20 May Malaria Vaccine Challenge Trial
The University of Washington is seeking volunteers for a Phase 1 malaria vaccine challenge trial. The purpose of this clinical trial to test an investigational malaria vaccine to determine if it is safe and to evaluate the immune systems responses.
The study will enroll participants who will be assigned to receive 3 doses of the investigational malaria vaccine or a placebo vaccine. All participants will undergo a malaria challenge 2-3 months after receiving the last vaccine. During the vaccination period and malaria challenge period, participants will be asked to not travel outside the greater Seattle area for safety reasons.
The trial will last about one year and will involve up to 38 in-person visits depending on the group assignment. At certain times during the study, visits will be daily, including weekends. Participants will undergo a screening assessment to see whether they are eligible. Study visits will involve physical exams, frequent blood draws, vital signs, and injections.
Participants will be compensated up to $3,600 depending on group assignment. Our clinic is located on the 11th floor of the Ninth and Jefferson Building at Harborview Medical Center.
Participant Eligibility
To be eligible for the trial you must:
▪ Be 18 -45 years of age
▪ Not planning to become pregnant or cause a pregnancy in the near future
▪ Have not recently and do not plan to travel to malaria endemic countries in the near future
▪ Must be willing to come to the clinic frequently (daily at times) and avoid travel at specific time
points during the study
Conditions which would prevent you from participating:
▪ Current pregnancy or breastfeeding
▪ Serious reactions to vaccines
▪ Living with HIV, Hepatitis B or C
Contact
Virology Research Clinic
(206) 520-4340
Additional Study Details
Full Study Title
A randomized, double-blind, placebo-controlled Phase 1 trial to evaluate the safety, tolerability, immunogenicity, and efficacy of Sanaria® PfSPZ-LARC2 Vaccine, a late-arresting, replicationcompetent, genetically attenuated Plasmodium falciparum vaccine by controlled human malaria infection in malaria-naïve healthy adults
Investigator(s)
Dr. R Scott McClelland, MD, MPH
Accepts Healthy Volunteers?
Yes
Study Site(s)
University of Washington Virology Research Clinic
908 Jefferson Street Suite 11NJ-1166
Seattle, Washington 98105