HPV Vaccination in HIV Infected and HIV Uninfected Adolescents in Eswatini

NCT04982614 | Completed Phase 4 FDA Drug

• 2 other identifiers: AAAT69127200AA19CA 00003
• Study Type: interventional
• Target: 1,403
• Locations: 1 country
• Sites: 5

Brief 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

HPV Infection; Hiv; HPV Vaccine

Keywords

HPV; Adolescents living with HIV; HPV immunogenicity; Vaccine adherence

Outcome Measures

Primary Outcomes (2)

• Anti-HPV geometric mean antibody titers

  Serum antibodies against HPV antigens (IgG, IFNg, TNF, IL2, CXCL10, granzyme, perforin, PTX3). Geometric mean titers will be summarized by treatment group, and the ratios of mean GMTs between treatment and control and their 95% confidence intervals calculated around point estimates.

  Month 7 (4 weeks post Month 6 vaccine dose)

• Number of seroconversions

  Number of participants who seroconvert, defined as having no HPV antibodies pre-vaccination, but detectable HPV antibodies at 4 weeks post month 6 vaccine dose

  Month 7 (4 weeks post Month 6 vaccine dose)

Secondary Outcomes (2)

• Number of participants with serious adverse events (SAE)

  Up to 6 months

• Number of participants completing vaccination series

  Up to 6 months

Study Arms (2)

2-dose regimen group

EXPERIMENTAL

Boys and girls (aged 9-14 years) and young women (aged 15-26 years) living with HIV will receive a two-dose regimen of the HPV vaccine at baseline (Month 0) and Month 6.

Biological: Gardasil ® 9

3-dose regimen group (SOC)

ACTIVE COMPARATOR

HIV-uninfected young women (aged 15-26 years) will receive the standard of care three-dose regimen of the HPV vaccine at baseline (Month 0), Month 2 and Month 6.

Biological: Gardasil ® 9

Interventions

Gardasil ® 9 BIOLOGICAL

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

Also known as: Human Papillomavirus 9-valent Vaccine, Recombinant, 9vHPV vaccine

2-dose regimen group; 3-dose regimen group (SOC)

Eligibility Criteria

• Age: 9 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Jhpiego: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (5)

AHF Lamvelase

Manzini, Eswatini

Location

AHF Manzini

Manzini, Eswatini

Location

Raleigh Fitkin Memorial Hospital

Manzini, Eswatini

Location

AHF Matsapha

Matsapha, Eswatini

Location

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

Mbabane, Eswatini

Location

MeSH Terms

Conditions

Papillomavirus Infections; Acquired Immunodeficiency Syndrome

Interventions

Human Papillomavirus Recombinant Vaccine nonavalent

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Slow Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Elaine Abrams, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Xolisile Dlamini

  Ministry of Health Eswatini

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics and Epidemiology

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: July 29, 2021
• Study Start: April 1, 2022
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5)