Completed

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

What is being tested

Data Collection

Who is being recruted

Vector Borne Diseases+3

+ Mosquito-Borne Diseases

+ Infections

From 18 to 45 Years

+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Phase 1 & 2

Interventional

Study Start: December 2003

See protocol details

Summary

Principal SponsorU.S. Army Medical Research and Development Command

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitleDbl-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

NCT00075049

Principal SponsorU.S. Army Medical Research and Development Command

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

104 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Vector Borne DiseasesMosquito-Borne DiseasesInfectionsMalariaParasitic DiseasesProtozoan Infections

Criteria

2 inclusion criteria required to participate

Be in good general health

Be able to participate for 4-15 months

5 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Walter Reed Army Institute of Research

Silver Spring, United StatesOpen Walter Reed Army Institute of Research in Google Maps

CompletedOne Study Center