Status:
COMPLETED
Immunization With Plasmodium Falciparum Sporozoites Under Chloroquine Versus Mefloquine Prophylaxis
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Malaria
Plasmodium Falciparum
Eligibility:
All Genders
18-35 years
Phase:
NA
Brief Summary
Malaria is one of the major infectious diseases in the world with a tremendous impact on the quality of life, significantly contributing to the ongoing poverty in endemic countries. It causes 800.000 ...
Eligibility Criteria
Inclusion
- Age \> 18 and \< 35 years healthy volunteers (males or females)
- Good health based on history and clinical examination
- Negative pregnancy test
- Use of adequate contraception for females
- Signing of the informed consent form, thereby demonstrating understanding of the meaning and procedures of the study
- Agreement to inform the general practitioner and to sign a request to release medical information concerning contra-indications for participation in the study
- Willingness to undergo a Pf controlled infection through mosquito bites
- Agreement to stay in a hotel room close to the trial center during a part of the study (Day 5 after challenge till treatment is finished)
- Reachable (24/7) by mobile phone during the whole study period
- Available to attend all study visits
- Agreement to refrain from blood donation to Sanquin or for other purposes, during the whole study period
- Willingness to undergo HIV, hepatitis B and hepatitis C tests
- Negative urine toxicology screening test at screening visit and the day before challenge
- Willingness to take a prophylactic regime of chloroquine or mefloquine and curative regimen of Malarone®
Exclusion
- History of malaria
- Plans to travel to malaria endemic areas during the study period
- Plans to travel outside of the Netherlands during the challenge period
- Previous participation in any malaria vaccine study and/or positive serology for Pf
- 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
- History of diabetes mellitus or cancer (except basal cell carcinoma of the skin)
- History of arrhythmias or prolonged QT-interval
- Positive family history in 1st and 2nd degree relatives for cardiac events \< 50 years old
- 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 (ECG) at screening
- Body Mass Index (BMI) below 20 or above 30 kg/m2
- Any clinically significant deviation from the normal range in biochemistry or hematology blood tests or in urine analysis
- Positive HIV, HBV or HCV tests
- Participation in any other clinical study within 30 days prior to the onset of the study
- Enrollment in any other clinical study during the study period
- For women: pregnancy or lactation
- Volunteers unable to give written informed consent
- Volunteers unable to be closely followed for social, geographic or psychological reasons
- History of drug or alcohol abuse interfering with normal social function
- A history of treatment for psychiatric disease or moderate or severe psychological episode in volunteer
- A history of convulsions in volunteer
- Severe depression, anxiety disorder of psychosis in first or second degree family
- Contra-indications to Malarone®, chloroquine or mefloquine including hypersensitivity or treatment taken by the volunteer that interferes with Malarone®, chloroquine or mefloquine
- The use of chronic immunosuppressive drugs, antibiotics, or other immune modifying drugs within three months of study onset (inhaled and topical corticosteroids and oral anti-histaminic are allowed) and during the study period
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including asplenia
- Co-workers or trainees of the departments of Medical Microbiology, Parasitology, or Internal Medicine of the Leiden University medical Centre
- A history of sickle cell anemia, sickle cell trait, thalassemia, thalassemia trait or G6PD deficiency
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01422954
Start Date
January 1 2012
End Date
April 1 2013
Last Update
April 29 2013
Active Locations (1)
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1
Leiden University Medical Centre
Leiden, Netherlands, 2333 ZA