Clinical trial NCT04982614: HPV Vaccination in HIV Infected and HIV Uninfected Adolescents in Eswatini
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HPV Infection
Hiv
HPV Vaccine
Keywords: HPV
Adolescents living with HIV
HPV immunogenicity
Vaccine adherence
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Jhpiego
name: Merck Sharp & Dohme LLC
First posted: 2021-07-29
Enrollment: 1403
Sex: ALL
Minimum age (years): 9
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Anti-HPV geometric mean antibody titers
timeFrame: Month 7 (4 weeks post Month 6 vaccine dose)
measure: Number of seroconversions
timeFrame: Month 7 (4 weeks post Month 6 vaccine dose)
Secondary outcomes:
measure: Number of participants with serious adverse events (SAE)
timeFrame: Up to 6 months
measure: Number of participants completing vaccination series
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Manzini
country: Swaziland
facility: AHF Lamvelase
city: Manzini
country: Swaziland
facility: AHF Manzini
city: Manzini
country: Swaziland
facility: Raleigh Fitkin Memorial Hospital
city: Matsapha
country: Swaziland
facility: AHF Matsapha
city: Mbabane
country: Swaziland
facility: Baylor College of Medicine - Bristol Myers-Squibb Children's Clinical Centre of Excellence
Study officials:
affiliation: Columbia University
name: Elaine Abrams, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ministry of Health Eswatini
name: Xolisile Dlamini
role: PRINCIPAL_INVESTIGATOR
References: