Status:
COMPLETED
A Phase II Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 With or Without HIV-1 SF-2 RGP120 in HIV-1 Uninfected Adult Volunteers
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
To expand the available data regarding the safety and immunogenicity of 2 HIV-1 vaccine strategies: canarypox vector vCP205, or vCP205 with SF-2 rgp120. \[AS PER AMENDMENT 7/2/98: To obtain immunogeni...
Detailed Description
In previous ALVAC vCP205/SF-2 rgp 120 studies, patients have developed antibodies that neutralize homologous laboratory strains; over 50% of patients have developed CD8+ cytotoxic T-lymphocyte respons...
Eligibility Criteria
Inclusion Criteria
Participants must have:
- Negative ELISA for HIV within 8 weeks of immunization.
- Normal history and physical examination.
- Availability for follow-up for planned duration of at least 24 months and willing to have 2 brief evaluations at 36 and 48 months.
Exclusion Criteria
Co-existing Condition:
Participants with the following symptoms or conditions are excluded:
- Active syphilis.
NOTE:
- AS PER AMENDMENT 6/25/97:
- Participant eligible if the serology is documented to be a false positive or due to adequately treated infection.
- Active tuberculosis (TB).
NOTE:
- Participant eligible if positive purified protein derivative and normal chest x-ray shows no evidence of TB and does not require isoniazid therapy.
Participants with the following prior conditions are excluded:
- History of immunodeficiency, chronic illness, malignancy, idiopathic anaphylaxis (AS PER AMENDMENT 6/25/97) or autoimmune disease. Participants with a history of cancer are excluded unless they have undergone surgery followed by a sufficient observation period to give a reasonable assurance of cure.
- Any history of anaphylaxis or history of other serious adverse reactions to vaccines.
- Immediate-type hypersensitivity reaction to egg products or neomycin (used to prepare ALVAC vaccines).
Prior Medication:
Excluded:
- Immunosuppressive medications.
- Live attenuated vaccines within 60 days of study.
- Use of investigational agents within 30 days prior to study.
- Prior receipt of HIV-1 vaccines or placebo recipient in a previous HIV vaccine trial.
Prior Treatment:
Excluded:
- Receipt of blood products or immunoglobulin within past 6 months.
Risk Behavior:
Excluded:
- Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol. Specifically excluded are persons with a history of suicide attempts within 3 years, recent suicidal ideation or who have past or present psychosis.
- Medically indicated subunit or killed vaccines, e.g., influenza, pneumococcal, hepatitis A and B allowed provided administered more than 2 weeks from HIV study immunizations.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
January 1 2000
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00000871
End Date
January 1 2000
Last Update
November 4 2021
Active Locations (18)
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1
UAB AVEG
Birmingham, Alabama, United States, 35294
2
Public Health Enterprises Foundation, Inc. HIVNET
San Francisco, California, United States
3
Denver Dept. of Health HIVNET
Denver, Colorado, United States
4
Denver Public Health CRS
Denver, Colorado, United States