Elig.phs001346.v1.p1.1
Item
Inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
Elig.phs001346.v1.p1.2
Item
Age > 18 and < 35 years healthy volunteers, males or females
boolean
C0001779 (UMLS CUI [1,1])
C1708335 (UMLS CUI [1,2])
C0079399 (UMLS CUI [1,3])
Elig.phs001346.v1.p1.3
Item
Good health based on history and clinical examination
boolean
C0517226 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
Elig.phs001346.v1.p1.4
Item
Negative pregnancy test
boolean
C0427780 (UMLS CUI [1,1])
Elig.phs001346.v1.p1.5
Item
Use of adequate contraception for females
boolean
C0205411 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Elig.phs001346.v1.p1.6
Item
All volunteers must sign the informed consent form demonstrating their understanding of the meaning and procedures of the study
boolean
C0021430 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Elig.phs001346.v1.p1.7
Item
Volunteer agrees to inform the general practitioner and agrees to sign a request to release medical information concerning contra-indications for participation in the study
boolean
C0030705 (UMLS CUI [1,1])
C1511481 (UMLS CUI [1,2])
C0017319 (UMLS CUI [1,3])
C1301624 (UMLS CUI [1,4])
C2348568 (UMLS CUI [1,5])
Elig.phs001346.v1.p1.8
Item
Willingness to undergo a P. falciparum mosquito challenge
boolean
C0600109 (UMLS CUI [1,1])
C0032150 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C4520766 (UMLS CUI [1,4])
Elig.phs001346.v1.p1.9
Item
For volunteers not living in Leiden: agreement to stay in a hotel room close to the trial center during a part of the study Day 5 after challenge till 3 days after treatment
boolean
C0600109 (UMLS CUI [1,1])
C2982691 (UMLS CUI [1,2])
C0442514 (UMLS CUI [1,3])
C2825164 (UMLS CUI [1,4])
C0017446 (UMLS CUI [1,5])
C0205390 (UMLS CUI [1,6])
C0008976 (UMLS CUI [1,7])
Elig.phs001346.v1.p1.10
Item
Reachable 24/7j by mobile phone during the whole study period
boolean
C0470187 (UMLS CUI [1,1])
C0039457 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
Elig.phs001346.v1.p1.11
Item
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 center during a part of the study Day 5 after challenge till 3 days after treatment
boolean
C1443355 (UMLS CUI [1,1])
C2184147 (UMLS CUI [1,2])
C0557130 (UMLS CUI [1,3])
C0557128 (UMLS CUI [1,4])
C0332158 (UMLS CUI [1,5])
C0031831 (UMLS CUI [1,6])
C0392747 (UMLS CUI [1,7])
C0234425 (UMLS CUI [1,8])
C0600109 (UMLS CUI [2,1])
C2982691 (UMLS CUI [2,2])
C0442514 (UMLS CUI [2,3])
C2825164 (UMLS CUI [2,4])
C0017446 (UMLS CUI [2,5])
C0205390 (UMLS CUI [2,6])
C0008976 (UMLS CUI [2,7])
Elig.phs001346.v1.p1.12
Item
Available to attend all study visits
boolean
C0470187 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0444868 (UMLS CUI [1,3])
C4684786 (UMLS CUI [1,4])
Elig.phs001346.v1.p1.13
Item
Agreement to refrain from blood donation to Sanquin or for other purposes, during the study period until day 337
boolean
C0680240 (UMLS CUI [1,1])
C3843422 (UMLS CUI [1,2])
C0005794 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C2347804 (UMLS CUI [1,5])
Elig.phs001346.v1.p1.14
Item
Willingness to undergo HIV, hepatitis B and hepatitis C tests
boolean
C0600109 (UMLS CUI [1,1])
C0019693 (UMLS CUI [1,2])
C0019163 (UMLS CUI [1,3])
C0019196 (UMLS CUI [1,4])
C0587081 (UMLS CUI [1,5])
Elig.phs001346.v1.p1.15
Item
Negative urine toxicology screening test at screening visit and day before challenge
boolean
C0205160 (UMLS CUI [1,1])
C0202274 (UMLS CUI [1,2])
C1320303 (UMLS CUI [1,3])
C2097637 (UMLS CUI [1,4])
C0439228 (UMLS CUI [1,5])
