Back to resultsA Study of AIDSVAX B/B and AIDSVAX B/E, Two Possible Vaccines
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
MN rgp120/HIV-1 and A244 rgp120/HIV-1
Aluminum hydroxide
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV-1, Dose-Response Relationship, Drug, Acquired Immunodeficiency Syndrome, AIDS Vaccines, HIV Seronegativity, Antigens, Viral, Alum Compounds
Eligibility Criteria
Patients must: Be HIV-uninfected men and women at low or intermediate risk for HIV-1 infection.
Sites / Locations
- Dr Frank Judson / Director of Public Health Dept
- Johns Hopkins Bloomberg School of Public Health
- Fenway Community Health Ctr
- Saint Louis Univ Health Sciences Ctr
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002402
Brief Title
A Study of AIDSVAX B/B and AIDSVAX B/E, Two Possible Vaccines
Official Title
Phase I/II Trial to Evaluate the Safety and Immunogenicity of AIDSVAX B/B and B/E Vaccines in the United States
Study Type
Interventional
2. Study Status
Record Verification Date
August 1998
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
VaxGen
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to see if it is safe and effective to give AIDSVAX B/B or AIDSVAX B/E, two potential HIV vaccines, to HIV-negative volunteers.
Detailed Description
Patients are randomized to 1 of the 2 following arms and administered 1 or 2 injections into the deltoid muscle at 0, 1, 6, and 12 months:
Arm A: Patients receive 1 of 3 doses of AIDSVAX B/B vaccine (MN rgp120/HIV-1 plus GNE8 rgp120/HIV-1) in alum adjuvant.
Arm B: Patients receive AIDSVAX B/E (MN rgp120/HIV-1 plus A244 rgp120/HIV-1) vaccine in alum adjuvant.
Patients are evaluated at 1 hr, 3 days, and 14 days after each immunization and at 18 months after the first immunization.
An interim analysis is performed after all patients receive the second dose (at 1 month).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Dose-Response Relationship, Drug, Acquired Immunodeficiency Syndrome, AIDS Vaccines, HIV Seronegativity, Antigens, Viral, Alum Compounds
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
Intervention Type
Biological
Intervention Name(s)
MN rgp120/HIV-1 and A244 rgp120/HIV-1
Intervention Type
Biological
Intervention Name(s)
Aluminum hydroxide
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Patients must:
Be HIV-uninfected men and women at low or intermediate risk for HIV-1 infection.
Facility Information:
Facility Name
Dr Frank Judson / Director of Public Health Dept
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Johns Hopkins Bloomberg School of Public Health
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Fenway Community Health Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Saint Louis Univ Health Sciences Ctr
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Mayer K, Judson F, Gorse G, Harro C, Peterson M, Zaharias E, Good J, Shibata R, Lee S, Eastman D, Chernow M, Francis D, Berman P. A phase I/II trial to evaluate the safety and immunogenicity of the AIDSVAX B/B vaccine in the United States (final report). 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 178)
Results Reference
background
Learn more about this trial
A Study of AIDSVAX B/B and AIDSVAX B/E, Two Possible Vaccines
We'll reach out to this number within 24 hrs