Status:

COMPLETED

A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 MN rsgp120 and Bivalent AIDSVAX B/E (HIV-1 MN rgp120/A244 rgp120) in Combination With QS-21 With or Without Alum in Healthy HIV-1 Uninfected Adults

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Eligibility:

All Genders

18-50 years

Phase:

PHASE1

Brief Summary

To assess the safety and immune response to two experimental vaccines when formulated with QS-21 or QS-21 plus alum. To determine whether the new preparation of QS-21 in polysorbate 80 is less reactog...

Detailed Description

An effective vaccine to prevent HIV-1 infection may need to generate diverse and multifaceted immunologic responses. Required parts of the immune response may include: humoral antibodies, which broadl...

Eligibility Criteria

Inclusion Criteria

Volunteers must have:

  • Negative ELISA for HIV within 8 weeks prior to immunization.
  • CD4 count greater than or equal to 400 cells/mm3.
  • Normal history and physical examination. [Refer to Laboratory values for additional requirements.]

Exclusion Criteria

Co-existing Condition:

Volunteers with the following conditions or symptoms are excluded:

  • Medical or psychiatric conditions or occupational responsibilities which preclude subject compliance with the protocol.
  • Recent suicidal ideation or psychosis.
  • Active syphilis. NOTE: If the serology is documented to be a false positive or due to a remote (greater than 6 months) treated infection, the volunteer is eligible.
  • Active tuberculosis. NOTE: Volunteers with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring INH therapy are eligible.
  • Positive for hepatitis B surface antigen.

Volunteers with the following prior conditions are excluded:

  • History of immunodeficiency, chronic illness, or autoimmune disease.
  • History of cancer unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure.
  • History of suicide attempts, recent suicidal ideation, or past or present psychosis.
  • History of anaphylaxis or other serious adverse reactions to vaccines.
  • History of serious allergic reaction to any substance requiring hospitalization or emergency medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
  • History of reaction to thimerosal.

Prior Medication:

Excluded:

  • Live attenuated vaccine within 60 days of study. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary, but should be given at least 2 weeks away from HIV immunizations.
  • Experimental agents within 30 days prior to study.
  • HIV-1 vaccines or placebo as part of a previous HIV vaccine trial.

Prior Treatment:

Excluded:

  • Blood products or immunoglobulin in the past 6 months.
  • Experimental agents within 30 days prior to study.

Risk Behavior:

Excluded:

  • Volunteers with an identifiable higher- or intermediate-risk sexual behavior for HIV infection (i.e., AVEG Risk Groups C or D ).
  • History of intravenous drug use within 12 months prior to enrollment.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

March 1 2000

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT00001096

End Date

March 1 2000

Last Update

November 4 2021

Active Locations (4)

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Page 1 of 1 (4 locations)

1

JHU AVEG

Baltimore, Maryland, United States, 21205

2

Univ. of Rochester AVEG

Rochester, New York, United States, 14642

3

Vanderbilt Univ. Hosp. AVEG

Nashville, Tennessee, United States, 37232

4

UW - Seattle AVEG

Seattle, Washington, United States, 98104