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OpenTrials
Completed

NCT Number: NCT00075049

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

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.

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Walter Reed Army Institute of Research

Silver Spring, Maryland, 20910, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RTS,S with AS02A/AS01B adjuvant

Biological

Primary outcomes

  1. To assess the safety and reactogenicity of the candidate vaccine

Secondary outcomes

  1. To assess the humoral immune response to the candidate vaccine

  2. To assess the efficacy of the candidate vaccine

Sponsors and collaborators

Lead sponsor

U.S. Army Medical Research and Development Command

Fed

Collaborators

  • GlaxoSmithKline
  • Walter Reed Army Institute of Research (WRAIR)

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Jan 1, 2004
Registry last updated
Aug 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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