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 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT01540903
Eligibility Criteria:
Inclusion Criteria:
* Healthy Male aged between 20-35 years, healthy volunteers
* Good Health status based on history \& clinical examination
* Residing in or near DaresSalaam
* Willing to contribute to science in Tanzania
* Free from malaria parasite by blood smear \& qRT-PCR
* Not suffering from any chronic illness including HIV/AIDS
* No documented history of malaria infection for the past 5 yrs
* Able \& willing to come for complete one year follow up including minimum of three weeks of hospitalization
* All volunteers must sign the informed consent form \& answer correctly 15 out 15 questions demonstrating their understanding of the meaning \& procedures of the study
* Volunteer agrees to inform study doctor \& agrees to release medical information concerning contra-indications for participation in the study
* Living with a third party that will contact the study team if in case of alteration of consciousness during the first month of the study
* Willing to undergo a Pf sporozoite challenge.
* Willing to take curative treatment for malaria (Coartem®) \& any other medication which may be prescribed by a study doctor during study period
* All volunteers agree to stay in the hospital during parts of the study (overnight after challenge, up to 15 days during follow up \& 3 days of Coartem® treatment)
* Reachable (24/7) by mobile phone during the whole study period
* Agreement not to participate in another study during the study period.
* Agreement not to donate blood during the study period.
* Available to attend all study visits
* Willingness to undergo HIV, hepatitis B \& hepatitis C tests
Exclusion Criteria:
* History of malaria in the past 5 yrs
* Plans to travel outside the Dar-es-salaam or Coast Region in first month (day 0-28) of the study
* Plans to travel to highly malarious areas in the 6 months following the study period
* Previous participation in malaria vaccine study \&/or positive serology for Plasmodium falciparum asexual crude extract antibodies above acceptable cut off established for the site.
* History of arrhythmias or prolonged QT-interval or other cardiac disease
* Positive family history of in the 1st \& 2nd degree relative for cardiac disease \<50 yrs old.
* Volunteers unable to read \& write in English \& give written informed consent
* Previous history of drug or alcohol abuse interfering with normal social function
* A history of psychiatric disease
* The use of chronic immunosuppressive drugs, antibiotics, or other immune modifying drugs within three months of study onset (inhaled \& topical corticosteroids are allowed) \& during the study period
* A history or confirmed sickle cell anemia, sickle cell trait, thalassemia , thalassemia trait or G6PD deficiency
* Co-worker of the Ifakara Health Institute
* Symptoms, physical signs \& laboratory values suggestive of systemic disorders including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, \& other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteers
* History of diabetes mellitus or cancer
* An estimated, ten year risk of fatal cardiovascular disease of \<5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system
* Clinically significant abnormalities in electrocardiogram at screening
* Body Mass Index below 18 or above 30kg/m2
* Any clinically significant deviation from the normal range in biochemistry or hematology blood tests or in urine analysis or electrolytes
* Positive HIV, Hepatitis B virus or Hepatitis C Virus tests
* Participation in any other clinical study within 30 days prior to the onset of the study or during the study period
* Volunteers unable to be closely followed for social, geographic or psychological reasons
* Known hypersensitivity of other contra-indications to Coaterm® or Malarone® including treatment taken by the volunteer that interferes with Coartem® or Malarone®
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including asplenia
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
35 Years
Study:
NCT01540903
Study Brief:
Protocol Section:
NCT01540903