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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00075049

Enrollment

104

Registered

2004-01-01

Start date

2003-12-31

Completion date

2006-01-31

Last updated

2014-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Keywords

malaria

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.

Interventions

BIOLOGICALRTS,S with AS02A/AS01B adjuvant

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
To assess the safety and reactogenicity of the candidate vaccine	—

Secondary

Measure	Time frame
To assess the humoral immune response to the candidate vaccine	—
To assess the efficacy of the candidate vaccine	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026