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

Primary Purpose

Malaria

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RTS,S with AS02A/AS01B adjuvant
Sponsored by
U.S. Army Medical Research and Development Command
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria focused on measuring malaria

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Walter Reed Army Institute of Research

Outcomes

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

Full Information

First Posted
December 31, 2003
Last Updated
August 20, 2014
Sponsor
U.S. Army Medical Research and Development Command
Collaborators
GlaxoSmithKline, Walter Reed Army Institute of Research (WRAIR)
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1. Study Identification

Unique Protocol Identification Number
NCT00075049
Brief Title
Safety and Efficacy Study of RTS,S AS02A/AS01B Vaccine to Prevent Malaria
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 Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
U.S. Army Medical Research and Development Command
Collaborators
GlaxoSmithKline, Walter Reed Army Institute of Research (WRAIR)

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
malaria

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
104 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
RTS,S with AS02A/AS01B adjuvant
Primary Outcome Measure Information:
Title
To assess the safety and reactogenicity of the candidate vaccine
Secondary Outcome Measure Information:
Title
To assess the humoral immune response to the candidate vaccine
Title
To assess the efficacy of the candidate vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kent Kester, MD
Organizational Affiliation
Walter Reed Army Institute of Research (WRAIR)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed Army Institute of Research
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16904798
Citation
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. doi: 10.1016/j.vaccine.2006.06.033. Epub 2006 Jul 3.
Results Reference
result
PubMed Identifier
32236404
Citation
Kurtovic L, Atre T, Feng G, Wines BD, Chan JA, Boyle MJ, Drew DR, Hogarth PM, Fowkes FJI, Bergmann-Leitner ES, Beeson JG. Multifunctional Antibodies Are Induced by the RTS,S Malaria Vaccine and Associated With Protection in a Phase 1/2a Trial. J Infect Dis. 2021 Oct 13;224(7):1128-1138. doi: 10.1093/infdis/jiaa144.
Results Reference
derived
PubMed Identifier
19569965
Citation
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. doi: 10.1086/600120.
Results Reference
derived

Learn more about this trial

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

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