Human Papillomavirus InfectionPhase 2NCT03036930
Preventive Human Papillomavirus (HPV) Vaccine Trial in Kidney Transplant Recipients
A Phase 2 study testing Biospecimen Collection, HPV Self-Collection and Questionnaire Administration in people with Human Papillomavirus Infection and Human Papillomavirus-Related Carcinoma, run by National Cancer Institute (NCI) at 6 sites in United States.
Trial summary
This phase II trial studies whether the nonavalent human papillomavirus vaccine given to adults prior to kidney transplantation can help the body build and maintain an effective immune response during the post-transplant period when they receive immunosuppressive drugs to prevent transplant rejection. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Human Papillomavirus Infection, Human Papillomavirus-Related Carcinoma
- What is being tested?
- Biospecimen Collection, HPV Self-Collection and Questionnaire Administration
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 6 sitesUnited States
- Study dates
- 23 Jun 2017to 10 Mar 2027
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Candidate for renal transplant, expected to undergo transplant surgery >= 30 days and =< 12 months after enrollment
- 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
- 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:
- 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
- Transplant recipients of both genders: The study was originally designed to be conducted only among women; however, in October 2018, the Food and Drug Administration (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; 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 high (> 99%) seroconversion 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); another advantage of expanding this study to males will be to facilitate efficiencies in accrual, since men constitute the majority (55%-65%) of all kidney transplant recipients in the United States; although a majority of current HPV-associated cancers among solid organ transplant recipients occur among women, there is increasing evidence of the link between HPV infection and oropharyngeal cancers that disproportionately affect men; HPV-related oropharyngeal cancers are now the most common HPV-related cancers in the United States, surpassing even the incidence of cervical cancer; 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
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- 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 United States (U.S.) are between the ages of 18-49 years, selecting this age range permits efficiency in study accrual
- Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
- 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
- Ability to understand and the willingness to sign a written informed consent document and medical release form
- Willing and able to comply with trial protocol and follow-up
Who cannot join
- Previous prophylactic HPV vaccination
- Prior organ transplant
- 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 exclusion due to anticipated desensitization is warranted for a particular participant in the study
- Current use of any other investigational agents
- History of allergic reactions to yeast or attributed to compounds of similar chemical or biologic composition to Gardasil 9 HPV vaccine
- 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
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- 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
- History of cervical cancer or anal cancer
- History of active malignancy, including basal/squamous cell skin cancer
- 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
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Northwestern University
Chicago, Illinois, 60611
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
UCSF Medical Center-Mount Zion
San Francisco, California, 94115
About this study
Official title: Immunogenicity of Nonavalent HPV Vaccine Administered Prior to Renal Transplantation in Adults: A Prospective, Single-Arm, Multi-Center Clinical Trial
This phase II trial studies whether the nonavalent human papillomavirus vaccine given to adults prior to kidney transplantation can help the body build and maintain an effective immune response during the post-transplant period when they receive immunosuppressive drugs to prevent transplant rejection. This study will help inform our scientific understanding about vaccine-induced immune responses among immunosuppressed individuals.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess human papillomavirus (HPV) vaccine-type-specific seroconversion rates at 12-months post-transplantation among kidney transplant recipients who receive >= 1 doses of the recombinant human papillomavirus nonavalent vaccine (Gardasil [registered trademark] 9 HPV vaccine) >= 30 days prior to transplantation.
SECONDARY OBJECTIVE:
- 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 recipients who receive >= 1 doses of the Gardasil 9 HPV vaccine prior to transplantation.
EXPLORATORY OBJECTIVES:
- To assess the following among kidney transplant recipients who receive >= 1 doses of the Gardasil 9 HPV vaccine >= 30 days prior to transplantation:
Ia. HPV vaccine-type-specific seroconversion rates at 12-months post-transplantation stratified by:
Ii. Time elapsed between last vaccine dose and the transplant procedure; Iii. Variations in dosing and types of post-transplant immunosuppressant medications; and interactions with type of transplant surgery (living donor/deceased donor); Iiii. Differences in human leukocyte antigen (HLA) histocompatibility between donor and recipient; Iiv. Differences in biological sex (i.e. male versus [vs.] female) of the transplant recipient; Ib. 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; Ic. 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; Id. 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.
OUTLINE:
Participants receive the first dose of the recombinant human papillomavirus nonavalent vaccine intramuscularly (IM) at baseline, at least 30 days prior to the kidney transplant surgery. The second dose is given at least one month after the first dose. The third dose is given at least five months after the first dose and at least three months after the second dose. The timing of the second and third doses is dependent on the scheduling of the kidney transplant surgery. Patients are followed up at 6- and 12-months after the kidney transplant surgery to measure vaccine-induced immune responses. Patients may receive either one, two, or all three vaccine doses prior to the kidney transplant surgery, and are offered additional visits at least one year after the surgery to complete any remaining doses of the three-dose vaccine series. Patients also undergo collection of blood samples and self-collection of cervical/vaginal samples (female participants only) on study.
