Prophylactic Antimalarial Activity of DB289 in Volunteers

This is an interventional prevention trial for Prophylactic Activity Against Malaria focused on measuring prophylactic, malaria, challenge Read More

Inclusion Criteria:

• Age between 18 and 45 years
• BMI between 19 and 30 (Appendix IV)
• Able to provide home address and phone number; work description, address, and phone number; and to provide the name, address, and phone number of a person willing and able to assist the investigators in making contact with the cognate volunteer during the study period
• Able and willing to follow-up intensively for 3 months of scheduled visits
• Post-menopausal or surgically sterilized women
• Score of 80% or more on a written exam to test malaria knowledge and comprehension of the study
• Serum and red cells support growth of P. falciparum in vitro (Appendix V)
• Blood type A or O
• Able and willing to provide written informed consent for screening, HIV testing, and study participation-

Exclusion Criteria:

• Clinically significant abnormalities on screening examinations

  • AST, ALT, bilirubin, hemoglobin, hematocrit, prothrombin time, partial thromboplastin time, or creatinine outside the limits of normal as defined at the time of testing by the Johns Hopkins Medical Laboratories
  • laboratory evidence of HIV infection or active viral hepatitis
  • G6PD deficiency, or hemoglobin S or C
  • Significant medical illnesses requiring systemic treatment and/or hospitalization within one month of enrollment
  • History of chronic medical illnesses, significant in the investigators' judgment
  • Self-described use of tobacco
  • History of alcohol or drug abuse
  • Use of prescribed or over-the-counter medications or nutritional supplements within two weeks of enrollment (vitamins, at or below the daily recommended dose, may be taken during the study)
  • Women of childbearing potential
  • Blood or plasma donation within 2 weeks of enrollment
  • History of malaria or residence in a malaria-endemic area
  • Allergy to mosquito bites
  • Intolerance to chloroquine, Malarone, quinine, quinidine, or tetracycline
  • Taken anti-infective drugs or quinine-containing beverages in the week prior to enrollment
  • Currently participating in other clinical trials, participated in a drug trial within two weeks of enrollment, or plan to participate in another clinical trial within three months from challenge
  • Any factors for which the investigator believes that participation of the volunteer in the study is not appropriate