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
Current as of December 07, 2023
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...
- 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:
- 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:
- 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:
- 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.
The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Nashville, Tennessee, United States
Rochester, New York, United States
Baltimore, Maryland, United States
Birmingham, Alabama, United States
All reviews come from applied patients