Status:
COMPLETED
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 Mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months
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
To evaluate in healthy volunteers the safety and immune response to 200 mcg gp120 candidate vaccine in MF59 emulsion without MTP-PE at 0, 1 and 6 months. Preliminary evaluations of two dose levels of...
Detailed Description
Preliminary evaluations of two dose levels of gp120 administered to volunteers in protocol VEU 007A indicate that a gp120 dose of potentially greater immunogenicity may be of interest. Ten healthy vo...
Eligibility Criteria
Inclusion Criteria
Subjects must have:
- Normal history and physical exam.
- Negative ELISA for HIV.
- Normal cell-mediated immune responses using Merieux skin test.
- Normal urinalysis.
Exclusion Criteria
Co-existing Condition:
Subjects with the following conditions are excluded:
- Evidence of psychological or psychiatric problems that may lead to noncompliance with study requirements.
- Positive syphilis serology. If serology is documented as a false positive or is due to a remote (> 6 months) treated infection, subject is eligible.
- Circulating hepatitis B surface antigen.
Subjects with the following prior conditions are excluded:
- History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
- History of anaphylaxis or other adverse reactions to vaccines.
Prior Medication:
Excluded:
- Prior HIV vaccines.
- Immunoglobulins or vaccines within the past 3 months.
- Experimental agents within the past 30 days.
Prior Treatment:
Excluded:
- Blood transfusions or cryoprecipitates within the past 3 months.
Identifiable high-risk behavior for HIV infection, including:
- Any history of intravenous (IV) drug use within the past year.
- 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 :
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00000749
Last Update
October 30 2012
Active Locations (2)
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1
Vanderbilt Univ Hosp
Nashville, Tennessee, United States, 37232
2
Univ of Washington / Pacific Med Ctr
Seattle, Washington, United States, 98144