Search / Trial NCT00001020

A Phase I Study of the Safety and Immunogenicity of rgp120/HIV-1IIIB Vaccine in Healthy Adult Subjects (NOTE: Study Extended ONLY for Subjects Who Have Previously Received rgp120/HIV-1IIIB or rgp120/HIV-1MN on VEU 006 or VEU 006 Rollover Study)

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

Apply for Trial

Trial Information

Current as of March 02, 2024

Completed

Keywords

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

Description

Recent evidence suggests that gp120 is the HIV-1 protein with the greatest potential as a vaccine against HIV-1 infection. The gp120 envelope protein may be produced by recombinant DNA technology, and studies have shown that the vaccine is capable of eliciting neutralizing antibody activity in both rodents and nonhuman primate species. AMENDED 11/17/93: Selected subjects from VEU 006 or VEU 006 Rollover study will receive two injections of MN rgp120 vaccine, administered 28 days apart beginning 10-16 months after their last injection. Eight additional clinic visits will be required. Subjec...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Patients must have:
  • Documented HIV seronegativity.
  • Good general health.
  • No high-risk behavior for HIV infection.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Postive PPD (unless a chest x-ray is negative and there is no suggestion of active or old pulmonary tuberculosis).
  • Positive VDRL or HBsAG.
  • No febrile illness within 1 week of study.
  • Concurrent Medication:
  • Excluded:
  • Concomitant corticosteroids or other known immunosuppressive drugs.
  • Other experimental agents.
  • Patients with the following prior conditions are excluded:
  • History of clinically significant cardiac, pulmonary, hepatic, renal, neurologic, or autoimmune disease.
  • Prior Medication:
  • Excluded:
  • Other immunization within 4 weeks prior to study entry.
  • Identifiable high-risk behavior for HIV infection.

Attachments

readout_NCT00001020_2024-03-02.pdf

4.5 MB

NCT00001020_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

Philadelphia, Pennsylvania, United States

St Louis, Missouri, 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
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
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?

Discussion 0