 should be used during 
pregnancy only if clearly needed. It is not known whether Gardasil® 9 is excreted in human milk. Because 
many drugs are excreted in human milk, caution should be exercised when Gardasil® 9 is administered to 
a nursing woman. 
 

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The safety and effectiveness of Gardasil® 9 have not been established in pediatric patients below nine 
years of age. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, 
cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune 
responses to Gardasil® 9. However, immunosuppressive therapies are not prohibited concomitant 
medications for this study. 
 
6.3 
Availability 
 
Gardasil® 9 will either be provided by Merck and distributed via NCI, DCP’s repository contractor 
MRIGlobal (Kansas City, MO), procured and distributed by MRIGlobal, or procured locally at the study 
sites. 
 
6.4 
Agent Distribution 
 
Agents will only be released by NCI, DCP after documentation of NCI Central IRB (CIRB) approval of 
the DCP-approved protocol and consent is provided to DCP and the collection of all Essential Documents 
is complete (see DCP website for description of Essential Documents). 
 
NCI, DCP-supplied agents may be requested by the Investigator (or their authorized designees) at each 
participating organization. DCP guidelines require that the agent be shipped directly to the institution or 
site where the agent will be prepared and administered. DCP does not permit the transfer of agents 
between institutions (unless prior approval from DCP is obtained). DCP does not automatically ship 
agents; the site must make a request. Agents are requested by completing the DCP Clinical Drug Request 
form (NIH-986) (to include complete shipping contact information) and faxing or mailing the form to the 
DCP agent repository contractor: 
 
John Cookinham 
MRIGlobal 
DCP Repository 
1222 Ozark Street 
North Kansas City, MO 64116 
Phone: (816) 360-3805 
FAX: (816) 753-5359 
Emergency Telephone: (816) 360-3800 
Email: NCI.DCP@mriglobal.org 
 
6.5 
Agent Accountability 
 
The Investigator, or a responsible party designated by the Investigator, must maintain a careful record of 
the inventory and disposition of all agents received from DCP using the NCI Drug Accountability Record 
Form (DARF). The Investigator is required to maintain adequate records of receipt, dispensing, and final 
disposition of study agent. This responsibility has been delegated to the study pharmacists or their 
designees at each site . Include on receipt record from whom the agent was received and to whom study 
agent was shipped, date, quantity and batch or lot number. On dispensing record, note quantities and dates 
study agent was dispensed to and returned by each participant. 
 
6.6 
Packaging and Labeling 
 
Gardasil® 9 will be supplied by NCI DCP in the original manufacturer’s packaging and not re-labeled for 
study purposes. 

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6.7 
Storage 
 
Gardasil® 9 is supplied in single-dose vials or pre-filled syringes and should be stored in a secure location 
protected from light at temperatures between 2°C and 8°C (36°F and 46°F). Gardasil® 9 will be stored in 
a safe, secure, temperature monitored limited access drug storage area specifically for research 
medication at the Research Pharmacy at each site. 
 
6.8 
Registration/Randomization 
 
The Lurie Cancer Center Clinical Trials Management System (CTMS) will be the database of record. The 
study coordinator must upload (via CTMS), a signed and complete informed consent along with HIPAA 
authorization and a completed registration form for each participant identified as eligible to be entered 
into the study. 
 
All participants must be registered in CTMS M-F between the hours of 9:30 a.m. and 5:00 p.m., Central 
Time (CT). Participants must not start protocol treatment prior to registration in CTMS. 
 
This is a non-randomized trial. 
 
6.9 
Blinding and Unblinding Methods 
 
Not applicable. 
 
6.10 
Agent Destruction/Disposal 
 
At the completion of the study, all unused study agent will be returned to NCI, DCP Repository according 
to the DCP “Guidelines for AGENT RETURNS” and using the DCP form “Return Drug List”. 
7. 
CLINICAL EVALUATIONS AND PROCEDURES 
 
7.1 
Schedule of Events 
 
 
 
Study Procedures 
 
Consent 
and 
Screen- 
ing Visit 
Pre- 
Trans- 
plant 
Vaccine 
Visit 11 
Pre- 
Trans- 
plant 
Vaccine 
Visits 2 
and 32 
 
Trans- 
plant 
Surgery 
6 Month 
Post- 
Trans- 
plant 
Visit3 
12 
Month 
Post- 
Trans- 
plant 
Visit4 
13 
Month 
Post- 
Trans- 
plant 
Visit5 
 
Add- 
itional 
Study 
Visit(s)6 
Assess eligibility 
X 
X 
 
 
 
 
 
 
Informed consent form and 
HIPAA authorization 
X 
 
 
 
 
 
 
 
Pregnancy test7 
X 
 
 
 
 
X8 
 
 
Enrollment 
 
X 
 
 
 
 
 
 
Demographics (race, ethnicity, 
education) 
 
X 
 
 
 
 
 
 
Review medical history, 
medications, and laboratory test 
results 
 
 
X 
 
X 
 
 
X 
 
X 
 
 
Symptoms assessment and 
ECOG performance status 
 
X 
X 
 
X 
X 
 
 

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Physical exam including vital 
signs and weight 
 
X 
X 
 
X 
X 
 
 
Gardasil® 9 HPV vaccination 
 
X 
X 
 
 
X8 
 
X 
Collect blood specimen for 
research 
 
X9 
X9 
X10 
X9 
X9 
X11 
 
Self-collection of 
cervical/vaginal, and oral 
samples for HPV DNA 
 
 
X 
 
X 
 
 
X 
 
X 
 
 
Self-collection of urine samples 
for HPV DNA (optional)12 
 
X 
X 
 
X 
X 
 
 
Collection of eyebrow hairs for 
future viral DNA testing 
(optional)12 
 
 
X 
 
X 
 
 
X 
 
X 
 
 
Self-collection of male genital 
samples for future HPV DNA 
testing (optional)12 
 
 
X 
 
X 
 
 
X 
 
X 
 
 
Interviewer-administered risk 
factor questionnaire13 
 
X 
X 
 
X 
X 
 
 
Review eligibility criteria 
X 
X 
 
 
 
 
 
 
Assess adverse events14 
 
X 
X 
 
 
X 
 
 
Telephone contact15 
X 
X 
X 
 
X 
X 
 
X 
1 Pre-Transplant Vaccine Visit 1 may occur the same day as the Consent and Screening Visit, and will be scheduled 
GD\VSULRUWRWKHSODQQHGWUDQVSODQWVXUJHU\ 
2 Pre-Transplant Vaccine Visits 1 and 2 are optional, guided by the timing of surgery and feasibility of additional 
study-related visits. Participants who do not have Pre-Transplant Vaccine Visits 1 and/or 2 will still receive the 
complete 3-dose series of the vaccine (the remaining vaccination(s) will occur post-transplant; see Appendix B for a 
detailed schedule). If the Pre-Transplant Vaccine Visits 1 and 2 occur, the following intervals must be used: 
x 
Pre-7UDQVSODQW9DFFLQH9LVLWVKRXOGRFFXUGD\VDIWHU3UH-Transplant Vaccine Visit 1.
x 
Pre-7UDQVSODQW9DFFLQH9LVLWVKRXOGRFFXUmonths after Pre-Transplant Vaccine Visit 2, and 
months after Pre-Transplant Vaccine Visit 1. 
3 The 6 Month Post-Transplant Visit will occur 6 months (±2 weeks) after the participant’s renal transplant 
procedure. 
4 The 12 Month Post-Transplant Visit will occur 12 months (±2 weeks) after the participant’s renal transplant 
procedure. 
x 
Participants who received only one dose of the vaccine prior to transplant will receive the second dose of 
the vaccine at this visit.
x 
Participants who received two vaccine doses prior to transplant will receive the third dose of the vaccine at 
this visit.
x 
Participants who received three vaccine doses prior to transplant will not receive a third dose of the vaccine 
at this visit.
5 The 13 Month Post-Transplant Visit will occur 1 month (+2 weeks) after the 12 Month Post-Transplant Visit. This 
visit will occur only for participants who received a vaccine at the 12 Month Post-Vaccine Visit. 
6 Additional Study Visit(s) will be offered for participants only for the purpose of completing their vaccine series 
(second and/or third doses) in the following scenarios: 
x 
Participants who receive only one dose prior to transplant and second dose at the 12 Month Post-Transplant 
Visit will be offered an Additional Study Visit at 3 months (+4 weeks) after 12 Month Post-Transplant 
Visit.
x 
Participants who receive one vaccine dose, but their transplant surgery is postponed/rescheduled/cancelled 
and eventually not scheduled within 12 months of the study enrollment date, will be offered two Additional 
Study Visits to complete the three dose vaccine series. Additional Study Visit 1 will occur 12 months (±2 
weeks) after Pre-Transplant Vaccine Visit 1, and Additional Study Visit 2 will occur 3 months (+ 4 weeks) 
after Additional Study Visit 1.

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x 
Participants who receive two vaccine doses, but their transplant surgery does not occur within 12 months of 
the study enrollment date, will complete an Additional Study Visit to complete the three dose vaccine series 
at 12 months (±2 weeks) after Pre-Transplant Vaccine Visit 1.
7 Pregnancy test (urine/blood) for women able to become pregnant. Women who are able to become pregnant must 
have a confirmed negative pregnancy test result within the past 28 days prior to enrollment. Women with both 
ovaries removed/tubal ligation will not be required to have a pregnancy test. Women who are pregnant will be 
excluded and will not receive vaccine. 
8 Gardasil 9 vaccine and the pregnancy test (for women able to become pregnant) at the 12 Month Post-Transplant 
Visit will occur only for participants who complete 1-2 vaccines prior to transplant. 
9 A 28 mL blood specimen will be collected. 
10 For participants who completed only one vaccine prior to surgery, a 28 mL blood specimen will be collected. For 
participants who received 2-3 vaccines prior to surgery, no blood will be collected. 
11 A 10 mL blood specimen will be collected. 
12 For participants who noted in the consent form that they agree to the optional collection of these specimens. 
13 A detailed interviewer-administered questionnaire (Appendix E) will be used at baseline (Pre-Transplant Vaccine 
Visit 1) and a shortened questionnaire (Appendix F) will be used at subsequent visits to ask about changes in 
exposures/behaviors between visits. 
14 Adverse event assessments after Gardasil® 9 vaccination will include monitoring for syncope/convulsive 
syncope, pain, swelling, redness or itching at the vaccine injection site, headache, fever, nausea, and signs of a 
severe allergic reaction: hives, a fast heartbeat, dizziness, weakness, difficulty breathing, or swelling of the face and 
throat. 
15 Participants will also be contacted by telephone 24-72 hours after receiving each vaccine dose to ask about 
potential side effects. If participant reports adverse symptoms there will be a follow-up call on day 7 ± 2 days to 
assess resolution. Participants will also be contacted 5-7 days before each study visit to confirm the appointment. 
Contact can be made using site standard procedures and/or mechanisms (i.e. automated or manual phone call, 
text message, or email) 
 
7.2 
Pre-Study Evaluation 
Consent and Screening Visit 
Renal transplant candidates who are 18-49 years of age, expected to undergo transplant surgery within 12 
months of enrollment, and interested in participating in the study will be consented into the trial during a 
clinic visit. Research staff will be present at the clinic during this visit and will be available to review 
study materials with the patient and answer questions about the study. Patients will be encouraged to 
review the consent documents with family, friends, and/or other physicians. The patient will be told that 
the decision to join or not join the study will not affect the medical treatment that patients receive, and 
that patients can withdraw from the study at any time. Patients who have had all their questions about the 
study answered on the day they first learn about the study, and who wish to participate, may be consented 
the same day they are first informed of the research. Otherwise, another appointment may be scheduled. 
 
Research staff will obtain signatures on the consent documents for kidney transplant candidates who wish 
to volunteer for the study after all clinical options have been presented and the patient's questions have 
been answered. The patient will carefully review and sign the study consent form and HIPAA 
authorization. Copies of each form will be given to the patient and placed in the medical record. Written 
consent will be obtained before any research related procedures are initiated. 
 
At the Screening and Consent visit, the following procedures will be performed: 
1) Consent will be obtained. Appendix C and Appendix D are optional to use when consenting the 
participant. 
2) A thorough review of the patient’s medical history will be done, including past cervical cytology 
results 
3) Inclusion and exclusion criteria will be evaluated for the patient 
4) Women able to become pregnant will be required to have a confirmed negative pregnancy test 
(urine or blood) within 28 days prior to enrollment. Women who have had a both ovaries 

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removed or a tubal ligation will not be required to have a pregnancy test. 
 
7.3 
Baseline Testing and Evaluation During Study Intervention 
Pre-Transplant Vaccine Visit 1 
The first vaccine visit may occur the same day as the Consent and Screening Visit, and wilORFFXU
days before the patient’s kidney transplant procedure. The following procedures will be performed during 
this visit: 
1) Review of medical and surgical history, medications, and laboratory test results 
2) Symptom assessment and ECOG performance status 
3) Physical exam including vital signs, height, and weight 
4) Review of inclusion/exclusion criteria and study requirements, final determination of eligibility, 
and enrollment 
5) The first dose of Gardasil® 9 will be administered to the participant. 
6) Blood draw – A 28 mL blood specimen will be collected from each participant. 
7) Self-collection of cervical/vaginal and oral samples for HPV DNA detection. 
8) Self-collection of urine for HPV DNA detection from participants who consent to collection of 
optional urine samples. 
9) Collection of eyebrow hairs (collected by research staff) for future viral DNA testing from participants 
who consent to collection of optional samples for biobanking for future studies 
10) Self-collection of male genital samples for future HPV DNA testing from participants who 
consent to collection of these optional samples for biobanking for future studies 
11) Interviewer-administered baseline questionnaire to obtain demographic information (detailed race 
and ethnicity, education); skin sensitivity and type; tobacco and alcohol use; recent sexual 
activity; medical history, including frequency of Pap smears; and medication use (Appendix E) 
 
Pre-Transplant Vaccine Visits 2 and 3 
 
These visits are optional, and should be guided by the timing of surgery and feasibility of additional 
study-related visits. Participants who do not have Pre-Transplant Vaccine Visits 1 and/or 2 will still 
receive the complete 3-dose series of the vaccine (the remaining vaccination(s) will occur post-transplant. 
See Appendix B for a detailed schedule). If the Pre-Transplant Vaccine Visits 1 and 2 occur, the 
following intervals must be used: 
x 
Pre-7UDQVSODQW9DFFLQH9LVLWVKRXOGRFFXUGD\VDIWHU3UH-Transplant Vaccine Visit 1. If 
possible (but not required), Pre-Transplant Vaccine Visit 2 should occur at least 30 days prior to 
Transplant Surgery.
x 
Pre-7UDQVSODQW9DFFLQH9LVLWVKRXOGRFFXUPRQWKVDIWHU3UH-Transplant Vaccine Visit 2, and
PRQWKVDIWHr Pre-Transplant Vaccine Visit 1. If possible (but not required), Pre-Transplant 
Vaccine Visit 3 should occur at least 30 days prior to Transplant Surgery. 
 
