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A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 Mcg of Env 2-3 in MF59

This study has been completed.
Study NCT00000632.   Last updated on June 23, 2005.   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

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Descriptive Information Fields
Brief Title  A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 Mcg of Env 2-3 in MF59
Official Title  A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 Mcg of Env 2-3 in MF59
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 functional antibodies in the form of increased peptide binding and development of neutralizing antibodies. Evaluation of an antigen dose having potentially greater immunogenicity is therefore of particular interest.

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. Evaluation of an antigen dose having potentially greater immunogenicity is therefore of particular interest.

Twelve healthy volunteers receive injections of 100 mcg Env 2-3 in MF59 emulsion and two volunteers receive MF59 only on days 0, 30, 180, and 365. Follow-up continues for 6 months after the last injection.

Study Phase Phase I
Study Type  Interventional
Study Design  Prevention, Randomized, Safety Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
HIV Seronegativity
Intervention  Biological: Env 2-3
MEDLINE PMIDs 9486388,   8744579
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  14
Start Date 
Completion Date
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.
Gender Both
Ages 18 Years to 50 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00000632
Organization ID AVEG 005C
Secondary IDs ††
Study Sponsor  National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators †† Biocine
Investigators 
Study Chair:     Dolin R        
Information Provided By National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date October 2002
First Received Date  November 2, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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