Malaria Vaccine - Silver Spring MD

Summary:

Objective: This study is being conducted to evaluate the safety and effectiveness of an experimental malaria vaccine. This new vaccine is made up of two parts. The first part is called FMP012 and it is designed to look like a part of the malaria parasite. The second part is called GLA-SE, and is the component to boost the body’s immune response to FMP012.

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 Influenza 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 this parasite would be a major contribution to public health. The US 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 WRAIR.

Duration: The active portion of the study will be up to 11 months for vaccinated subjects (up to 3 months for screening and 8 months for vaccination and follow-up), and approximately 6 months for non-immunized controls (up to 3 months for screening and 3 months for the malaria challenge and follow-up). There will also be 2 follow-up phone calls at 6 and 12 months after the final vaccination.

Inclusion:

• Men and non-pregnant, non-lactating women, civilian or military
• ages 18-50 (inclusive)
• in good health
• no plans to travel to a country with malaria throughout the study
• low cardiac risk (based on NHANES I criteria and screening electrocardiogram (EKG))

• History of malaria or receipt of an investigational malaria vaccine
• Recent travel to P. falciparum 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, hepatitis C, or hepatitis B
• Use of investigational drug or non-registered vaccine within 30 days before the first vaccination
• Use of any licensed vaccine within 7 days before the first vaccination (we recommend that you get any approved preventive vaccines that you need during the study, but ask that you schedule them for at least seven days before or after the study vaccination day)
• Allergic reaction to a vaccine (vaccine group)
• Pregnancy or planned pregnancy during the study time period
• Use of certain prescription medications
• Inability to make all follow-up appointments
• Active duty military volunteers will require approval from their supervisory chain
• Alcohol or drug abuse

Qualified Participants May Receive:

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