The following procedures will be performed during these visits: 
1) Review of medical and surgical history, medications, and laboratory test results 
2) Symptom assessment and ECOG performance status 
3) Physical exam including vital signs and measurement of weight 
4) Gardasil® 9 will be administered to the participant. 
5) Blood draw – A 28 mL blood specimen will be collected from each participant. 
6) Self-collection of cervical/vaginal and oral samples for HPV DNA detection. 
7) Self-collection of urine for HPV DNA detection from participants who consent to collection of 
optional urine samples. 
8) Collection of eyebrow hairs (collected by research staff) for future viral DNA testing from 
participants who consent to collection of optional samples for biobanking for future studies 

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9) Self-collection of male genital samples for future HPV DNA testing from participants who 
consent to collection of these optional samples for biobanking for future studies 
10) Interviewer-administered follow-up questionnaire to obtain information about changes in 
exposures and behaviors between study visits (Appendix F) 
11) Review of inclusion/exclusion criteria and study requirements 
 
Telephone Calls 
 
Research staff will contact study participants by phone 24-72 hours after receiving each vaccine dose 
throughout the study, including pre-transplant vaccines, post-transplant vaccines, and Additional Study 
Visit(s). Research staff will ask the participant about potential side effects of the immunization. If the 
participant reports adverse symptoms there will be a follow-up call on day 7 ± 2 days to assess resolution. 
Participants will also be contacted 5-7 days before each study visit to confirm the appointment. Contact 
can be made using site standard procedures and/or mechanisms (i.e. automated or manual phone call, text 
message, or email) . 
The following information with be collected during the telephone calls: 
x 
Concomitant medication review
x 
Adverse events. Participants will be asked if they have experienced any of the following 
symptoms to assess adverse events:
o Pain, swelling, redness, or itching at the vaccine injection site 
o Headache 
o Fever 
o Nausea 
o Signs of a severe allergic reaction: hives, a fast heartbeat, dizziness, weakness, difficulty 
breathing, or swelling of the face and throat 
x 
Additional symptoms experienced by participants will be recorded to assess adverse events
 
7.3.4 
Transplant Surgery 
 
For participants who receive only one vaccine dose prior to transplant, a blood sample (28 ml) will be 
obtained for antibody titers before/at transplant surgery. All other participants (who received two or more 
vaccines prior to transplant) will have no research activity on the day of transplant surgery. 
 
7.4 
Evaluation at Completion of Study Intervention 
6 Month Post-Transplant Visit 
This study visit will occur 6 months (± 2 weeks) after the participant’s kidney transplant procedure. The 
following procedures will be performed during this visit: 
1) Review of medical and surgical history, and medications, and laboratory test results 
2) Symptom assessment and ECOG performance status 
3) Physical exam including vital signs and measurement of weight 
4) Blood draw – A 28 mL blood specimen will be collected from each participant. 
5) Self-collection of cervical/vaginal and oral samples for HPV DNA detection. 
6) Self-collection of urine for HPV DNA detection from participants who consent to collection of 
optional urine samples. 
7) Collection of eyebrow hairs (collected by research staff) for future viral DNA testing from 
participants who consent to collection of optional samples for biobanking for future studies 
8) Self-collection of male genital samples for future HPV DNA testing from participants who 
consent to collection of these optional samples for biobanking for future studies 
9) Interviewer-administered follow-up questionnaire to obtain information about changes in 
exposures and behaviors between study visits (Appendix F) 

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10) Review of inclusion/exclusion criteria and study requirements 
 
12 Month Post-Transplant Visit 
 
This study visit will occur 12 months (± 2 weeks) after the participant’s kidney transplant procedure. The 
following procedures will be performed during this visit: 
1) Review of medical and surgical history, medications, and laboratory test results 
2) Symptom assessment and ECOG performance status 
3) Physical exam including vital signs and measurement of weight 
4) Pregnancy test (urine or blood) for women who meet both of the following criteria: 
a. Received only one or two vaccines earlier in the study, AND 
b. Are able to become pregnant (women who have had both ovaries removed or a tubal 
ligation will not be required to have a pregnancy test) 
Women who are pregnant will not receive the Gardasil® 9 HPV vaccine. 
5) Participants who have received two vaccine doses prior to transplant will receive the third dose of 
the vaccine. Participants who have received only one dose of the vaccine prior to transplant will 
receive the second dose of the vaccine at this visit. 
6) Blood draw – A 28 mL blood specimen will be collected from each participant. 
7) Self-collection of cervical/vaginal and oral samples for HPV DNA detection. 
8) Self-collection of urine for HPV DNA detection from participants who consent to collection of 
optional urine samples. 
9) Self-collection of male genital samples for future HPV DNA testing from participants who 
consent to collection of these optional samples for biobanking for future studies 
10) Collection of eyebrow hairs (collected by research staff) for future viral DNA testing from 
participants who consent to collection of optional samples for biobanking for future studies 
11) Interviewer-administered follow-up questionnaire to obtain information about changes in 
exposures and behaviors between study visits (Appendix F) 
12) Review of inclusion/exclusion criteria and study requirements 
 
7.5 
Post-intervention Follow-up Period 
13 Month Post-Transplant Visit 
If the participant received a vaccine dose at the 12 Month Post-Transplant Visit, the participant will return 
for a 13 Month Post-Transplant Visit. This visit will occur 1 month (+2 weeks) after the 12 Month Post- 
Transplant Visit. The following procedures will be performed during this visit: 
1) Blood draw – A 10 mL blood specimen will be collected from each participant to measure HPV 
vaccine-type-specific antibody titers. 
 
7.6 
Additional Study Visit(s) 
 
Additional Study Visits will be offered only for the purpose of completing the vaccine series for 
participants who are unable to receive their second or third vaccine doses in accordance to the proposed 
schedule of events. These Visits will be offered in the following scenarios: 
1. Participants who only received one dose prior to transplant, and their second dose administered at 
12 Month Post-Transplant Visit. These participants will receive their third dose at an Additional 
Study Visit 3 months (+4 weeks) after the 12 Month Post-Transplant Visit. 
2. Participants who received two vaccine doses prior to transplant, but their transplant surgery is 
postponed/rescheduled/cancelled and eventually not scheduled within 12 months of the study 
enrollment date, will complete their three dose vaccine series at an Additional Study Visit at 12 
months (±2 weeks) after Pre-Transplant Vaccine Visit 1. These participants will be considered 
off-study after the Additional Study Visit is completed, and follow-up calls were made, as 

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discussed in Section 8.4. 
3. Participants who receive one vaccine dose prior to transplant, but their transplant surgery does not 
occur within 12 months of Pre-Transplant Vaccine Visit 1, will be offered two Additional Study 
Visits to complete the three dose vaccine series. Additional Study Visit 1 will occur 12 months 
(±2 weeks) after the Pre-Transplant Vaccine Visit 1.  Additional Study Visit 2 will occur 3 
months (+4 weeks) after Additional Study Visit 2. These participants will be considered off- 
study after the Additional Study Visits are completed, and follow-up phone calls were made, as 
discussed in Section 8.4. 
 
The following procedures will be performed during the Additional Study Visits: 
1) The second or third dose of Gardasil® 9 is administered. 
 
7.7 
Methods for Clinical Procedures 
Administration of Vaccine. The CDC HPV VIS (http://www.immunize.org/vis/hpv.pdf) will be 
provided to the participant prior to administration of the vaccine. The vaccine will be administered as a 
0.5 mL injection in the deltoid region of the upper arm or in the higher anterolateral area of the thigh. 
Participants will be monitored for adverse reactions to the vaccine for 30 minutes. 
 
Blood specimen. A 28 mL blood specimen will be collected from each participant at the Pre-Transplant 
Vaccine Visits 1, 2, and 3, at the 6 Month and 12 Month Post-Transplant Visits, and (for participants who 
do not complete Pre-Transplant Vaccine Visit 2) before/at transplant surgery for measurement of the 
primary and secondary endpoints for the study. Ten mL of blood will be collected at the 13 Month Post- 
Transplant Visit to measure the anamnestic response to the booster vaccine dose by assessing HPV 
vaccine-type-specific titers. The primary biomarker of interest, HPV vaccine-type-specific seroconversion 
rates, will be measured in peripheral blood that will be drawn by routine venipuncture at the time of 
mandated blood draws, thus there will be no added risk to the participant. 
 
Collection of cervical/vaginal and oral samples for HPV DNA testing. Cervical/vaginal and oral 
samples will be self-collected at the Pre-Transplant Vaccine Visits 1, 2, and 3, and at the 6 Month and 12 
Month Post-Transplant Visits for HPV DNA testing. Cervical/vaginal samples will be self-collected using 
the Evalyn Brush® (Rovers Medical Devices B.V., Oss, Netherlands) for female participants only. Oral 
samples will be self-collected using a mouthwash gargle. 
 
Collection of urine samples for HPV DNA testing. Urine samples will be self-collected at the Pre- 
Transplant Vaccine Visits 1, 2, and 3, and at the 6 Month and 12 Month Post-Transplant Visits from 
participants who consent to the collection of optional urine samples. Approximately 20-30 mL of urine 
will be self-collected at each visit in a sterile urine specimen container. Urine samples will be used for 
HPV DNA testing. 
 
Collection of eyebrow hair samples for future viral DNA testing. Eyebrow hair samples will be 
collected at the Pre-Transplant Vaccine Visits 1, 2, and 3, and at the 6 Month and 12 Month Post- 
Transplant Visits from participants who consent to collection of optional samples for biobanking for 
future studies. Clinical research staff will collect six eyebrow hairs with the attached follicle from each 
consenting participant using sterile tweezers. Eyebrow hair samples will be used for future viral DNA 
testing. 
 
Collection of male genital samples for HPV DNA testing. Male genital samples will be collected using 
a validated male genital sampler collection protocol [40,46] from participants who consent to the 
collection of these optional samples for an exploratory analysis of detection of HPV DNA during the 
course of the study. This analysis is exploratory since there is no FDA-approved HPV sampling or testing 
protocol in males. Male genital samples will be self-collected by rubbing a dry swab over the entire 
exterior surface of the penis and placed into a vial. Male genital samples will be self-collected at the Pre- 

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Transplant Vaccine Visits 1, 2, and 3, and at the 6 Month and 12 Month Post-Transplant Visits and will 
be used for HPV DNA testing. 
 
8. 
CRITERIA FOR EVALUATION AND ENDPOINT DEFINITION 
 
8.1 
Primary Endpoint 
 
HPV vaccine-type-specific seroconversion rates at 12-months post-transplantation among 18-49 year old 
NLGQH\WUDQVSODQWUHFLSLHQWVZKRUHFHLYHGRVHVRIWKH*DUGDVLO® +39YDFFLQHGD\VSULRUWR
transplantation. 
 
8.2 
Secondary and Exploratory Endpoints 
 
Secondary Endpoint 
HPV vaccine-type-specific seroconversion rates at 6- and 12-months post-transplantation stratified by 
number of doses (1, 2, or 3) of the vaccine given pre-transplant.  
 
Exploratory Endpoints 
1) HPV vaccine-type-specific seroconversion rates at 12-months post-transplantation stratified by: 
a) time elapsed between last vaccine dose and the transplant procedure; 
b) variations in doses and types of post-transplant immunosuppressant medications; and interactions 
with type of transplant surgery (living donor/deceased donor); 
c) differences in Human Leukocyte Antigen (HLA) histocompatibility between donor and recipient;  
d) differences in biological sex (i.e. male vs. female) of the transplant recipient. 
 
2) Stability of HPV vaccine-type-specific geometric mean titers (GMT) at 6- and 12-months post-
transplantation and rise in HPV vaccine-type-specific GMT at the 13-month post-transplant visit. 
 
3) Vaccine safety profile and allograft rejection/opportunistic infections stratified by number of vaccine 
doses and time between the last vaccine dose and the transplant procedure. 
 
4) HPV detection in samples from the cervix/vagina, and oral cavity at baseline (pre-vaccination) and at 
6- and 12-months post-vaccination, overall and by number of vaccine doses (1, 2, or 3), sexual 
behavior, type-specific seroconversion rates, and time elapsed between the last vaccine dose and the 
transplant procedure. 
 
8.3 
Off-Agent Criteria 
 
Participants may stop taking study agent for the following reasons: completed the protocol-prescribed 
intervention, AE or serious adverse event (SAE), inadequate agent supply, noncompliance, or medical 
contraindications. Participants will continue to be followed, if possible, for safety reasons (e.g., telephone 
contact 24-72 hours after receiving each vaccine dose to ask about potential side effects of the 
immunization; and a follow-up call on day 7 ± 2 days to assess resolution if the participant reports 
adverse symptoms). Participants who receive one or two doses of the vaccine in the pre-transplant period 
and go off-agent due to any reason stated above will be offered the post-transplant study visits at 6- 
months, 12-months and 13-months to collect endpoint data according to the schedule of events, even 
though the clinical and/or logistical situation that led to the participant going ‘off-agent’ might not permit 
giving the remaining vaccine doses at any of these visits. 
 
8.4 
Off-Study Criteria 
 
Participants may go ‘off-study’ for the following reasons: the protocol intervention and any protocol- 

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required follow-up period is completed, AE/SAE, lost to follow-up, non-compliance, medical 
contraindications, withdraw consent, death, determination of ineligibility (including screen failure), or 
pregnancy. Participants whose planned transplant surgery does not occur within 12 months of enrollment 
will be taken ‘off-study’ after Additional Study Visit(s) and follow-up phone calls (described in Section 
7.5.2) are completed, to finish the remaining vaccine doses of the series. All participants who do not 
receive transplant surgery within 12 months of enrollment will be notified prior to going off study. 
 
8.5 
Study Termination 
 
NCI, DCP as the clinical study protocol sponsor has the right to discontinue the study at any time. 
 
9. 
CORRELATIVE/SPECIAL STUDIES 
 
9.1 
Rationale for Methodology Selection 
9.1.1 Vaccine-induced seroconversion: Serum samples obtained at baseline and at follow-up study visits 
will be assessed for antibodies to HPV VLP types 6/11/16/18/31/33/45/52/58 by competitive Luminex 
immunoassay (HPV-F/,$9HUVLRQ)RUWKHSULPDU\HQGSRLQWDSDUWLFLSDQWZLOOEHGH¿QHGDV
seroconverted i.e., anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, or 58 positive by Merck’s proprietary 
competitive Luminex Immunoassay (cLIA) assay if the anti-HPV serum level at the 12-months post- 
WUDQVSODQWYLVLWLVRUPLOOL0HUFNXQLWVP08P/UHVSHFWLYHO\
by the cLIA assay [21,23]. The cLIA assay uses a multiplex format with each of the nine virus like 
particle (VLP)-types in the vaccine fixed to Luminex microspheres with distinct fluorescent properties. 
Antibody titers are determined in a competitive format, where type-specific phycoerythrin (PE)-labeled, 
neutralizing monoclonal antibodies (mAbs-PE) compete with an individual's vaccine-induced antibodies 
in the serum for binding to conformationally-sensitive, neutralizing epitopes on the VLPs [23,24]. There 
is no specific (minimum) number of serotypes required for classifying someone as seroconverted, since 
the seroconversion for each vaccine-serotype will be assessed independently. Further, since the cLIA 
antibody titers to each HPV type are determined using type-specific monoclonal antibodies, it is not 
possible to make a direct comparison of assay results across HPV types. Given the age of the participants, 
there is high likelihood of having prior sexual exposure to some, if not all, individual HPV types targeted 
by the nonavalent HPV vaccine. However, anti-HPV antibodies induced due to such ’natural’ infection 
are usually detected at a much lower titer levels than the aforementioned cutoffs defined for vaccine- 
induced seropositivity. Type-specific sensitivity analyses, restricted to participants who are seronegative 
for individual types at baseline, will also be conducted. Assays will be performed at Merck Research 
Laboratories. If access to cLIA is not feasible due to technical or operational reasons, a 9-valent multiplex 
HPV assay (based on same principle/framework as the cLIA assay) developed at the NCI Frederick 
National Laboratory for Cancer Research (FNLCR) will be used for the study.  
 
