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

Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00075049
• Other study ID #: WRAIR 1032
• Secondary ID: HSRRB A-12227257
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 31, 2003
• Last updated: August 20, 2014
• Start date: December 2003
• Est. completion date: January 2006

Study information

• Verified date: August 2014
• Source: U.S. Army Medical Research and Materiel Command
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

Biological:
• RTS,S with AS02A/AS01B adjuvant

Locations

Country	Name	City	State
United States	Walter Reed Army Institute of Research	Silver Spring	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
U.S. Army Medical Research and Materiel Command	GlaxoSmithKline, Walter Reed Army Institute of Research (WRAIR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Stewart VA, McGrath SM, Walsh DS, Davis S, Hess AS, Ware LA, Kester KE, Cummings JF, Burge JR, Voss G, Delchambre M, Garçon N, Tang DB, Cohen JD, Heppner DG Jr. Pre-clinical evaluation of new adjuvant formulations to improve the immunogenicity of the mala — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and reactogenicity of the candidate vaccine
Secondary	To assess the humoral immune response to the candidate vaccine
Secondary	To assess the efficacy of the candidate vaccine