A Phase I Safety and Immunogenicity Trial of UBI SynVac (HIV-1 MN Octameric V3 Peptide Vaccine)

NCT00000775 | Completed Phase 1

• 1 other identifier: AVEG 011
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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 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.

Conditions

HIV Infections

Keywords

Vaccines, Synthetic; HIV-1; HIV Envelope Protein gp120; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine

Interventions

rgp120/HIV-1MN Monovalent Octameric V3 Peptide Vaccine BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

St Louis Univ School of Medicine

St Louis, Missouri, 63104, United States

Location

Univ of Rochester Med Ctr

Rochester, New York, 14642, United States

Location

Related Publications (1)

• Gorse GJ, Keefer MC, Belshe RB, Matthews TJ, Forrest BD, Hsieh RH, Koff WC, Hanson CV, Dolin R, Weinhold KJ, Frey SE, Ketter N, Fast PE. A dose-ranging study of a prototype synthetic HIV-1MN V3 branched peptide vaccine. The National Institute of Allergy and Infectious Diseases AIDS Vaccine Evaluation Group. J Infect Dis. 1996 Feb;173(2):330-9. doi: 10.1093/infdis/173.2.330.

  PMID: 8568293 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Gorse G

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 2002-10

Locations

US (2)