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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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 fou...

Gender

ALL

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).

Trial Officials