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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00001031

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

296

Expected to finish

1997-12-01

Last updated by the study team

2021-11-04

Who can join

Age: 16 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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).

Where it is running

• UAB AVEG — Birmingham, Alabama, United States
• St. Louis Univ. School of Medicine AVEG — St Louis, Missouri, United States
• Univ. of Rochester AVEG — Rochester, New York, United States
• Univ. of Rochester ACTG CRS — Rochester, New York, United States
• JHU AVEG — Pittsburgh, Pennsylvania, United States
• Vanderbilt Univ. Hosp. AVEG — Nashville, Tennessee, United States
• UW - Seattle AVEG — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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