drugset / Trial / NCT04982614

HPV Vaccination in HIV Infected and HIV Uninfected Adolescents in Eswatini

NCT04982614

Non-randomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2022-04-01
Primary completion
2024-12-09
Completion
2024-12-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Gardasil 9 Vaccine 0.5 ml Intramuscular