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COMPLETED
NCT04982614
PHASE4

HPV Vaccination in HIV Infected and HIV Uninfected Adolescents in Eswatini

Sponsor: Columbia University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

9 Years - 26 Years

Study Type

INTERVENTIONAL

Enrollment

1403

Start Date

2022-03-31

Completion Date

2024-12-09

Last Updated

2026-10-27

Healthy Volunteers

No

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

Locations (5)

AHF Lamvelase

Manzini, Eswatini

AHF Manzini

Manzini, Eswatini

Raleigh Fitkin Memorial Hospital

Manzini, Eswatini

AHF Matsapha

Matsapha, Eswatini

Baylor College of Medicine - Bristol Myers-Squibb Children's Clinical Centre of Excellence

Mbabane, Eswatini