ID

45637

Descrizione

Principal Investigator: Hernan A. Lorenzi, PhD, The J. Craig Venter Insititute, Rockville, MD, USA MeSH: Malaria,Malaria, Falciparum,Malaria Vaccines,Transcriptome,Gene Expression Profiling https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001346 Description: Experimental exposure to malaria parasites can lead to development of protective immunity, providing a foothold for the development of a malaria vaccine. The goal of this study is to investigate immune transcriptional profiles associated with malaria protective immune responses induced by experimental Chemo-Prophylaxis and Sporozoites (CPS) immunization of P. *falciparum*-naive human volunteers. Samples for this study were obtained from a CPS-immunization study conducted in 2011 (ClinicalTrials.gov Identifier: NCT01218893), where healthy volunteers received CPS-immunization with bites from different numbers of P. *falciparum*-infected mosquitoes (three times 15 (n=5), 10 (n=9) or 5 (n=10)). Five control subjects received uninfected mosquito bites under chloroquine prophylaxis. Fifteen weeks after discontinuation of chloroquine prophylaxis, all volunteers were challenged by exposure to infected mosquito bites. Study Design: A maximum of 30 volunteers were divided into four groups. All volunteers received weekly chloroquine prophylaxis for a period of 13 weeks (91 days). During these 13 weeks, on days 8, 36 and 64 they were exposed to the bites of 15 mosquitoes. Group 1 (n=5, positive control) received three CPS immunizations by 15 mosquitoes infected with P. falciparum sporozoites. Group 2 (n=10) received three times 10 bites from infected mosquitoes and 5 bites from uninfected mosquitoes. Group 3 (n=10) received three times 5 bites from infected mosquitoes and 10 bites from uninfected mosquitoes. Group 4 (n=5), the negative control, received three placebo immunizations with 15 bites of uninfected mosquitoes. Fifteen weeks after discontinuation of chloroquine prophylaxis, all 30 volunteers were challenged at day 196 by the bites of 5 infectious mosquitoes and followed for 21 days. All subjects were treated with chloroquine 21 days after challenge or whenever they had a positive thick smear during that period.

collegamento

dbGaP-study=phs001346

Keywords

  1. 11/03/23 11/03/23 - Chiara Middel
Titolare del copyright

Hernan A. Lorenzi, PhD, The J. Craig Venter Insititute, Rockville, MD, USA

Caricato su

11 marzo 2023

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0

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dbGaP phs001346 Human Gene Expression Patterns Associated with Experimental P. falciparum Infection

Eligibility Criteria

Inclusion and exclusion criteria
Descrizione

Inclusion and exclusion criteria

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
Inclusion criteria:
Descrizione

Elig.phs001346.v1.p1.1

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1512693
Age > 18 and < 35 years healthy volunteers, males or females
Descrizione

Elig.phs001346.v1.p1.2

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1708335
UMLS CUI [1,3]
C0079399
Good health based on history and clinical examination
Descrizione

Elig.phs001346.v1.p1.3

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0517226
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0031809
Negative pregnancy test
Descrizione

Elig.phs001346.v1.p1.4

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0427780
Use of adequate contraception for females
Descrizione

Elig.phs001346.v1.p1.5

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0205411
UMLS CUI [1,2]
C0700589
All volunteers must sign the informed consent form demonstrating their understanding of the meaning and procedures of the study
Descrizione

Elig.phs001346.v1.p1.6

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C2348563
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
Descrizione

Elig.phs001346.v1.p1.7

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1511481
UMLS CUI [1,3]
C0017319
UMLS CUI [1,4]
C1301624
UMLS CUI [1,5]
C2348568
Willingness to undergo a P. falciparum mosquito challenge
Descrizione

Elig.phs001346.v1.p1.8

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0600109
UMLS CUI [1,2]
C0032150
UMLS CUI [1,3]
C0805586
UMLS CUI [1,4]
C4520766
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
Descrizione

Elig.phs001346.v1.p1.9

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0600109
UMLS CUI [1,2]
C2982691
UMLS CUI [1,3]
C0442514
UMLS CUI [1,4]
C2825164
UMLS CUI [1,5]
C0017446
UMLS CUI [1,6]
C0205390
UMLS CUI [1,7]
C0008976
Reachable 24/7j by mobile phone during the whole study period
Descrizione

Elig.phs001346.v1.p1.10

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0039457
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0008976
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
Descrizione

Elig.phs001346.v1.p1.11

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1443355
UMLS CUI [1,2]
C2184147
UMLS CUI [1,3]
C0557130
UMLS CUI [1,4]
C0557128
UMLS CUI [1,5]
C0332158
UMLS CUI [1,6]
C0031831
UMLS CUI [1,7]
C0392747
UMLS CUI [1,8]
C0234425
UMLS CUI [2,1]
C0600109
UMLS CUI [2,2]
C2982691
UMLS CUI [2,3]
C0442514
UMLS CUI [2,4]
C2825164
UMLS CUI [2,5]
C0017446
UMLS CUI [2,6]
C0205390
UMLS CUI [2,7]
C0008976
Available to attend all study visits
Descrizione

