Search / Trial NCT00000775

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

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Vaccines, Synthetic Hiv 1 Hiv Envelope Protein Gp120 Aids Vaccines Hiv Seronegativity Hiv Preventive Vaccine

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 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.

Attachments

readout_NCT00000775_2023-12-10.pdf

4.5 MB

NCT00000775_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

St Louis, Missouri, United States

Rochester, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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