9.1.2 HPV detection and genotyping: HPV DNA will be extracted from cervical/vaginal (in women), 
oral, and, optionally, urine samples (in both genders) and male genital samples (in men) by use of 
commercial reagents (Qiagen, Valencia, CA). A 450 bp region of the L1 HPV genome will be amplified 
using the PGMY09/11 primer system, a nondegenerate, pooled primer system modified from the original, 
degenerate MY09/11 primer system [25]. GH20 and PC04 primers will be used to coamplify a 268 bp 
UHJLRQRIWKHKXPDQȕ-globin gene as an internal control for sample sufficiency. Specimens positive for 
the 450- and 268-ESEDQGVRI+39DQGȕ-globin, respectively, will be considered positive. Specimens 
IRXQGQHJDWLYHIRUȕ-globin on co-amplification will be re-amplified in a single amplification reaction. 
7KRVHUHPDLQLQJQHJDWLYHIRUȕ-globin will be excluded from analysis. HPV DNA-positive specimens 
will be genotyped using a reverse line-blot detection method for 37 different HPV types [26], including 
high-risk [oncogenic] types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68; possible high-risk types 
26, 34, 53, 66, 70, 73, and 82; low-risk [nononcogenic] types 6, 11, 40, 42, 44, 54, 61, 72, 81, and 89; and 
undetermined-risk types 62, 67, 71, 83, and 84 [27]. HPV-positive specimens that subsequently have 
negative results in the genotyping assay will be considered to be unclassified HPV-positive specimens. 

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Urine samples are optional because patients on dialysis may be unable to provide a urine sample. Male 
genital samples are optional because, unlike female cervical/vaginal HPV testing, there is limited 
evidence on the ideal methods for HPV testing and the clinical correlates of HPV test positivity results in 
men. 
 
9.1.3 Eyebrow hair samples for future viral DNA testing. Solid organ transplant recipients are at high 
risk (30-fold) for non-melanoma skin cancers, most notably squamous cell skin cancer. UV exposure is a 
major risk factor for these cancers in immunosuppressed and immunocompetent populations. Infections 
have been hypothesized to play a role in the development of these malignancies, namely genus beta HPVs 
[28,29]. Studies of skin biopsies indicate that levels of cutaneous HPVs are higher in squamous cell 
cancers than normal appearing skin, and even higher among those who are immunosuppressed with 
cancer [30]. Eyebrow hair follicles represent a sun-exposed reservoir for HPV [31]. Compared to the 
general population, HPV DNA levels in these follicles are higher in those who develop squamous cell 
skin cancer [32], and even higher in solid organ transplant recipients [31]. There is also growing interest 
regarding the role of polyomaviruses in squamous cell skin cancer development [33]. Polyomaviruses 
reside in eyebrow hair follicles [34], and there is recent evidence that polyomavirus DNA in eyebrow hair 
follicles are associated with squamous cell cancer [35]. Eyebrow hair samples will be collected by 
research staff at the baseline and follow-up study visits from participants who consent to collection of 
optional samples for biobanking for future studies. Eyebrow hair samples will be stored for future viral 
DNA testing. 
9.2 
Comparable Methods 
 
Proposed methods represent standard technology for HPV detection and genotyping and assessment of 
HPV antibodies. 
 
10. 
SPECIMEN MANAGEMENT 
 
10.1 
Laboratories 
 
10.1.1 Blood samples for HPV serology will be tested at Merck Research Laboratories through support 
from the Merck Investigator Studies Program (MISP) and an agreement between Merck and NCI DCP 
or at the National Cancer Institute’s Frederick National Laboratory for Cancer Research (FNLCR). 
 
10.1.2 Laboratory for testing the urine, cervical/vaginal, and oral samples for HPV detection and 
genotyping will be finalized in consultation with the study sponsor, National Cancer Institute-Division of 
Cancer Prevention. 
 
10.2 
Collection and Handling Procedures 
 
10.2.1 Blood samples. A 28 mL blood specimen will be collected from each participant at the Pre- 
Transplant Vaccine Visits 1, 2, and 3, at the 6 Month and 12 Month Post-Transplant Visits, and (for 
participants who do not complete Pre-Transplant Vaccine Visit 2) before/at transplant surgery for 
measurement of the primary and secondary endpoints for the study. The blood will be collected using four 
blood collection tubes, including one 10 mL heparin green top tube, two 4 mL EDTA lavender top tubes, 
and one 10 mL red top tube. A 10 mL blood specimen will be collected at the 13 Month Post-Transplant 
Visit into one red top tube to measure HPV vaccine-type-specific antibody titers. The blood samples will 
be processed as specified in the Laboratory Manual and will be separated into plasma, serum, red blood 
cells, and buffy coat for DNA extraction. These blood components will be transferred to cryovials and 
will be stored at -80°C. Centrifugation and aliquoting will be done as soon as is feasible (recommended < 
2 hours) after the blood draw to allow the samples to be frozen quickly and maintained frozen until 
thawed and tested. All blood samples will be shipped to CSMC for batch HPV serology at the end of the 

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study and long-term storage. 
 
10.2.2 Cervical/vaginal and oral samples will be self-collected at the Pre-Transplant Vaccine Visits 1, 
2, and 3, and at the 6 Month and 12 Month Post-Transplant Visits for HPV DNA testing. Samples will be 
collected and processed as specified in the Laboratory Manual. Cervical/vaginal samples will be self- 
collected using the Evalyn Brush® (Rovers Medical Devices B.V., Oss, Netherlands). Oral samples will 
be self-collected using a mouthwash gargle. All specimens will be shipped to CSMC as specified in the 
shipping instructions and will be stored in a -80°C freezer for batch HPV detection and genotyping at the 
end of the study. 
 
10.2.3 Urine samples will be self-collected at the Pre-Transplant Vaccine Visits 1, 2, and 3, and at the 6 
Month and 12 Month Post-Transplant Visits from participants who consent to the collection of optional 
urine samples. Approximately 20-30 mL of urine (first void catch) will be self-collected at each visit in a 
sterile urine specimen container. All specimens will be shipped to CSMC as specified in the shipping 
instructions and will be stored in a -80°C freezer for batch HPV detection and genotyping at the end of 
the study. 
10.2.4 Eyebrow hair samples will be collected at the Pre-Transplant Vaccine Visits 1, 2, and 2, and at 
the 6 Month and 12 Month Post-Transplant Visits from participants who consent to collection of 
optional samples for biobanking for future studies. Clinical research staff will collect a total of six 
eyebrow hairs with the attached follicle from each consenting participant using sterile tweezers and 
place in a cryovial. Eyebrow hair samples will be shipped to CSMC as specified in the shipping 
instructions and will be stored in a -80°C freezer for future viral DNA testing. 
 
10.2.5 Male genital samples will be collected at the Pre-Transplant Vaccine Visits 1, 2, and 2, and at the 
6 Month and 12 Month Post-Transplant Visits from male participants who consent to collection of these 
optional samples. Samples will be collected and processed as specified in the Laboratory Manual. 
 
10.3 
Shipping Instructions 
 
Samples collected from all study sites will be shipped to the CSMC specimen manager. 
Please see the study’s Laboratory Manual for the shipping address. 
 
All processed blood and non-blood samples (cervical/vaginal, oral, urine, and eyebrow) will be shipped 
overnight in dry ice. All samples will be shipped on Monday or Tuesday in compliance with the 
International Air Transport Association (IATA) Dangerous Goods Regulations. 
 
10.4 
Tissue Banking 
 
Biologic specimens collected during the conduct of each clinical trial that are not used during the course 
of the study will be considered deliverables under the contract and thus the property of the NCI. At study 
completion, NCI reserves the option to either retain or relinquish ownership of the unused biologic 
specimens. If NCI retains ownership of specimens, the Contractor shall collect, verify, and transfer the 
requested biologic specimens from the site to a NCI-specified repository or laboratory at NCI’s expense. 
 
11. 
REPORTING ADVERSE EVENTS 
 
DEFINITION: AE means any untoward medical occurrence associated with the use of a drug in humans, 
whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign, 
symptom, or disease temporally associated with participation in a study, whether or not related to that 
participation. This includes all deaths that occur while a participant is on a study. 
 
Please note that all abnormal clinical laboratory values that are determined to be of clinical significance 

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based on a physician’s assessment are to be reported as AEs. Those labs determined to be of no clinical 
significance or of unknown clinical significance (per the physician’s assessment) should not be reported 
as AEs. Any lab value of unknown clinical significance should continue to be investigated/followed-up 
further for a final determination, if possible. 
 
A list of AEs that have occurred or might occur can be found in §6.2 Reported Adverse Events and 
Potential Risks, as well as the Investigator Brochure or package insert. 
 
Each center has the capacity to link to the electronic medical record enabling study personnel to monitor 
adverse outcomes. Although there is variability in the frequency of post-transplant follow-up and 
monitoring at the five participating transplant centers, all centers obtain a metabolic panel (BMP) and 
urinalysis at 6 months, 1 year, and at 2 years post-transplant, as required by the United Network for Organ 
Sharing (UNOS). Declining renal function is tracked via creatinine levels and allograft rejection is 
monitored via biopsy when clinically indicated; although one participating center, UCSF, does perform 
protocol biopsies post-transplant at 6 months and another biopsy at 1 year if the initial biopsy 
demonstrates inflammation. Data related to post-transplant infectious (bacterial, viral, and fungal) and 
rejection episodes will be collected as a part of this study. 
 
Postoperative complications, including biopsy-confirmed graft rejection, recurrent kidney disease, and 
post-transplant infections, will be monitored by the renal transplant teams. Patients receiving additional 
immunotherapy to treat graft rejection or experiencing post-transplant infectious complications during the 
study period will be monitored. Standardized definitions will be developed by the investigative team, 
including nosocomial infections and common opportunistic viral infections [36]. 
 
11.1 
Adverse Events 
 
11.1.1 Reportable AEs 
 
All AEs that occur after the informed consent is signed and baseline assessments are completed 
(including run-in) must be recorded on the AE CRF (paper and/or electronic) whether or not related to 
study agent. 
 
For all unsolicited AEs not meeting the criteria for “Serious Adverse Events”, the following caveats will 
apply: 
a. AEs in the immediate (up to 14 days) post-vaccination periods: All unsolicited AEs, including 
anticipated and unanticipated clinical events, clinically significant laboratory abnormalities, and 
vaccine-related injection site local reactions (e.g., pain, swelling, erythema, pruritus, induration, 
warmth, etc.) and vaccine-related systemic side-HIIHFWVHJKHDGDFKHRUDOWHPSHUDWXUHGHJUHHV
F, nausea, fatigue, dizziness, allergic events, bronchospasm, etc.) will be collected for up to 14 days 
following vaccine administration (1st, 2nd, and 3rd dose) and reported on AE CRFs. 
i. 
Note that clinically significant laboratory abnormalities that pre-dated vaccine 
administration and remain unchanged (as per the Site Principal Investigator’s judgment) 
after vaccine-administration should not be reported as AEs 
 
b. AEs outside of the immediate post-vaccination periods (i.e., beyond 14 days): 
i. 
Anticipated clinically significant laboratory abnormalities, that in the view of either the Site 
Principal Investigator or the Sponsor, are related to the underlying renal disease, transplant 
procedure, or post-transplant regimens will not be collected or reported. (*exceptions 
below) 
ii. 
Anticipated adverse events, that in the view of either the Site Principal Investigator or the 
Sponsor, are related to the underlying renal disease, transplant procedure, or post-transplant 
regimens will not be collected or reported. (*exceptions below) 

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iii. 
All other adverse events will be collected and reported on AE CRFs. In situations where 
multiple AEs relate to a single unifying diagnosis, only the main unifying diagnosis should 
be reported as an AE on AE CRFs. 
Example: In case of pneumonia with leukocytosis and chest pain that only requires 
outpatient treatment; the diagnosis of pneumonia should be reported as an AE, but 
leukocytosis and chest pain should not be reported as AEs. 
 
*exceptions: 
x 
All unsolicited clinical events/laboratory parameters signifying allograft rejection at any 
time in the study follow-up period and regardless of the need for hospitalization, will be 
reported as SAEs. Rejection events that are required to be reported to UNOS (United 
Network for Organ Sharing) will be reported simultaneously to DCP using the Adult 
Kidney Transplant Recipient Follow-Up Worksheet (https://www.transplantpro.org/wp- 
content/uploads/sites/3/Adult_TRF_Kidney.pdf). 
x 
Clinical events or laboratory investigations (e.g., cross-match change) resulting in 
cancellation of a planned transplant will be reported as SAEs. 
11.1.2 AE Data Elements: 
 
The following data elements are required for AE reporting. 
x 
AE verbatim term 
x 
NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) AE term 
(MedDRA lowest level term) 
x 
CTCAE (MedDRA) System Organ Class (SOC) 
x 
Event onset date and event ended date 
x 
Treatment assignment code (TAC) at time of AE onset 
x 
Severity grade 
x 
Attribution to study agent (relatedness) 
x 
Whether or not the event was reported as a SAE 
x 
Whether or not the participant dropped due to the event 
x 
Outcome of the event 
 
11.1.3 Severity of AEs 
 
11.1.3.1 
Identify the AE using the CTCAE version 4.0. The CTCAE provides descriptive 
terminology (MedDRA lowest level term) and a grading scale for each AE listed. A copy of the CTCAE 
can be found at http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm [37]. 
 
AEs will be assessed according to the grade associated with the CTCAE term. AEs that do not have a 
corresponding CTCAE term will be assessed according to the general guidelines for grading used in the 
CTCAE v4.0. as stated below. 
 
CTCAE v4.0 general severity guidelines: 
 
Grade 
Severity 
Description 
1 
Mild 
Mild; asymptomatic or mild symptoms; clinical or diagnostic 
observations only; intervention not indicated. 
2 
Moderate 
Moderate; minimal, local or noninvasive intervention indicated; 
limiting age-appropriate instrumental activities of daily living 
(ADL)*. 

