Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

HIV Seronegativity

Eligibility:

All Genders

18-50 years

Phase:

PHASE1

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of giving healthy volunteers a new oral HIV vaccine which has been incorporated into a bacterial cell. This oral vaccine (HIV-1 LA...

Detailed 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...

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

May 1 2000

Estimated Enrollment :

27 Patients enrolled

Trial Details

Trial ID

NCT00000868

End Date

May 1 2000

Last Update

October 28 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

JHU AVEG

Baltimore, Maryland, United States, 21205