Comparison of three Plasmodium falciparum isolates in an experimental human malaria infectio

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

1. Age > 18 and < 35 years healthy volunteers (males or females)
2. General good health based on history and clinical examination
3. Negative pregnancy test
4. Use of adequate contraception for females
5. All volunteers have to sign the informed consent form following proper understanding of the meaning and procedures of the study
6. Volunteer agrees to inform the general practitioner and agrees to sign a request for medical information concerning contra-indications for participation in the study
7. Willingness to undergo a Pf sporozoite challenge
8. Agreement to stay in a hotel room close to the trial center during a part of the study (Day 5 till Day T +3)
9. Reachable by mobile phone during the whole study period
10. Available to attend all study visits
11. Agreement to refrain from blood donation to Sanquin or for other purposes, during the course of the study
12. Willingness to undergo an HIV, hepatitis B and C test
13. Negative urine toxicology screening test at screening visit and day before challenge
14. Willingness to take a curative regimen of Malarone®

Exclusion Criteria

1. History of malaria
2. Plans to travel to endemic malaria areas during the study period
3. Plans to travel outside of the Netherlands during day 0-28 of the study
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 arrhythmia*s or prolonged QT-interval
8. Positive family history in 1st and 2nd degree relatives for cardiac disease < 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. Body Mass Index (BMI) below 18 or above 30 kg/m2
11. Any clinically significant deviation from the normal range in biochemistry or haematology blood tests or in urine analysis
12. Positive HIV, HBV or HCV tests
13. Participation in any other clinical study within 30 days prior to the onset of the study
14. Volunteers enrolled in any other clinical study during the study period
15. Pregnant or lactating women
16. Volunteers unable to give written informed consent
17. Volunteers unable to be closely followed for social, geographic or psychological reasons
18. Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study
19. A history of psychiatric disease
20. Known hypersensitivity for anti-malaria drugs
21. History of severe reactions or allergy to mosquito bites
22. The use of chronic immunosuppressive drugs, antibiotics, or other immune modifying drugs within three months before study onset (inhaled and topical corticosteroids are allowed) and during the study period
23. Contra-indications to Malarone® including treatment taken by the volunteers that interfere with Malarone®
24. Any confirmed or suspected immunosuppressive or immunodeficiency condition, including asplenia
25. Co-workers of the departments of Medical Microbiology or Internal Medicine of the Radboud University Nijmegen Medical Centre or Leiden University Medical Center
26. A history of sickle cell, thalasaemia trait and G6PD deficiency

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A significant difference in kinetics of parasitemia between groups A, B and C.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Mean time to thick smear positivity in groups A, B and C<br /><br>• Mean duration of parasitemia and peak height of parasitemia as measured by<br /><br>PCR in groups A, B and C<br /><br>• Mean frequency of signs or symptoms in groups A, B and C<br /><br>• Significant differences in antibody production between<br /><br>groups A, B and C<br /><br>• Significant differences in cellular immune response between groups A, B and C<br /><br>• Significant differences in memory cytokine profile between groups A, B and C</p><br>