Controlled Human Malaria Infection using PfSPZ® in Healthy Volunteers
Research type
Research Study
Full title
A Single Centre Exploratory Study to Verify the Safe and Reproduceable Use of Aseptic, Purified, Cryopreserved Plasmodium falciparum sporozoites for the Induction of Controlled Human Malaria Infection in Healthy Malaria-Naïve Adult Participants within the hVIVO Medical Research Unit
IRAS ID
308407
Contact name
Anand Arjan Odedra
Contact email
Sponsor organisation
hVIVO Services Limited (hVIVO)
Duration of Study in the UK
0 years, 1 months, 5 days
Research summary
This is a single centre exploratory study in healthy adult male and female participants. The aim of this study is to deliberately infect participants with malaria by injecting Plasmodium falciparum sporozoites (Sanaria® PfSPZ) directly into a vein. Sporozoites are the form of malaria that cause malaria infection in humans after a bite from an infected mosquito. The objectives of this study is to demonstrate that healthy participants can safely and reliably be injected with Plasmodium falciparum sporozoites.
Participants meeting the eligibility criteria for the approved protocol will be enrolled onto the study.
The study will consist of a screening phase, an inpatient phase which involves a 4 day quarantine stay, and an outpatient phase. The duration of participation is expected to be 1 month from injection with PfSPZ to the last scheduled study visit.
Enrolled participants will check into the Quarantine Unit on Day-1 where they will remain for 4 days and will be infected with PfSPZ on Day 1. Participants will be discharged from the quarantine unit on Day 3.
After discharge from the Quarantine Unit, participants will be assessed daily, either by telephone calls (from Day4 to Day6) or in person (from Day7 until clearance of the malaria infection).
From Day 7, participants will attend daily clinic visits to monitor for the appearance of malaria parasites in the blood using a specific and sensitive test (PCR). As soon as the level of parasites in the blood reaches a point that has been associated with early mild to moderate symptoms of malaria(>/=250 parasites/mL), the participants will be provided with an established treatment to cure malaria. The participants will continue to be followed up with daily PCR to Day 28 or until clearance of the malaria infection.
Participants will be required to complete a final follow-up visit on Day 32.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
21/YH/0284
Date of REC Opinion
30 Nov 2021
REC opinion
Unfavourable Opinion