C0332152 (UMLS CUI [1,6])
C0805586 (UMLS CUI [1,7])
Elig.phs001346.v1.p1.16
Item
Willingness to take a prophylactic regime of chloroquine and curative regimen of Malarone~
boolean
C0600109 (UMLS CUI [1,1])
C0199176 (UMLS CUI [1,2])
C0008269 (UMLS CUI [1,3])
C1276305 (UMLS CUI [1,4])
C1276413 (UMLS CUI [1,5])
C0595490 (UMLS CUI [1,6])
Elig.phs001346.v1.p1.17
Item
Exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
Elig.phs001346.v1.p1.18
Item
History of malaria
boolean
C0262926 (UMLS CUI [1,1])
C0024530 (UMLS CUI [1,2])
Elig.phs001346.v1.p1.19
Item
Plans to travel to malaria endemic areas during the study period
boolean
C1301732 (UMLS CUI [1,1])
C0040802 (UMLS CUI [1,2])
C0024530 (UMLS CUI [1,3])
C0017446 (UMLS CUI [1,4])
C0277550 (UMLS CUI [1,5])
C0347984 (UMLS CUI [1,6])
C2348563 (UMLS CUI [1,7])
C1948053 (UMLS CUI [1,8])
Elig.phs001346.v1.p1.20
Item
Plans to travel outside of the Netherlands during the challenge period
boolean
C1301732 (UMLS CUI [1,1])
C0040802 (UMLS CUI [1,2])
C3846158 (UMLS CUI [1,3])
C0027778 (UMLS CUI [1,4])
C0347984 (UMLS CUI [1,5])
C0805586 (UMLS CUI [1,6])
C2347804 (UMLS CUI [1,7])
Elig.phs001346.v1.p1.21
Item
Previous participation in any malaria vaccine study and/or positive serology for Pf
boolean
C2348568 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1519888 (UMLS CUI [1,4])
C0024530 (UMLS CUI [1,5])
C0242089 (UMLS CUI [2,1])
C0032150 (UMLS CUI [2,2])
Elig.phs001346.v1.p1.22
Item
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
boolean
C0037088 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C0332299 (UMLS CUI [1,3])
C0442893 (UMLS CUI [1,4])
C0022658 (UMLS CUI [1,5])
C0023895 (UMLS CUI [1,6])
C0007222 (UMLS CUI [1,7])
C0024115 (UMLS CUI [1,8])
C1719933 (UMLS CUI [1,9])
C0021051 (UMLS CUI [1,10])
C0004936 (UMLS CUI [1,11])
C3843040 (UMLS CUI [1,12])
C0521102 (UMLS CUI [1,13])
C0459471 (UMLS CUI [1,14])
C0683954 (UMLS CUI [1,15])
C2945640 (UMLS CUI [1,16])
C1113679 (UMLS CUI [1,17])
Elig.phs001346.v1.p1.23
Item
History of diabetes mellitus or cancer except basal cell carcinoma of the skin
boolean
C0262926 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C1705847 (UMLS CUI [1,4])
C0007117 (UMLS CUI [1,5])
Elig.phs001346.v1.p1.24
Item
History of arrhythmias or prolonged QT-interval
boolean
C0262926 (UMLS CUI [1,1])
C0003811 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
Elig.phs001346.v1.p1.25
Item
Positive family history in 1st and 2nd degree relatives for cardiac disease < 50 years old
boolean
C1446409 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C1517194 (UMLS CUI [1,3])
C1519210 (UMLS CUI [1,4])
C0018799 (UMLS CUI [1,5])
Elig.phs001346.v1.p1.26
Item
An estimated, ten year risk of fatal cardiovascular disease of >5%, as estimated by the Systematic Coronary Risk Evaluation SCORE system
boolean
C0750572 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C1320716 (UMLS CUI [1,3])
C1822568 (UMLS CUI [1,4])
Elig.phs001346.v1.p1.27
Item
Clinically significant abnormalities in electrocardiogram ECG at screening
boolean
C2985739 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,3])
Elig.phs001346.v1.p1.28
Item
Body Mass Index BMI below 18 or above 30 kg/m<sup>2</sup>
boolean
C1305855 (UMLS CUI [1,1])
Elig.phs001346.v1.p1.29
Item
Any clinically significant deviation from the normal range in biochemistry or hematology blood tests or in urine analysis
boolean
C2985739 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0005477 (UMLS CUI [1,3])
C0474523 (UMLS CUI [1,4])
C0042014 (UMLS CUI [1,5])
