Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513526
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2007-08-06
Brief Title:
Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection
Sponsor:
AIDS Malignancy Consortium
Organization:
AIDS Malignancy Consortium
Study Overview
Official Title:
A Single-Arm Open-Label Pilot Trial of the Safety and Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Men
Status:
COMPLETED
Status Verified Date:
2023-10
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:
None
Brief Summary:
RATIONALE Vaccines made from human papillomavirus may help the body build an effective immune response to kill HIV cells
PURPOSE This phase II trial is studying the side effects and how well human papillomavirus vaccine therapy works in treating men with HIV-1 infection
PURPOSE This phase II trial is studying the side effects and how well human papillomavirus vaccine therapy works in treating men with HIV-1 infection
Detailed Description:
OBJECTIVES
Primary
To assess the safety and tolerability of quadrivalent human papillomavirus HPV types 6 11 16 18 recombinant vaccine in HIV-infected men
To assess the immunogenicity of the quadrivalent HPV vaccine for types 6 11 16 and 18 in subjects who are antibody-negative at baseline
Secondary
To evaluate the changes in plasma HIV-1 RNA and CD4 count after the vaccination series
To describe the associations of CD4 count nadir CD4 count and age on antibody response
To evaluate the levels and persistence of HPV 6 11 16 and 18 antibody titers after the vaccination series among subjects according to serostatus at baseline
To evaluate the oral levels of serum IgA before and after the vaccination series
Tertiary
To evaluate prevalent and incident HPV infections in the anal canal
To evaluate cytological and histological abnormalities in the anal canal
To evaluate prevalent and incident HPV infections in the oral cavity
To compare oral and anal compartmental shedding of HPV before and after vaccination
OUTLINE This is a multicenter study
Patients receive quadrivalent human papillomavirus types 6 11 16 18 recombinant vaccine intramuscularly on day 0 and weeks 8 and 24
After completion of protocol therapy patients are followed at 7 12 and 18 months
Primary
To assess the safety and tolerability of quadrivalent human papillomavirus HPV types 6 11 16 18 recombinant vaccine in HIV-infected men
To assess the immunogenicity of the quadrivalent HPV vaccine for types 6 11 16 and 18 in subjects who are antibody-negative at baseline
Secondary
To evaluate the changes in plasma HIV-1 RNA and CD4 count after the vaccination series
To describe the associations of CD4 count nadir CD4 count and age on antibody response
To evaluate the levels and persistence of HPV 6 11 16 and 18 antibody titers after the vaccination series among subjects according to serostatus at baseline
To evaluate the oral levels of serum IgA before and after the vaccination series
Tertiary
To evaluate prevalent and incident HPV infections in the anal canal
To evaluate cytological and histological abnormalities in the anal canal
To evaluate prevalent and incident HPV infections in the oral cavity
To compare oral and anal compartmental shedding of HPV before and after vaccination
OUTLINE This is a multicenter study
Patients receive quadrivalent human papillomavirus types 6 11 16 18 recombinant vaccine intramuscularly on day 0 and weeks 8 and 24
After completion of protocol therapy patients are followed at 7 12 and 18 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01CA121947 | NIH | NCI | httpsreporternihgovquickSearchU01CA121947 |
| CDR0000559149 | OTHER | None | None |