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
Data Collection
Vector Borne Diseases+3
+ Mosquito-Borne Diseases
+ Infections
Prevention Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.104 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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
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