Clinical trial NCT06436274: Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV.
Official title: Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV: A Prospective, Individual, Double-Blind, Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Human Papilloma Virus
Hiv
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of Witwatersrand, South Africa
name: Botswana Harvard Health Partnership
name: Ministry of Health, Rwanda
name: Fred Hutchinson Cancer Center
name: National Cancer Institute (NCI)
name: Karolinska Institutet
First posted: 2024-05-31
Enrollment: 750
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. Assigned female at birth
2. Age 16 years and above on the day of signing the informed consent form
3. Living with HIV with confirmed test results or clinic records
4. History of receiving a single dose of an HPV vaccine before HIV diagnosis
5. Self-reported sexually active in the last six months
6. Lives within the study area and willing to provide updated locator information over the course of the study
7. Does not have an autoimmune, degenerative, or genetic disease
8. Does not have known advanced HIV (as per stage IV World Health Organization clinical staging criteria for HIV)
9. No other Investigator-determined factor would limit participation in the trial
10. Has not and is not enrolled in a monoclonal, investigational vaccine, or a large quantity blood draw study
11. The participant has a cervix

Exclusion Criteria:

1. Anyone with cervical abnormality on examination
2. Anyone with an allergy to vaccine components or yeast

Primary outcomes:
measure: Efficacy of single-dose HPV among women living with HIV who were vaccinated against HPV 16/18 before their HIV diagnosis.
timeFrame: 18 Months
Secondary outcomes:
measure: Safety and tolerability of single-dose nonavalent HPV vaccination in women living with HIV.
timeFrame: 18 Months
Other outcomes:
Locations:
city: Gaborone
country: Botswana
facility: Botswana Harvard Health Partnershi
city: Kigali
country: Rwanda
facility: Ministry of Health and Center for Family Health Research
city: Johannesburg
country: South Africa
facility: Wits RHI, University of the Witwatersrand
state: Gauteng
Study officials:
affiliation: Mass General Brigham
name: Ruanne Barnabas, MBChB, MSc, DPhil
role: PRINCIPAL_INVESTIGATOR
affiliation: Wits RHI, University of The Witwatersrand
name: Sinead Delany-Moretlwe, MBBCh, PhD, DTM&H
role: PRINCIPAL_INVESTIGATOR
References: