Completed

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

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What is being tested

RTS,S with AS02A/AS01B adjuvant

Biological
Who is being recruted

Malaria

From 18 to 45 Years
+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Phase 1
Interventional
Study Start: December 2003

See protocol details

Summary

Principal SponsorU.S. Army Medical Research and Development Command
Last updated: August 21, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2003Actual 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 
Principal SponsorU.S. Army Medical Research and Development Command
Last updated: August 21, 2014
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 45 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Malaria
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
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 ResearchSilver Spring, United StatesSee the location
CompletedOne Study Center