Search / Trial NCT00000868

A Study to Evaluate the Safety and Effectiveness of HIV-1 LAI gp120 (an HIV Vaccine) Given With or Without HIV-1 MN rgp120 (Another HIV Vaccine) to HIV-Negative Volunteers

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

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Trial Information

Current as of May 23, 2024

Completed

Keywords

Vaccines, Synthetic Hiv 1 Administration, Oral Aids Vaccines Hiv Seronegativity Hiv Envelope Protein Gp120 Recombination, Genetic Salmonella Typhi Hiv Preventive Vaccine

Description

Although recent advances have been made in antiviral therapy for AIDS, there is no cure for HIV-1 infection or AIDS, and drug therapy is too expensive for most affected populations. The development of safe, effective vaccines to prevent HIV-1 infection and AIDS worldwide is a global priority. One promising approach in the development of HIV-1 vaccines utilizes live vaccines as vectors to express HIV-1 antigens. The potential advantages of the live vector approach include the ability of live vector recombinants to induce long-lasting humoral and cell-mediated immunity (particularly neutraliz...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • You may be eligible for this study if you:
  • Are 18-50 years old.
  • Are HIV-negative.
  • Are healthy and have a normal history and physical exam.
  • Agree to practice abstinence or use of effective birth control for 1 month before and during the study.
  • Exclusion Criteria
  • You will not be eligible for this study if you:
  • Have a history of immune deficiency, chronic illness, or autoimmune disease.
  • Have received immunosuppressive medications, blood products, trial drugs, immunoglobulins, or an HIV or typhoid vaccine.
  • Have a history of severe allergic reactions.
  • Have had prior suicidal attempts or have a psychiatric condition or job commitments which would prevent you from completing the study.
  • Have a history of cancer (unless the cancer has been successfully cured), gallbladder disease, typhoid fever, migraines or other severe headaches, cardiac valve defects, or congenital heart disease.
  • Have active syphilis or tuberculosis.
  • Are allergic to certain medications.
  • Are pregnant or breast-feeding.
  • Have household contact with infants or persons who are pregnant, immunodeficient, or HIV-positive.
  • Are unavailable for 12 months of follow-up.
  • Have hepatitis B.
  • Have a history of injection drug use within 12 months of enrollment or have higher or intermediate risk sexual behavior.

Attachments

readout_NCT00000868_2024-05-23.pdf

4.5 MB

NCT00000868_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

Baltimore, Maryland, 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
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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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