CompletedNot Applicable

Controlled Human Malaria Infection After Bites From Mosquitoes Infected With Two Novel P. Falciparum Strains

Netherlands24 participantsStarted 2014-08

Plain-language summary

An effective vaccine against malaria is urgently needed to combat the scourge of this disease. Before candidate vaccines can be tested in endemic countries, they are first tested in human volunteers in so-called Controlled Human Malaria Infections (CHMI's). Ideally, a candidate vaccine should be tested against multiple strains of malaria, representative of the disease's global distribution. Recently we compared, for the first time, infections with the novel malaria strains NF135 and NF166 to those with the broadly-used and well-characterised strain NF54. The purpose of the current study is to optimise the course of infections with these novel strains by determining the minimum number of infectious bites necessary to reliably induce a malaria infection.

Who can participate

Age range18 Years – 35 Years

SexALL

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Inclusion criteria

✓. Subject is aged ≥ 18 and ≤ 35 years and in good health.
✓. Subject has adequate understanding of the procedures of the study and agrees to abide strictly thereby.
✓. Subject is able to communicate well with the investigator, is available to attend all study visits, lives in proximity to the trial centre (\<10 km) or (if \>10km) is willing to stay in a hotel close to the trial centre during part of the study (day five post-infection until three days post-treatment). Furthermore the subject will remain within the Netherlands during the study period and is reachable (24/7) by mobile telephone throughout the entire study period.
✓. Subject agrees to inform his/her general practitioner and (if applicable) medical specialist about participation in the study and to sign a request to release by the GP any relevant medical information concerning possible contra-indications for participation in the study.
✓. Subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period and for a defined period thereafter according to current Sanquin guidelines.
✓. For female subjects: subject agrees to use adequate contraception and not to breastfeed for the duration of study.
✓. Subject has signed informed consent.

Exclusion criteria

What they're measuring

Proportion of subjects in each group who develop patent parasitaemia as assessed by QRT-PCR

Timeframe: between day 5 and day 13

Trial details

NCT IDNCT02149550

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-10

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