EUpertstrain 4 Study of Bordetella Pertussis Isolates
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03197597|
Recruitment Status : Completed
First Posted : June 23, 2017
Last Update Posted : June 23, 2017
|Condition or disease||Intervention/treatment|
|Bordetella Pertussis, Whooping Cough||Other: Strain isolation from the nasopharynx|
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|
|Official Title:||EUpertstrain 4 Study of Bordetella Pertussis Isolates|
|Actual Study Start Date :||October 12, 2015|
|Primary Completion Date :||December 31, 2016|
|Study Completion Date :||December 31, 2016|
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
- 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.
Biospecimen Retention: Samples With DNA
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
|University of Turku|
|Turku, Finland, 20014|
|Principal Investigator:||Qiushui He, MD, PhD||University of Turku|