A Multicenter, Randomized, Placebo-Controlled, Double-Blinded, Phase I Trial to Evaluate the Safety and Immunogenicity of Live Recombinant Canarypox ALVAC-HIV vCP205 Combined With GM-CSF in Healthy, HIV-1 Uninfected Volunteers

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

Keywords

ClinConnect Summary

ALVAC-HIV candidate vaccines have induced HIV-specific CTL responses in more than half of recipients in some protocols. Depending on the HIV-1 gene products expressed by the particular ALVAC-HIV candidate vaccine, volunteers have generated anti-Envelope (vCP125, vCP205, and vCP300), anti-Gag (vCP205 and vCP300), and anti-Nef (vCP300) CTL activity. Although 3 to 4 immunizations with the different ALVAC-HIV experimental vaccines induce anti-HIV-1 neutralizing antibodies in a portion, often the majority, of volunteers, the geometric mean titers of these antibodies are modest, usually less than...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Volunteers must have:
• • Negative ELISA for HIV within 8 weeks prior to immunization.
• • CD4 count of 400 cells/mm3 or higher.
• • Normal history and physical examination.
• * Viable EBV line prior to initial immunization. \[AS PER AMENDMENT 4/30/99:
• • Negative anti-dsDNA antibodies (for volunteers receiving booster vaccine).\]
• • Exclusion Criteria
• Co-existing Condition:
• Volunteers with the following conditions or symptoms are excluded:
• • Medical or psychiatric condition or occupational responsibilities that preclude compliance with the protocol.
• • Recent suicidal ideation or psychosis.
• * Active syphilis. NOTE:
• • If the serology is documented to be a false positive or due to a remote (greater than 6 months) treated infection, the volunteer is eligible.
• * Active tuberculosis. NOTE:
• • Volunteers who have a positive PPD and a normal chest x-ray showing no evidence of TB and who do not require INH therapy are eligible.
• • Positive for hepatitis C antibody or hepatitis B surface antigen.
• * Allergy to eggs, neomycin, or thimerosal. \[AS PER AMENDMENT 4/30/99:
• • Hypersensitivity to bupivacaine or other amide-type anesthetics (e.g., lidocaine, mepivacaine) for volunteers receiving booster vaccine).\]
• Concurrent Medication:
• Excluded:
• • Lithium or cimetidine.
• Volunteers with the following prior conditions are excluded:
• • History of immunodeficiency, chronic illness, or autoimmune disease.
• • History of cancer unless there has been surgical excision with reasonable assurance of cure.
• • History of suicide attempts or past psychosis.
• • History of anaphylaxis or other serious adverse reactions to vaccines.
• • History of serious allergic reaction to any substance requiring hospitalization or emergent care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
• \[AS PER AMENDMENT 11/13/97:
• • History of cardiac disease or cardiac arrhythmias.\]
• Prior Medication:
• Excluded:
• * Live attenuated vaccines within 60 days of study. NOTE:
• • Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary, but should be given at least 2 weeks away from HIV immunizations.
• • Experimental agents within 30 days prior to study.
• • Blood products or immunoglobulin in the past 6 months.
• • HIV-1 vaccines or placebo as part of a previous HIV vaccine trial.
• • Immunosuppressive medications.
• Risk Behavior:
• Excluded:
• • Volunteers with an identifiable higher-risk behavior for HIV infection (i.e., AVEG Risk Group C or D), including a history of injection drug use within 12 months prior to enrollment or higher-risk sexual behavior as defined by the AVEG.

Trial Officials