Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV: A Prospective, Individual, Double-Blind, Randomized Controlled Study.

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 16
Healthy Volunteers: f
View:

• Age 16 years and above on the day of signing the ICF

• Living with HIV with confirmed test results or clinic records

• History of receiving HPV vaccine

• 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 WHO 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

Locations
Other Locations
Botswana
Botswana Harvard Health Partnership
RECRUITING
Gaborone
Rwanda
Ministry of Health and Center for Family Health Research
RECRUITING
Kigali
South Africa
Wits RHI, University of the Witwatersrand
RECRUITING
Johannesburg
Contact Information
Primary
Meighan Krows, BA
mkrows@mgb.org
617-724-4160
Time Frame
Start Date: 2024-10-14
Estimated Completion Date: 2027-06
Participants
Target number of participants: 750
Treatments
Experimental: Group 1
Will receive GARDASIL®9 vaccine at Day 0 and Menveo®/Menactra® vaccine at Month 18
Active_comparator: Group 2
Will receive the Menveo®/Menactra® vaccine at Day 0 and GARDASIL®9 at Month 18
Sponsors
Collaborators: Karolinska Institutet, Botswana Harvard Health Partnership, Ministry of Health, Rwanda, Fred Hutchinson Cancer Center, National Cancer Institute (NCI), University of Witwatersrand, South Africa
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov