Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00393276
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2006-10-25
Brief Title:
Determining Responses to Two Different Vaccines in HIV and HCV Infected Individuals
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Optimizing Vaccine Responsiveness in HIV-1 and HCV Infections by Identifying Determinants of Responsiveness A Pilot Study
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:
Infection with either HIV or hepatitis C virus HCV affects immune system responses The purpose of this study is to investigate the immune responses to two different vaccine formulations in HIV-infected HCV-infected and HCVHIV- coinfected individuals
Detailed Description:
Individuals with HCV and HIV coinfection are especially hard to treat and as a result account for a high rate of deaths each year Because HCV and HIV share transmission routes HCVHIV coinfection is common Liver disease has emerged as a significant cause of death in individuals coinfected with HCV and HIV Currently the mechanisms by which HCV and HIV interact in HCVHIV-coinfected individuals including how these infections affect immune responses are poorly understood Research suggests that vaccination may prevent other comorbidities associated with HCVHIV coinfection however responses to new vaccine antigens have been shown to be impaired in HCV or HIV-infected individuals The purpose of this study is to identify the innate and adaptive immune defects present in HCV-infected HIV-infected and HCVHIV-coinfected individuals This study will evaluate whether these innate and adaptive immune defects predict responses to HBV neoantigen in the form of both a diphtheriatetanus toxoid immunization Decavacand a hepatitis A-hepatitis B immunization Twinrix
This study will last approximately 24 weeks Participants will be stratified to one of three arms based on their HCV and HIV status
Arm A will enroll HCV-infected individuals who are HIV-uninfected
Arm B will enroll HIV-infected individuals who are HCV-uninfected
Arm C will enroll HCVHIV-coinfected individuals
Arms B and C will open for enrollment before Arm A Opening of enrollment for Arm A will be determined by the accrual progress of Arms B and C as evaluated by the ACTG Scientific Agenda Steering committee
All participants will receive Decavac vaccination on Day 0 and a Twinrix vaccination on Days 0 7 and 21 Study visits will occur around Days 0 7 and 21 and at Weeks 6 8 12 and 24 all visits will include medical and medication history blood collection and a physical exam Medication to treat HCV or HIV will not be provided by the study
This study will last approximately 24 weeks Participants will be stratified to one of three arms based on their HCV and HIV status
Arm A will enroll HCV-infected individuals who are HIV-uninfected
Arm B will enroll HIV-infected individuals who are HCV-uninfected
Arm C will enroll HCVHIV-coinfected individuals
Arms B and C will open for enrollment before Arm A Opening of enrollment for Arm A will be determined by the accrual progress of Arms B and C as evaluated by the ACTG Scientific Agenda Steering committee
All participants will receive Decavac vaccination on Day 0 and a Twinrix vaccination on Days 0 7 and 21 Study visits will occur around Days 0 7 and 21 and at Weeks 6 8 12 and 24 all visits will include medical and medication history blood collection and a physical exam Medication to treat HCV or HIV will not be provided by the study
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 |
|---|---|---|---|
| 10154 | REGISTRY | None | None |
| 1R21AI066957-01 | NIH | None | None |
| ACTG A5232 | US NIH GrantContract | DAIDS ES Registry Number | httpsreporternihgovquickSearch1R21AI066957-01 |