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

Tracking Information

First Received Date ^ICMJE

December 31, 2003

Last Updated Date

December 1, 2006

Start Date ^ICMJE

December 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

To assess the safety and reactogenicity of the candidate vaccine

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00075049 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To assess the humoral immune response to the candidate vaccine
To assess the efficacy of the candidate vaccine

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Dbl-Blind, Rand Phase 1/2a Human Challenge Study, to Eval Safety, Reactognty, Immunognty and Preliminary Efficacy After Sporozoite Challenge/Rechallenge of Vaccines Containing RTS,S

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.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Malaria

Intervention ^ICMJE

Biological: RTS,S with AS02A/AS01B adjuvant

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

104

Completion Date

January 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00075049

Responsible Party

Study ID Numbers ^ICMJE

WRAIR 1032, HSRRB A-12227, 257049/027

Study Sponsor ^ICMJE

U.S. Army Office of the Surgeon General

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

Principal Investigator:

Kent Kester, MD

Walter Reed Army Institute of Research (WRAIR)

Information Provided By

Walter Reed Army Institute of Research (WRAIR)

Verification Date

January 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP