Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06436274
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-24
Brief Title:
Efficacy of Human Papillomavirus HPV Vaccination to Prevent Infection Among Women Living With HIV
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Efficacy of Human Papillomavirus HPV Vaccination to Prevent Infection Among Women Living With HIV A Prospective Individual Double-Blind Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOPE II
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 16183133455258 vaccine efficacy VE The study will provide evidence on the efficacy of single-dose HPV 16183133455258 vaccination among women living with HIV
Participants will be randomized 11 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
Participants will be randomized 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None