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3 
Severe 
Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; 
disabling; limiting self-care ADL**. 
4 
Life-threatening 
Life-threatening consequences; urgent intervention indicated. 
5 
Fatal 
Death related to AE. 
 
ADL 
*Instrumental ADL refers to preparing meals, shopping for groceries or clothes, using the telephone, 
managing money, etc. 
**Self-care ADL refers to bathing, dressing and undressing, feeding self, using the toilet, taking 
medications, and not bedridden. 
 
11.1.4 Assessment of relationship of AE to treatment 
 
The possibility that the AE is related to study agent will be classified as one of the following: not related, 
unlikely, possible, probable, or definite. 
 
11.1.5 Follow-up of AEs 
 
All AEs, including lab abnormalities that in the opinion of the investigator are clinically significant, will 
be followed according to good medical practices and documented as such. 
 
11.2 
Serious Adverse Events 
 
11.2.1 DEFINITION: Regulations at 21 CFR §312.32 (revised April 1, 2014) defines an SAE as any 
untoward medical occurrence that at any dose has one or more of the following outcomes: 
 
• 
Death 
• 
A life-threatening AE 
• 
Inpatient hospitalization or prolongation of existing hospitalization 
• 
A persistent or significant incapacity or substantial disruption of the ability to perform normal life 
functions 
• 
A congenital anomaly or birth defect 
• 
Important medical events that may not be immediately life-threatening or result in death 
or hospitalization should also be considered serious when, based upon appropriate 
medical judgment, they may jeopardize the patient and may require intervention to 
prevent one of the other outcomes. 
 
All unsolicited clinical events/laboratory parameters signifying allograft rejection at any time in the study 
follow-up period and regardless of the need for hospitalization, will be reported as SAEs. Rejection 
events that are required to be reported to UNOS (United Network for Organ Sharing) will be reported 
simultaneously to DCP using the Adult Kidney Transplant Recipient Follow-Up Worksheet 
(https://www.transplantpro.org/wp-content/uploads/sites/3/Adult_TRF_Kidney.pdf). 
 
Clinical events or laboratory investigations (e.g., cross-match change) resulting in cancellation of a 
planned transplant will be reported as SAEs. 
 
11.2.2 Reporting SAEs to DCP 
 
a. All SAEs, including all hospitalizations, during the study period will be reported as per DCP SAE 
reporting procedures, with the following exception. 

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i. Hospitalization for planned renal transplant surgery will not be reported. However, if this 
hospitalization event lasts longer than the usual period at the institution (as determined by the 
Site Principal Investigator or Sponsor), it will be reportable as an SAE. Adverse events (AEs) 
relevant to the prolongation of this hospitalization will also be collected and reported on AE 
CRFs. 
b. In situations prompting SAE reporting when multiple abnormalities/associated 
concurrent/concomitant adverse events are present: 
i. The primary/most significant adverse event will be recorded as the SAE. Associated events 
should be included in the chronology of the case provided in the ‘Describe Event’ field on the 
SAE form. Multiple signs and symptoms can be incorporated under a single diagnosis, 
disease, or condition. These associated events should not be separately reported as AEs on 
AE CRFs. 
Example: pneumonia resulting in hospitalization would be the primary SAE, and 
concomitant events such as leukocytosis, anemia, fever, etc. can be reported in the 
‘Describe Event’ field on the SAE form but would not be listed separately as AEs on AE 
CRFs. 
ii. Concurrent/concomitant events that prolong hospitalization, or that independently fulfill other 
serious adverse event reporting criteria (e.g., life-threatening, medically significant), will be 
reported as separate SAEs. 
Example: pneumonia resulting in hospitalization, along with renal failure requiring 
dialysis, will be reported separately as two SAEs as (i) pneumonia, and (ii) renal failure 
requiring dialysis. 
 
11.2.2.1 
The Lead Organization and all Participating Organizations will report SAEs on the DCP 
SAE Report Form found at http://prevention.cancer.gov/clinical-trials/clinical-trials- 
management/protocol-information-office/pio-instructions-and-tools/2012-consortia. 
 
11.2.2.2 
Contact the DCP Medical Monitor by phone within 24 hours of knowledge of the event. 
 
Eva Szabo, MD 
Chief, Lung & Upper Aerodigestive Cancer Research Group 
Division of Cancer Prevention 
National Cancer Institute 
9609 Medical Center Drive, Room 5E-102, MSC 9781 
Bethesda, MD 20892-9781 (For FedEx, use Rockville, MD 20850) 
Tel: (240) 276-7011 
Fax: (240) 276-7848 
Email: szaboe@mail.nih.gov 
 
Include the following information when calling the Medical Monitor: 
x 
Date and time of the SAE 
x 
Date and time of the SAE report 
x 
Name of reporter 
x 
Call back phone number 
x 
Affiliation/Institution conducting the study 
x 
DCP protocol number 
x 
Title of protocol 
x 
Description of the SAE, including attribution to drug 
 
11.2.2.3 
The Lead Organization and all Participating Organizations will email written SAE reports 
to the following within 48 hours of learning of the event using the fillable PDF SAE Report Form. 

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x 
DCP’s Regulatory Contractor CCS Associates, Inc. (CCSA; phone: 650-691-4400) at 
safety@ccsainc.com 
x 
NCI DCP Medical Monitor, Dr. Eva Szabo (szaboe@mail.nih.gov) 
x 
Northwestern Cancer Prevention Consortium (ncpc@northwestern.edu) 
 
11.2.2.4 
The DCP Medical Monitor and CCSA regulatory and safety staff will determine which 
SAEs require FDA submission as IND safety reports. 
 
11.2.2.5 
The Lead Organization and all Participating Organizations will comply with applicable 
regulatory requirements related to reporting SAEs to the CIRB/IEC. 
 
11.2.3 Follow-up of SAE 
 
Site staff should send follow-up reports as requested when additional information is available. Additional 
information should be entered on the DCP SAE Report Form in the appropriate format. Follow-up 
information should be sent to DCP as soon as available. All SAEs will be followed according to standard 
of care. SAEs possibly, probably, or definitely related to the study agent will be followed until resolved. 
Serious AEs (SAEs) will be monitored throughout the study regardless of cause by the study physicians 
and the Data and Safety Monitoring Board (DSMB). 
 
12. 
STUDY MONITORING 
 
12.1 
Data Management 
 
Data will be managed by the study statistician, Dr. Kocherginsky, according to standard operating 
procedures, which meet the guidelines of DCP Requirements for Data Management and which follow the 
Data Management Plan that Northwestern University has on file with the Division of Cancer Prevention, 
NCI. Source data verification will be performed by the Northwestern Cancer Prevention Consortium. The 
Consortia 2012 Data Management Plan, submitted as part of a contract agreement with the NCI 
(HHSN261201200035I), was approved. 
 
Clinical data will be reported to the Lurie Cancer Center Clinical Trials Management System (CTMS), 
which will be the database of record. 
 
12.2 
Case Report Forms 
 
Participant data will be collected using protocol-specific case report forms (CRFs) developed from the 
standard set of DCP Chemoprevention CRF Templates and utilizing NCI-approved Common Data 
Elements (CDEs). The approved CRFs will be used by Northwestern University to create the electronic 
CRFs (e-CRFs) screens in the CTMS-RDC application. Site staff will enter data into the e-CRFs for 
transmission to DCP according to DCP standards and procedures. 
 
All specimen results that are batch analyzed will be collected and stored on excel spreadsheets. The excel 
spreadsheets will constitute the database of record. 
 
12.3 
Source Documents 
 
All source documents will be collected and stored by the research staff at the site of accrual. Any data 
recorded directly in CTMS that constitute no prior written or electronic record of data, will be specifically 
identified as source data. Questionnaires completed in person may be completed on paper and entered into 
CTMS. 
 

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12.4 
Data and Safety Monitoring Plan 
 
A comprehensive Data Safety and Monitoring Plan has been submitted by Northwestern University, 
approved by the DCP, and is on file there. Any future changes will be forwarded for review. 
 
This trial is subject to review by the Lurie Cancer Center Data & Safety Monitoring Committee (DSMC). 
Semi-Annual reports, SAEs, and protocol deviations will be reviewed by the DSMC at bi-weekly 
meetings. This trial is also subject to possible audits by the Lurie Cancer Center Clinical Trials Audit 
Committee (CTAC). 
12.5 
Sponsor or FDA Monitoring 
 
The NCI, DCP (or their designee), pharmaceutical collaborator (or their designee), or FDA may 
monitor/audit various aspects of the study. These monitors will be given access to facilities, databases, 
supplies, and records to review and verify data pertinent to the study. 
 
12.6 
Record Retention 
 
Clinical records for all participants, including CRFs, all source documentation (containing evidence to 
study eligibility, history and physical findings, laboratory data, results of consultations, etc.), as well as 
CIRB records and other regulatory documentation will be retained by the Investigator in a secure storage 
facility in compliance with Health Insurance Portability and Accountability Act (HIPAA), Office of 
Human Research Protections (OHRP), Food and Drug Administration (FDA) regulations and guidances, 
and NCI/DCP requirements, unless the standard at the site is more stringent. The records for all studies 
performed under an IND will be maintained, at a minimum, for two years after the approval of a New 
Drug Application (NDA). For NCI/DCP, records will be retained for at least three years after the 
completion of the research. NCI will be notified prior to the planned destruction of any materials. The 
records should be accessible for inspection and copying by authorized persons of the Food and Drug 
Administration. If the study is done outside of the United States, applicable regulatory requirements for 
the specific country participating in the study also apply. 
 
12.7 
Cooperative Research and Development Agreement (CRADA)/Clinical Trials Agreement 
(CTA) 
 
Not applicable. 
 
13. 
STATISTICAL CONSIDERATIONS 
 
13.1 
Study Design/Description 
 
This is a prospective single-arm trial to evaluate if the Gardasil® 9 HPV vaccine induces and sustains an 
adequate immune response at 12-months post-transplantation among 18-49 year old kidney transplant 
UHFLSLHQWVZKHQGRVHVRIWKHYDFFLQHDUHDGPLQLVWHUHGSULRUWRWUDQVSODQWDWLRQ7KHVWXG\population 
includes candidates for renal transplant within 12 months of enrollment at five transplant centers in the 
United States. We anticipate that 96 eligible kidney transplant recipients will ultimately be enrolled and 
complete follow-up during the study period of 36 months, and 24-28 of them will have received the 
second vaccine dose before their transplant. For the analytical dataset for the primary endpoint, 
participants will have received the first dose of Gardasil® 9 nonavalent HPV vaccine at baseline and 
their post-transplant serology titers are assessed at 12-months post-transplant visit. Kidney transplant 
candidates who receive one or two doses of the vaccine but do not get transplanted within 12 months of 
enrollment will be considered off-study after they are offered the remainder of the vaccine doses to 
complete the three-dose vaccine series. 
 

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13.2 
Randomization/Stratification 
 
Not applicable. 
 
13.3 
Accrual and Feasibility 
 
Sample size: Consent/enrollment = 180; Intervention = 96; Analytic sample = 64 after drop-outs. The 
expected accrual rate is 10 participants per month across five sites, and the planned recruitment duration is 
18 months. We anticipate that all evaluable participants will have completed all study procedures within 36 
months. 
 
Initial accrual estimates were calculated based on; 1) the number of kidney transplant candidates aged 18-
49 who come forward for kidney transplant who eventually get transplanted; and 2) the number of kidney 
transplants performed in this age sub-set at the five participating transplant centers in 2017.  
 
After accounting for experiences in recruitment of participants during the years the protocol has been open, 
as well as the additional accrual and retention challenges encountered due to the COVID-19 pandemic, it 
was projected that the expected accrual for the study will be in the range of n=24 to 28 participants who 
will receive one or more vaccine doses pre-transplant and complete the necessary post-transplant follow-
up period for the primary endpoint analysis.  
 
13.4 
Primary Objective, Endpoint(s), Analysis Plan 
 
The primary objective is to estimate HPV vaccine-type-specific seroconversion rates at 12-months post-
WUDQVSODQWDWLRQDPRQJNLGQH\WUDQVSODQWUHFLSLHQWVZKRUHFHLYHGRVHVRIWKH*DUGDVLO® 9 HPV 
vaccine prior to transplantation,  
 
An estimate of the seroconversion rate will be provided along with exact Clopper-3HDUVRQ
confidence intervals (CIs).  
 
Originally (until version 3.10), the study was designed with the expectation of at least n=64 evaluable 
participants for the primary analysis, and the analytic plan was focused on comparisons with pre-
specified benchmarks (e.g., 0.75 and 0.90) of the expected seroconversion rate estimate.  
 
In version 3.11, responding to the lower accrual expectations of between n=24 to n=28 evaluable 
participants in the study, the study’s focus was revised to only focus on description of the estimation of 
WKHVHURFRQYHUVLRQUDWHDQGWKHXSSHUOLPLWRILWVRQHVLGHGFRQILGHQFHLQWHUYDODVRSSRVHGWRDQ\
pre-specified comparisons.   
 
Even without pre-specified comparison benchmarks, the revised analysis plan will permit cross-study 
comparisons with other relevant HPV vaccination studies (e.g., those conducted among individuals 
undergoing solid organ transplants or other immunosuppressed individuals). The study will generate key 
preliminary data for testing clinically relevant hypotheses in future larger studies to evaluate the full 
extent of protection afforded by HPV vaccination administered prior to transplant. 
 
With the study expecting to yield between n=24 to n=28 evaluable participants, Table 3 (below) provides 
H[SHFWHGXSSHUOLPLWVRIWKHRQHVLGHG&,IRUWKHHVWLPDWHVRIWKHVHURFRQYHUVLRQUDWHVUDQJLQJ
between 0.65 to 0.90.  
 
Table 3. Expected upper limits of one sided 95% CI for seroconversion rates 
Expected accrual n=24 evaluable 
participants 
Expected accrual n=28 evaluable 
participants 

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Estimate P 
One-VLGHG&,
Upper Limit 
Estimate P 
One-VLGHG&,
Upper Limit 
0.65 
0.8088 
0.65 
0.7977 
0.70 
0.8480 
0.70 
0.8380 
0.75 
0.8851 
0.75 
0.8763 
0.80 
0.9197 
0.80 
0.9123 
0.90 
0.9776 
0.90 
0.9739 
 
 
13.5 
Secondary and Exploratory Objectives, Endpoints, Analysis Plans 
 
Secondary Endpoint: 
Descriptive statistics, such as probabilities DQGH[DFWFRQILGHQFHLQWHUYDOV, will be used to 
summarize HPV vaccine-type-specific seroconversion rates at 6- and 12-months post-transplantation 
stratified by number of doses (1, 2, or 3) of the vaccine given pre-transplant. Seroconversion 
probabilities will be compared between dose groups using Fisher’s exact test. Armitage trend test 
will be used to examine whether there is a trend for increased seropositivity across dose groups. Due 
to the limited sample size, these tests will be sufficiently powered to detect only very large 
differences and will be considered exploratory. 
 