Elig.phs001346.v1.p1.12

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0444868
UMLS CUI [1,4]
C4684786
Agreement to refrain from blood donation to Sanquin or for other purposes, during the study period until day 337
Descrizione

Elig.phs001346.v1.p1.13

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0680240
UMLS CUI [1,2]
C3843422
UMLS CUI [1,3]
C0005794
UMLS CUI [1,4]
C0347984
UMLS CUI [1,5]
C2347804
Willingness to undergo HIV, hepatitis B and hepatitis C tests
Descrizione

Elig.phs001346.v1.p1.14

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0600109
UMLS CUI [1,2]
C0019693
UMLS CUI [1,3]
C0019163
UMLS CUI [1,4]
C0019196
UMLS CUI [1,5]
C0587081
Negative urine toxicology screening test at screening visit and day before challenge
Descrizione

Elig.phs001346.v1.p1.15

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0205160
UMLS CUI [1,2]
C0202274
UMLS CUI [1,3]
C1320303
UMLS CUI [1,4]
C2097637
UMLS CUI [1,5]
C0439228
UMLS CUI [1,6]
C0332152
UMLS CUI [1,7]
C0805586
Willingness to take a prophylactic regime of chloroquine and curative regimen of Malarone~
Descrizione

Elig.phs001346.v1.p1.16

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0600109
UMLS CUI [1,2]
C0199176
UMLS CUI [1,3]
C0008269
UMLS CUI [1,4]
C1276305
UMLS CUI [1,5]
C1276413
UMLS CUI [1,6]
C0595490
Exclusion criteria:
Descrizione

Elig.phs001346.v1.p1.17

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0680251
History of malaria
Descrizione

Elig.phs001346.v1.p1.18

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0024530
Plans to travel to malaria endemic areas during the study period
Descrizione

Elig.phs001346.v1.p1.19

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1301732
UMLS CUI [1,2]
C0040802
UMLS CUI [1,3]
C0024530
UMLS CUI [1,4]
C0017446
UMLS CUI [1,5]
C0277550
UMLS CUI [1,6]
C0347984
UMLS CUI [1,7]
C2348563
UMLS CUI [1,8]
C1948053
Plans to travel outside of the Netherlands during the challenge period
Descrizione

Elig.phs001346.v1.p1.20

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1301732
UMLS CUI [1,2]
C0040802
UMLS CUI [1,3]
C3846158
UMLS CUI [1,4]
C0027778
UMLS CUI [1,5]
C0347984
UMLS CUI [1,6]
C0805586
UMLS CUI [1,7]
C2347804
Previous participation in any malaria vaccine study and/or positive serology for Pf
Descrizione

Elig.phs001346.v1.p1.21

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C1519888
UMLS CUI [1,5]
C0024530
UMLS CUI [2,1]
C0242089
UMLS CUI [2,2]
C0032150
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
Descrizione

Elig.phs001346.v1.p1.22

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C1254595
UMLS CUI [1,3]
C0332299
UMLS CUI [1,4]
C0442893
UMLS CUI [1,5]
C0022658
UMLS CUI [1,6]
C0023895
UMLS CUI [1,7]
C0007222
UMLS CUI [1,8]
C0024115
UMLS CUI [1,9]
C1719933
UMLS CUI [1,10]
C0021051
UMLS CUI [1,11]
C0004936
UMLS CUI [1,12]
C3843040
UMLS CUI [1,13]
C0521102
UMLS CUI [1,14]
C0459471
UMLS CUI [1,15]
C0683954
UMLS CUI [1,16]
C2945640
UMLS CUI [1,17]
C1113679
History of diabetes mellitus or cancer except basal cell carcinoma of the skin
Descrizione

Elig.phs001346.v1.p1.23

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0011849
UMLS CUI [1,3]
C0006826
UMLS CUI [1,4]
C1705847
UMLS CUI [1,5]
C0007117
History of arrhythmias or prolonged QT-interval
Descrizione

Elig.phs001346.v1.p1.24

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0003811
UMLS CUI [1,3]
C0151878
Positive family history in 1st and 2nd degree relatives for cardiac disease < 50 years old
Descrizione

Elig.phs001346.v1.p1.25

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1446409
UMLS CUI [1,2]
C0241889
UMLS CUI [1,3]
C1517194
UMLS CUI [1,4]
C1519210
UMLS CUI [1,5]
C0018799
An estimated, ten year risk of fatal cardiovascular disease of >5%, as estimated by the Systematic Coronary Risk Evaluation SCORE system
Descrizione

