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

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT00001031
Collaborator
Biocine (Industry), Genentech, Inc. (Industry)
296
7
42.3

Study Details

Study Description

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 ability of immunization with MN rgp120/HIV-1 in combination with alum or SF-2 rgp120 in combination with MF59 to induce an HIV-1 envelope-specific delayed-type hypersensitivity (DTH) response in volunteers who receive rsgp120/MN skin testing.

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 major challenge in AIDS vaccine development. Two candidate vaccines, recombinant envelope subunit proteins from the SF-2 and MN isolates of HIV-1, have shown immunogenicity and good tolerance in healthy immunocompetent adults. This study will expand testing into a larger population base, particularly targeting individuals at high risk for HIV infection.

Condition or Disease Intervention/Treatment Phase
  • Biological: rgp120/HIV-1MN
  • Biological: rgp120/HIV-1 SF-2
Phase 2

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 major challenge in AIDS vaccine development. Two candidate vaccines, recombinant envelope subunit proteins from the SF-2 and MN isolates of HIV-1, have shown immunogenicity and good tolerance in healthy immunocompetent adults. This study will expand testing into a larger population base, particularly targeting individuals at high risk for HIV infection.

HIV-seronegative volunteers (including four populations at higher risk for HIV infection and two populations at lower risk) receive one of four regimens. Two treatment groups receive 50 mcg SF-2 rgp 120 (BIOCINE) in MF59 adjuvant or 600 mcg MN rgp120 (Genentech) in alum. Two control groups receive vehicle (placebo) in MF59 adjuvant alone or alum adjuvant alone. Immunizations are given at months 0, 1, and 6. AS PER AMENDMENT 10/93: patients enrolled by June 15, 1993, receive a fourth immunization at month 12 or 18 (50 percent of patients for each schedule). Patients are followed until 2 years after the first injection. AS PER AMENDMENT 05/10/94: a special study of vaccine acceptability and HIV-related risk behavior will be conducted at some time between months 12 and 18. AS PER AMENDMENT 07/02/97: a special DTH study will be conducted in consenting volunteers who have received three or four immunizations. The injections will be given at the end of the study (on or after day 1, & 56). Followup is extended to 56 days after administration of the intradermal injection.

Study Design

Study Type:
Interventional
Actual Enrollment :
296 participants
Masking:
Double
Primary Purpose:
Prevention
Official Title:
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
Actual Study Completion Date :
Dec 1, 1997

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UAB AVEG Birmingham Alabama United States
    2 St. Louis Univ. School of Medicine AVEG Saint 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
    5 JHU AVEG Pittsburgh Pennsylvania United States
    6 Vanderbilt Univ. Hosp. AVEG Nashville Tennessee United States 37232
    7 UW - Seattle AVEG Seattle Washington United States 98195

    Sponsors and Collaborators

    • National Institute of Allergy and Infectious Diseases (NIAID)
    • Biocine
    • Genentech, Inc.

    Investigators

    • Study Chair: Corey L,
    • Study Chair: McElrath J,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov Identifier:
    NCT00001031
    Other Study ID Numbers:
    • AVEG 201
    • 10588
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Nov 4, 2021
    Last Verified:
    Oct 1, 2021
    Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 4, 2021