A Phase I Safety and Immunogenicity Trial of UBI SynVac (HIV-1 MN Octameric V3 Peptide Vaccine)
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 11, 2025
Completed
Keywords
ClinConnect Summary
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 attached to a heptalysyl core to form radial octamers. In animal studies, the vaccine appears safe and demonstrates the capability for producing immune responses.
Twelve volunteers are entered at one of three dose levels of SynVac. At each dose level, 10 volunteers receive vaccine and two receive placebo. At least eight volunteers at each dose level must be monitored for 1 week before subsequen...
Gender
ALL
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.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
St Louis, Missouri, United States
Rochester, New York, United States
Patients applied
Trial Officials
Gorse G
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials