VAC069: A study of blood-stage controlled human P. vivax infection
Research type
Research Study
Full title
A clinical study to assess the safety and feasibility of controlled blood-stage Plasmodium vivax malaria infection through experimental inoculation of cryopreserved infected erythrocytes in healthy malaria-naive UK adults Study Code: VAC069
IRAS ID
252499
Contact name
Angela Minassian
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance
Duration of Study in the UK
2 years, 4 months, 1 days
Research summary
This is a clinical study to assess the safety and feasibility of Plasmodium vivax (P. vivax) blood-stage controlled human malaria infection (CHMI), by inoculation using a newly created source of P. vivax malaria-infected blood. As the first CHMI, or challenge, utilising this inoculum, this study also aims to establish the optimal dose to take forward to future P. vivax CHMI studies.
As a secondary objective, the safety and feasibility of a second and third P. vivax blood-stage CHMI will be evaluated. This study will also assess parasite growth, including quantifying the sexual-stage parasites in the blood, as well as the immune responses in primary, secondary and tertiary P. vivax blood-stage challenge, as further secondary aims.
Six healthy adult volunteers, ages between 18 and 50 years, will be recruited and undergo three separate P. vivax blood-stage challenges at the CCVTM, Oxford. We will do this by adminstering a small amount of P. vivax infected blood intravenously on three separate occasions. Through each challenge period, volunteers will have blood taken at regular intervals to measure the parasite growth, quantify the sexual parasite forms and assess the immune response to P. vivax infection. After the first challenge, the optimal dose for blood-stage CHMI will be selected and used for the second and third challenges.
In each challenge, volunteers will be treated with a standard antimalarial course of oral artether-lumefantrine (Riamet) given over 3 days.
Volunteers who take part in this study will be involved in the trial for approximately 2 years, receiving each of the three challenges at intervals of approxiamtely 5 months.
The study is funded through MultiViVax, a European Commission Horizon 2020 funded project.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
18/SC/0577
Date of REC Opinion
12 Nov 2018
REC opinion
Further Information Favourable Opinion