Elig.phs001346.v1.p1.30
Item
Positive HIV, HBV or HCV tests
boolean
C0019699 (UMLS CUI [1,1])
C0149709 (UMLS CUI [1,2])
C1112419 (UMLS CUI [1,3])
Elig.phs001346.v1.p1.31
Item
Participation in any other clinical study within 30 days prior to the onset of the study
boolean
C2348568 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0808070 (UMLS CUI [1,5])
C0008976 (UMLS CUI [1,6])
Elig.phs001346.v1.p1.32
Item
EnroAment in any other clinical study during the study period
boolean
C2348568 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0681814 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C2347804 (UMLS CUI [1,5])
Elig.phs001346.v1.p1.33
Item
Pregnant or lactating women
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Elig.phs001346.v1.p1.34
Item
Volunteers unable to give written informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Elig.phs001346.v1.p1.35
Item
Volunteers unable to be closely followed for social, geographic or psychological reasons
boolean
C1299582 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C0017444 (UMLS CUI [1,3])
C0337460 (UMLS CUI [1,4])
C0033898 (UMLS CUI [1,5])
Elig.phs001346.v1.p1.36
Item
History of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study
boolean
C0038586 (UMLS CUI [1,1])
C0085762 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0205307 (UMLS CUI [1,4])
C0815198 (UMLS CUI [1,5])
C1948053 (UMLS CUI [1,6])
C0332152 (UMLS CUI [1,7])
C1516879 (UMLS CUI [1,8])
C0008976 (UMLS CUI [1,9])
Elig.phs001346.v1.p1.37
Item
A history of psychiatric disease
boolean
C0455498 (UMLS CUI [1,1])
Elig.phs001346.v1.p1.38
Item
Known hypersensitivity to Malarone~ or chloroquine
boolean
C0020517 (UMLS CUI [1,1])
C0595490 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0008269 (UMLS CUI [2,2])
Elig.phs001346.v1.p1.39
Item
The use of chronic immunosuppressive drugs, antibiotics, or other immune modifying drugs within three months of study onset inhaled and topical corticosteroids are allowed and during the study period
boolean
C1524063 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0021081 (UMLS CUI [1,3])
C0003232 (UMLS CUI [1,4])
C3846158 (UMLS CUI [1,5])
C0332152 (UMLS CUI [1,6])
C4684789 (UMLS CUI [1,7])
C2065041 (UMLS CUI [2,1])
C4050091 (UMLS CUI [2,2])
C1298908 (UMLS CUI [2,3])
C0680251 (UMLS CUI [2,4])
Elig.phs001346.v1.p1.40
Item
Contra-indications to Malarone~ or chloroquine including treatment taken by the volunteer that interferes with Malarone~ or chloroquine
boolean
C1301624 (UMLS CUI [1,1])
C0595490 (UMLS CUI [1,2])
C0008269 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0595490 (UMLS CUI [2,3])
C0008269 (UMLS CUI [2,4])
Elig.phs001346.v1.p1.41
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, including asplenia
boolean
C0750484 (UMLS CUI [1,1])
C0242114 (UMLS CUI [1,2])
C0021051 (UMLS CUI [1,3])
C4048329 (UMLS CUI [1,4])
C0600031 (UMLS CUI [1,5])
C4523973 (UMLS CUI [1,6])
Elig.phs001346.v1.p1.42
Item
Co-workers or trainees of the departments of Medical Microbiology, Parasitology, or Internal Medicine of the Leiden University medical Centre
boolean
C3842307 (UMLS CUI [1,1])
C0040605 (UMLS CUI [1,2])
C0037778 (UMLS CUI [1,3])
C1274022 (UMLS CUI [1,4])
C0565990 (UMLS CUI [1,5])
Elig.phs001346.v1.p1.43
Item
A history of sickle cell anemia, sickle cell trait, thalassemia, thalassemia trait or G6PD deficiency
boolean
C0262926 (UMLS CUI [1,1])
C0018939 (UMLS CUI [1,2])
C0002895 (UMLS CUI [1,3])
C0037054 (UMLS CUI [1,4])
C0039730 (UMLS CUI [1,5])
C2939465 (UMLS CUI [1,6])