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 range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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