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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Page 1 of 2 (7 locations)

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