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Trial record 5 of 305 for:    "Whooping cough"

EUpertstrain 4 Study of Bordetella Pertussis Isolates

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ClinicalTrials.gov Identifier: NCT03197597
Recruitment Status : Completed
First Posted : June 23, 2017
Last Update Posted : June 23, 2017
Sponsor:
Collaborators:
GlaxoSmithKline
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Qiushui He, University of Turku

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.

Condition or disease Intervention/treatment
Bordetella Pertussis, Whooping Cough Other: Strain isolation from the nasopharynx

Detailed Description:

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.


Study Type : Observational
Actual Enrollment : 265 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: EUpertstrain 4 Study of Bordetella Pertussis Isolates
Actual Study Start Date : October 12, 2015
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Strain isolation from the nasopharynx
A group of culture positive whooping cough patients.
Other: Strain isolation from the nasopharynx
B. pertussis strains has been collected from the nasopharynx of the patients during the clinical visit




Primary Outcome Measures :
  1. Vaccine antigen deficient (VAD) B. pertussis clinical isolates [ Time Frame: 24 months ]
    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.

  2. Study of genetic changes in the B. pertussis genomic content measured by specific molecular methods [ Time Frame: 24 months ]
    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.

  3. Association between vaccine antigen deficient (VAD) B. pertussis clinical isolates and their association to the introduction of acellular pertussis vaccination (ACV) [ Time Frame: 24 months ]
    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.


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.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

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.

Exclusion Criteria:

  • There is no strict exclusion criteria for this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03197597


Locations
Finland
University of Turku
Turku, Finland, 20014
Sponsors and Collaborators
University of Turku
GlaxoSmithKline
Sanofi Pasteur, a Sanofi Company
Investigators
Principal Investigator: Qiushui He, MD, PhD University of Turku

Publications:

Responsible Party: Qiushui He, Professor, University of Turku
ClinicalTrials.gov Identifier: NCT03197597     History of Changes
Other Study ID Numbers: EUpert IV
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Qiushui He, University of Turku:
B. pertussis
Acellular vaccination
Strain variation

Additional relevant MeSH terms:
Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases