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HPV Vaccination in HIV Infected and HIV Uninfected Adolescents in Eswatini

NCT04982614 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1403

Last updated 2025-08-24

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Gardasil ® 9

GARDASIL 9 is a vaccine indicated in girls and women 9 through 45 years of age for the prevention of the following diseases: Cervical, vulvar, vaginal, and anal cancer, and Genital warts (condyloma acuminata) caused by Human Papillomavirus (HPV). 0.5-mL suspension for intramuscular injection as a single-dose vial and prefilled syringe at the following regimen/schedule: 9 through 14 years - 2-dose at 0, 6 to 12 months OR 3-dose at 0, 2, 6 months 15 through 45 years - 3-dose at 0, 2, 6 months

Sponsors & Collaborators

Principal Investigators

  • Elaine Abrams, MD · Columbia University

  • Xolisile Dlamini · Ministry of Health Eswatini

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
26 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2024-12-09
Completion
2024-12-09
FDA Drug
Yes

Countries

  • Eswatini

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04982614 on ClinicalTrials.gov