Exploratory Endpoints: 
1) Descriptive statistics, VXFKDVSUREDELOLWLHVDQGH[DFWFRQILGHQFHLQWHUYDOV, will be used to 
summarize probability of seroconversion at 12 months post-transplant for the following groups:  
 
a) time elapsed between last vaccine dose and the transplant procedure, e.g. <3 months vs. >3 
months. Different groupings will be considered based on observed (e.g. median) and 
clinical considerations. Time will be summarized using descriptive statistics, e.g. median, 
interquartile range, or range; groups defined by dosing and types of post-transplant 
immunosuppressant medications, as well as; 
b) type of transplant surgery (living donor/deceased donor); 
c) differences in Human Leukocyte Antigen (HLA) histocompatibility between donor and 
recipient;  
d) differences by biological sex (i.e., male vs. female) of the transplant recipient.  
 
2) Stability of HPV vaccine-type-specific geometric mean titers (GMT) at 6 and 12- months post-transplantation, 
and rise in HPV vaccine-type-specific GMT at the 13 month post-transplant visit.  
a) Stability will be evaluated in relation to changes in the type-specific GMTs between the two post-transplant 
time points (6- and 12-months post-transplant) and reported as follows: (i) decrease: more than 2-fold 
decrease, (ii) stable: within 2-fold change, and (iii) increase: greater than 2-fold increase. 
b) The magnitude of increase in type-specific GMTs at the 13-month post-transplant visit (i.e., 1 
month after the booster dose) will be described in relation to the type-specific GMTs at the 
other post-transplant visits (6 and 12-months post -transplant). Patterns over time will also be 
explored using graphical techniques. 
c) Stability, and post-booster dose increase in type-specific GMTs will also be described in 
relation to the number of vaccine doses (1, 2 or 3) received in the pre-transplant period.   
 
3) Vaccine safety profile and allograft rejection/opportunistic infections will be summarized using 
descriptive statistics, stratified by number of vaccine doses and time between the last vaccine 
dose and the transplant procedure.  
 
4) HPV detection in samples from the anogenital, and oral cavity specimens at baseline (pre-
vaccination) and at 6- and 12-months post-vaccination, overall and by number of vaccine 

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doses (1, 2, or 3), sexual behavior, type-specific seroconversion rates, and time elapsed 
between the last vaccine dose and the transplant procedure. All rates of HPV detection will be 
specified, overall and stratified by number of doses (1, 2, or 3) and time to transplant. 
 
13.6 
Reporting and Exclusions 
 
We anticipate some drop-outs due to transplantation complications, health deterioration, or death. The 
drop-RXWUDWHLVH[SHFWHGWREHUHVXOWLQJLQDILQDOVDPSOHRI24-28 participants who complete the 
study. 
 
13.7 
Evaluation of Toxicity 
 
All participants will be evaluable for toxicity from the time of their first dose of the Gardasil® 9 
nonavalent HPV vaccine. 
 
13.8 
Evaluation of Response 
 
Vaccine serologic response will be evaluated for all participants who receive at least one dose of 
Gardasil® 9. 
 
13.9 
Interim Analysis 
 
There will be no planned interim analyses. 
 
13.10 Ancillary Studies 
 
Not applicable. 
 
14. 
ETHICAL AND REGULATORY CONSIDERATIONS 
 
14.1 
Form FDA 1572 
 
Prior to initiating this study, the Protocol Lead Investigator at the Lead or Participating Organization(s) 
will provide a signed Form FDA 1572 stating that the study will be conducted in compliance with 
regulations for clinical investigations and listing the investigators, at each site that will participate in the 
protocol. All personnel directly involved in the performance of procedures required by the protocol and 
the collection of data should be listed on Form FDA 1572. 
14.2 
Other Required Documents 
 
14.2.1 Current (within two years of Drug Shipment Authorization) CV or biosketch for all study 
personnel listed on the Form FDA 1572 and Delegation of Tasks form for the Lead Organization and all 
Participating Organizations. 
 
14.2.2 Current professional licensure (if applicable) for all study personnel listed on Form FDA 1572 
and Delegation of Tasks form for the Lead Organization and all Participating Organizations. 
 
14.2.3 Lab certification (e.g., CLIA, CAP) and lab normal ranges for all labs listed on Form FDA 1572 
for the Lead Organization and all Participating Organizations. 
 
14.2.4 Documentation of training in “Good Clinical Practice (GCP)” for all study personnel listed on the 
FDA Form 1572 and Delegation of Tasks form for the Lead Organization and all Participating 
Organizations. 

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14.2.5 Documentation of Federal Wide Assurance (FWA) number for the Lead Organization and all 
Participating Organizations. 
 
14.2.6 Signed Investigator’s Brochure/Package Insert acknowledgement form 
 
14.2.7 Delegation of Tasks form for the Lead Organization and all Participating Organizations signed by 
the Principal Investigator for each site and initialed by all study personnel listed on the form 
 
14.2.8 Signed and dated NCI, DCP Financial Disclosure Form for all study personnel listed on Form 
FDA 1572 for the Lead Organization and all Participating Organizations 
 
14.3 
Institutional Review Board Approval 
 
Prior to initiating the study and receiving agent, the Investigators at the Lead Organization and the 
Participating Organization(s) must obtain written approval to conduct the study from the NCI Central IRB 
(CIRB). Should changes to the study become necessary, protocol amendments will be submitted to the 
DCP PIO according to DCP Amendment Guidelines. The DCP-approved amended protocol must be 
approved by the CIRB prior to implementation 
 
14.4 
Informed Consent 
 
All potential study participants will be given a copy of the CIRB-approved Informed Consent to review. 
The investigator will explain all aspects of the study in lay language and answer all questions regarding 
the study. If the participant decides to participate in the study, participants will be asked to sign and date 
the Informed Consent document. The study agent(s) will not be released to a participant who has not 
signed the Informed Consent document. Subjects who refuse to participate or who withdraw from the 
study will be treated without prejudice. 
 
Participants will be provided the option to allow the use of blood samples, other body fluids, and tissues 
obtained during testing, operative procedures, or other standard medical practices for further research 
purposes. A statement of this option will be included within the informed consent document. 
 
Prior to study initiation, the informed consent document must be reviewed and approved by NCI, DCP, 
the Consortium Lead Organization, NCI CIRB, and the IRB at each Organization at which the protocol 
will be implemented. Any subsequent changes to the informed consent must be approved by NCI, DCP, 
the Consortium Lead Organization’s IRB, NCI CIRB, and then submitted to each organization’s IRB for 
approval prior to initiation. 
 
14.5 
Submission of Regulatory Documents 
 
All regulatory documents are collected by the Consortia Lead Organization and reviewed for 
completeness and accuracy. Once the Consortia Lead Organization has received complete and accurate 
documents from a participating organization, the Consortium Lead Organization will forward the 
regulatory documents to DCP’s Regulatory Contractor: 
 
Paper Document/CD-ROM Submissions: 
Regulatory Affairs Department 
CCS Associates, Inc. 
2001 Gateway Place, Suite 350 West 
San Jose, CA 95110 
Phone: 650-691-4400 

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Van Damme P, Olsson SE, Block S, Castellsague X, Gray GE, Herrera T, Huang LM, Kim DS, 
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A. Immunogenicity and safety of a 9-valent HPV vaccine. Pediatrics. Jul 2015;136(1):e28–39. 
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Castellsagué X, Giuliano AR, Goldstone S, Guevara A, Mogensen O, Palefsky JM, Group T, 
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CONSENT FORM 
 
 
Introduction 
This is a clinical trial, a type of research study. Your doctor will explain the clinical trial to you. 
Clinical trials include only people who choose to take part in the research. This document has 
important information about the reason for the study, what you will do if you choose to be in this 
research study, and the way we would like to use information about you and your health. 
 
Please take your time to make your decision about volunteering. You may discuss your decision 
with your friends and family. You can also discuss this study with your health care team. If you 
have any questions, you can ask your doctor for more of an explanation. You should only agree 
to participate in this study when you are comfortable enough with the information so that you 
can make an informed decision about joining. 
 
What is the usual approach to managing infections with human papillomavirus (HPV) 
among people who receive a kidney transplant? 
You are being asked to take part in this research study because you are eligible to receive a 
kidney transplant procedure. People who receive organ transplants are at increased risk for 
cancers caused by human papillomavirus (HPV). People who receive kidney transplants at 
increased risk for cancer are followed closely by their doctor to watch for the development of 
cancer. The Centers for Disease Control and Prevention (CDC) and American Society of 
Transplantation recommend that immunosuppressed individuals, including transplant candidates, 
receive the same HPV vaccines according to the same schedule as individuals in the general 
population. Currently the vaccine is approved by the FDA for individuals between ages 9 
through 45 years. 
 
What are my other choices if I do not take part in this study? 
x You may choose to have the usual approach described above; 
x You may choose to receive the HPV vaccine outside of this study if you are between 18- 
45 years of age; 
x You may choose to take part in a different study, if one is available; or 
x You may choose to do nothing. 
 
Why is this study being done? 
Nearly all sexually active men and women will be exposed to HPV in their lifetime. About 14 
million Americans get infected every year. Most individuals are able to clear HPV infections, but 
(Insert Institution name) 
Consent Form 
Study Title for Study Participants: Preventive Human Papillomavirus (HPV) Vaccine Trial 
in Kidney Transplant Recipients 
Protocol Title: NWU2015-06-02, Immunogenicity of Nonavalent HPV Vaccine Administered 
Prior To Renal Transplantation in Adults: A Prospective, Single-Arm, Multi-Center Clinical 
Trial 

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in a small proportion of people, HPV infection can lead to development of several cancers, 
including cervical cancer, vulvar cancer, vaginal cancer, anal cancer, and cancer of the mouth 
and throat region. 
 
Gardasil® 9 is a vaccine approved by the Food and Drug Administration (FDA) to guard against 
many strains of HPV infection. The vaccine protects males and females from getting certain 
strains of HPV and is not meant for treatment of a previously established HPV infection. It is 
unknown how Gardasil® 9 affects the immune system of individuals who have received a 
transplant, so the side effects of getting this vaccination will also be evaluated in this study. It is 
also unknown how the immune system responds to vaccine among individuals between ages 27- 
49, who are older than the age group for whom the vaccine is currently approved. 
 
People who receive organ transplants are at greater risk for cancers linked to HPV. The purpose 
of this study is to learn whether individuals who receive the Gardasil® 9 vaccine prior to 
undergoing a kidney transplant produce a strong immune response against HPV infection during 
the post-transplant period. The use of Gardasil® 9 in this study is experimental in nature, and the 
vaccination schedule being administered in this study is different from the FDA-approved 
vaccination schedule. 
 
There will be about 180 kidney transplant candidates taking part in this study at Cedars-Sinai 
Medical Center; Northwestern University Feinberg School of Medicine; the University of 
California, San Francisco Medical Center; the University of Alabama at Birmingham and the 
University of North Carolina at Chapel Hill. 
 
How long will I be in this study? 
The amount of time you are in the study depends on how soon your transplant surgery is 
scheduled. The total time you could be involved in the study is up to 12 months before the 
transplant, and then up to 15 months after the transplant. Your doctor and your research team do 
not know exactly when you may have your surgery and cannot control when it might happen. 
The timing of your transplant surgery will not change if you take part in this study. 
 
What are the study groups? 
This study has one group: adults who are expected to receive a kidney transplant within 12 
months after you start the study. There will be 180 participants in the group. All participants in 
this study will receive three doses of the Gardasil® 9 vaccine. 
 
Within this one study group, there are a few different schedules you might follow. You, your 
doctor, and your research team will decide which schedule works best for you. Your schedule 
will depend on when you have your transplant surgery, and on how many times you are able to 
come to the clinic before your surgery. If you have your transplant surgery within 12 months 
after you start the study, your schedule will look like this: 

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The study will involve the following parts: 
 
Consent and Screening 
During this period you will be offered information about the study and your risks and benefits of 
participating in it. After you sign the consent form, the following tests and procedures will be 
done to determine if you are eligible to participate in the study: 
x Your doctor will review your medical history and medications, and evaluate the study 
inclusion and exclusion criteria as they apply to you 
x Confirmation that you have not previously received a preventive HPV vaccine 
x Pregnancy test (for women who are able to become pregnant). Your pregnancy test could 
be a urine test or a blood test. 
 
If you are pregnant or you have previously received a preventive HPV vaccination, you will not 
be eligible for the study. 
 
Before Your Transplant 
If the Screening exams and tests show that you can take part in the study, and you choose to, 
then you will be enrolled in the study. As you wait for your transplant surgery, you will be asked 
to participate in at least one, but up to three study visits. You will receive one dose of the 
Gardasil® 9 vaccine at each visit. Research staff will contact you by phone 24-72 hours each 
time after you receive the Gardasil® 9 vaccine to ask you if you are experiencing any potential 
side effects from the vaccine and to answer any questions you may have. These phone calls will 
last approximately 10 minutes. 
 
x Pre-Transplant Vaccine Visit 1 – The study visit will take place at (site specific clinic and 
address) may occur the same day as the Consent and Screening visit if all of your 
information is obtained for eligibility. This study visit will last approximately 3 hours, 
and include the following tests or procedures: 
o Review of your medical history, medications, and laboratory test results 
o Review of your symptoms and current activity level and limitations 
o Physical exam including blood pressure, heart rate, temperature, and weight 
o Collection of a blood sample to measure your immune response to the HPV 
vaccine. About 5½ teaspoons of your blood will be collected. Your blood will 
drawn by a person who is trained to collect blood. 
o Self-collection of cervical/vaginal (for women only) and mouth samples for HPV 
testing. The cervical/vaginal samples (for women only) from your genital tract 
will be self-collected using a specially made brush. The mouth sample will be 
self-collected using a saliva collection kit. 
o Completion of a 30-minute questionnaire that asks about your background (race, 
education, marital status), reproductive history, sexual history, and tobacco and 
alcohol use. The questionnaire will be administered by a research staff person. 
o Gardasil® 9 HPV vaccination. The vaccine will be given in your shoulder muscle 
or in the side of your thigh. 
 
x Pre-Transplant Vaccine Visit 2 – If there is enough time before your transplant surgery, 
you will be asked to come to (site specific clinic and address) around 30 days after your 

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Vaccine Visit 1. This study visit will last approximately 2 hours. If you and your study 
doctor agree that you are unable to complete this visit prior to your transplant surgery, 
this visit may be skipped, and you will have blood drawn on the day of your transplant 
surgery. This visit will include the following tests or procedures: 
o Review of your medical history, medications, and laboratory test results 
o Review of your symptoms and current activity level and limitations 
o Physical exam 
o Gardasil® 9 HPV vaccination 
o Collection of a blood sample (about 5½ teaspoons) 
o Self-collection of cervical/vaginal (for women only) and mouth samples 
o Completion of a 15-minute questionnaire. 
 
x Pre-Transplant Vaccine Visit 3 – If there is enough time before your transplant surgery, 
you will be asked to come to (site specific clinic and address) for a third study visit. If 
you and your study doctor agree that you are unable to complete this visit prior to your 
transplant surgery, this visit may be skipped. This will be at least 3 months after Vaccine 
Visit 2, and at least 5 months after Vaccine Visit 1. This study visit will last 
approximately 2 hours and include the same tests and procedures as Vaccine Visit 2. 
 
x Transplant Surgery – If you completed only one dose of the vaccine before your surgery, 
you will have a blood sample collected before your surgery (about 5½ teaspoons). If you 
complete two or three doses of the vaccine before your surgery, you will have no study 
procedures on the day of your surgery. 
 
