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Safety and Efficacy Study of RTS,S AS02A/AS01B Vaccine to Prevent Malaria

This study has been completed.
Walter Reed Army Institute of Research (WRAIR)
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command Identifier:
First received: December 31, 2003
Last updated: August 20, 2014
Last verified: August 2014
This is a double blinded study where 2 test vaccines will be evaluated to see if they protect persons who have never had malaria against malaria infection when bitten by mosquitoes.

Condition Intervention Phase
Biological: RTS,S with AS02A/AS01B adjuvant
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Dbl-Blind, Rand Phase 1/2a Human Challenge Study, to Eval Safety, Reactogenicity, Immunogenicity and Preliminary Efficacy After Sporozoite Challenge/Rechallenge of Vaccines Containing RTS,S

Resource links provided by NLM:

Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • To assess the safety and reactogenicity of the candidate vaccine

Secondary Outcome Measures:
  • To assess the humoral immune response to the candidate vaccine
  • To assess the efficacy of the candidate vaccine

Estimated Enrollment: 104
Study Start Date: December 2003
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Be in good general health
  • Be able to participate for 4-15 months

Exclusion Criteria:

  • Pregnant or planning pregnancy
  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00075049

United States, Maryland
Walter Reed Army Institute of Research
Silver Spring, Maryland, United States, 20910
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Walter Reed Army Institute of Research (WRAIR)
Principal Investigator: Kent Kester, MD Walter Reed Army Institute of Research (WRAIR)
  More Information