Immunization Via Mosquito Bite With Radiation-attenuated Sporozoites (NCT01994525) | Clinical Trial Compass
CompletedPhase 1
Immunization Via Mosquito Bite With Radiation-attenuated Sporozoites
United States54 participantsStarted 2014-01-24
Plain-language summary
This study is to assess the safety, tolerability, and biomarkers of protection in healthy malaria-naïve adults, who will receive bites from Anopheles stephensi mosquitoes either infected with Plasmodium falciparum Sporozoites (PfRAS) (true-immunization) or noninfected (mock-immunization).
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* Healthy adults (male or non-pregnant, non-breastfeeding female) 18-50 years of age (inclusive).
* Available and willing to participate for duration of study.
* Able and willing to provide written informed consent.
* Able to complete an Assessment of Understanding with a score of at least 70% correct.
* In good general health with no clinically significant health problems as established by medical history, physical exam and laboratory screening.
* Females of childbearing potential must have a negative pregnancy test at screening and agree to not become pregnant or breastfeed for the duration of the study. She must be willing to use a reliable form of contraception during the study. Reliable forms of birth control include use of condoms, diaphragm or cervical cap, birth control pills, IUD or sperm killing products.
* Agree to refrain from blood donation (except as required in this study) for 3 years following P falciparum challenge.
* Agree not to travel to a malaria-endemic region during the study.
* Good peripheral venous access.
Exclusion Criteria:
* Positive HIV, HBsAg, or HCV serology.
* Positive sickle cell screening test, including evidence of sickle trait.
* Reactivity by CSP or AMA1 ELISpot assay or ELISA as determined by IMRAS Study Specific Procedure #204.
* Anemia (below normal reference laboratory value of hemoglobin) on screening.
* Weight less than 110 pounds (this does not apply to infectivity controls as it is a weight cut-off for subje…
What they're measuring
1
Solicited adverse events
Timeframe: 7 days
2
Unsolicited adverse events
Timeframe: 14 days
3
Laboratory adverse events
Timeframe: 7 days
4
Serious adverse events
Timeframe: 52 weeks
5
Signs and symptoms related to malaria infection
Timeframe: 7 days
6
Parasitemia
Timeframe: 52 weeks
Trial details
NCT IDNCT01994525
SponsorU.S. Army Medical Research and Development Command