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

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Walter Reed Army Institute of Research (WRAIR)
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00075049
First received: December 31, 2003
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00075049     History of Changes
Other Study ID Numbers: WRAIR 1032, HSRRB A-12227, 257049/027
Study First Received: December 31, 2003
Last Updated: February 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by U.S. Army Medical Research and Materiel Command:
malaria

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on July 22, 2014