Search / Trial NCT00000631

A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination With Soluble Recombinant Envelope Vaccine (VaxSyn)

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of March 02, 2024

Completed

Keywords

Vaccines, Synthetic Vaccinia Virus Viral Envelope Proteins Viral Vaccines Aids Vaccines Hiv Seronegativity Hiv Preventive Vaccine

Description

Recent Phase I trials conducted at the AIDS Vaccine Units have shown that antibodies have persisted in most recipients for 6 months after boosting, and responses seem significantly higher and more persistent than responses achieved by just two doses of soluble protein vaccine alone or two doses of HIVAC-1e alone. This study tests in a previously recruited cohort of volunteers whether additional boosting with soluble recombinant gp160 results in increased immunogenicity of longer duration. Twelve volunteers who have previously received two doses of HIVAC-1e (or DryVax) and two doses of gp16...

Gender

Male

Eligibility criteria

  • Inclusion Criteria
  • Patients must have:
  • Normal history and physical exam.
  • Negative ELISA for HIV.
  • Negative HIV p24 antigen test.
  • Normal urinalysis.
  • Prior Medication: Required:
  • Two prior doses of HIVAC-1e (or DryVax) and two prior doses of gp160 vaccine.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms and conditions are excluded:
  • Risk factors for HIV infection including active intravenous drug use and more than 2 sexual partners.
  • History of immunodeficiency or chronic illness.
  • Hypersensitivity to insects.
  • Medical or psychiatric condition that makes it unlikely the patient will comply with the protocol.
  • Patients with the following prior conditions are excluded:
  • History of immunodeficiency or chronic illness.
  • Prior Medication:
  • Excluded:
  • Immunosuppressive medications.
  • Prior Treatment:
  • Excluded:
  • Blood or blood product transfusion within the past 6 months.
  • Risk Behavior: Excluded:
  • Intravenous drug use.
  • More than 2 sexual partners.

Attachments

readout_NCT00000631_2024-03-02.pdf

4.5 MB

NCT00000631_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

Seattle, Washington, 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

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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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