Status:
COMPLETED
A Phase I Safety and Immunogenicity Trial of UBI SynVac (HIV-1 MN Octameric V3 Peptide Vaccine)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
To determine the safety, immunogenicity, and optimal dose of rgp120/HIV-1MN octameric V3 peptide vaccine (SynVac) in healthy volunteers. It is likely that the ultimate control of AIDS will depend on ...
Detailed Description
It is likely that the ultimate control of AIDS will depend on the development of safe and effective vaccines against HIV-1. SynVac is a synthetic candidate vaccine based on eight V3-derived peptides a...
Eligibility Criteria
Inclusion Criteria
Subjects must have:
- Normal history and physical exam.
- Negative for HIV by ELISA within 6 weeks of immunization.
- CD4 count >= 400 cells/mm3.
- Normal urinalysis.
Exclusion Criteria
Co-existing Condition:
Subjects with the following conditions are excluded:
- Medical or psychiatric condition or occupational responsibilities that preclude compliance.
- Active syphilis (volunteers are eligible if serology is documented to be a false positive or due to a remote (> 6 months) treated infection).
- Active tuberculosis (volunteers with a positive PPD and normal chest x-ray showing no evidence of TB and not requiring INH therapy are eligible).
- Hepatitis B surface antigenemia.
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.
Prior Medication:
Excluded:
- Live attenuated vaccines within the past 60 days. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are permitted if received at least 2 weeks prior to first immunization.
- Experimental agents within the past 30 days.
- 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 the last 12 months prior to enrollment and higher or intermediate risk sexual behavior.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00000775
Last Update
June 24 2005
Active Locations (2)
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1
St Louis Univ School of Medicine
St Louis, Missouri, United States, 63104
2
Univ of Rochester Med Ctr
Rochester, New York, United States, 14642