Recruiting Studies

WRAIR #2651/2652- Malaria Vaccine Study

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.

Duration:
18 months
Max Compensation:
$6,060
Requirements
  • ✔ MUST
    be a healthy adult male or non-pregnant, non-breastfeeding female.
  • ✔ MUST
    be between the ages of 18 & 55.
  • ✔ MUST
    be willing to take anti-malarial treatment after malaria challenge, and make all required follow up visits.
  • ✔ MUST
    have approval from your supervisory chain to participate if military employee. The appropriate approval form will be provided to you.
  • ✔ MUST
    be willing and able to participate in all planned study visits for the duration of the study.
  • ✔ MUST
    agree not to travel to places where there is malaria during the time of the study.
  • ✔ MUST
    agree to NOT donate blood during the course of and 3 years after malaria challenge.
  • ✔ MUST
    be of low cardiac risk.
  • ✘ CANNOT
    have a history of malaria infection.
  • ✘ CANNOT
    have lived in a malaria-endemic area for more than 5 years.
  • ✘ CANNOT
    have any past or current infection with HIV, hepatitis C, or hepatitis B.
  • ✘ CANNOT
    have 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.
  • ✘ CANNOT
    have EVER received a malaria vaccine and/or medications.
  • ✘ CANNOT
    be currently participating in another clinical research study.
  • ✘ CANNOT
    have any history of a severe, life threatening allergic reaction (anaphylaxis).
  • ✘ CANNOT
    have any history of allergic reaction to mosquito bites that required hospitalization.
  • ✘ CANNOT
    plan to have surgery between enrollment and 3 months after malaria challenge.
  • ✘ CANNOT
    have a history of sickle cell trait or disease.
  • ✘ CANNOT
    be currently pregnant, breastfeeding, or plan to become pregnant during the study.
  • ✘ CANNOT
    have a history of cancer.
  • ✘ CANNOT
    have a history of autoimmune disease.
  • ✘ CANNOT
    have had your spleen removed.
  • ✘ CANNOT
    have diabetes mellitus (type I or II) and/or thyroid disease.
  • ✘ CANNOT
    have 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.
  • ✘ CANNOT
    have any active alcohol or drug abuse.
  • ✘ CANNOT
    have neurologic disease (including seizure disorder and migraine headaches).
  • ✘ CANNOT
    have a history of arthritis diagnosis or other rheumatologic disease.
  • ✘ CANNOT
    have any serious medical illness or condition involving the heart, liver, lungs, or kidneys.
WRAIR #2567.07 – Cohort Development for Phase 1 COVID-19 Trials

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.

Duration:
12 Months
Max Compensation:
contact us for information
Requirements
  • ✔ MUST
    be a healthy adult male or non-pregnant, non-breastfeeding female
  • ✔ MUST
    be willing and able to read, sign, and date the informed consent document before study-related procedures are performed
  • ✔ MUST
    be between the ages of 18 and 55
  • ✔ MUST
    be willing and able to participate in all planned study visits for the duration of the study
  • ✔ MUST
    have NO previously documented COVID-19 disease
  • ✔ MUST
    have a negative pregnancy test at screening and continue to not become pregnant during the period of observation if biologically female
  • ✔ MUST
    have acceptable screening laboratory results
  • ✔ MUST
    have a body mass index (BMI) ≥18.1 and <35.0 kg/m2
  • ✘ CANNOT
    be currently participating in another clinical research study
  • ✘ CANNOT
    have donated a unit of blood within 8 weeks of day 1 or plan to donate blood during the course of the study
  • ✘ CANNOT
    have had a major surgery (per self-report) in the month prior to screening or plans to have major surgery during the study
  • ✘ CANNOT
    have any past or current infection with HIV, hepatitis C, or hepatitis B
  • ✘ CANNOT
    be unwilling to have samples collected and stored for future research and genetic testing
  • ✘ CANNOT
    have tattoos, scars, or other marks that would, in the opinion of the investigator, interfere with assessment of the vaccination site
  • ✘ CANNOT
    have known allergy or history of anaphylaxis, or other serious reaction to a vaccine, vaccine component, or latex
  • ✘ CANNOT
    have a history of cancer or autoimmune disease
  • ✘ CANNOT
    have diabetes mellitus (type I or II) and/or thyroid disease
  • ✘ CANNOT
    Have 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).
  • ✘ CANNOT
    have received blood products or immunoglobulin in the 3 months prior to screening or plans to use during the course of the study
  • ✘ CANNOT
    have a history of organ and/or stem cell transplantation
  • ✘ CANNOT
    have any serious medical illness or condition involving the heart, liver, lungs, or kidneys
  • ✘ CANNOT
    be a healthcare worker (including dental providers engaged in direct patient care)