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Home > "A" Clinical Trials Conditions > A Study of AIDSVAX B/B and AIDSVAX B/E, Two Possible Vaccines  A Study of AIDSVAX B/B and AIDSVAX B/E, Two Possible Vaccines
A Study of AIDSVAX B/B and AIDSVAX B/E, Two Possible Vaccines
For Condition: HIV Infections
Status: Completed
Sponsor(s): VaxGen ,
Synopsis: 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.
Details: 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).
Eligibility:
Study Type: Interventional, Prevention, Dose Comparison, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Patients must: Be HIV-uninfected men and women at low or intermediate risk for HIV-1 infection.
Total Enrollment: 120
Location and Contact Information:
Saint Louis Univ Health Sciences Ctr
St. Louis, Missouri, 63110
United States
Dr Frank Judson / Director of Public Health Dept
Denver, Colorado, 80204
United States
Fenway Community Health Ctr
Boston, Massachusetts, 02115
United States
Johns Hopkins Bloomberg School of Public Health
Washington D.C., District of Columbia, 20037
United States
Additional Information:
Study ID Numbers: VAX 002;
Study Start Date:
Record last reviewed: August 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002402
Other Hiv Infections Studies:
1. A Study of 141W94 Used Alone or in Combination with Zidovudine Plus 3TC in HIV-Infected Patients
2. A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women.
3. T-20 with Anti-HIV Combination Therapy for Patients with Prior Anti-HIV Drug Treatment and/or Drug Resistance to Each of the Three Classes of Approved Anti-HIV Drugs
4. BufferGel and PRO 2000/5: Vaginal Gels to Prevent HIV Infection in Women
5. An Open-Label Study to Evaluate the Efficacy and Safety of Amprenavir (141W94) and Abacavir Combination Therapy in Protease Inhibitor Experienced Subjects with HIV-1 Infection Who Are Failing Their Current Antiretroviral Treatment Regimen
Related Studies:
Other HIV Infections Clinical Trials
Other Missouri Clinical Trials
Other St. Louis Clinical Trials
A Study of AIDSVAX B/B and AIDSVAX B/E, Two Possible Vaccines
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