Hiv, Human Papilloma Virus
Conditions
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 prior HPV vaccination.
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.
Interventions
BIOLOGICALGARDASIL®9
GARDASIL®9 or equivalent vaccines will be used for this study. These are FDA-approved vaccines.
BIOLOGICALMenveo®/Menactra®
Menveo®/Menactra® or equivalent vaccines will be used for this study. These are FDA-approved vaccines.
Sponsors
University of Witwatersrand, South Africa
Botswana Harvard Health Partnership
Ministry of Health, Rwanda
Fred Hutchinson Cancer Center
National Cancer Institute (NCI)
Karolinska Institutet
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 16 years and above on the day of signing the ICF 2. Living with HIV with confirmed test results or clinic records 3. History of receiving HPV vaccine 4. Self-reported sexually active in the last six months 5. Lives within the study area and willing to provide updated locator information over the course of the study 6. Does not have an autoimmune, degenerative, or genetic disease 7. Does not have known advanced HIV (as per stage IV WHO clinical staging criteria for HIV) 8. No other Investigator-determined factor would limit participation in the trial 9. Has not and is not enrolled in a monoclonal, investigational vaccine, or a large quantity blood draw study 10. The participant has a cervix
Exclusion criteria
1. Anyone with cervical abnormality on examination 2. Anyone with an allergy to vaccine components or yeast
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of single-dose HPV among women living with HIV who were vaccinated against HPV 16/18. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Botswana, Rwanda, South Africa
Outcome results
None listed