HPV Vaccination in HIV Infected and HIV Uninfected Adolescents in Eswatini

NCT ID: NCT04982614

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1403 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2024-12-09

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.

Detailed Description

Cervical cancer remains a significant threat to public health worldwide and remains the leading cause of cancer-associated mortality in women in Sub Saharan Africa. Cervical cancer-associated morbidity and mortality is preventable through HPV vaccination, and screening and treatment of pre-cancerous lesions. To date, there is no nationwide HPV vaccination program in Eswatini and the country is not eligible for Global Alliance for Vaccines and Immunization (GAVI) procurement of HPV vaccines, and yet the triad of HIV, sexually transmitted infections (STI) and cervical cancer generates a severe disease burden warranting immediate introduction of this intervention. Given the global limitations in vaccine supply and the high cost for procurement, country programs, including in Eswatini, must optimize vaccine resources in order to maximize HPV vaccine coverage.

Conditions

HPV Infection; Hiv; HPV Vaccine

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

2-dose regimen group

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.

Group Type: EXPERIMENTAL

Gardasil ® 9

Intervention Type: 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

3-dose regimen group (SOC)

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.

Group Type: ACTIVE_COMPARATOR

Gardasil ® 9

Intervention Type: 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

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Human Papillomavirus 9-valent Vaccine, Recombinant; 9vHPV vaccine

Eligibility Criteria

Inclusion Criteria

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)
• Intending to remain in the vicinity of the study sites for the study period

Exclusion Criteria

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jhpiego

OTHER

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Elaine J. Abrams, MD

Professor of Pediatrics and Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elaine Abrams, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Xolisile Dlamini

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health Eswatini

Locations

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

Countries

Eswatini

Other Identifiers

7200AA19CA 00003

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AAAT6912

Identifier Type: -

Identifier Source: org_study_id