Recruiting Studies
Malaria is caused by Plasmodium parasites that are transmitted to humans by the bite of an infected Anopheles mosquito. The parasites first infect cells in the liver and then they move into the bloodstream, resulting in high fevers, shaking chills, flu-like symptoms and anemia.
The FMP013/FMP014 vaccines have been designed to prevent malaria caused by Plasmodium falciparum. This is the first time these vaccine will be tested in humans. Ultimately, this trial will help determine if these experimental malaria vaccines are safe and tolerable. Another purpose of this study is to see if this experimental vaccine helps your body to make the antibodies that protect against malaria. The only way to prove new drugs and vaccines will protect humans against malaria is to give them to human subjects and then expose those subjects to malaria to see if they are protected.
- ✔ MUSTbe a healthy adult male or non-pregnant, non-breastfeeding female.
- ✔ MUSTbe between the ages of 18 & 55.
- ✔ MUSTbe willing to take anti-malarial treatment after malaria challenge, and make all required follow up visits.
- ✔ MUSThave approval from your supervisory chain to participate if military employee. The appropriate approval form will be provided to you.
- ✔ MUSTbe willing and able to participate in all planned study visits for the duration of the study.
- ✔ MUSTagree not to travel to places where there is malaria during the time of the study.
- ✔ MUSTagree to NOT donate blood during the course of and 3 years after malaria challenge.
- ✔ MUSTbe of low cardiac risk.
- ✘ CANNOThave a history of malaria infection.
- ✘ CANNOThave lived in a malaria-endemic area for more than 5 years.
- ✘ CANNOThave any past or current infection with HIV, hepatitis C, or hepatitis B.
- ✘ CANNOThave recently traveled to a malaria-endemic region (within 6 months of receiving your first vaccine) or have plans to travel to a malaria endemic region during the study period.
- ✘ CANNOThave EVER received a malaria vaccine and/or medications.
- ✘ CANNOTbe currently participating in another clinical research study.
- ✘ CANNOThave any history of a severe, life threatening allergic reaction (anaphylaxis).
- ✘ CANNOThave any history of allergic reaction to mosquito bites that required hospitalization.
- ✘ CANNOTplan to have surgery between enrollment and 3 months after malaria challenge.
- ✘ CANNOThave a history of sickle cell trait or disease.
- ✘ CANNOTbe currently pregnant, breastfeeding, or plan to become pregnant during the study.
- ✘ CANNOThave a history of cancer.
- ✘ CANNOThave a history of autoimmune disease.
- ✘ CANNOThave had your spleen removed.
- ✘ CANNOThave diabetes mellitus (type I or II) and/or thyroid disease.
- ✘ CANNOThave any other physical or psychologic condition or laboratory abnormality that the study doctor thinks may increase your risk of having side effects or compromise the results of the study.
- ✘ CANNOThave any active alcohol or drug abuse.
- ✘ CANNOThave neurologic disease (including seizure disorder and migraine headaches).
- ✘ CANNOThave a history of arthritis diagnosis or other rheumatologic disease.
- ✘ CANNOThave any serious medical illness or condition involving the heart, liver, lungs, or kidneys.
This specimen collection study is seeking to enroll volunteers from the community to identify a group of individuals who may be eligible and willing to participate in a phase 1 clinical trial that’s currently in development by WRAIR and for other SARS-CoV-2/COVID-19 related trials.
- ✔ MUSTbe a healthy adult male or non-pregnant, non-breastfeeding female
- ✔ MUSTbe willing and able to read, sign, and date the informed consent document before study-related procedures are performed
- ✔ MUSTbe between the ages of 18 and 55
- ✔ MUSTbe willing and able to participate in all planned study visits for the duration of the study
- ✔ MUSThave NO previously documented COVID-19 disease
- ✔ MUSThave a negative pregnancy test at screening and continue to not become pregnant during the period of observation if biologically female
- ✔ MUSThave acceptable screening laboratory results
- ✔ MUSThave a body mass index (BMI) ≥18.1 and <35.0 kg/m2
- ✘ CANNOTbe currently participating in another clinical research study
- ✘ CANNOThave donated a unit of blood within 8 weeks of day 1 or plan to donate blood during the course of the study
- ✘ CANNOThave had a major surgery (per self-report) in the month prior to screening or plans to have major surgery during the study
- ✘ CANNOThave any past or current infection with HIV, hepatitis C, or hepatitis B
- ✘ CANNOTbe unwilling to have samples collected and stored for future research and genetic testing
- ✘ CANNOThave tattoos, scars, or other marks that would, in the opinion of the investigator, interfere with assessment of the vaccination site
- ✘ CANNOThave known allergy or history of anaphylaxis, or other serious reaction to a vaccine, vaccine component, or latex
- ✘ CANNOThave a history of cancer or autoimmune disease
- ✘ CANNOThave diabetes mellitus (type I or II) and/or thyroid disease
- ✘ CANNOTHave any current or past history of substance abuse (alcohol or drug abuse, this includes current smokers: defined as an adult who has smoked 100 cigarettes in his or her lifetime and who currently smokes cigarettes).
- ✘ CANNOThave received blood products or immunoglobulin in the 3 months prior to screening or plans to use during the course of the study
- ✘ CANNOThave a history of organ and/or stem cell transplantation
- ✘ CANNOThave any serious medical illness or condition involving the heart, liver, lungs, or kidneys
- ✘ CANNOTbe a healthcare worker (including dental providers engaged in direct patient care)