Safety and Efficacy Study of RTS,S AS02A/AS01B Vaccine to Prevent Malaria
NCT ID: NCT00075049
Last Updated: 2014-08-21
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/PHASE2
104 participants
INTERVENTIONAL
2003-12-31
2006-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
DOUBLE
Interventions
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RTS,S with AS02A/AS01B adjuvant
Eligibility Criteria
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Inclusion Criteria
* Be able to participate for 4-15 months
Exclusion Criteria
* History of malaria or exposure to malaria in past 12 months
* Received an investigational malaria vaccine
* Past history of allergic reaction to previous immunization
* Positive blood tests for HIV and specific types of hepatitis
18 Years
45 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Walter Reed Army Institute of Research (WRAIR)
FED
U.S. Army Medical Research and Development Command
FED
Responsible Party
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Principal Investigators
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Kent Kester, MD
Role: PRINCIPAL_INVESTIGATOR
Walter Reed Army Institute of Research (WRAIR)
Locations
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Walter Reed Army Institute of Research
Silver Spring, Maryland, United States
Countries
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References
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Stewart VA, McGrath SM, Walsh DS, Davis S, Hess AS, Ware LA, Kester KE, Cummings JF, Burge JR, Voss G, Delchambre M, Garcon N, Tang DB, Cohen JD, Heppner DG Jr. Pre-clinical evaluation of new adjuvant formulations to improve the immunogenicity of the malaria vaccine RTS,S/AS02A. Vaccine. 2006 Oct 30;24(42-43):6483-92. doi: 10.1016/j.vaccine.2006.06.033. Epub 2006 Jul 3.
Kurtovic L, Atre T, Feng G, Wines BD, Chan JA, Boyle MJ, Drew DR, Hogarth PM, Fowkes FJI, Bergmann-Leitner ES, Beeson JG. Multifunctional Antibodies Are Induced by the RTS,S Malaria Vaccine and Associated With Protection in a Phase 1/2a Trial. J Infect Dis. 2021 Oct 13;224(7):1128-1138. doi: 10.1093/infdis/jiaa144.
Kester KE, Cummings JF, Ofori-Anyinam O, Ockenhouse CF, Krzych U, Moris P, Schwenk R, Nielsen RA, Debebe Z, Pinelis E, Juompan L, Williams J, Dowler M, Stewart VA, Wirtz RA, Dubois MC, Lievens M, Cohen J, Ballou WR, Heppner DG Jr; RTS,S Vaccine Evaluation Group. Randomized, double-blind, phase 2a trial of falciparum malaria vaccines RTS,S/AS01B and RTS,S/AS02A in malaria-naive adults: safety, efficacy, and immunologic associates of protection. J Infect Dis. 2009 Aug 1;200(3):337-46. doi: 10.1086/600120.
Other Identifiers
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HSRRB A-12227
Identifier Type: -
Identifier Source: secondary_id
257049/027
Identifier Type: -
Identifier Source: secondary_id
WRAIR 1032
Identifier Type: -
Identifier Source: org_study_id
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