NCT00075049

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2003

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 31, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 1, 2004

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

August 21, 2014

Status Verified

August 1, 2014

Enrollment Period

2.1 years

First QC Date

December 31, 2003

Last Update Submit

August 20, 2014

Conditions

Malaria

Keywords

malaria

Outcome Measures

Primary Outcomes (1)

  • To assess the safety and reactogenicity of the candidate vaccine

Secondary Outcomes (2)

  • To assess the humoral immune response to the candidate vaccine

  • To assess the efficacy of the candidate vaccine

Interventions

RTS,S with AS02A/AS01B adjuvantBIOLOGICAL

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Be in good general health
  • Be able to participate for 4-15 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed Army Institute of Research

Silver Spring, Maryland, 20910, United States

Location

Related Publications (3)

  • 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.

    PMID: 16904798RESULT

  • 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.

    PMID: 32236404DERIVED

  • 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.

    PMID: 19569965DERIVED

MeSH Terms

Conditions

Malaria

Interventions

AS01B adjuvant

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Kent Kester, MD

    Walter Reed Army Institute of Research (WRAIR)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2003

First Posted

January 1, 2004

Study Start

December 1, 2003

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

August 21, 2014

Record last verified: 2014-08

Locations

US(1)