Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00413725
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2006-12-18
Brief Title:
Safety and Efficacy of a Three-Dose Regimen of an Adenoviral HIV Vaccine MRKAd5 HIV-1 GagPolNef in HIV Uninfected South African Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multicenter Double-Blind Randomized Placebo-Controlled Phase IIB Test-of-Concept Study to Evaluate the Safety and Efficacy of a Three-Dose Regimen of the Clade B-based Merck Adenovirus Serotype 5 HIV-1 GagPolNef Vaccine in HIV-1 Uninfected Adults in South Africa
Status:
COMPLETED
Status Verified Date:
2021-10
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:
The purpose of this study is to determine the safety efficacy and tolerability of a three-dose regimen of an adenovirus-based HIV-1 vaccine in healthy South African adults
Detailed Description:
The HIV epidemic is a major global health challenge The Joint United Nations Program on HIVAIDS UNAIDS reported that in 2004 3 million people worldwide died of AIDS and an estimated 5 million people acquired HIV Studies in animal models and observational data from humans suggest that cell-mediated immune responses may be key to controlling HIV infection MRKAd5 HIV-1 gagpolnef a clade B-based adenovirus serotype 5 HIV-1 vaccine has been shown to elicit T-cell mediated immune responses The vaccine appears to be safe and generally well tolerated in previous Phase 1 and 2 studies in HIV-uninfected people The purpose of this study is to evaluate the safety and efficacy of the MRKAd5 HIV-1 gagpolnef vaccine in HIV-uninfected participants from South Africa where clade C is predominant The study will address whether a clade B-based vaccine designed to elicit T-cellular immunity will demonstrate efficacy in reducing acquisition of infection or reducing HIV viral load in persons who become infected in a non-clade B region
This study will last about 42 months for HIV-uninfected participants for those who become HIV infected visits continue for 18 months after diagnosis Participants will be randomly assigned to receive 3 doses of either vaccine or placebo All participants will receive their injections at study entry and at Months 1 and 6 Participants will be asked to complete a post-vaccination symptom log for the 3 days following each vaccination to monitor body temperature and symptoms known to be associated with the vaccine At all study visits participants will be asked about any adverse events they may have experienced There will be at least 14 study visits over the first 4 years of the study A physical exam medication history risk reduction counseling and blood collection will occur at every visit Participants will be asked to complete a social impact questionnaire at Weeks 12 78 and 208 an outside testing and belief questionnaire at Weeks 30 78 130 182 and 208 and a circumcision status assessment at Week 208 Participants will undergo HIV testing to check their HIV status approximately every 3 months
Participants who become HIV infected during the study will have eight study visits at Weeks 4 8 12 16 20 26 52 and 78 post-diagnosis A physical exam risk reduction counseling blood and urine collection and a pregnancy test will occur at all visits Genital secretion collection may also occur at some visits Participants who become HIV infected and need to begin anti-HIV therapy will be discontinued from this study but encouraged to enroll in the study HVTN 802
As of September 17 2007 enrollment and vaccinations for this study were suspended Participants already enrolled have been asked to continue attending follow-up visits with this study
Participants who were not diagnosed with HIV infection during their participation in the study will be eligible to enroll in a substudy The purpose of the substudy is to expand HIV testing and to gather data on behavioral risk factors for HIV infection among participants in the original study Participants in the substudy will attend a study visit which will include a physical examination HIV risk reduction counseling blood collection and a behavioral risk questionnaire Some participants may have an HIV test as part of this visit these participants will attend a second study visit 2 weeks later to receive their HIV test results Upon completion of the substudy researchers will contact participants to provide further information about the substudy results
This study will last about 42 months for HIV-uninfected participants for those who become HIV infected visits continue for 18 months after diagnosis Participants will be randomly assigned to receive 3 doses of either vaccine or placebo All participants will receive their injections at study entry and at Months 1 and 6 Participants will be asked to complete a post-vaccination symptom log for the 3 days following each vaccination to monitor body temperature and symptoms known to be associated with the vaccine At all study visits participants will be asked about any adverse events they may have experienced There will be at least 14 study visits over the first 4 years of the study A physical exam medication history risk reduction counseling and blood collection will occur at every visit Participants will be asked to complete a social impact questionnaire at Weeks 12 78 and 208 an outside testing and belief questionnaire at Weeks 30 78 130 182 and 208 and a circumcision status assessment at Week 208 Participants will undergo HIV testing to check their HIV status approximately every 3 months
Participants who become HIV infected during the study will have eight study visits at Weeks 4 8 12 16 20 26 52 and 78 post-diagnosis A physical exam risk reduction counseling blood and urine collection and a pregnancy test will occur at all visits Genital secretion collection may also occur at some visits Participants who become HIV infected and need to begin anti-HIV therapy will be discontinued from this study but encouraged to enroll in the study HVTN 802
As of September 17 2007 enrollment and vaccinations for this study were suspended Participants already enrolled have been asked to continue attending follow-up visits with this study
Participants who were not diagnosed with HIV infection during their participation in the study will be eligible to enroll in a substudy The purpose of the substudy is to expand HIV testing and to gather data on behavioral risk factors for HIV infection among participants in the original study Participants in the substudy will attend a study visit which will include a physical examination HIV risk reduction counseling blood collection and a behavioral risk questionnaire Some participants may have an HIV test as part of this visit these participants will attend a second study visit 2 weeks later to receive their HIV test results Upon completion of the substudy researchers will contact participants to provide further information about the substudy results
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 |
|---|---|---|---|
| HVTN 503 | Registry Identifier | DAIDS ES Registry Number | None |
| 10392 | REGISTRY | None | None |