Clinical Research Directory
Browse clinical research sites, groups, and studies.
HPV Vaccination in HIV Infected and HIV Uninfected Adolescents in Eswatini
Sponsor: Columbia University
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
Conditions
Interventions
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