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 range18 Years – 45 Years
SexALL
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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…
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