EUpertstrain 4 Study of Bordetella Pertussis Isolates

NCT ID: NCT03197597

Last Updated: 2017-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

265 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-12

Study Completion Date

2016-12-31

Brief Summary

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This study focus on the genetic changes of B. pertussis clinical isolates. For this panels of B. pertussis isolates has been collected during four periods in different European countries.

Detailed Description

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B. pertussis is considered as a monomorphic pathogen. However, genetic changes have been observed in several antigens (pertussis toxin, pertactin, filamentous haemagglutinin and fimbriae) included in the current acellular pertussis vaccines between vaccine strains and circulating isolates.

To study genetic changes in the B. pertussis populations in Europe, four distinct panels have been collected: EUpert I in 1999-2001 including 102 isolates, EUpert II in 2004-2005 including 154 isolates, EUpert III in 2007-2009 including 140 isolates and EUpert IV in 2012-2015 including 265 isolates. Selection criteria have remained unchanged for all four collections, which enables the opportunity to study changes in B. pertussis populations during the last 15 years.

Conditions

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Bordetella Pertussis, Whooping Cough

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Strain isolation from the nasopharynx

A group of culture positive whooping cough patients.

Strain isolation from the nasopharynx

Intervention Type OTHER

B. pertussis strains has been collected from the nasopharynx of the patients during the clinical visit

Interventions

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Strain isolation from the nasopharynx

B. pertussis strains has been collected from the nasopharynx of the patients during the clinical visit

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* B. pertussis clinical isolates should be collected from subjects from different regions and be epidemiologically unrelated.
* An equal number of isolates from vaccinated and unvaccinated subjects should be collected. Optimally, the isolates are preferred to be selected from individuals less than 5 years of age.
* For countries with large numbers of isolates in their collections, isolates should be randomly selected according to criteria above.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role collaborator

University of Turku

OTHER

Sponsor Role lead

Responsible Party

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Qiushui He

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qiushui He, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Turku

Locations

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University of Turku

Turku, , Finland

Site Status

Countries

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Finland

References

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Advani A, Hallander HO, Dalby T, Krogfelt KA, Guiso N, Njamkepo E, von Konnig CH, Riffelmann M, Mooi FR, Sandven P, Lutynska A, Fry NK, Mertsola J, He Q. Pulsed-field gel electrophoresis analysis of Bordetella pertussis isolates circulating in Europe from 1998 to 2009. J Clin Microbiol. 2013 Feb;51(2):422-8. doi: 10.1128/JCM.02036-12. Epub 2012 Nov 21.

Reference Type BACKGROUND
PMID: 23175253 (View on PubMed)

Bouchez V, Brun D, Cantinelli T, Dore G, Njamkepo E, Guiso N. First report and detailed characterization of B. pertussis isolates not expressing Pertussis Toxin or Pertactin. Vaccine. 2009 Oct 9;27(43):6034-41. doi: 10.1016/j.vaccine.2009.07.074. Epub 2009 Aug 8.

Reference Type BACKGROUND
PMID: 19666155 (View on PubMed)

Barkoff AM, Mertsola J, Guillot S, Guiso N, Berbers G, He Q. Appearance of Bordetella pertussis strains not expressing the vaccine antigen pertactin in Finland. Clin Vaccine Immunol. 2012 Oct;19(10):1703-4. doi: 10.1128/CVI.00367-12. Epub 2012 Aug 22. No abstract available.

Reference Type BACKGROUND
PMID: 22914363 (View on PubMed)

Mooi FR, van Loo IH, van Gent M, He Q, Bart MJ, Heuvelman KJ, de Greeff SC, Diavatopoulos D, Teunis P, Nagelkerke N, Mertsola J. Bordetella pertussis strains with increased toxin production associated with pertussis resurgence. Emerg Infect Dis. 2009 Aug;15(8):1206-13. doi: 10.3201/eid1508.081511.

Reference Type BACKGROUND
PMID: 19751581 (View on PubMed)

Barkoff AM, Guiso N, Guillot S, Xing D, Markey K, Berbers G, Mertsola J, He Q. A rapid ELISA-based method for screening Bordetella pertussis strain production of antigens included in current acellular pertussis vaccines. J Immunol Methods. 2014 Jun;408:142-8. doi: 10.1016/j.jim.2014.06.001. Epub 2014 Jun 10.

Reference Type BACKGROUND
PMID: 24925807 (View on PubMed)

Caro V, Njamkepo E, Van Amersfoorth SC, Mooi FR, Advani A, Hallander HO, He Q, Mertsola J, Riffelmann M, Vahrenholz C, Von Konig CH, Guiso N. Pulsed-field gel electrophoresis analysis of Bordetella pertussis populations in various European countries with different vaccine policies. Microbes Infect. 2005 Jun;7(7-8):976-82. doi: 10.1016/j.micinf.2005.04.005.

Reference Type BACKGROUND
PMID: 15994109 (View on PubMed)

Heikkinen E, Xing DK, Olander RM, Hytonen J, Viljanen MK, Mertsola J, He Q. Bordetella pertussis isolates in Finland: serotype and fimbrial expression. BMC Microbiol. 2008 Sep 25;8:162. doi: 10.1186/1471-2180-8-162.

Reference Type BACKGROUND
PMID: 18816412 (View on PubMed)

van Amersfoorth SC, Schouls LM, van der Heide HG, Advani A, Hallander HO, Bondeson K, von Konig CH, Riffelmann M, Vahrenholz C, Guiso N, Caro V, Njamkepo E, He Q, Mertsola J, Mooi FR. Analysis of Bordetella pertussis populations in European countries with different vaccination policies. J Clin Microbiol. 2005 Jun;43(6):2837-43. doi: 10.1128/JCM.43.6.2837-2843.2005.

Reference Type BACKGROUND
PMID: 15956406 (View on PubMed)

Other Identifiers

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EUpert IV

Identifier Type: -

Identifier Source: org_study_id

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