A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined With MF59 in HIV-1 Uninfected Adult Volunteers

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

Keywords

ClinConnect Summary

One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant.

Healthy volunteers receive intramuscular injections of rgp120/HIV-1SF2 with MF59 adjuvant emulsion or MF59 alone at months 0, 1, 6, 9, 10 and 12 (was months 0, 1, 6 and 10, amended 12/19/96).

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Volunteers must have:
• • Normal history and physical exam.
• • HIV negativity.
• • Absolute CD4 count \>= 400 cells/mm3.
• • Normal urine dipstick with esterase and nitrite.
• • Lower risk sexual behavior.
• • Exclusion Criteria
• Co-existing Condition:
• Subjects with the following symptoms or conditions are excluded:
• • Positive hepatitis B surface antigen.
• • Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance.
• • Active syphilis. NOTE: Subjects with serology documented to be a false positive or due to a remote (\> 6 months) treated infection are eligible.
• • Active tuberculosis. NOTE: Subjects with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.
• Subjects with the following prior conditions are excluded:
• • History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
• • History of anaphylaxis or other serious adverse reactions to vaccines.
• • History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
• • Prior psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance.
• • History of cancer unless there has been surgical excision that is considered to have achieved cure.
• Prior Medication:
• Excluded:
• • Live attenuated vaccines within 60 days prior to study entry. NOTE: Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from HIV immunizations.
• • Experimental agents within 30 days prior to study entry.
• • Prior HIV vaccines.
• Prior Treatment:
• Excluded:
• • Blood products or immunoglobulin within the past 6 months.
• Identifiable high-risk behavior for HIV infection, including:
• • History of injection drug use within past 12 months.
• • Higher risk sexual behavior.