clinical investigation study to evaluate the consistency and reproducibility of two consecutive mosquito feeding assays

Conditions: Malaria

Summary: the proposed trial design has been developed to assess the consistency and reproducibility of two consecutive direct skin feeding assays (dsfa) at 24-hour interval.

the proposed trial design has been developed to assess the consistency and reproducibility of two consecutive direct skin feeding assays (dsfa) at 24-hour interval. the results will determine the type of pivotal trial design for a follow-on phase 2b trial whose objective is to bridge the standard membrane feeding assay (smfa) to the direct skin feeding assay (dsfa) and direct membrane feeding assay (dmfa) using a monoclonal antibody intervention, tb31f monoclonal antibody (mab), which interrupts transmission from human to mosquito. the results from this experimental medicine study will inform whether the preferred "before-after" trial design in which each human volunteer serves as their own internal control can be utilized for a follow-on phase 2b trial.

Eligibility criteria:
inclusion criteria: * provision of signed or thumb printed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * male or female aged between 18 years and 55 years inclusive. * resident within the study area * in good general health as evidenced by medical history and clinical examination before entering the study ability to take oral coartem and low-dose primaquine anti-malarials upon conclusion of day 2 (2nd direct skin feed) and be willing to adhere to the medication regimen * for females, she must be of non-childbearing potential or use appropriate measures to prevent pregnancy for 30 days after receiving coartem and primaquine. non-childbearing potential means she is surgically sterilized or at least one year post-menopausal. appropriate measures to prevent pregnancy include abstinence or adequate contraceptive precautions (i.e. intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; norplant or depo-provera). * for males, he must be willing to ensure that he does not get his partner(s) pregnant for at least 3 months after treatment with primaquine. appropriate measures to prevent pregnancy include abstinence or adequate contraceptive precautions in either the participant or the partner. * positive for p. falciparum gametocytes as measured by polymerase chain reaction (pcr) with cycle threshold (ct) value \< 31. exclusion criteria: presence of any signs or symptoms of malaria * presence of contraindications to administration of coartem and primaquine as indicated in the respective drug package inserts * history of severe allergic reactions to mosquito bites (other than pruritus and local swelling) * pregnant (i.e. a positive pregnancy test) * current or recent (within the preceding 2 weeks) use of antimalarial treatment * current participation in a malaria vaccine study * any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.