A Systems Biology Approach to Malaria Immunity

This is an interventional other trial for Plasmodium Falciparum Infection focused on measuring Biology, falciparum, Immunity, Infections, Malaria, Pf, Plasmodium, Systems Read More

Inclusion Criteria:

1. Male or non-pregnant/non-lactating female between the ages of 18 and 50 years, inclusive.
2. Able and willing to participate for the duration of the study.
3. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
4. Able and willing to complete the informed consent process.
5. Willing to donate blood for sample storage to be used for future research (Note: refusal to allow future use is exclusionary).
6. Willing to refrain from blood donation to blood banks for 3 years following P. falciparum CHMI.
7. Agrees not to travel to a malaria endemic region during the entire course of study participation.

8. Physical examination and laboratory results without clinically significant findings and a body mass index (BMI) = / < 35.

   Laboratory Criteria within 56 days prior to enrollment:

9. Hemoglobin = / >11.2 g/dL for women; = / > 12.6 g/dL for men.
10. Platelet count within institutional normal range.
11. Alanine aminotransferase (ALT) = / < upper limit of normal.
12. Serum creatinine = / < upper limit of normal.

13. Negative for HIV and Hepatitis B/C infection.

    Laboratory Criterion documented any time prior to enrollment:

14. Negative sickle cell screening test.

    Female-Specific Criteria:

15. Negative beta-HCG pregnancy test (serum) on day of screening or urine pregnancy test at subsequent time points for women of childbearing potential.
16. Women of childbearing potential (exclusive of women in a same sex relationship) must agree to use effective means of birth control.* *(e.g. oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner). Women with a history of amenorrhea (> 1 year duration) or surgical or chemical sterilization (e.g. tubal ligation, hysterectomy, other) must provide written documentation of infertility from a health care provider.

Exclusion Criteria:

1. Women who are breast-feeding or planning to become pregnant during the time interval needed to complete the study.
2. Receipt of a malaria vaccine in a prior clinical trial.
3. Any history of malaria infection.
4. Evidence of increased cardiovascular disease risk; defined as > 10% five year risk by the non-laboratory method.
5. Current use of systemic immunosuppressant pharmacotherapy.
6. History of a splenectomy, sickle cell disease or sickle cell trait.
7. Known history of anaphylactic response to mosquito-bites; or known allergy to artemether lumefantrine or atovaquone or proguanil or other component of the product.
8. Participation in any study involving investigational vaccine or drug within 4 weeks prior to enrollment, or expects to receive vaccine or drug during the 2-month post-challenge period.
9. Use or planned use of any drug with anti-malarial activity that would coincide with challenge.
10. Anticipated use of medications known to cause drug reactions with atovaquone-proguanil (Malarone(R)) such as cimetidine, metoclopramide, antacids, and kaolin.
11. Plans to undergo surgery (elective or otherwise) between enrollment and 4 weeks (28 days) after any of the challenges.
12. Received a licensed vaccine within 1 month prior to enrollment in this study or expects to receive one during the 28 day post challenge period.
13. History of psychiatric disorders or behavioral tendencies (including active alcohol or drug abuse) that in the opinion of the investigator would make compliance with the protocol difficult.* *Medical and psychiatric illness defined as personality disorders, anxiety disorders, or schizophrenia or social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent or to comply with the protocol schedule.