Elig.phs001346.v1.p1.26

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0750572
UMLS CUI [1,2]
C0332167
UMLS CUI [1,3]
C1320716
UMLS CUI [1,4]
C1822568
Clinically significant abnormalities in electrocardiogram ECG at screening
Descrizione

Elig.phs001346.v1.p1.27

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2985739
UMLS CUI [1,2]
C0522055
UMLS CUI [1,3]
C1710477
Body Mass Index BMI below 18 or above 30 kg/m<sup>2</sup>
Descrizione

Elig.phs001346.v1.p1.28

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1305855
Any clinically significant deviation from the normal range in biochemistry or hematology blood tests or in urine analysis
Descrizione

Elig.phs001346.v1.p1.29

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2985739
UMLS CUI [1,2]
C0587081
UMLS CUI [1,3]
C0005477
UMLS CUI [1,4]
C0474523
UMLS CUI [1,5]
C0042014
Positive HIV, HBV or HCV tests
Descrizione

Elig.phs001346.v1.p1.30

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0019699
UMLS CUI [1,2]
C0149709
UMLS CUI [1,3]
C1112419
Participation in any other clinical study within 30 days prior to the onset of the study
Descrizione

Elig.phs001346.v1.p1.31

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0332152
UMLS CUI [1,5]
C0808070
UMLS CUI [1,6]
C0008976
EnroAment in any other clinical study during the study period
Descrizione

Elig.phs001346.v1.p1.32

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0681814
UMLS CUI [1,4]
C0347984
UMLS CUI [1,5]
C2347804
Pregnant or lactating women
Descrizione

Elig.phs001346.v1.p1.33

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
Volunteers unable to give written informed consent
Descrizione

Elig.phs001346.v1.p1.34

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
Volunteers unable to be closely followed for social, geographic or psychological reasons
Descrizione

Elig.phs001346.v1.p1.35

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C3274571
UMLS CUI [1,3]
C0017444
UMLS CUI [1,4]
C0337460
UMLS CUI [1,5]
C0033898
History of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study
Descrizione

Elig.phs001346.v1.p1.36

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0085762
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0205307
UMLS CUI [1,5]
C0815198
UMLS CUI [1,6]
C1948053
UMLS CUI [1,7]
C0332152
UMLS CUI [1,8]
C1516879
UMLS CUI [1,9]
C0008976
A history of psychiatric disease
Descrizione

Elig.phs001346.v1.p1.37

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0455498
Known hypersensitivity to Malarone&#126; or chloroquine
Descrizione

Elig.phs001346.v1.p1.38

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0595490
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0008269
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
Descrizione

Elig.phs001346.v1.p1.39

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0021081
UMLS CUI [1,4]
C0003232
UMLS CUI [1,5]
C3846158
UMLS CUI [1,6]
C0332152
UMLS CUI [1,7]
C4684789
UMLS CUI [2,1]
C2065041
UMLS CUI [2,2]
C4050091
UMLS CUI [2,3]
C1298908
UMLS CUI [2,4]
C0680251
Contra-indications to Malarone&#126; or chloroquine including treatment taken by the volunteer that interferes with Malarone&#126; or chloroquine
Descrizione

Elig.phs001346.v1.p1.40

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0595490
UMLS CUI [1,3]
C0008269
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0595490
UMLS CUI [2,4]
C0008269
Any confirmed or suspected immunosuppressive or immunodeficient condition, including asplenia
Descrizione

Elig.phs001346.v1.p1.41

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0242114
UMLS CUI [1,3]
C0021051
UMLS CUI [1,4]
C4048329
UMLS CUI [1,5]
C0600031
UMLS CUI [1,6]
C4523973
Co-workers or trainees of the departments of Medical Microbiology, Parasitology, or Internal Medicine of the Leiden University medical Centre
Descrizione

Elig.phs001346.v1.p1.42

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3842307
UMLS CUI [1,2]
C0040605
UMLS CUI [1,3]
C0037778
UMLS CUI [1,4]
C1274022
UMLS CUI [1,5]
C0565990
A history of sickle cell anemia, sickle cell trait, thalassemia, thalassemia trait or G6PD deficiency
Descrizione

Elig.phs001346.v1.p1.43

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0018939
UMLS CUI [1,3]
C0002895
UMLS CUI [1,4]
C0037054
UMLS CUI [1,5]
C0039730
UMLS CUI [1,6]
C2939465

Similar models

Eligibility Criteria

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Elig.phs001346.v1.p1.1
Item
Inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
Elig.phs001346.v1.p1.2
Item
Age &#62; 18 and &#60; 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&#126;
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 &#60; 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 &#62;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&#126; 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&#126; or chloroquine including treatment taken by the volunteer that interferes with Malarone&#126; 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])

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