- Being tested
- Biospecimen Collection, HPV Self-Collection, Questionnaire Administration, Recombinant Human Papillomavirus Nonavalent Vaccine
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo collection of blood samples
HPV Self-CollectionProcedure or surgery
Also called At-home HPV Self Collection, HPV Self Collection, Human Papillomavirus Self-Collection
Undergo self-collection of vaginal/cervical samples
Questionnaire AdministrationOther
Ancillary studies
Recombinant Human Papillomavirus Nonavalent VaccineBiological
Also called Gardasil 9, Nonavalent HPV VLP Vaccine, Recombinant HPV Nonavalent Vaccine, Recombinant Human Papillomavirus 9-valent Vaccine
Given IM
| Study group | Role | What they receive |
|---|---|---|
| Prevention (Gardasil 9 HPV vaccine) | Experimental | Participants receive the first dose of the recombinant human papillomavirus nonavalent vaccine IM at baseline, at least 30 days prior to the kidney transplant surgery. The second dose is given at least one month after the first dose. The third dose is given at least five months after the first dose and at least three months after the second dose. The timing of the second and third doses is dependent on the scheduling of the kidney transplant surgery. Patients are followed up at 6- and 12-months after the kidney transplant surgery to measure vaccine-induced immune responses. Patients may receive either one, two, or all three vaccine doses prior to the kidney transplant surgery, and are offered additional visits at least one year after the surgery to complete any remaining doses of the three-dose vaccine series. Patients also undergo collection of blood samples and self-collection of cervical/vaginal samples (female participants only) on study. Receives: Procedure: Biospecimen Collection; Procedure: HPV Self-Collection; Other: Questionnaire Administration; Biological: Recombinant Human Papillomavirus Nonavalent Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV Vaccine-type-specific Seroconversion Rates Among Kidney Transplant Recipients Who Received ≥ 1 Doses of the Vaccine.
An estimate of the Human papillomavirus (HPV) vaccine-type-specific seroconversion rate provided along with exact Clopper-Pearson 95% confidence intervals (CIs). All participants who received a kidney transplant were included in the primary endpoint analysis, regardless of whether the last vaccine dose was administered ≥ 30 days prior to transplantation.
Measured: At 12 months post-transplant
Secondary outcomes (2)
To Assess HPV Vaccine-type-specific Seroconversion Rates at 6-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant.
An estimate of the HPV vaccine-type-specific seroconversion rates at 6-months post-transplantation stratified by number of doses (1, 2, or 3) of the vaccine given pre-transplant was provided along with 95% confidence intervals (CIs). Clopper-Pearson CIs were provided for the overall and stratified estimates.
Measured: At 6-months post-transplant
To Assess HPV Vaccine-type-specific Seroconversion Rates at 12-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant.
An estimate of the HPV vaccine-type-specific seroconversion rates at 12-months post-transplantation stratified by number of doses (1, 2, or 3) of the vaccine given pre-transplant was provided along with 95% confidence intervals (CIs). Clopper-Pearson CIs were provided for the overall and stratified estimates.
Measured: At 12- months post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start23 Jun 2017
- Primary completion4 Mar 2024
- Study completion10 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human Papillomavirus InfectionStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Marc T Goodman, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036930
- Sponsor's protocol ID
- NCI-2017-00116
- Other IDs
- NCI-2017-00116, N01-CN-2012-00035, NCI2015-06-02, NWU2015-06-02, N01CN00035, P30CA060553
- Status last verified
- Sep 2026
- First submitted
- 30 Jan 2017
- Last updated
- 14 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of Nonavalent HPV Vaccine Administered Prior to Renal Transplantation in Adults: A Prospective, Single-Arm, Multi-Center Clinical Trial
- ClinicalTrials.gov ID
- NCT03036930
- Acronym / sponsor ID
- NCI-2017-00116
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 51 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 23 Jun 2017 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- 10 Mar 2027 (estimated)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Posted 30 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies whether the nonavalent human papillomavirus vaccine given to adults prior to kidney transplantation can help the body build and maintain an effective immune response during the post-transplant period when they receive immunosuppressive drugs to prevent transplant rejection. This study will help inform our scientific understanding about vaccine-induced immune responses among immunosuppressed individuals.
Detailed description
PRIMARY OBJECTIVE:
- To assess human papillomavirus (HPV) vaccine-type-specific seroconversion rates at 12-months post-transplantation among kidney transplant recipients who receive >= 1 doses of the recombinant human papillomavirus nonavalent vaccine (Gardasil [registered trademark] 9 HPV vaccine) >= 30 days prior to transplantation.
SECONDARY OBJECTIVE:
- 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 recipients who receive >= 1 doses of the Gardasil 9 HPV vaccine prior to transplantation.
