Status:
COMPLETED
Safety of and Immune Response to an HIV Vaccine (SF-2 gp120) With or Without MTP-PE/MF59 Adjuvant
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Biocine
Conditions:
HIV Infections
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
Part A: To compare the safety and immunogenicity of two dose levels of gp120 (CHO) in MF59 emulsion alone or with MTP-PE/MF59 adjuvant, administered at 0, 1, and 6 months. Part B: To evaluate the saf...
Detailed Description
One experimental AIDS vaccine is the gp120 vaccine. The HIV envelope glycoprotein 120 is manufactured through recombinant DNA technology and used as an immunogen. Antibodies directed against gp120 can...
Eligibility Criteria
Inclusion Criteria
Patients must have:
- Normal history and physical exam.
- No identifiable high-risk behavior for HIV infection.
- Negative ELISA for HIV.
- Normal cell-mediated immune responses using Merieux skin test.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Significant evidence of depression.
- Positive syphilis serology (e.g., RPR) that is documented not to be a false positive or from a remote (> 6 months) treated infection.
- Circulating Hepatitis B antigenemia.
- More than two sexual partners, or sexual contact with a high-risk partner, within the past 6 months.
Patients with the following prior conditions are excluded:
- History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
- Significant evidence of depression or under treatment for psychiatric problems within the past year.
- History of anaphylaxis or other adverse vaccine reactions.
- Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) within the past 6 months.
Prior Medication:
Excluded:
- Immunoglobulin or vaccines within the past 2 months.
- Experimental agents within the past 30 days.
Prior Treatment:
Excluded:
- Blood transfusions or cryoprecipitates within the past 3 months.
Risk Behavior: Excluded:
- History of IV drug use within the past year.
- More than two sexual partners, or sexual contact with a high-risk partner, within the past 6 months.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00001019
Last Update
October 30 2012
Active Locations (4)
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1
St Louis Univ School of Medicine
St Louis, Missouri, United States, 63104
2
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
3
Vanderbilt Univ Hosp
Nashville, Tennessee, United States, 37232
4
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States, 981050371