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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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