Status:
COMPLETED
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Biocine
Conditions:
HIV Infections
HIV Seronegativity
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
To evaluate the safety and immune response of 100 mcg Env 2-3 antigen administered on days 0, 30, 180, and 365. Preliminary immunologic data from protocol VEU 005B show evidence of the development of...
Detailed Description
Preliminary immunologic data from protocol VEU 005B show evidence of the development of functional antibodies in the form of increased peptide binding and development of neutralizing antibodies. Evalu...
Eligibility Criteria
Inclusion Criteria
Subjects are:
- Normal, healthy adults (by history and physical examination) who fully comprehend the purpose and details of the study.
Exclusion Criteria
Co-existing Condition:
Subjects with the following conditions or symptoms are excluded:
- Positive syphilis serology (such as VDRL) unless positive test is due to a documented clinical event that occurred and was treated 5 or more years prior to enrollment.
- Circulating hepatitis B antigenemia.
Subjects with the following prior conditions are excluded:
- History of immunodeficiency, chronic illness, or autoimmune disease.
- Evidence of depression or under treatment for psychiatric problems during the past year.
Prior Medication:
Excluded:
- Immunosuppressive medications.
Prior Treatment:
Excluded:
- Blood transfusions or cryoprecipitates within the past 6 months.
Identifiable high-risk behavior for HIV infection, including:
- history of intravenous drug use; syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the last 6 months; more than two sexual partners, or sexual contact with a high-risk partner, in the preceding 6 months.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 1992
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00000632
End Date
May 1 1992
Last Update
November 2 2021
Active Locations (3)
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1
Univ. of Rochester AVEG
Rochester, New York, United States, 14642
2
Vanderbilt Univ. Hosp. AVEG
Nashville, Tennessee, United States, 37232
3
UW - Seattle AVEG
Seattle, Washington, United States, 981050371