Expired Study
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Clinical Trial 8317

Silver Spring, MD 20910


Study Summary:

The purpose of this study is to test the safety and effectiveness of a new malaria vaccine, called VMP001. The study is specifically looking at a vaccine against Plasmodium vivax, the most common form of malaria in Asia. This is the first time the VMP001 vaccine will be given to humans.

Background: Malaria is a parasitic disease transmitted by mosquitoes. Approximately 40% of the world’s population is at risk for malaria caused by Plasmodium vivax. This parasite causes 132 - 391 million infections around the world each year. 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. In some parts of the world, P. vivax has become resistant to drugs used in the past, and a vaccine against this disease would therefore help people living in, or traveling to areas where it is commonly found. The U.S. Army is at the forefront of malaria vaccine research and development because soldiers are deployed to areas with malaria.

Inclusion:

  • Men and non-pregnant, non-lactating women
  • ages 18-55 (inclusive)
  • in good health
  • no plans to travel to a country with malaria throughout the study
  • low cardiac risk

Exclusion:
  • History of malaria or receipt of an investigational malaria vaccine
  • Recent travel to P. vivax endemic area within the past three months
  • Heart, lung, liver, or kidney disease (high blood pressure, diabetes)
  • Neurologic disease
  • Splenectomy
  • History of sickle cell disease or other blood diseases
  • Positive for HIV or hepatitis C
  • Use of 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
  • Allergic reaction to a vaccine
  • Pregnancy or planned pregnancy during the study time period
  • Use of certain prescription medications
  • Inability to make all follow-up appointments
  • Alcohol or drug abuse


Qualified Participants May Receive:

Compensation and free medical screening.


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.