Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-24 @ 1:39 PM
NCT ID:
NCT01083095
Eligibility Criteria:
Inclusion Criteria:
* Healthy male or non-pregnant female adults (18- 50 years of age).
* Use of adequate contraceptive method from the initiation of the study until two months after sporozoite challenge for females.
* No plans to travel to a malaria endemic area during the course of the study and agree to not travel outside the study area from Day 7 to Day 23 post-challenge (the high risk period for becoming parasitemic).
* Reachable by phone during the entire study period
* Duffy positive phenotype
Exclusion Criteria:
* Are \<18 or \>49 years of age.
* Any female who is pregnant at serum positive B-HCG screening or who is nursing.
* Duffy negative phenotype.
* G-6-PD deficiency or any other hemoglobinopathy.
* Current or past infection with any species of malaria
* History of allergy to antimalarial drugs or immediate type hypersensitivity reactions to mosquito bites.
* Clinical or laboratory evidence of significant systemic disease, including hepatic, renal, cardiac, immunologic or hematological disease. Are HIV positive or have any other known immunodeficiency (including receiving immunosuppressive therapy or a history of splenectomy); are infected with hepatitis B or C virus; have a history of autoimmune disease (including inflammatory bowel disease, hemolytic anemia, autoimmune hepatitis, rheumatoid arthritis, lupus, etc.) or connective tissue disease or have any other serious underlying medical condition.
* Clinically significant laboratory abnormalities as determined by the Investigator(s).
* Plan to have surgery between enrollment and the end of the challenge follow-up.
* Have any other conditions that are determined by at least two concurring investigators that may interfere with the capacity to provide free and willing informed consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01083095
Study Brief:
Protocol Section:
NCT01083095