VAC068. Study of controlled human Plasmodium vivax infection
Research type
Research Study
Full title
A clinical study to assess the safety of controlled human Plasmodium vivax malaria infection through experimental sporozoite infection of healthy malaria-naïve UK adults, and to characterise parasite growth and immune responses to P. vivax
IRAS ID
228948
Contact name
Angela M Minassian
Contact email
Sponsor organisation
University of Oxford, CTRG
Duration of Study in the UK
5 years, 3 months, 1 days
Research summary
This is a clinical study where 2 volunteers are challenged with malaria (Plasmodium vivax species) by mosquito bite. The primary aims are to assess the safety and feasibility of controlled human P. vivax infection, the growth of the parasite and the immune response to P. vivax infection, and to measure induction of sexual-stage parasites as a marker of transmission. A secondary aim is to develop a blood inoculum of P. vivax-infected blood for future testing of candidate vaccines. \n\nTwo healthy, malaria-naïve adults aged between 18 and 50 years will be recruited at the CCVTM, Oxford. Controlled human malaria challenge (CHMI) by sporozoites will be delivered by mosquito bite at Imperial College, London, and follow-up during the post-challenge period will be at the CCVTM in Oxford.\n\nBoth volunteers will have blood taken at regular intervals to assess the immune response to primary P. vivax infection, and also the parasite growth following P. vivax infection. They will both be monitored closely until they meet the criteria for treatment. Up to 250 mL (half a unit) of blood will be taken just prior to treatment from each successfully infected volunteer (as determined by measurement of the blood parasite load) and frozen down for future use in blood-stage CHMI trials. \n\nBoth volunteers will be treated with a standard antimalarial course of oral artemether-lumefantrine (Riamet) given over 3 days followed by a 2-week course of partially-observed oral Primaquine. Primaquine is given to eradicate any P. vivax parasites that may be lying dormant in the liver with the potential to reactivate and cause recurrent disease later on if not eliminated. The volunteers will be followed up for 3 months in the clinic and by email out to 5 years to monitor for clinical relapse.\n\nThe study is funded through MultiViVax, a European Commission Horizon 2020 funded project\n
REC name
South Central - Oxford A Research Ethics Committee
REC reference
17/SC/0389
Date of REC Opinion
22 Aug 2017
REC opinion
Favourable Opinion