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HPV Vaccination in HIV Infected and HIV Uninfected Adolescents in Eswatini

CompletedPhase 4

Sponsor: Columbia University

Conditions: HPV Infection, Hiv, HPV Vaccine

Interventions: Gardasil ® 9

Countries: Eswatini

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.

Eligibility overview

Sex: ALL

Age: 9 Years to 26 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (5)

Manzini, Eswatini
Manzini, Eswatini
Manzini, Eswatini
Matsapha, Eswatini
Mbabane, Eswatini