ID

45637

Description

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.

Lien

dbGaP-study=phs001346

Mots-clés

B50.9

11/03/2023 11/03/2023 - Chiara Middel

Détendeur de droits

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

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11 mars 2023

DOI

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Licence

Creative Commons BY 4.0

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

model
Détails

Eligibility Criteria

5 Formulaires

StudyEvent: SEV1

Name

Type

Description | Question | Decode (Coded Value)

Type de données

Alias

IG.elig

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 > 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])

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Lien

Mots-clés

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DOI

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Modèle Commentaires :

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Item commentaires pour :

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

Eligibility Criteria

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