CompletedPhase 4

HPV Vaccination in HIV Infected and HIV Uninfected Adolescents in Eswatini

Eswatini1,403 participantsStarted 2022-04-01

Plain-language summary

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.

Who can participate

Age range

9 Years – 26 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Anti-HPV geometric mean antibody titers

Timeframe: Month 7 (4 weeks post Month 6 vaccine dose)

Number of seroconversions

Timeframe: Month 7 (4 weeks post Month 6 vaccine dose)

Trial details

NCT IDNCT04982614

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-09

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