Status:
COMPLETED
A Phase II Clinical Trial to Evaluate the Immunogenicity and Reactogenicity of the Recombinant HIV-1 Envelope Vaccines SF-2 rgp120 (CHO) [Chiron Vaccines] in MF59 Adjuvant and MN rgp120/HIV-1 [VaxGen] in Alum Adjuvant in Healthy Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Biocine
Genentech, Inc.
Conditions:
HIV Infections
Eligibility:
All Genders
16-60 years
Phase:
PHASE2
Brief Summary
To evaluate the safety and immunogenicity of SF-2 rgp120 vaccine in MF59 versus MN rgp120 vaccine in alum in volunteers who are seronegative for HIV-1. AS PER AMENDMENT 07/02/97: To determine the abil...
Detailed Description
The amino acid sequence of HIV-1 gp120 can vary as much as 40 percent from isolate to isolate. Thus, the identification of an immunogen that can elicit broadly neutralizing antibodies to HIV-1 is a ma...
Eligibility Criteria
Inclusion Criteria
Subjects must have:
- Normal history and physical exam.
- HIV negativity by ELISA.
- CD4 count >= 400 cells/mm3.
- No clinically significant medical disease.
- No history of immunodeficiency, autoimmune disease, or use of immunosuppressive medication.
- No prior HIV vaccines.
- Classification in one of the eligible risk groups defined in the Disease Status field.
Eligible higher risk groups:
- Heterosexual teenagers and young adults (ages 16-28 permitted) who have attended a clinic for sexually transmitted diseases in the last 3 months or have higher risk sexual behavior.
- Homosexually active males who are practicing higher risk behavior (ages 18-60).
- Injection drug users active within the past 3 years (ages 18-60).
- Heterosexual partners of HIV seropositive individuals (ages 18-60).
Eligible lower risk groups:
- Homosexually active males who are practicing lower risk behavior (ages 18-60).
- Adult women and heterosexual adult men practicing lower risk sexual behavior (ages 18-60).
Exclusion Criteria
Prior Medication:
Excluded:
- Prior HIV vaccines.
- Prior immunosuppressive medications.
- Experimental agents within the past 30 days.
- AS PER AMENDMENT 07/02/97: Use of systemic steroids in the past month (for volunteers undergoing DTH testing).
AS PER AMENDMENT 07/02/97:
- History of eczema or allergic-type reactions to vaccines used in protocol 201 (for volunteers undergoing DTH testing).
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 1997
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT00001031
End Date
December 1 1997
Last Update
November 4 2021
Active Locations (7)
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1
UAB AVEG
Birmingham, Alabama, United States
2
St. Louis Univ. School of Medicine AVEG
St Louis, Missouri, United States, 63104
3
Univ. of Rochester AVEG
Rochester, New York, United States, 02115
4
Univ. of Rochester ACTG CRS
Rochester, New York, United States, 14642