After Your Transplant 
After your transplant surgery, you will be asked to participate in two to four study visits over the 
next 12 to 15 months. If you received fewer than 3 doses of the vaccine before your transplant 
surgery, you will receive the remaining doses of the Gardasil® 9 vaccine. 
 
x 6 Month Post-Transplant Visit – You will need to come to (site specific clinic and 
address) for this study visit 6 months after you have your kidney transplant. This study 
visit will last approximately 2 hours and include the following tests and procedures: 
o Review of your medical history, medications, and laboratory test results 
o Review of your symptoms and current activity level and limitations 
o Physical exam 
o Collection of a blood sample (about 5½ teaspoons) 
o Self-collection cervical/vaginal (for women only) and mouth samples 
o Completion of a 15-minute questionnaire. 
 
x 12 Month Post-Transplant Visit – This study visit will take place at (site specific clinic 
and address) 12 months after you have your kidney transplant procedure. This study visit 
will last approximately 2 hours and will include the following tests and procedures: 
o Review of your medical history, medications, and laboratory test results 
o Review of your symptoms and current activity level and limitations 
o Physical exam 

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o If you had only one or two doses of the vaccine before your transplant, and you 
are able to become pregnant, you will receive a pregnancy test 
o If you had only one or two doses of the vaccine before your transplant, you will 
receive a Gardasil® 9 HPV vaccination 
o Collection of a blood sample (about 5½ teaspoons) 
o Self-collection of cervical/vaginal (for women only) and mouth samples 
o Completion of a 15-minute questionnaire. 
 
x 13 Month Post-Transplant Visit – If you received a vaccine dose at the 12 Month Post- 
Transplant Visit, you will be asked to come to (site specific clinic and address) 13 
months after you have your kidney transplant procedure. If you did not receive a vaccine 
dose at the 12 Month Post-Transplant Visit, you will skip this visit. This study visit will 
last approximately 30 minutes and will include the following tests and procedures: 
o Collection of a blood sample (about 2 teaspoons) 
 
Additional Study Visits 
If you received only one dose of the Gardasil® 9 vaccine before your transplant surgery, and 
your received your second dose at your 12 Month Post-Transplant Visit, you will have an 
Additional Study Visit at (site specific clinic and address) 15 months after your transplant 
surgery to receive the third dose of Gardasil® 9 vaccine. 
 
If you received one or two doses of the Gardasil® 9 vaccine, but your transplant surgery does not 
occur within 12 months after you start the study, you will be offered one or two Additional Study 
Visits. These visits will be offered at 12-months and 15-months after you began the study and 
you will receive the remaining doses of the Gardasil® 9 vaccine. 
 
What possible risks can I expect from taking part in this study? 
Your involvement in this study may involve the following risks: 
 
Risks associated with Gardasil® 9 vaccine 
The Gardasil® 9 HPV vaccine has been found to be very safe, and effective at preventing several 
types of HPV infections that cause cancer and genital warts. Vaccines, like any medicine, can 
have side effects. Many people who get the Gardasil® 9 HPV vaccine have no side effects at all. 
Some people report having very mild side effects, like a sore arm from the shot. The most 
common side effects are usually mild and temporary. 
 
Here are important points about side effects: 
x Doctors do not know who will or will not have side effects. 
x Some side effects may go away soon, some may last a long time, or some may never go 
away. 
x Some side effects may be serious and may even result in death 
Here are important points about how you and your doctor can make side effects less of a 
problem: 
x Tell your doctor if you notice or feel anything different so they can see if you are having 
a side effect. 

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Questionnaires 
You may feel uncomfortable answering some of the questions you will be asked. If you feel 
uncomfortable answering any question, you can choose not to answer it. 
 
Unknown Risks 
There may be risks of the study that are not yet known. 
 
Incidental Findings 
You will be informed of significant new findings developed during the course of the research 
which may relate to your willingness to continue in the study. 
 
What possible benefits can I expect from taking part in this study? 
While you may not directly benefit from taking part in the study, we hope that studying your 
samples and data may, in the future, help to decrease or prevent HPV-associated cancers in 
people who receive transplants. 
 
Can I stop taking part in this study? 
Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let 
the study doctor know as soon as possible so you can stop safely. If you stop, you can decide 
whether or not to let the study doctor continue to provide your medical information to the 
organization running the study. 
 
The study doctor will tell you about any new information or changes in the study that could 
affect your health or your willingness to continue in the study. 
 
The study doctor may take you out of the study for the following reasons: 
x If you develop a dangerous side effect; 
x If you become pregnant; 
x If your health changes; 
x If the study is no longer in your best interest; 
x If new information becomes available; 
x If you do not follow the study rules; 
x If the study is stopped early for any reason by the sponsor, the National Cancer Institute 
(NCI); the Central Institutional Review Board (CIRB) of the National Cancer Institute; or 
the Food and Drug Administration (FDA). 
 
What are my rights in this study? 
Taking part in this study is your choice. No matter what decision you make, and even if your 
decision changes, there will be no penalty to you. You will not lose medical care or any legal 
rights. 
 
For questions about your rights while in this study, call the (Insert institution name and 
Institutional Review Board or other site specific entity) at (insert phone number) or contact them 
by email at (insert email address). 

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What are the costs of taking part in this study? 
The Gardasil® 9 vaccine will be supplied at no charge while you take part in this study. The cost 
of study-specific exams, tests, and any other procedures will be paid for by the study. Some costs 
associated with your care may be considered standard of care, and will be billed to you or your 
insurance company. You will have to pay for any costs (including deductibles and co-payments) 
not covered by your health insurer. Before you decide to be in the study, you should check with 
your health plan or insurance company to find out exactly what they will pay for. 
 
Will I receive payment for taking part in this study? 
You will receive payment at the completion of certain study visits to reimburse you for your 
time, transportation, parking, and other expenses related to the study, as summarized in the table 
below. For your travel, you will be provided with parking validation or a parking voucher if you 
incur any costs related to parking. Additionally, a mileage reimbursement will provided for the 
entire, round trip distance driven from your home address, to (site specific clinic(s) and 
address(es)), and back to your home address. The amount reimbursed for mileage will be 
calculated using the current IRS standard mileage rate at the time of your consenting. The total 
amount you will receive if you complete all of your study visits is $675-$750, depending on 
when you have your transplant. If you do not complete the entire research study, you will only be 
paid for those visits you do complete. Finishing the visit means that you complete all of the 
following study procedures: get the Gardasil® 9 vaccination, and collection of blood, 
cervical/vaginal (for women only) and mouth samples. 
 
Study Visit 
Covered (done for research purposes at no cost 
to you) 
Payment (if you 
complete this visit) 
Consent and Screening 
Visit 
Pregnancy test 
You will not be paid for 
this visit. 
 
Pre-Transplant Vaccine 
Visit 1 
Medical history, medications, and laboratory test 
results review; physical exam; blood draw; 
Gardasil® 9 vaccination; collection cervical 
/vaginal (for women only) and mouth samples; 
questionnaire 
$150 
 
Pre-Transplant Vaccine 
Visits 2 and Vaccine 
Visit 3 
Medical history, medications, and laboratory test 
results review; physical exam; blood draw; 
Gardasil® 9 vaccination; collection cervical / 
vaginal (for women only) and mouth samples; 
questionnaire 
$150 for each visit 
 
6 Month Post- 
Transplant Visit 
Medical history, medications, and laboratory test 
results review; physical exam; blood draw; 
collection of cervical / vaginal (for women only) 
and mouth samples; questionnaire 
$150 
 
12 Month Post- 
Transplant Visit 
Medical history, medications, and laboratory test 
results review; physical exam; blood draw; 
pregnancy test; Gardasil® 9 vaccination; 
collection of cervical / vaginal (for women only) 
and mouth samples; questionnaire 
$150 
13 Month Post- 
Blood draw 
$75 

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Transplant Visit 
 
 
Additional Study 
Visit(s) (if needed) 
Gardasil® 9 vaccination 
You will not be paid for 
these visits. 
 
Financial Interest in the Research 
The Principal Investigator and institution have no potential financial conflict of interest with 
respect to this study. 
 
What happens if I am injured or hurt because I took part in this study? 
If you feel you have been injured or hurt as a result of taking part in the study, it is important that 
you tell the study doctor immediately: (Insert site specific study doctor's name and telephone 
number). You will get medical treatment if you are injured or hurt as a result of taking part in 
this research study. 
 
The study sponsors will not offer to pay for medical treatment for injury. Your insurance 
company may not be willing to pay for study-related injury. If you have no insurance coverage, 
you would be responsible for any costs. Even though you are in a study, you keep all of your 
legal rights to receive payment for injury caused by medical errors. 
 
Who will see my medical information? 
Your privacy is very important to us and we will make every effort to protect it. The study 
doctors have a privacy permit to help protect your records if there is a court case. Your 
information may be given out if required by law. For example, certain states require doctors to 
report to health boards if they find a disease like tuberculosis. However, we will do our best to 
make sure that any information that is released will not be able to identify you. Some of your 
health information, and information about your specimens, from this study will be kept in a 
central database for research. Your name or contact information will not be put in the database. 
 
There are organizations that may inspect your records. These organizations are required to make 
sure your information is kept private. Some of these organizations are: 
x The study sponsor, the National Cancer Institute (NCI) 
x The Institutional Review Board, IRB, is a group of people who review the research with 
the goal of protecting the people who take part in the study. 
x The Food and Drug Administration and the National Cancer Institute in the US, and 
similar organizations if other countries are involved in the study. 
x The National Cancer Institute will obtain information for this clinical trial under data 
collection authority Title 42 U.S.C. 285 
 
Where can I get more information? 
You may visit the NCI website at http://cancer.gov/ for more information about studies or 
general information about cancer. You may also call the NCI Cancer Information Service to 
get the same information at: 1-800-4-CANCER (1-800-422-6237). 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, 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. 

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Who can answer my questions about this study? 
You can talk to the study doctor about any questions or concerns you have about this study or to 
report side effects or injuries. Contact the study doctor (insert name of site specific study 
doctor(s)) at (insert telephone number). 

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This section is about optional studies you can choose to take part in. 
Optional Sample Collections for Biobanking for Possible Future Studies 
This part of the consent form is about optional studies that you can choose to take part in. You 
will not get health benefits from any of these studies. The researchers leading this optional study 
hope the results will help other people with cancer in the future. 
 
The results will not be added to your medical records, and you or your study doctor may not 
know the results. You will not be billed for these optional studies. 
 
You can still take part in the main study even if you say ‘no’ to any or all of these studies. If you 
sign up for but cannot complete any of the studies for any reason, you can still take part in the 
main study. 
 
Researchers are trying to learn more about cancer and other health problems. Much of this 
research is done using samples from your biopsies, blood, or other fluids. Through these studies, 
researchers hope to find new ways to prevent, detect, treat, or cure health problems. Some of 
these studies may be about genes. Genes carry information about features that are found in you 
and in people who are related to you. Researchers are interested in the way that genes affect how 
your body responds to treatment. 
 
The researchers would like to ask your permission to store left over samples and health 
information obtained during your participation in this study for future medical research. Storing 
samples for future studies is called biobanking. The Biobank is being run by Cedars-Sinai 
Medical Center and supported by the National Cancer Institute. If you agree, the blood and tissue 
samples, and information collected about you during the study, will be coded and kept at Cedars- 
Sinai Medical Center until the end of the study, when they may be transferred to the National 
Institutes of Health. Your samples and information will be labeled with a unique study number 
(code), not with your name or other information that may identify you. 
 
We would also like your permission to collect urine samples at several study visits to look for 
HPV infection in your body. If you agree, you will provide a small cup of urine during each 
indicated visit. 
 
For male participants, we would like your permission to collect genital samples at several study 
visits to look for HPV infection in your body. If you agree, you will provide a specimen 
collection kit during each indicated visit. 
 
Lastly, we would like your permission to collect samples of your eyebrow hairs at several study 
visits for future viral DNA testing. Several types of viruses have been found in eyebrow hairs, 
including beta-papillomavirus (beta-HPV) and polyomaviruses. Virus infections may play a role 
in causing skin cancers, and people who receive organ transplants are at high risk for several 
types of skin cancers. If you agree, the clinical research staff will collect six eyebrow hairs at 
each study visit. Your eyebrow hair samples will be stored for future viral DNA testing. 

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The research that may be done is unknown at this time. Future research may include: 1) studies 
to identify genes and/or biomarkers and proteins that influence a risk of cancer in people who 
receive transplants; 2) studies to identify specific pathways and mechanisms that promote cancer; 
3) studies to investigate viral DNA infection and cancer. A biomarker is a biological molecule 
found in blood, other body fluids, or tissues that may be a sign of a condition or disease. 
 
What is involved? 
Your samples and related information may be stored in the NCI Biobank, along with samples 
and information from other people who take part. The samples will be stored at (insert name of 
institution storing samples during study) and Cedars Sinai Medical Center until the end of the 
study, when they may be transferred to the National Institutes of Health. 
 
Qualified researchers can submit a request to use the materials stored in the NCI Biobank. A 
research committee will review each request. There will also be an ethics review to ensure that 
the request is necessary and proper. All samples and information sent to approved researchers 
will be coded with your unique study number to protect your privacy and confidentiality. 
Researchers will not be given your name or any other information that could directly identify 
you. You will not be notified if/when research is conducted using your samples. 
 
What are the possible risks? 
1) There is a risk that an unauthorized person could obtain the personal information in your 
medical records or other information we have stored about you. 
2) There is a potential risk that someone could trace genetic information about you. Even 
without your name or other identifiers, your genetic information is unique to you. The 
researchers believe the chance that someone will identify you is very small, but the risk 
may change in the future as people come up with new ways of tracing information. There 
are laws against the misuse of genetic information, but they may not give full protection. 
New health information about inherited traits that might affect you or your blood 
relatives could be found during a study. The researchers believe the chance these things 
will happen is very small, but cannot promise that they will not occur. 
 
A new Federal law, called the Genetic Information Nondiscrimination Act (GINA), generally 
makes it illegal for health insurance companies, group health plans, and most employers to 
discriminate against you based on your genetic information. This law generally will protect you 
in the following ways: 
x Health insurance companies and group health plans may not request your genetic 
information that we get from this research. 
x Health insurance companies and group health plans may not use your genetic information 
when making decisions regarding your eligibility or premiums. 
 
Employers with 15 or more employees may not use your genetic information that we get from 
this research when making a decision to hire, promote, or fire you or when setting the terms of 
your employment. All health insurance companies and group health plans must follow this law 
by May 21, 2010. All employers with 15 or more employees must follow this law as of 
November 21, 2009. 

