Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001136
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2000-01-25
Brief Title:
A Study of the Effectiveness of an HIV Vaccine ALVAC vCP205 to Boost Immune Functions in HIV-Negative Volunteers Who Have Already Received an HIV Vaccine
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multi-Centered Phase 1 Trial to Evaluate the Memory Responses to a Single Boosting Vaccination With ALVAC-HIV vCP205 in Volunteers Who Have Previously Received Poxvirus-Based Vaccines
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 see if it is safe to give an HIV vaccine vCP205 to volunteers who received an HIV vaccine at least 2 years ago and to study how the immune system responds to this vaccine
Vaccines are given to people to try to resist infection or prevent disease There are a number of different HIV vaccines that are currently being tested The vaccines that seem to be the most promising are canarypox vaccines known as ALVAC vaccines the vaccine tested in this study is ALVAC-HIV vCP205 This study will look at the safety of the vaccine and how the immune system responds to it
Vaccines are given to people to try to resist infection or prevent disease There are a number of different HIV vaccines that are currently being tested The vaccines that seem to be the most promising are canarypox vaccines known as ALVAC vaccines the vaccine tested in this study is ALVAC-HIV vCP205 This study will look at the safety of the vaccine and how the immune system responds to it
Detailed Description:
Vaccines may provide a route of therapy against HIV-1 infections by boosting the immune system responses An artificially constructed HIV-1 vaccine NYCBH using vaccinia virus as its vector has the advantage of conferring both cellular and humoral immune responses that are long-lived Studies have shown that a second artificially constructed vector vaccine HIV-1 canarypox vCP205 also increases CD8 cytotoxic T lymphocyte CTL activity a cell-mediated immune response Yet immune responses are not boosted in volunteers previously vaccinated with vaccinia-based HIV-1 vaccines when a second vaccination with the same vaccine is given One theory for vaccinia vaccines failure is that immunologic barriers by antibodies to the vector itself may be responsible This study examines the effectiveness of boosting the immune responses following vCP205 vaccination in the following 1 volunteers who were previously immunized with vCP205 vaccine who may or may not have shown increased immune responses following the first immunization and 2 volunteers who were previously immunized with NYCBH vaccine
Upon study entry volunteers receive one injection of ALVAC-HIV vCP205 Temperature and symptoms should be recorded by the volunteer each day for 2 days and reported to the clinic staff Volunteers will have seven clinic visits for drawing blood collecting urine specimens and performing clinical evaluations At Month 3 HIV testing will be done Volunteers will be followed for 3 months with a passive follow-up call at the end of a year and once or twice a year for the next 5 years Counseling on avoidance of HIV infection and pregnancy will be done
Upon study entry volunteers receive one injection of ALVAC-HIV vCP205 Temperature and symptoms should be recorded by the volunteer each day for 2 days and reported to the clinic staff Volunteers will have seven clinic visits for drawing blood collecting urine specimens and performing clinical evaluations At Month 3 HIV testing will be done Volunteers will be followed for 3 months with a passive follow-up call at the end of a year and once or twice a year for the next 5 years Counseling on avoidance of HIV infection and pregnancy will be done
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 |
|---|---|---|---|
| 10586 | REGISTRY | DAIDS ES Registry Number | None |