Status:
COMPLETED
A Phase I Multicenter Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Protein Sciences Corporation
Conditions:
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
To evaluate the safety and immune response to 160 mcg HIV-1 recombinant envelope glycoprotein gp160. To evaluate the duration of antibody response and its relationship to dose and frequency of inocula...
Detailed Description
Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicate that, although serum anti-gp160 antibody responses were detected, the level and duration of those responses we...
Eligibility Criteria
Inclusion Criteria
Subjects must have:
- Normal history and physical exam.
- Negative for HIV infection by ELISA and Western blot (i.e., no reactivity at gp160, gp120, gp41, or p24).
- T4 count >= 800 cells/mm3.
- Normal chest x-ray and urinalysis.
- Negative hepatitis B surface antigen.
- Negative HIV p24 antigen test.
- Normal skin reactivity by Merieux test.
Exclusion Criteria
Co-existing Condition:
Subjects with the following symptoms or conditions are excluded:
- Positive PPD.
- Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease).
Subjects with the following prior conditions are excluded:
- History of immunodeficiency, chronic illness, or use of immunosuppressive medications.
- Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.
Prior Treatment:
Excluded:
- Prior blood transfusions or cryoprecipitates within the past 6 months.
Identifiable high-risk behavior for HIV infection (as determined by prescreening questions designed to identify risk factors for HIV infection), including:
- Any history of IV drug use.
- Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.
- More than two sexual partners, or sexual contact with a high-risk partner, in the past 6 months.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
October 1 1992
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00000757
End Date
October 1 1992
Last Update
November 4 2021
Active Locations (1)
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1
St. Louis Univ. School of Medicine AVEG
St Louis, Missouri, United States, 63104