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Be aware that this new Federal law does not protect you against genetic discrimination by 
companies that sell life insurance, disability insurance, or long-term care insurance. 
 
How will information about me be kept private? 
Your privacy is very important to the researchers and they will make every effort to protect it. 
Here are just a few of the steps they will take: 
1) When your sample(s) is sent to the researchers, no information identifying you (such as 
your name or birth date) will be sent. Samples will be identified by a unique study code 
only. 
2) The list that links the unique code to your name will be kept separate from your sample 
and health information. Any NCI Biobank and Cedars-Sinai Medical Center staff with 
access to the list must sign an agreement to keep your identity confidential. 
3) Researchers to whom Cedars-Sinai Medical Center sends your sample and information 
will not know who you are. They must also sign an agreement that they will not try to 
find out who you are. 
4) Information that identifies you will not be given to anyone, unless required by law. 
5) The results from research on your samples will not be put in your medical record. 
6) If research results are published, your name and other personal information will not be 
used. 
 
What are the possible benefits? 
While you may not directly benefit from taking part in the study, we hope that studying your 
samples and data may, in the future, help to decrease or prevent HPV-associated cancers in 
people who receive transplants. 
 
Are there any costs or payments? 
There will be no cost to you or your insurance company for storage of your samples. Your blood 
and tissue samples will be used only for research and will not be sold. You will not be paid for 
allowing your leftover samples to be used in research. If any of the research leads to new tests, 
drugs, or other commercial products, you will not share in any profits. 
 
What if I change my mind? 
If you decide you no longer want your samples to be used, you can call Dr. Marc T. Goodman at 
(310) 423-6188, who will let the researchers know. Then, any samples that remain in the bank 
will be destroyed. Samples or related information that have already been given to or used by 
researchers will not be returned. 
 
What if I have more questions? 
If you have questions about the use of your samples for research, contact the principal 
investigator, Dr. Marc T. Goodman, at (310) 423-6188. 
 
Urine sample to look for HPV infection 
I agree to provide a small cup of urine at the indicated study visits and agree that my samples may be 
used to look for HPV infection in my body. 
Please circle one: 
YES 
NO 

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Eyebrow hair samples for future viral DNA testing 
I agree to have samples of my eyebrow hairs collected at the indicated study visits and agree that 
my samples may be used for detecting HPV in my body. 
Please circle one: 
YES 
NO 
 
Male genital samples for future HPV testing 
I agree to provide self-collected samples at the indicated study visits and agree that my samples 
may be used for detecting HPV in my body. 
Please circle one: 
YES 
NO 
N/A 
 
 
Samples for future research studies 
Please circle your answer to show whether or not you would like to take part in each option. 
 
My samples and related information may be kept in the NCI Biobank for use in future health 
research. 
Please circle one: 
YES 
NO 
 
I agree that the researchers, or their representative, may contact me or my physician to see if I 
wish to participate in other research in the future. 
Please circle one: 
YES 
NO 
 
Access to unused samples 
The researchers would like your permission to access unused samples collected for clinical 
purposes as part of your usual care, such as leftover tissue from Pap smears, biopsies, pathology 
slides, and tissue blocks. Please circle your answer to show whether or not you give permission. 
 
I agree that the researchers, or their representative, may have to access to my unused samples. 
Please circle one: 
YES 
NO 
 
Follow-up and future contact 
There may be other important questions about you that have not been answered during the course 
of this research study. In order to answer these questions, we may need to contact you in the 
future. 
 
I agree that the researchers, or their representative, may contact me in the future if they have 
additional questions. 
Please circle one: 
YES 
NO 

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I provide permission to my study doctor, or their representatives, to contact me once the entire 
study has been completed for the purposes of sending study results when they become available 
 
YES 
NO 
 
This is the end of the section about optional studies. 

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My Signature Agreeing to Take Part in the Main Study 
I have read this consent form or had it read to me. I have discussed it with the study doctor and 
my questions have been answered. I will be given a signed copy of this form. I agree to take part 
in the main study and any additional studies where I circled ‘yes’. 
 
 
 
Participant’s signature 
Date of Signature 
 
 
 
Signature of person(s) conducting the informed consent discussion 
Date of Signature 

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APPENDIX A 
Performance Status Criteria 
 
ECOG Performance Status Scale 
 
Grade 
Descriptions 
0 
Normal activity. Fully active, able to 
carry on all pre-disease performance 
without restriction. 
1 
Symptoms, but ambulatory. Restricted in 
physically strenuous activity, but 
ambulatory and able to carry out work of 
a light or sedentary nature (e.g., light 
housework, office work). 
2 
,QEHGRIWKHWLPH$PEXODWRU\DQG
capable of all self-care, but unable to 
carry out any work activities. Up and 
DERXWPRUHWKDQRIZDNLQJKRXUV 
3 
,QEHG!RIWKHWLPH&DSDEOHRI only 
limited self-care, confined to bed or chair 
PRUHWKDQRIZDNLQJKRXUV 
4 
EHGULGGHQ&RPSOHWHO\GLVDEOHG 
Cannot carry on any self-care. Totally 
confined to bed or chair. 
5 
Dead. 
Karnofsky Performance Scale 
 
Percent 
Description 
100 
Normal, no complaints, no evidence of 
disease. 
90 
Able to carry on normal activity; minor 
signs or symptoms of disease. 
80 
Normal activity with effort; some signs 
or symptoms of disease. 
70 
Cares for self, unable to carry on 
normal activity or to do active work. 
60 
Requires occasional assistance, but is 
able to care for most of his/her needs. 
50 
Requires considerable assistance and 
frequent medical care. 
40 
Disabled, requires special care and 
assistance. 
30 
Severely disabled, hospitalization 
indicated. Death not imminent. 
20 
Very sick, hospitalization indicated. 
Death not imminent. 
10 
Moribund, fatal processes progressing 
rapidly. 
0 
Dead. 

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APPENDIX C 
Study Procedures for Potential Participants  
Remember, the visits you complete will depend on the timing of your transplant surgery. You will 
complete only some of the visits below. Your research team will let you know which visits you may 
complete. 
 

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APPENDIX E 
 
Participant ID:   
 
Date:   
 
 
 
 
 
 
 
 
 
 
Preventive Human Papillomavirus (HPV) Vaccine Trial 
in Kidney Transplant Recipients 
 
 
 
Baseline Questionnaire 
 
 
 
We appreciate the time you are taking to complete this interview. We will be 
asking you questions about factors and behaviors that we believe may 
contribute to an individual’s risk of disease. Please try to answer each 
question as completely as you can, even if you are unsure about the answer. 
If you feel uncomfortable answering any question, you can choose not to 
answer it. All answers will be kept confidential. 

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DEMOGRAPHICS
1.
What is your racial background? Check all boxes that apply. 
1 
White or Caucasian
2 
African-American or Black
3 
American Indian or Alaska Native
4 
Chinese or Taiwanese
5 
Japanese or Okinawan
6 
Filipino
7 
Korean
8 
Vietnamese
9 
Other Asian
10
Native Hawaiian
11
Samoan
12
Other Pacific Islander
13
Asian Indian
14
Iranian
15
Armenian
16
Israeli
17
Egyptian
18
Other race
2.
Are you of Hispanic or Latino/a ancestry?
1 
Yes
0 
No
a. Which group best represents your Hispanic origin or ancestry? Check all boxes that apply.
3.
1 
No formal education
5 
Technical or vocational school
2 
8th grade or less
6 
Associate degree or some college
3 
Some high school (9th -11th grade)
7 
Bachelor’s degree
4 
High school graduate or GED
8 
Advanced degree (Master’s or Doctoral degree)
4.
Are you currently employed (including self-employed)?
1 
Yes
0 
No
a.  On average, how many hours do you work each week?  Check one box only. 
1 
1-29 hours
2 
30-44 hours
3 
45-54 hours
4 
55+ hours
5.
What is your current marital status? Check one box only. 
1 
Single (never married)
2 
Married
3 
Living with partner
4 
Separated
5 
Divorced
6 
Widowed
6.
With whom do you currently live? Check all boxes that apply. 
1 
Spouse/partner
2 
Children 
3 
Parent(s)
4 
Parent(s)-in-law  
5 
Other relative(s)
6 
Friend(s) 
7 
I live alone
8 
Other (please describe)   
PHYSICAL HEALTH AND FRAILTY
1.
How tall are you? 
  
Feet 
  
Inches
<< The next 5 questions are Components of the FRAIL AAH Questionnaire >>
2.
How much do you currently weigh with your clothes on butwithout shoes?  
Pounds
3.
One year ago in (  
/  
Month/Year), how much did you weigh with your clothes on but withoutshoes?
Pounds
4.
How much of the time during the past 4 weeks did you feel tired? Please select one answeronly.
1 
All of the time 
2 
Most of the time 3 
Some of the time
4 
A little of the time
5 
None of the 
time
5.
By yourself and not using aids, do you have any difficulty walking up 10 steps without resting? 
1 
Yes
0 
No
6.
By yourself and not using aids, do you have any difficulty walking several hundred yards? 
1 
Yes
0 
No
The next questions ask about your physical health.
1 
Mexican, Mexican American, Chicano
2 
Caribbean
3 
Central American
5 
Other Hispanic (please describe)
4 
South American
What is the highest grade or level of schooling you have completed? Check one boxonly.
The first questions ask about your personal background.

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SF-12® HEALTH SURVEY 
1. In general, would you say your health is (please select one answer only): 
1 
Excellent 
2 
Very Good 
3 
Good 
4 
Fair 
5 
Poor 
2. The following questions are about activities you might do during a typical day. Does your health now 
limit you in these activities? If so, how much? 
 
Yes, limited 
a lot 
Yes, limited 
a little 
No, not 
limited at all 
a. Moderate activities, such as moving a table, pushing 
a vacuum cleaner, bowling, or playing golf 
 
1 
 
2 
 
3 
b. Climbing several flights of stairs 
1 
2 
3 
3. During the past 4 weeks, have you had any of the following problems with your work or other regular 
daily activities as a result of your physical health? 
 
Yes 
No 
a. Accomplished less than you would like 
1 
2 
b. Were limited in the kind of work or other activities 
1 
2 
4. During the past 4 weeks, have you had any of the following problems with your work or other regular 
daily activities as a result of any emotional problems (such as feeling depressed or anxious)? 
 
Yes 
No 
a. Accomplished less than you would like 
1 
2 
b. Did work or activities less carefully than usual 
1 
2 
5. During the past 4 weeks, how much did pain interfere with your normal work (including both work 
outside the home and housework)? Please select one answer only. 
1 
Not at all 
2 
A little bit 
3 
Moderately 
4 
Quite a bit 
5 
Extremely 
6. These questions are about how you feel and how things have been with you during the past 4 weeks. 
For each question, please give the one answer that comes closest to the way you have been feeling. 
How much of the time during the past 
4 weeks: 
All of 
the time 
Most of 
the time 
A good bit 
of the time 
Some of 
the time 
A little of 
the time 
None of 
the time 
a. Have you felt calm and peaceful? 
1 
2 
3 
4 
5 
6 
b. Did you have a lot of energy? 
1 
2 
3 
4 
5 
6 
c. Have you felt downhearted and blue? 
1 
2 
3 
4 
5 
6 
7. During the past 4 weeks, how much of the time has your physical health or emotional problems 
interfered with your social activities (like visiting friends, relatives, etc.)? Please select one answer only. 
1 
All of the time 2 
Most of the time 3 
Some of the time 4 
A little of the time 5 
None of the time 
 
 
SKIN TYPE, SUN EXPOSURE, AND SUN PROTECTION 
1. What is your natural eye color? 
0 
Light Blue, Gray, or Green 
1 
Blue, Gray, or Green 
2 
Dark Blue or Hazel 
3 
Dark Brown 
4 
Brownish Black 
 
 
2. What is the natural color of your hair? 
0 
Sandy Red   1 
Blonde 
2 
Chestnut or Dark Blonde  3 
Dark Brown 
4 
Black 
This set of questions asks for your views about your health. This information will help you keep track of how 
you feel and how well you are able to do your usual activities. Answer every question by selecting one answer 
as indicated. If you are unsure about how to answer a question, please give the best answer you can. 
The next questions ask about your skin type, sun exposure, and sun protection. 

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INTERVIEWER'S REMARKS 
 
1. Participant ID 
 
2. Interviewer 
(Initials) 
 
3. Participant’s date of birth 
Month  
Day  
Year  
 
(Current Age:  
) 
 
4. Date of Interview 
Month  
Day  
Year   
 
 
5. Interview Start Time 
  
:  
(Hour: Minutes [24-hour time]) 
 
6. Interview End Time 
  
:  
(Hour: Minutes [24-hour time]) 
 
7. The interview included: (Check all boxes that apply.) 
1 
The participant only 
2 
A spouse or partner 
3 
Another family member 
4 
Another person (please specify)   
 
 
8. The participant's cooperation was: (Check one box only.) 
1 
Excellent 
2 
Very Good 
3 
Good 
4 
Fair 
5 
Poor 
 
9. The quality of the interview is: (Check one box only.) 
1 
Excellent 
2 
Generally reliable 
3 
Questionable 
4 
Unreliable 

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APPENDIX F 
 
Participant ID:   
 
Date:   
 
 
 
 
 
 
 
 
 
 
Preventive Human Papillomavirus (HPV) Vaccine Trial 
in Kidney Transplant Recipients 
 
 
 
Follow-Up Questionnaire 
 
 
 
We appreciate the time you are taking to complete this interview. We will be 
asking you questions that focus on any changes that may have occurred since 
your last research visit for this study on    (date of last study visit). Please try 
to answer each question as completely as you can, even if you are unsure 
about the answer. If you feel uncomfortable answering any question, you can 
choose not to answer it. All answers will be kept confidential. 

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PHYSICAL HEALTH AND FRAILTY 
1. How much do you currently weigh with your clothes on but without shoes?  
Pounds 
2. How much of the time during the past 4 weeks did you feel tired? Please select one answer only. 
1 
All of the time  2 
Most of the time  3 
Some of the time 4 
A little of the time 
5 
None of the 
time 
3. By yourself and not using aids, do you have any difficulty walking up 10 steps without resting? 
1 
Yes 
0 
No 
4. By yourself and not using aids, do you have any difficulty walking several hundred yards? 1 
Yes 
0 
No 
 
SF-12® HEALTH SURVEY 
 
1. In general, would you say your current health is (please select one answer only): 
1 
Excellent 
2 
Very Good 
3 
Good 
4 
Fair 
5 
Poor 
2. The following questions are about activities you might do during a typical day. Does your health now 
limit you in these activities? If so, how much? 
 
Yes, limited 
a lot 
Yes, limited 
a little 
No, not 
limited at all 
a. Moderate activities, such as moving a table, pushing 
a vacuum cleaner, bowling, or playing golf 
 
1 
 
2 
 
3 
b. Climbing several flights of stairs 
1 
2 
3 
3. During the past 4 weeks, have you had any of the following problems with your work or other regular 
daily activities as a result of your physical health? 
 
