EUpertstrain 4 Study of Bordetella Pert… | Clinical Trial

Key information

Conditions

Bordetella Pertussis, Whooping Cough Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Gram-Negative Bacterial Infections Infections Respiratory Tract Diseases Respiratory Tract Infections Whooping Cough

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Turku

Turku, 20014, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strain isolation from the nasopharynx

Other

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

Primary outcomes

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.
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.
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.

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Collaborators

GlaxoSmithKline
Sanofi Pasteur, a Sanofi Company

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Jun 23, 2017
Registry last updated: Jun 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed