VAC063C: A study to assess repeat blood-stage P. falciparum infection
Research type
Research Study
Full title
A clinical study to assess the safety of primary, secondary and tertiary blood-stage controlled human Plasmodium falciparum malaria infection of healthy malaria-naïve UK adults, and to characterise parasite growth dynamics
IRAS ID
253232
Contact name
Angela Minassian
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance
Duration of Study in the UK
0 years, 4 months, 28 days
Research summary
This is a clinical study to assess the safety of primary, secondary and tertiary blood-stage controlled human Plasmodium falciparum malaria infection of healthy malaria-naïve UK adults, as well as to evaluate any effect of prior exposure to a blood-stage controlled human malaria infection (CHMI) on the parasite multiplication rate.
As a secondary objective, the immune response to primary, secondary and tertiary P. falciparum blood-stage infection, as well as gametocytaemia, will also be assessed.
Nine to seventeen healthy adult volunteers, aged between 18 and 50 years, will be recruited and receive a blood-stage controlled human malaria infection (CHMI) at the CCVTM, Oxford. Of these volunteers, three will be newly recruited, malaria-naïve volunteers, who will receive a primary CHMI. The remaining volunteers will be invited to be involved in this study, following previous participation in the VAC063 study. VAC063 was a study to assess the safety, immune responses and efficacy of the new malaria vaccine RH5.1/AS01. As part of this study, control volunteers, who did not received a vaccine, received a blood-stage CHMI, or “challenge”, in order to compare to the vaccinated volunteers. Some control (unvaccinated) participants received two challenges and some received just one challenge, therefore, in this study, participants who previously took part in VAC063 will receive either a third or second malaria challenge.
Volunteers will be challenged with malaria by administering a small amount of P. falciparum infected blood intravenously. Blood will then be taken at regular intervals to measure the parasite growth, quantify the sexual parasite forms and assess the immune response to primary, secondary or tertiary P. falciparum CHMI.
When volunteers are diagnosed with malaria, treatment with a standard antimalarial course of oral artether-lumefantrine (Riamet) will be given over 3 days.
Volunteers who take part in this study will be involved in the trial for approximately 3 months.REC name
South Central - Oxford A Research Ethics Committee
REC reference
18/SC/0521
Date of REC Opinion
18 Sep 2018
REC opinion
Favourable Opinion