Yes 
No 
a. Accomplished less than you would like 
1 
2 
b. Were limited in the kind of work or other activities 
1 
2 
4. During the past 4 weeks, have you had any of the following problems with your work or other regular 
daily activities as a result of any emotional problems (such as feeling depressed or anxious)? 
 
Yes 
No 
a. Accomplished less than you would like 
1 
2 
b. Did work or activities less carefully than usual 
1 
2 
5. During the past 4 weeks, how much did pain interfere with your normal work (including both work 
outside the home and housework)? Please select one answer only. 
1 
Not at all 
2 
A little bit 
3 
Moderately 
4 
Quite a bit 
5 
Extremely 
6. These questions are about how you feel and how things have been with you during the past 4 weeks. 
For each question, please give the one answer that comes closest to the way you have been feeling. 
How much of the time during the past 
4 weeks: 
All of 
the time 
Most of 
the time 
A good bit 
of the time 
Some of 
the time 
A little of 
the time 
None of 
the time 
a. Have you felt calm and peaceful? 
1 
2 
3 
4 
5 
6 
b. Did you have a lot of energy? 
1 
2 
3 
4 
5 
6 
c. Have you felt downhearted and blue? 
1 
2 
3 
4 
5 
6 
7. During the past 4 weeks, how much of the time has your physical health or emotional problems 
interfered with your social activities (like visiting friends, relatives, etc.)? Please select one answer only. 
1 
All of the time 2 
Most of the time 3 
Some of the time 4 
A little of the time 5 
None of the time 
This set of questions asks for your views about your health since your last research study visit on  
(date 
of last study visit). If you are unsure about how to answer a question, please give the best answer you can. 
The first questions ask about your physical health. << Components of the FRAIL AAH Questionnaire >> 

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ALCOHOL AND TOBACCO USE
1.
How often do you have a drink containing alcohol? If NEVER skip to question # 4 (cigarette smoking) 
0 
Never  1 
Monthly or less 2 
2-4 times a month 3 
2-3 times a week 
4 
4 or more times a 
week 
2.
How many standard drinks containing alcohol do you have on a typical day? A standard drink is a 12-ounce 
bottle or can of beer, a 4-ounce glass of wine, a shot of liquor, or a mixed drink.  
drinks
3.
How often do you have six or more drinks on one occasion?
0 
Never 
1 
Less than monthly
2 
Monthly
3 
Weekly 
4 
Daily or almost daily
4.
Since your last research study visit on  
(date of last study visit), have you smoked cigarettes? 
1 
Yes
0 
EŽїIf NO skip to next section – SEXUAL HISTORY
5.
When did you last smoke a cigarette?
(Month/Day/Year)
6.
How many cigarettes do you usually smoke each day? 
cigarettes per day
SEXUAL ACTIVITY
1.
Have you been sexually active since your last research study visit on  
? 
1 
Yes
0 
EŽїIf NO the interview is completed
a. With how many partners have you been sexually active since your laststudy visit?  
partners 
Females only: 
2.
Since your last research study visit, have you had sexual (vaginal) intercourse with a malepartner?
1 
Yes
0 
EŽїIf NO skip to question # 3 
a. How often have you had sexual intercourse since your last study visit? Interviewer: probe for frequency. 
1 
1-2 times since last visit
2 
3-5 times since last visit
3 
Once per month
4 
2-3 times per month
5 
1 or more times per week
Females only:
3.
Since your last study visit, have you had oral sex with a male partner?
1 
Yes
0 
EŽїIf NO the interview is completed
a. How often have you had oral sex since your last study visit? Interviewer: probe forfrequency.
1 
1-2 times since last visit
2 
3-5 times since last visit
3 
Once per month
4 
2-3 times per month
5 
1 or more times per week
Males only:
2.
Since your last research study visit, have you had sexual intercourse?
1 
Yes
0 
EŽїIf NO skip to question # 3 
a. How often have you had sexual intercourse since your last study visit? Interviewer: probe for frequency. 
1 
1-2 times since last visit
2 
3-5 times since last visit
3 
Once per month
4 
2-3 times per month
5 
1 or more times per week
The last questions ask about your sexual activity since your last research studyvisit on
(date of last visit). 
We ask you these questions because human papillomavirus (HPV) is spread primarily through sexualcontact.
You can skip any questions you feel uncomfortable answering.
The next questions ask about your use of alcohol and tobacco since your last research study visit.

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Males only:
3.
Since your last study visit, have you had oral sex?
1 
Yes
0 
EŽїIf NO the interview is completed
a. How often have you had oral sex since your last study visit? Interviewer: probe forfrequency.
1 
1-2 times since last visit
2 
3-5 times since last visit
3 
Once per month
4 
2-3 times per month
5 
1 or more times per week
END OF INTERVIEWER-ADMINISTERED QUESTIONNAIRE
Thank you for taking the time to complete the interview. This information is vitally important to our study and 
we greatly appreciate your contributions.

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INTERVIEWER'S REMARKS 
 
1. Participant ID   
 
 
2. Study Visit Number 
2 
Second 
3 
Third 
4 
Fourth 
 
3. Date of This Study Visit 
Month  
Day  
Year   
 
 
4. Date of Last Study Visit 
Month  
Day  
Year   
 
 
5. Interviewer 
  
(Initials) 
 
6. Interview Start Time 
  
:  
(Hour: Minutes [24-hour time]) 
 
7. Interview End Time 
  
:  
(Hour: Minutes [24-hour time]) 
 
8. The interview included: (Check all boxes that apply.) 
1 
The participant only 
2 
A spouse or partner 
3 
Another family member 
4 
Another person (please specify)   
 
 
9. The participant's cooperation was: (Check one box only.) 
1 
Excellent 
2 
Very Good 
3 
Good 
4 
Fair 
5 
Poor 
 
10. The quality of the interview is: (Check one box only.) 
1 
Excellent 
2 
Generally reliable 
3 
Questionable 
4 
Unreliable 

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APPENDIX G 
 
COVID-19 Contingency Plan 
 
Background: In response to the public health emergency due to the COVID-19 pandemic, several 
adaptations have been included to ensure that the protocol will be able to meet its primary endpoint. This 
Appendix lists the specific modifications to the protocol that may be permitted to be undertaken in the 
context of the COVID-19 Contingency plans. 
 
1. Remote Specimen Collection: Considering the closure of several study clinics to non-emergency 
study visits due to the COVID-19 crisis and concerns about SARS-COV2 transmission, an 
alternative plan for remote specimen collection will be offered to eligible and affected participants. 
This includes an at-home self-collection of a cervical/vaginal specimen that is described in the 
protocol and would also be self-collected in clinic. In addition, we include an at-home finger stick 
capillary blood collection of a dried blood spot via a novel sample collection device (Neoteryx Mitra 
cartridge). This device is based on volumetric absorptive microsampling (VAMS) technique that has 
been previously evaluated in measuring vaccine antibody responses and other biomarkers (See 
references below). Incorporating this device will allow the possibility of measurement of HPV 
antibody responses closer to the original/protocol-specified visit time points when COVID-19- 
related concerns preclude the possibility of in-person clinic visits. The procedures for remote 
specimen collection includes an addendum consent (APPENDIX H) for an at-home finger-stick 
capillary blood collection (dried blood spot) via a special collection device and return shipment of 
the specimen, along with phone calls to review medical and surgical history, medications, symptom 
assessment, determination of ECOG performance status and administration of study questionnaire. 
Applicable visits: 
x 6-months post-transplant visit 
x 12-months post-transplant visit 
x 13-months post-transplant visit (to be conducted only if, and 1-month after, any original 
scheduled or rescheduled in-person 12-month post-transplant visit is conducted). 
Procedures: 
1. Study staff will identify appropriate participants affected by the cancellation/deferral of 
regularly scheduled study visits. 
2. Eligible participants will be contacted by phone and procedures will be explained by the 
study investigators and staff. 
3. Participants will be administered the remote consent as per COVID-19 remote consent 
procedures approved by the CIRB. (see ‘Appendix H’) 
4. Staff will interview the participants for review of medical and surgical history, medications, 
symptom assessment, determination of ECOG performance status, and follow-up 
questionnaire for the 6-months and 12-months visits. 
5. Participants will be sent an Evalyn cervical/vaginal specimen collection kit, and a Neoteryx 
Mitra sampling cartridge. All collection kits will have standardized instructions and study 
specific information sheets (see ‘Finger Stick Participant Information material’ and 
‘Vaginal Self-Collection Instructions’). All devices and return collection kits will have 
barcoded labels that confidentially link back to the participant record without any identifying 
information (participant name, other contact details, etc.). 
6. Participants will self-collect a personal cervical/vaginal specimen and a finger stick blood 
specimen and will return to the Cedars Sinai biorepository using pre-labeled, pre-paid 
packages that will be picked up by a courier at the participant’s home or pre-arranged 
location. 

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2. Expansion of window for 12-months post-transplant visit for specimen collection for primary 
endpoint: The visit for specimen collection for the primary endpoint (12-months post- 
transplantation time point) is regularly scheduled at 12-months +/- 2 weeks after the transplant 
surgery. The +/- 2 weeks window will now be extended to up to +/- 6 months to permit maximum 
operational flexibility due to the scheduling challenges due to COVID-19, and may be rescheduled 
to a convenient date and time once it is considered safe to resume study activities. 
 
3. 6-months post-transplant study visits: The rescheduled 12-month post-transplant visit (for the 
primary endpoint) now includes a very broad/expanded window (+/- 6 months) that may overlap 
with the original 6-month post-transplant visit timeframe. The 6-month post-transplant visit will 
therefore be considered an optional one due to the COVID-19-related scheduling challenges. 
 
4. 13-months post-transplant study visits: This visit will also be considered an optional one and can 
now be rescheduled to occur one month (+/- 2 weeks) after the rescheduled 12-month post-transplant 
visit, only for participants who have received the booster injection. 
 
5. Visit procedures: All procedures in Section 7 “CLINICAL EVALUATIONS AND 
PROCEDURES” corresponding to the rescheduled visits will be conducted as outlined. In addition, 
cervical/vaginal, and blood specimens may occur for eligible and consenting participants for the 6- 
months, 12-months, and 13-months (finger stick only) post-transplant visits. 
 
6. Specimen Management: The finger-prick collection method will yield dried blood spot collection 
that will be stored in the biorepository at Cedars Sinai Medical Center for future analysis for the 
HPV serological analysis for the primary and secondary endpoints. The cervical/vaginal specimens 
will be used per protocol for analysis of secondary aims. 
 
7. Participant reimbursement: For participants seen under the COVID-19 Contingency Plan 
compensation will be per protocol. 
 
References: 
i. Wang et al. Application of VAMS to measure multidimensional anti-influenza IgG 
antibodies by the mPlex-Flu assay J Clin Transl Sci 2019;3(6):332-34) 
ii. Shufelt et al. A Protocol Integrating Remote Patient Monitoring Patient Reported 
Outcomes and Cardiovascular Biomarkers. NPJ Digit Med 2019 Sep 3;2:84 

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APPENDIX H 
 
Consent Form Addendum 
 
This form is an Addendum to the Informed Consent for study entitled “Immunogenicity of 
Nonavalent HPV Vaccine Administered Prior To Renal Transplantation in Adults: A Prospective, 
Single-Arm, Multi-Center Clinical Trial” for participants whose post-transplant study visits are 
delayed during the COVID-19 pandemic. 
 
Official Study Title for Internet Search on http://www.ClinicalTrials.gov: Immunogenicity of 
Nonavalent HPV Vaccine Administered Prior To Renal Transplantation in Adults: A Prospective, Single- 
Arm, Multi-Center Clinical Trial 
 
How long will I be in this study? 
Under regular circumstances, the total time you would be involved in this study would be no more than 
13 months after your transplant. However, if you are not able to come into the clinic for your 6-month, 
12-month, or 13-month post-transplant study visit during the time of the COVID-19 pandemic, we will 
ask you to come in to the clinic at a later date. This may extend the period of participation in the study by 
about six additional months. 
 
What extra tests and procedures will I have if I take part in this study? 
Because you cannot come into clinic in person, there will be some changes to study related tests and 
procedures. Instead of your 6-month or 12-month post-transplant in-person visit, you will receive a phone 
call. You will be asked about your medical history, medications, symptoms, and current activity level and 
limitations. You will go through the questionnaire you would have done in the clinic as well. Instead of 
the blood that would normally be drawn at your 6-month, 12-month, or 13-month post-transplant study 
visit, a new method for at-home finger stick sampling is being proposed in this study. The at-home finger- 
stick device has been used in several studies previously, and given the challenges in scheduling in-person 
clinic visits during the COVID-19 pandemic, it will provide an opportunity for collection of key 
information for this HPV vaccine study even though study visits do not occur at their original scheduled 
time. You will receive a blood collection kit in the mail around the time of these visits to collect a blood 
sample at home and send it back. A brochure included in the kit will instruct you how to collect a few 
drops of blood from your finger using a disposable lancet (a small medical tool used to puncture your skin 
to obtain blood sample, often used by persons with diabetes) and collect it on the special collection device 
provided in the kit. For female participants, you will also be offered the opportunity for self-collection of 
a cervical/vaginal specimen. Instructions for collection and returning the sample will be included with the 
specimen collection kits sent to you. Your missed visits (at 6-, 12-, and 13-months post-transplant) may 
be rescheduled to a convenient date and time once it is considered safe to resume study activities. The 
procedures in the rescheduled study visits will be the same as you would have done originally in the study. 
These visits will take place at the same clinic you have visited for this study before. If the study physician 
determines that these visits are not useful for the study goals, they may be cancelled, and you will be 
informed accordingly. 
 
What possible risks can I expect from the addendum participation? 
If used correctly there are minimal risks to utilizing an at home lancet device. You may feel slight pain 
when you prick your finger with the testing device. Your fingertip may be sore for a short time and you 
could have a small bruise. Your privacy remains very important and we will make every effort to protect 
it. Your specimens will be confidentially identified with a barcode (not your name or other contact 
information) for return shipment to the clinical research facility. 

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What are the costs of taking part in this study? 
For the home-based specimen collection and phone visits, you will receive compensation for your time 
and effort. The amount of compensation will be $150 for the 6-month Post-Transplant Study Visit, $150 
for the 12-month Post-Transplant Study Visit, and $75 for the 13-Month Post-Transplant Visit. If and 
when you are able to come into clinic to make up the missed in person visits at a later date, you will be 
compensated for expenses associated with study participation for that visit, such as travel expenses, time 
missed from work or other. The amount of compensation for in person visits remains unchanged ($150 
for the 6-month, $150 for the 12-month Post-Transplant Study Visits, and $75 for the 13-Month Post- 
Transplant Visit). 
 
My Signature Agreeing to extend study participation 
 
I have read this consent addendum, or had it read to me. I have discussed it with the study doctor and my 
questions have been answered. I will be given a signed copy of this form. I agree to the changes discussed 
in this addendum. 
 
 
 
 
Participant’s signature 
Date of Signature 
 
 
 
Signature of person(s) conducting the informed consent discussion 
Date of Signature 
 
 
 
 
 
 
 
Participant witness signature 
Date of Signature