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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Biocine Genentech |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001031 |
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 | Intervention | Phase |
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HIV Infections |
Biological: rgp120/HIV-1MN Biological: rgp120/HIV-1 SF-2 |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Double-Blind, Safety Study |
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 |
Estimated Enrollment: | 330 |
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.
Ages Eligible for Study: | 16 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Subjects must have:
Eligible higher risk groups:
Eligible lower risk groups:
Exclusion Criteria
Prior Medication:
Excluded:
AS PER AMENDMENT 07/02/97:
United States, Maryland | |
Johns Hopkins Univ / Ctr for Immunological Research | |
Baltimore, Maryland, United States, 21205 | |
United States, Missouri | |
St Louis Univ School of Medicine | |
St. Louis, Missouri, United States, 63104 | |
United States, New York | |
Univ of Rochester Med Ctr | |
Rochester, New York, United States, 14642 | |
United States, Tennessee | |
Vanderbilt Univ Hosp | |
Nashville, Tennessee, United States, 37232 | |
United States, Washington | |
Univ of Washington Med Ctr | |
Seattle, Washington, United States, 98195 | |
Univ of Washington / Pacific Med Ctr | |
Seattle, Washington, United States, 98144 |
Study Chair: | Corey L | |
Study Chair: | McElrath J |
Study ID Numbers: | AVEG 201 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00001031 |
Health Authority: | United States: Federal Government |
Vaccines, Synthetic HIV-1 HIV Envelope Protein gp120 |
AIDS Vaccines HIV Seronegativity HIV Preventive Vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral Aluminum sulfate HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Healthy Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |