Status:
COMPLETED
A Phase I, Multicenter, Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived MN HIV-1 Recombinant Envelope Glycoprotein (rgp160) of Human Immunodeficiency Virus at Two Different Vaccination Schedules
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
To determine the safety and immunogenicity of 200 mcg MN rgp160 vaccine (Immuno-AG) versus placebo, administered on two immunization schedules to healthy volunteers. Per 06/15/94 amendment, to determi...
Detailed Description
A gp160 vaccine developed from the IIIB strain of HIV-1 has been found to be safe and immunogenic in healthy adults. Since the MN strain of HIV-1 is representative of a larger proportion of HIV-1 isol...
Eligibility Criteria
Inclusion Criteria
Subjects must have:
- Normal history and physical exam.
- Negative test for HIV by ELISA within 6 weeks prior to immunization.
- CD4 count >= 400 cells/mm3.
- Normal urine dipstick with esterase and nitrate.
- No history of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppresssive medications.
Exclusion Criteria
Co-existing Condition:
Subjects with the following conditions are excluded:
- Positive for hepatitis B surface antigen.
- Medical or psychiatric condition or occupational responsibilities that preclude compliance.
- Active syphilis (NOTE: If serology is documented to be a false positive or due to a remote (> 6 months) infection, subject is eligible).
- Active tuberculosis (NOTE: Subjects with a positive PPD and normal x-ray showing no evidence of TB and who do not require INH therapy are eligible).
Subjects with the following prior conditions are excluded:
- History of anaphylaxis or other serious adverse reactions to vaccines.
Prior Medication:
Excluded:
- Prior HIV vaccines.
- Live attenuated vaccines within the past 60 days. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) do not exclude but should be administered at least 2 weeks prior to HIV immunizations.
- Experimental agents within the past 30 days.
Prior Treatment:
Excluded:
- Blood products or immunoglobulin within the past 6 months.
Higher risk behavior for HIV infection as determined by screening questionnaire, including:
- History of injection drug use within 12 months prior to study entry.
- Higher or intermediate risk sexual behavior.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 1995
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00001037
End Date
May 1 1995
Last Update
November 4 2021
Active Locations (2)
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1
St. Louis Univ. School of Medicine AVEG
St Louis, Missouri, United States, 63104
2
UW - Seattle AVEG
Seattle, Washington, United States, 98144