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Clinical Trial 11624

Silver Spring, MD 20910

Study Summary:

This study is being conducted to evaluate the safety and effectiveness of an experimental malaria vaccine. This new vaccine is made up of a combination of two vaccines to prevent malaria.

This combination consists of one dose of a vaccine called Ad35.CS.01 followed by two doses of a vaccine called RTS,S/AS01B. Both Ad35.CS.01 and RTS,S/AS01B vaccines contain a protein that resembles one produced by the P. falciparum malaria parasite.

This protein is not the malaria germ itself and cannot cause the disease malaria.

Has this vaccine been tested in humans before? The combination vaccine has not been tested previously in humans but each individual component has been tested in humans.

Study Duration:

Approximately 11 months for vaccinated (up to 3 months for screening and 7.8 months for the immunization, malaria challenge and follow-up phases) and approximately 8 months for non-immunized controls (up to 3 months for screening and 5.3 months for the malaria challenge and follow-up phases)

Study Background:

Malaria is a parasitic disease transmitted by mosquitoes. It is a significant cause of death and disability in tropical areas of Africa, Asia, Oceania (Pacific islands) and Latin America. Humans become infected when they are bitten by infected mosquitoes. People don’t feel well with this disease – its effects are similar to the flu, with symptoms such as fever, headache, body aches, upset stomach and diarrhea. Therefore, this disease impacts people and communities due to lost time in the home, at work and school.

A vaccine against the parasite would be a major contribution to public health. The U.S. Army is at the forefront of malaria vaccine research and development because soldiers are deployed to areas with malaria. In the current proposed study, we want to evaluate the safety of a new anti-malarial vaccine developed by scientists at GSK and Crucell.

Qualified Participants Must:

Meet the following inclusion criteria:

  • Be men and non-pregnant, non-lactating women, civilian or military
  • Be ages 18-50 (inclusive)
  • Be in good health
  • Be able make all follow-up appointments
  • if active duty military volunteers obtain approval from supervisory chain
    Not have any of the following exclusions:
  • Plans to travel to a country with malaria throughout the study
  • High cardiac risk
  • History of malaria or receipt of an investigational malaria vaccine
  • Recently traveled to a P. falciparum endemic area within the past 60 days
  • Heart, lung, liver, or kidney disease (high blood pressure, diabetes)
  • Neurologic disease
  • Have had a splenectomy
  • History of sickle cell disease or other blood diseases
  • Been positive for HIV or hepatitis C
  • Use of an investigational drug or non-registered vaccine within 30 days before the first immunization
  • Use of any licensed vaccine within 7 days before the first immunization
  • Had an allergic reaction to a vaccine
  • Be pregnant or planning pregnancy during the study time period
  • Use certain prescription medications
  • Alcohol or drug abuse
  • Have any other significant finding that in the opinion of the clinical investigators would make participation in the study unsafe

Qualified Participants May Receive:

All study-related procedures and study vaccinations are performed at no cost, participants will be compensated for their time.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.