Seattle Malaria Clinical Trials Center (Seattle MCTC)

Now Enrolling: KAF156 Study

Evaluating the safety and ability of KAF156 to prevent malaria

The Seattle Malaria Clinical Trials Center is recruiting for a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of the antimalarial drug, KAF156. In this study some participants will get the study drug and others a placebo. The study investigators will not know who receives which.

This is a "malaria challenge" study being done in a controlled setting to determine if the drug prevents a person from getting malaria after being bitten by mosquitos infected with the malaria parasite. The Center for Infectious Disease Research will perform the malaria challenge under controlled conditions with trained and experienced personnel. If a person becomes infected with malaria as a part of the clinical trial, they are treated and cured with FDA-approved antimalarial drugs.

 

Study participation includes:

  • 24 in-person visits to the Fred Hutch Prevention Center over about 45 days
  • Visits range from 15-30 minutes with the exception of the challenge day
  • On challenge day participants will receive the malaria challenge and then they will be required to stay at a local hotel overnight. The following day, participants will return to the Prevention Center to receive the study drug or placebo and stay in the clinic for about 13 hours
  • Participants are required to stay at a local hotel for 48 hours after receiving study drug/placebo so that study staff can follow up and monitor for any side effects
  • After the hotel stay, if a participant is diagnosed with malaria at a regularly scheduled follow-up visit, then these visits are stopped and the anti-malarial treatment called Malarone® will be administered.  Clinic follow up will continue for three days.
  • Participants who are not diagnosed with malaria will receive treatment with Malarone® on day 29 and will be given additional tablets to take home.
  • All Participants will receive follow-up phone calls at three and six months
  • At any time throughout the study participants may be asked to return to the clinic for extra visits, if additional laboratory tests and/or medical exams are needed.
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  • Healthy male, ages 18-40
  • Healthy female (of non-childbearing potential), ages 18-40
  • Vital signs and lab work within normal ranges
  • Live in the greater Seattle area and available to participate for 6 weeks

If you do not meet the eligibility criteria, but wish to participate in a future study, please contact us.

You will not be eligible for the study if you:

  • Have a history of malaria
  • Previously participated in a malaria clinical trial
  • Are currently participating in another investigational drug trial
  • Have a history of allergic reactions to insect/mosquito bites
  • Are positive for HIV, Hepatitis B, or Hepatitis C
  • Have any other serious medical conditions