Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hiv | — | UNRESOLVED | — |
| HPV Infection | — | UNRESOLVED | — |
| HPV Vaccine | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gardasil ® 9 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 2-dose regimen group
- description
- Boys and girls (aged 9-14 years) and young women (aged 15-26 years) living with HIV will receive a two-dose regimen of the HPV vaccine at baseline (Month 0) and Month 6.
- interventionNames
- Biological: Gardasil ® 9
- type
- ACTIVE_COMPARATOR
- label
- 3-dose regimen group (SOC)
- description
- HIV-uninfected young women (aged 15-26 years) will receive the standard of care three-dose regimen of the HPV vaccine at baseline (Month 0), Month 2 and Month 6.
- interventionNames
- Biological: Gardasil ® 9
Primary outcomes (2)
- measure
- Anti-HPV geometric mean antibody titers
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 9 Years
- Maximum age
- 26 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDNuwagaba-Biribonwoha H, Lamb MR, Dlamini X, Zerbe A, Anabwani-Richter FA, Zech JM, Hsu A, Mabuza N, Lukhele NM, Fayorsey R, Sahabo R, Nkambule R, El-Sadr WM, Abrams EJ. Immunogenicity of 2 versus 3 dose HPV vaccination by HIV infection status in Eswatini. Vaccine. 2026 Jul 11;85:128692. doi: 10.1016/j.vaccine.2026.128692. Epub 2026 May 16. PMID 42142523