Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624839
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Evaluating Gardasil HPV Vaccine Humoral and Cellular Immune Responses in Sexual and Gender minoriTies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A PRe-pOsT Interventional Study Evaluating Gardasil Nine-valent Human Papilloma Virus HPV Vaccine Humoral and Cellular Immune Responses in Sexual and Gender minoriTies With or Without HIV
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROTECT
Brief Summary:
This is a phase 2 open-label study to assess the immunogenicity of the 9-valent human papillomavirus HPV recombinant vaccine Gardasil9 in transgender women TGW Investigators will enroll human immunodeficiency virus HIV positive transgender persons assigned male at birth TG-AMAB and HIV negative controls and administer Gardasil9 at timepoints Day 0 Month 2 and Month 6 The immune response to the vaccine will be analyzed at Month 7 1 month following the final vaccine dose
Detailed Description:
This will be a phase 2 open-label study to assess the humoral and cellular immune response to the FDA-approved 9-valent HPV recombinant vaccine in transgender persons assigned male at birth TG-AMAB At baseline TG-AMAB with HIV and HIV negative assigned male at birth AMAB controls will provide blood samples and anal swabs for evaluation of HPV immunity anal HPV and anal dysplasia All participants will undergo a 3-dose vaccine series of the Gardasil vaccine at Day 0 Month 2 and Month 6 Participants will then return one month after completion of third vaccine Month 7 to provide repeat blood samples and anal swabs Samples will be compared pre and post vaccination and in-between participants based on HIV and gender affirming hormone therapy GAHT status
Any participant with human papillomavirus 16 HPV16 andor anal dysplasia on anal cytology at any point will be referred to high-resolution anoscopy HRA for clinical management Anal biopsies will be procured from different pathology laboratories - after clinical evaluation has been complete - for research analysis including confocal microscopy Those who had anal dysplasia at study entry will undergo repeat HRA as clinically indicated and will have an optional study visit following their repeat HRA to provide blood draw and anal swabs
Any participant with human papillomavirus 16 HPV16 andor anal dysplasia on anal cytology at any point will be referred to high-resolution anoscopy HRA for clinical management Anal biopsies will be procured from different pathology laboratories - after clinical evaluation has been complete - for research analysis including confocal microscopy Those who had anal dysplasia at study entry will undergo repeat HRA as clinically indicated and will have an optional study visit following their repeat HRA to provide blood draw and anal swabs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None