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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00075049
Recruitment Status : Completed
First Posted : January 1, 2004
Last Update Posted : August 21, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Malaria Biological: RTS,S with AS02A/AS01B adjuvant Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
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
Study Start Date : December 2003
Primary Completion Date : January 2006
Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  1. To assess the humoral immune response to the candidate vaccine
  2. To assess the efficacy of the candidate vaccine

Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00075049


Locations
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
GlaxoSmithKline
Walter Reed Army Institute of Research (WRAIR)
Investigators
Principal Investigator: Kent Kester, MD Walter Reed Army Institute of Research (WRAIR)
More Information