Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV.
- Conditions
- HivHuman Papilloma Virus
- Interventions
- Biological: GARDASIL®9Biological: Menveo®/Menactra®
- Registration Number
- NCT06436274
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
The Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living with HIV: A Prospective, Individual, Double-Blind, Randomized Controlled Study is evaluating immediate or delayed single-dose nonavalent HPV vaccination among women living with HIV who received one HPV vaccination prior to HIV diagnosis.
- Detailed Description
The HOPE II Study is an individual-level, randomized trial of immediate or delayed vaccination with a single-dose of the nonavalent HPV vaccine. The primary outcome is single-dose HPV 16/18/31/33/45/52/58 vaccine efficacy (VE). The study will provide evidence on the efficacy of single-dose HPV 16/18/31/33/45/52/58 vaccination among women living with HIV.
Participants will be randomized 1:1 into two different Groups.
* Group 1: Will receive nonavalent HPV vaccine at Day 0 and meningococcal vaccine at Month 18
* Group 2: Will receive the meningococcal vaccine at Day 0 and nonavalent HPV at Month 18
The meningococcal vaccine was chosen as the control vaccination because meningococcal vaccination has no activity against HPV infection. Further, the meningococcal vaccine has the potential to be of benefit in a meningitis outbreak context and could be beneficial for young persons in a congregate setting such as tertiary institutions.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 750
- Assigned female at birth
- Age 16 years and above on the day of signing the informed consent form
- Living with HIV with confirmed test results or clinic records
- History of receiving a single dose of an HPV vaccine before HIV diagnosis
- Self-reported sexually active in the last six months
- Lives within the study area and willing to provide updated locator information over the course of the study
- Does not have an autoimmune, degenerative, or genetic disease
- Does not have known advanced HIV (as per stage IV World Health Organization clinical staging criteria for HIV)
- No other Investigator-determined factor would limit participation in the trial
- Has not and is not enrolled in a monoclonal, investigational vaccine, or a large quantity blood draw study
- The participant has a cervix
- Anyone with cervical abnormality on examination
- Anyone with an allergy to vaccine components or yeast
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group 1 GARDASIL®9 Will receive GARDASIL®9 vaccine at Day 0 and Menveo®/Menactra® vaccine at Month 18 Group 1 Menveo®/Menactra® Will receive GARDASIL®9 vaccine at Day 0 and Menveo®/Menactra® vaccine at Month 18 Group 2 Menveo®/Menactra® Will receive the Menveo®/Menactra® vaccine at Day 0 and GARDASIL®9 at Month 18 Group 2 GARDASIL®9 Will receive the Menveo®/Menactra® vaccine at Day 0 and GARDASIL®9 at Month 18
- Primary Outcome Measures
Name Time Method Efficacy of single-dose HPV among women living with HIV who were vaccinated against HPV 16/18 before their HIV diagnosis. 18 Months Efficacy will be measured by the incidence of persistent infection from at least one of these HPV 16/18/31/33/45/52/58, where persistence is defined as a positive test at two consecutive visits at least 4.5 months apart.
- Secondary Outcome Measures
Name Time Method Safety and tolerability of single-dose nonavalent HPV vaccination in women living with HIV. 18 Months This will be evaluated by comparing the occurrence of serious adverse events reported among each study arm.
Trial Locations
- Locations (3)
Botswana Harvard Health Partnershi
🇧🇼Gaborone, Botswana
Ministry of Health and Center for Family Health Research
🇷🇼Kigali, Rwanda
Wits RHI, University of the Witwatersrand
🇿🇦Johannesburg, Gauteng, South Africa