Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-27 @ 4:23 PM
Study NCT ID:
NCT00007332
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2000-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immune Response Study of the Vaccine ALVAC vCP1452 Alone or in Combination With AIDSVAX B/B
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of a Combined Regimen Using ALVAC vCP1452 and AIDSVAX B/B
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 the vaccines tested are safe when given alone and when given together, and how the immune system responds to the vaccines.
Vaccines are given to people to try to prevent an infection or disease. Early testing in a few people has shown that the HIV vaccines ALVAC vCP1452 and AIDSVAX B/B seem to be safe to use.
Vaccines are given to people to try to prevent an infection or disease. Early testing in a few people has shown that the HIV vaccines ALVAC vCP1452 and AIDSVAX B/B seem to be safe to use.
Detailed Description:
There is no cure for HIV infection or AIDS, and drug therapy is too expensive for most affected populations. For this reason, the development of safe, effective vaccines to prevent HIV infections worldwide is needed. ALVAC vCP1452 and MN rgp120/HIV-1 have been shown to be well tolerated in Phase I and II studies. ALVAC vCP1452 given alone or in combination with subunit antigens \[AS PER AMENDMENT 10/12/00: antigen\] is a candidate vaccine to be evaluated for the ability to produce and express vaccine antigen in greater quantity for a longer time and with improved immunogenicity.
Volunteers are randomized to 1 of 7 \[AS PER AMENDMENT 10/12/00: 1 of 4\] groups and stratified by risk status. Prior to immunization, evaluations and blood draws are done to monitor hematological, chemical, and immunologic parameters. Volunteers receive 2 injections of the following vaccines at Months 0, 1, 3, and 6:
Group A: ALVAC vCP1452 and alum placebo \[AS PER AMENDMENT 10/12/00: AIDSVAX placebo (aluminum hydroxide adjuvant)\] at Months 0, 1, 3, and 6.
Group B: ALVAC vCP1452 and alum placebo \[AS PER AMENDMENT 10/12/00: AIDSVAX placebo\] at Months 0 and 1 and ALVAC vCP1452 and AIDSVAX B/B at Months 3 and 6.
Group C: ALVAC placebo and alum placebo. \[AS PER AMENDMENT 10/12/00: ALVAC vCP1452 and AIDSVAX B/B at Months 0, 1, and 6 and ALVAC vCP1452 and AIDSVAX placebo at Month 3.\] Group D: ALVAC vCP1452 and alum placebo at Months 0 and 1 and ALVAC vCP1452 and MN rgp120 at Months 3 and 6. \[AS PER AMENDMENT 10/12/00: ALVAC placebo and AIDSVAX placebo at Months 0, 1, 3, and 6.\] Group E: ALVAC vCP1452 and AIDSVAX B/B at Months 0, 1, and 6; ALVAC vCP1452 and alum placebo at Month 3. \[AS PER AMENDMENT 10/12/00: Group E has been discontinued.\] Group F: ALVAC vCP1452 and AIDSVAX B/B. \[AS PER AMENDMENT 10/12/00: Group F has been discontinued.\] Group G: ALVAC vCP1452 and alum placebo at Months 0 and 1; ALVAC vCP1452 and AIDSVAX B/E at Months 3 and 6. \[AS PER AMENDMENT 10/12/00: Group G has been discontinued.\] Following each pair of injections, volunteers are observed in the clinic for 30 minutes. Volunteers keep a record of body temperature and any other symptoms and report results to their AIDS Vaccine Evaluation Unit. Evaluations are performed by telephone or clinic visit on Days 1 and 2 after each vaccination. \[AS PER AMENDMENT 10/12/00: Volunteers record all relevant signs and symptoms occurring 48 hours after each vaccination and provide that information at each clinic visit.\] HIV testing is conducted every 3 to 6 months and volunteers are asked to complete social harms questionnaires once at Day 168 and once at the end of the study. Volunteers are followed on the study for a minimum of 18 months after the first immunization. Safety is evaluated by closely monitoring for local and systemic adverse reactions during the course of the trial.
Volunteers are randomized to 1 of 7 \[AS PER AMENDMENT 10/12/00: 1 of 4\] groups and stratified by risk status. Prior to immunization, evaluations and blood draws are done to monitor hematological, chemical, and immunologic parameters. Volunteers receive 2 injections of the following vaccines at Months 0, 1, 3, and 6:
Group A: ALVAC vCP1452 and alum placebo \[AS PER AMENDMENT 10/12/00: AIDSVAX placebo (aluminum hydroxide adjuvant)\] at Months 0, 1, 3, and 6.
Group B: ALVAC vCP1452 and alum placebo \[AS PER AMENDMENT 10/12/00: AIDSVAX placebo\] at Months 0 and 1 and ALVAC vCP1452 and AIDSVAX B/B at Months 3 and 6.
Group C: ALVAC placebo and alum placebo. \[AS PER AMENDMENT 10/12/00: ALVAC vCP1452 and AIDSVAX B/B at Months 0, 1, and 6 and ALVAC vCP1452 and AIDSVAX placebo at Month 3.\] Group D: ALVAC vCP1452 and alum placebo at Months 0 and 1 and ALVAC vCP1452 and MN rgp120 at Months 3 and 6. \[AS PER AMENDMENT 10/12/00: ALVAC placebo and AIDSVAX placebo at Months 0, 1, 3, and 6.\] Group E: ALVAC vCP1452 and AIDSVAX B/B at Months 0, 1, and 6; ALVAC vCP1452 and alum placebo at Month 3. \[AS PER AMENDMENT 10/12/00: Group E has been discontinued.\] Group F: ALVAC vCP1452 and AIDSVAX B/B. \[AS PER AMENDMENT 10/12/00: Group F has been discontinued.\] Group G: ALVAC vCP1452 and alum placebo at Months 0 and 1; ALVAC vCP1452 and AIDSVAX B/E at Months 3 and 6. \[AS PER AMENDMENT 10/12/00: Group G has been discontinued.\] Following each pair of injections, volunteers are observed in the clinic for 30 minutes. Volunteers keep a record of body temperature and any other symptoms and report results to their AIDS Vaccine Evaluation Unit. Evaluations are performed by telephone or clinic visit on Days 1 and 2 after each vaccination. \[AS PER AMENDMENT 10/12/00: Volunteers record all relevant signs and symptoms occurring 48 hours after each vaccination and provide that information at each clinic visit.\] HIV testing is conducted every 3 to 6 months and volunteers are asked to complete social harms questionnaires once at Day 168 and once at the end of the study. Volunteers are followed on the study for a minimum of 18 months after the first immunization. Safety is evaluated by closely monitoring for local and systemic adverse reactions during the course of the trial.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: