NCT03197597

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 23, 2017

Completed
Last Updated

June 23, 2017

Status Verified

June 1, 2017

Enrollment Period

1.2 years

First QC Date

June 13, 2017

Last Update Submit

June 22, 2017

Conditions

Bordetella Pertussis, Whooping Cough

Keywords

B. pertussisAcellular vaccinationStrain variation

Outcome Measures

Primary Outcomes (3)

  • Vaccine antigen deficient (VAD) B. pertussis clinical isolates

    We screened a panel of 265 B. pertussis clinical isolates collected from 9 European countries. We used previously developed ELISA to measure the antigen expression of pertussis toxin (PT), filamentous haemagglutinin (FHA), pertactin (PRN) and fimbriae 2\&3 (Fim2\&3). In addition, we used sequencing to further characterize the pertactin gene of the bacteria.

    24 months

  • Study of genetic changes in the B. pertussis genomic content measured by specific molecular methods

    We studied genetic changes in the main virulence genes of B. pertussis. We genotyped pertussis toxin promoter (ptxP), pertactin (PRN), fimbriae3 (Fim3) and pertussis toxin subunit A (ptxA). Serotyping of Fimbriae (Fim), Pulsed-Field Gel Electrophoresis (PFGE) and Multiple-Locus Variable number tandem repeat Analysis (MLVA) were used for further genomic analysis.

    24 months

  • Association between vaccine antigen deficient (VAD) B. pertussis clinical isolates and their association to the introduction of acellular pertussis vaccination (ACV)

    We studied the association between the frequency of VAD B. pertussis clinical isolates and their association to the introduction of ACV. Data of vaccination schedules by country and number of VAD isolates were collected and compared.

    24 months

Study Arms (1)

Strain isolation from the nasopharynx

A group of culture positive whooping cough patients.

Other: Strain isolation from the nasopharynx

Interventions

Strain isolation from the nasopharynxOTHER

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

Strain isolation from the nasopharynx

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population consists of pertussis culture positive patients from nine European countries. From this population, B. pertussis clinical isolates are collected and studied.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Turku

Turku, 20014, Finland

Location

Related Publications (8)

  • 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.

    PMID: 23175253BACKGROUND

  • 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.

    PMID: 19666155BACKGROUND

  • 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.

    PMID: 22914363BACKGROUND

  • 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.

    PMID: 19751581BACKGROUND

  • 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.

    PMID: 24925807BACKGROUND

  • 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.

    PMID: 15994109BACKGROUND

  • 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.

    PMID: 18816412BACKGROUND

  • 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.

    PMID: 15956406BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Collection of nasopharyngeal swabs from the human nasopharynx. From the swab, B. pertussis bacteria is isolated and cultured and DNA is studied. However, no human DNA is used in the measurements.

MeSH Terms

Conditions

Whooping Cough

Condition Hierarchy (Ancestors)

Bordetella InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • Qiushui He, MD, PhD

    University of Turku

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 23, 2017

Study Start

October 12, 2015

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

June 23, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)