NCT04982614CompletedPhase 4
HPV Vaccination in HIV Infected and HIV Uninfected Adolescents in Eswatini
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
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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 (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1403 (actual)
- First submitted
- 20 Jul 2021
- Start date
- 31 Mar 2022
- Primary completion date
- 9 Dec 2024
- Lead sponsor
- Columbia University
- Diseases
- HIV
- NCT number
- NCT04982614
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 1403
- From 31 Mar 2022 to the primary completion date, 9 Dec 2024
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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,
Other illness
- Diagnosis of other immunosuppressive diseases or receipt of immunosuppressive medications,
- Diagnosis of other acute or chronic illness,
- Known allergies to a vaccine component
Other
- For all participants:
- Currently pregnant,
Who the study is looking for
- 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
Age in the registry: 9 years to 26 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Raleigh Fitkin Memorial Hospital Coordinator of this site? Confirm its status | Manzini | Eswatini | Unknown status |
| AHF Lamvelase Coordinator of this site? Confirm its status | Manzini | Eswatini | Unknown status |
| AHF Manzini Coordinator of this site? Confirm its status | Manzini | Eswatini | Unknown status |
| AHF Matsapha Coordinator of this site? Confirm its status | Matsapha | Eswatini | Unknown status |
| Baylor College of Medicine - Bristol Myers-Squibb Children's Clinical Centre of Excellence Coordinator of this site? Confirm its status | Mbabane | Eswatini | Unknown status |
Related publications
- Immunogenicity of 2 versus 3 dose HPV vaccination by HIV infection status in Eswatini.Vaccine · 2026 · PMID 42142523
This page is information, not medical advice. Discuss any trial with your doctor.