Clinical trial NCT00000775: A Phase I Safety and Immunogenicity Trial of UBI SynVac (HIV-1 MN Octameric V3 Peptide Vaccine)
Official title: A Phase I Safety and Immunogenicity Trial of UBI SynVac (HIV-1 MN Octameric V3 Peptide Vaccine)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Vaccines, Synthetic
HIV-1
HIV Envelope Protein gp120
AIDS Vaccines
HIV Seronegativity
HIV Preventive Vaccine
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: PREVENTION

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.

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 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 subsequent volunteers are entered at the next higher level. Intramuscular injections are given on day 0, 28, and 168. Approximately 12 clinic visits are required.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St Louis
country: United States
facility: St Louis Univ School of Medicine
state: Missouri
city: Rochester
country: United States
facility: Univ of Rochester Med Ctr
state: New York
Study officials:
name: Gorse G
role: STUDY_CHAIR
References:
citation: 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.