Safety and Efficacy Study of RTS,S AS02A/AS01B Vaccine to Prevent Malaria - Full Text View

Sponsor:	U.S. Army Medical Research and Materiel Command
Collaborators:	GlaxoSmithKline Walter Reed Army Institute of Research (WRAIR)
Information provided by:	U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:	NCT00075049

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 I Phase II

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:

MedlinePlus related topics: Malaria

U.S. FDA Resources

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

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:

Clinical Trials Center website This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2006 Jul 3.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Robert E. Miller, PhD, Sponsor Representative, Director of Regulated Activities and Compliance, USAMRMC, USAMMDA
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:	September 30, 2011
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 February 12, 2012