Status:
COMPLETED
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
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To evaluate the safety and immunogenicity of live recombinant canarypox ALVAC-HIV vCP205 in combination with recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) at 80 microg an...
Detailed Description
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 candi...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
October 1 1999
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00001090
End Date
October 1 1999
Last Update
November 1 2021
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
UAB AVEG
Birmingham, Alabama, United States, 35294
2
JHU AVEG
Baltimore, Maryland, United States
3
Univ. of Rochester AVEG
Rochester, New York, United States, 14642
4
Vanderbilt Univ. Hosp. AVEG
Nashville, Tennessee, United States, 37232