Safety, Tolerability and Immunogenicity of a Nine-valent Human Papillomavirus (HPV) Vaccine in HIV and Transplant Patients
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|ClinicalTrials.gov Identifier: NCT03482739|
Recruitment Status : Active, not recruiting
First Posted : March 29, 2018
Last Update Posted : April 23, 2019
This is a single-center, open-label study on safety, tolerability and immunogenicity of Gardasil®9 in 18 to 45 year-old HIV patients, in 18 to 55 year-old solid-organ transplant (SOT) patients.
This study will enrol 100 HIV patients with CD4+ count of >200cells/mm² and 170 SOT patients, all of whom have not yet received a prophylactic HPV vaccine. The 170 SOT patients will be equally divided over 3 different SOT patient groups, namely heart, lung and kidney transplant patients. Therefore the target is to include approximately 57 heart transplant patients, 57 lung transplant patients and 57 kidney transplant patients. Enrolment in a SOT subgroup will be stopped when 57 patients have been included unless recruitment cannot be achieved within one of the other SOT-patient population.
All enrolled subjects will receive a 3-dose regimen (Day 1, Month 2, and Month 6) of GARDASIL®9. Serum samples will be collected on Day 1 and Month 7 for anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 antibody determination. The time point for comparison of immune responses will be Month 7, or approximately 4 weeks after the administration of the third dose. The safety/tolerability profile of the vaccine will be evaluated in all subjects in the study. Safety information will be collected on Day 1 through 1 month following the third vaccination or for a total of approximately 7 months for each subject.
The immunogenicity and the safety data will be analyzed per group of patients. More specifically a separate analysis of HIV and SOT patients is planned, since it is expected that the immunosuppressive therapy of SOT patients might have a more profound effect on immunogenicity following vaccination.
This study will provide a comparison of immunogenicity of Gardasil ®9 in immunocompromised patients, with historical controls. The number of subjects to be enrolled in the study was determined based on the primary immunogenicity objective.
|Condition or disease||Intervention/treatment||Phase|
|Human Papilloma Virus Human Immunodeficiency Virus Solid Organ Transplant||Biological: nine-valent HPV vaccine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Phase III Study to Investigate the Safety, Tolerability and Immunogenicity of a Nine-valent Human Papillomavirus (HPV) Vaccine (Gardasil®9) in Solid Organ Transplant Recipients and HIV-infected Patients|
|Actual Study Start Date :||April 9, 2018|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2019|
Experimental: Immunocompromised patients
All patients will receive the nine-valent HPV vaccine
Biological: nine-valent HPV vaccine
Other Name: Gardasil9
- Anti-HPV seroconversion [ Time Frame: 4 weeks postdose 3 (Month 7) ]The seroconversion percentages to HPV 6, 11, 16, 18, 31, 33, 45, 52 and 58 at 4 weeks after the third dose of the vaccine as measured by a competitive Luminex immunoassay. The percentage of participants who were seronegative on Day 1 and have anti-HPV titer greater or equal to the type-specific serostatus cutoff at 4 weeks postdose 3 will be assessed.
- Anti-HPV geometric mean titers [ Time Frame: 4 weeks postdose 3 (Month 7) ]The geometric mean titers to HPV 6, 11, 16, 18, 31, 33, 45, 52 and 58 at 4 weeks after the third dose of the vaccine as measured by a competitive Luminex immunoassay.
- Adverse Events [ Time Frame: Up to 1 month after Dose 3 (up to 7 months) ]The percentage of participants with one or more adverse events will be assessed.
- Elevated Temperature (Fever) [ Time Frame: Up to 5 days after any vaccination ]The subjects will be asked to record oral body temperature in a vaccination diary. The percentage of participants with elevated temperature (≥37.8°C) will be assessed.
- Injection-site Adverse Events [ Time Frame: Up to 5 days after any vaccination ]The subjects will be asked to record any injection-site reactions in a vaccination diary, i.e., injection-site tenderness, swelling, or redness, occurring after each study vaccination (solicited injection-site reactions). The percentage of participants with one or more injection-site adverse events will be assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482739
|University Hospitals Leuven|
|Leuven, Belgium, 3000|