Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2003-08-31
Brief Summary
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Detailed Description
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All participants in this study will receive vaccine injections in the upper arm muscle. Participants will receive a second vaccine injection eight weeks after the first injection. Blood tests will be performed at study visits before the vaccine is given, during the eight weeks between injections, and at selected times for up to three years after the vaccine is given.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Interventions
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EnvPro
Eligibility Criteria
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Inclusion Criteria
* Normal medical history and physical exam
* Normal complete blood count
* Normal liver function
* Normal renal function
* Normal serum creatine phosphokinase (CPK)
* Availability for at least 1 year follow-up
Exclusion Criteria
* Medical or psychiatric condition or occupational responsibilities which preclude compliance with the study
* Live attenuated vaccines within 60 days of study entry
* Use of experimental agents within 30 days of study entry
18 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Karen Slobod, MD
Role: PRINCIPAL_INVESTIGATOR
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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References
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Slobod KS, Lockey TD, Howlett N, Srinivas RV, Rencher SD, Freiden PJ, Doherty PC, Hurwitz JL. Subcutaneous administration of a recombinant vaccinia virus vaccine expressing multiple envelopes of HIV-1. Eur J Clin Microbiol Infect Dis. 2004 Feb;23(2):106-10. doi: 10.1007/s10096-003-1075-3. Epub 2004 Jan 20.
Brown SA, Stambas J, Zhan X, Slobod KS, Coleclough C, Zirkel A, Surman S, White SW, Doherty PC, Hurwitz JL. Clustering of Th cell epitopes on exposed regions of HIV envelope despite defects in antibody activity. J Immunol. 2003 Oct 15;171(8):4140-8. doi: 10.4049/jimmunol.171.8.4140.
Zhan X, Slobod KS, Surman S, Brown SA, Lockey TD, Coleclough C, Doherty PC, Hurwitz JL. Limited breadth of a T-helper cell response to a human immunodeficiency virus envelope protein. J Virol. 2003 Apr;77(7):4231-6. doi: 10.1128/jvi.77.7.4231-4236.2003.
Related Links
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Click here for more information about the EnvPro study.
Other Identifiers
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EnvPro
Identifier Type: -
Identifier Source: secondary_id