Immunization of Human Volunteers With P. Vivax Irradiated Sporozoites (NCT01082341) | Clinical Trial Compass
CompletedPhase 1/2
Immunization of Human Volunteers With P. Vivax Irradiated Sporozoites
Colombia27 participantsStarted 2012-06
Plain-language summary
It is possible to safely protect human volunteers immunized with P. vivax irradiated sporozoites from P. vivax challenge with live sporozoites.
Who can participate
Age range
18 Years – 45 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 18 to 45 years old man or non-pregnant women.
* To have the capacity to sign an informed consent in a free and voluntary way.
* Have an acceptable understanding of the clinical trial through the approval of a questionnaire regarding the information given in the consent process.
* Obligatory use of adequate contra-conceptive method from beginning of recruitment and screening time up to three months after last immunization
* Do not have chronic or acute diseases. These conditions will be determined by clinical history, physical exam and laboratory tests.
* To accept not traveling to malaria endemic areas during the clinical trial should
* To have telephone at home or mobile phone that permit permanent contact for follow up
* He (she) manifest that is willing to participated during both steps of the clinical trial.
Exclusion Criteria:
* Volunteers with less than 18 old year or more than 45 old years.
* Pregnant and suckling women will be excluded. Pregnancy will be determined both by interview, and by serum B-subunit chorionic gonadotrophin testing.
* History of moderate or severe insect, or food allergies.
* G-6PD deficiency or any Hb genetic defect (for example; sickle cell disease)
* Previous malaria infection demonstrated by think smear, PCR or specific antimalarial antibodies.
* If the subject has previously participated in a malarial vaccine trial.
* Clinical record of allergies to drug or insect bites.
* Symptoms, signs or…
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
Three groups are considered to be intervened. Experimental, Control and Fy(-) groups. Comparison will be done between E and C groups for protective efficacy. For immune response tests E vs Fy(-),E vs Fy(-), and Fy(-) vs C, pairs will be compared.
Timeframe: 2 years
Trial details
NCT IDNCT01082341
SponsorMalaria Vaccine and Drug Development Center