Controlled human malaria infection after immunization with cryopreserved Plasmodium falciparum sporozoites under chloroquine prophylaxis

Sanaria Inc.0 sitesFebruary 27, 2015

Overview

No summary available.

Registry

who.int

Start Date

February 27, 2015

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Healthy volunteers (males or females) of \= 18 and \= 35 years of age
•2\.Good health based on history and clinical examination (physical examination and laboratory screening)
•3\.Negative pregnancy test
•4\.Use of adequate contraception for females
•5\.Signing of the informed consent form, thereby demonstrating understanding of the meaning and procedures of the study
•6\.Agreement to inform the general practitioner and to sign a request to release medical information concerning contraindications for participation in the study
•7\.Willingness to undergo administration of PfSPZ Challenge by needle and syringe and willingness to undergo challenge by mosquito bites
•8\.For volunteers not living in Nijmegen: agreement to stay in a hotel room close to the trial centre or living in Nijmegen with a third party that could contact the clinicians in case of alteration of consciousness during a part of the study (day 5 after challenge until treatment is finished)
•9\.Reachable (24/7\) by mobile phone during the whole study period
•10\.For volunteers living in Nijmegen: living with a third party that could contact the clinicians in case of alteration of consciousness or agreement to stay in a hotel room close to the trial centre during a part of the study (day 5 after challenge until treatment is finished)

•1\.History of malaria
•2\.Plans to travel to malaria endemic areas during the study period
•3\.Plans to travel outside of the Netherlands during the challenge period
•4\.Previous participation in any malaria vaccine study and/or positive serology for Pf
•5\.Symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, and other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteers
•6\.History of diabetes mellitus or cancer (except basal cell carcinoma of the skin)
•7\.History of arrhythmias or prolonged QT\-interval
•8\.Positive family history of 1st and/or 2nd degree relatives who experienced cardiac events when \< 50 years old
•9\.An estimated, ten year risk of fatal cardiovascular disease of \=5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system
•10\.Clinically significant abnormalities in electrocardiogram (ECG) at screening