Hiv Clinical Trial
Official title:
A Multi-site, Open-label Non-inferiority Trial to Assess Immunogenicity of Two Doses of the Nonavalent Human Papillomavirus (HPV) Vaccine Among Children, Adolescents and Young Adults (9-26 Years) Living With HIV vs Three Doses of Nonavalent HPV Vaccine Among HIV Uninfected Young Women (15-26 Years) in Eswatini
Verified date | March 2024 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a multi-site, open-label non-inferiority study of the 9vHPV vaccine among a population of children, adolescents and young women living with HIV in Eswatini. This protocol seeks to assess immunogenicity of a two-dose 9vHPV vaccine regimen among girls and boys (9-14 years) and young women (15-26 years) living with HIV on antiretroviral therapy versus a three-dose 9vHPV vaccine regimen among HIV uninfected young women (15-26 years) in Eswatini. The secondary objectives include examining the safety profiles of the two-dose 9vHPV regimen in those living with HIV and the three-dose 9vHPV regimen in HIV-uninfected young women, as well as measuring the completion of the vaccination series among those living with HIV and those who are not infected with HIV.
Status | Active, not recruiting |
Enrollment | 1403 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 9 Years to 26 Years |
Eligibility | Inclusion Criteria: For people living with HIV receiving two-dose regimen: - Females 9-26 years and males 9-14 years, - Documented HIV infection, - Aware of HIV+ status, - Currently receiving antiretroviral treatment (ART) for HIV infection for at least six months, - Living in Eswatini, - For individuals 18+ years: able to provide informed consent, - For individuals 15-17 years: able to provide informed assent, - For individuals 9-14 years of age: able to provide informed assent AND accompanied by an adult caregiver who is able to give informed consent, - Intending to remain in the vicinity of the study sites for the study period For reference group of HIV-uninfected women receiving three-dose regimen: - Females 15-26 years, - Documented negative HIV test at baseline - Living in Eswatini, - Able to provide informed assent (15-17 years) or informed consent (18-26 years) - Intending to remain in the vicinity of the study sites for the study period Exclusion Criteria: For all participants: - Diagnosis of other immunosuppressive diseases or receipt of immunosuppressive medications, - Diagnosis of other acute or chronic illness, - Receipt of other vaccinations within 2-3 weeks before or after study vaccination, - Receipt of blood-derived products within 6 months before or during the study, - Previous receipt of an HPV vaccine, - Currently pregnant, - Known allergies to a vaccine component |
Country | Name | City | State |
---|---|---|---|
Swaziland | AHF Lamvelase | Manzini | |
Swaziland | AHF Manzini | Manzini | |
Swaziland | Raleigh Fitkin Memorial Hospital | Manzini | |
Swaziland | AHF Matsapha | Matsapha | |
Swaziland | Baylor College of Medicine - Bristol Myers-Squibb Children's Clinical Centre of Excellence | Mbabane |
Lead Sponsor | Collaborator |
---|---|
Columbia University | Jhpiego, Merck Sharp & Dohme LLC |
Swaziland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anti-HPV geometric mean antibody titers | Serum antibodies against HPV antigens (IgG, IFNg, TNF, IL2, CXCL10, granzyme, perforin, PTX3). Geometric mean titers will be summarized by treatment group, and the ratios of mean GMTs between treatment and control and their 95% confidence intervals calculated around point estimates. | Month 7 (4 weeks post Month 6 vaccine dose) | |
Primary | Number of seroconversions | Number of participants who seroconvert, defined as having no HPV antibodies pre-vaccination, but detectable HPV antibodies at 4 weeks post month 6 vaccine dose | Month 7 (4 weeks post Month 6 vaccine dose) | |
Secondary | Number of participants with serious adverse events (SAE) | Number of participants who reported experiences of SAE. SAE is defined as those that experienced death, life-threatening conditions or hospitalizations. | Up to 6 months | |
Secondary | Number of participants completing vaccination series | Number of eligible participants completing the 2-dose or 3-dose regimens will be tallied. | Up to 6 months |
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