BIO-006
Research type
Research Study
Full title
BIO-006: A clinical study to assess the safety and feasibility of relapsing P. vivax controlled human malaria infection through experimental sporozoite infection of healthy malaria-naïve UK adults, and to characterise parasite growth and immune responses to primary and relapsing P. vivax infection
IRAS ID
342867
Contact name
Angela Minassian
Contact email
Sponsor organisation
Research Governance, Ethics and Assurance Team
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
After being bitten by a mosquito containing Plasmodium vivax malaria, the malaria parasite can hide in the liver in an inactive form and later reactivate to cause “relapse infections”. Relapse infections cause significant health and economic consequences in individuals living in endemic countries.
This study aims to find out more about relapse malaria infections. It is a malaria challenge study which means it involves deliberately infecting trial participants with malaria in a safe and controlled way.
Up to 5 healthy adult participants, screened to ascertain eligibility, will be recruited from Oxfordshire or surrounding area. The malaria challenge will be administered at Radbound University Medical Center (RUMC) in Nijmegen, Netherlands. All follow up visits will be performed at the Oxford Vaccine Group, CCVTM, Churchill Hospital in Oxford.The malaria challenge will be administered by mosquito bites. Participants will be phoned for the following 6 days. From day 7, daily in-person visits at CCTVM will be performed. This will continue until day 21 or until a malarial infection is detected. At this point the participant will be treated for the active infection, but any dormant infection will deliberately not be treated. Participants will be monitored for the next 6 months for relapse infections (fortnightly clinic and 24/7 doctor). Relapse infections will be treated. After 6 months, participants will be treated for any active infection, and with another medication to clear the dormant infection to stop relapse infections from occurring. Participants will be followed up by email until 5 years following malaria challenge.
Success would mean that we could repeat a similar study in the future to test new vaccines or medications that could be used to treat or prevent malaria relapsing infections.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
24/SC/0355
Date of REC Opinion
19 Dec 2024
REC opinion
Further Information Favourable Opinion