EXPLORATORY OBJECTIVES:
- To assess the following among kidney transplant recipients who receive >= 1 doses of the Gardasil 9 HPV vaccine >= 30 days prior to transplantation:
Ia. HPV vaccine-type-specific seroconversion rates at 12-months post-transplantation stratified by:
Ii. Time elapsed between last vaccine dose and the transplant procedure; Iii. Variations in dosing and types of post-transplant immunosuppressant medications; and interactions with type of transplant surgery (living donor/deceased donor); Iiii. Differences in human leukocyte antigen (HLA) histocompatibility between donor and recipient; Iiv. Differences in biological sex (i.e. male versus [vs.] female) of the transplant recipient; Ib. 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; Ic. 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; Id. 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.
OUTLINE:
Participants receive the first dose of the recombinant human papillomavirus nonavalent vaccine intramuscularly (IM) at baseline, at least 30 days prior to the kidney transplant surgery. The second dose is given at least one month after the first dose. The third dose is given at least five months after the first dose and at least three months after the second dose. The timing of the second and third doses is dependent on the scheduling of the kidney transplant surgery. Patients are followed up at 6- and 12-months after the kidney transplant surgery to measure vaccine-induced immune responses. Patients may receive either one, two, or all three vaccine doses prior to the kidney transplant surgery, and are offered additional visits at least one year after the surgery to complete any remaining doses of the three-dose vaccine series. Patients also undergo collection of blood samples and self-collection of cervical/vaginal samples (female participants only) on study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (Gardasil 9 HPV vaccine) | Experimental | Procedure: Biospecimen Collection, Procedure: HPV Self-Collection, Other: Questionnaire Administration, Biological: Recombinant Human Papillomavirus Nonavalent VaccineParticipants receive the first dose of the recombinant human papillomavirus nonavalent vaccine IM at baseline, at least 30 days prior to the kidney transplant surgery. The second dose is given at least one month after the first dose. The third dose is given at least five months after the first dose and at least three months after the second dose. The timing of the second and third doses is dependent on the scheduling of the kidney transplant surgery. Patients are followed up at 6- and 12-months after the kidney transplant surgery to measure vaccine-induced immune responses. Patients may receive either one, two, or all three vaccine doses prior to the kidney transplant surgery, and are offered additional visits at least one year after the surgery to complete any remaining doses of the three-dose vaccine series. Patients also undergo collection of blood samples and self-collection of cervical/vaginal samples (female participants only) on study. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Candidate for renal transplant, expected to undergo transplant surgery >= 30 days and =< 12 months after enrollment
- 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 United States (U.S.) are between the ages of 18-49 years, selecting this age range permits efficiency in study accrual
- Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
- 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
- Ability to understand and the willingness to sign a written informed consent document and medical release form
Key exclusion criteria (11 listed)
- Previous prophylactic HPV vaccination
- Prior organ transplant
- 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 exclusion due to anticipated desensitization is warranted for a particular participant in the study
- Current use of any other investigational agents
- History of allergic reactions to yeast or attributed to compounds of similar chemical or biologic composition to Gardasil 9 HPV vaccine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo collection of blood samples | Procedure or surgery | Prevention (Gardasil 9 HPV vaccine) |
| HPV Self-CollectionAlso: At-home HPV Self Collection, HPV Self Collection, Human Papillomavirus Self-CollectionUndergo self-collection of vaginal/cervical samples | Procedure or surgery | Prevention (Gardasil 9 HPV vaccine) |
| Questionnaire AdministrationAncillary studies | Other | Prevention (Gardasil 9 HPV vaccine) |
| Recombinant Human Papillomavirus Nonavalent VaccineAlso: Gardasil 9, Nonavalent HPV VLP Vaccine, Recombinant HPV Nonavalent Vaccine, Recombinant Human Papillomavirus 9-valent VaccineGiven IM | Biological | Prevention (Gardasil 9 HPV vaccine) |
Primary outcome
HPV Vaccine-type-specific Seroconversion Rates Among Kidney Transplant Recipients Who Received ≥ 1 Doses of the Vaccine.
Time frame: At 12 months post-transplant
An estimate of the Human papillomavirus (HPV) vaccine-type-specific seroconversion rate provided along with exact Clopper-Pearson 95% confidence intervals (CIs). All participants who received a kidney transplant were included in the primary endpoint analysis, regardless of whether the last vaccine dose was administered ≥ 30 days prior to transplantation.
2 secondary outcomes
To Assess HPV Vaccine-type-specific Seroconversion Rates at 6-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant.
Time frame: At 6-months post-transplant
To Assess HPV Vaccine-type-specific Seroconversion Rates at 12-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant.
Time frame: At 12- months post-transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc T Goodman principal investigator
Northwestern University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biospecimen Collection, HPV Self-Collection and Questionnaire Administration in people with Human Papillomavirus Infection and Human Papillomavirus-Related Carcinoma, run by National Cancer Institute (NCI) at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV Vaccine-type-specific Seroconversion Rates Among Kidney Transplant Recipients Who Received ≥ 1 Doses of the Vaccine. (time frame: At 12 months post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.