NCT03197597|Completed
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Sponsor study identifier
observational
265
1 country
1
Study Start
October 12, 2015
Actual (reported)Primary Completion
December 31, 2016
Actual (reported)Study Completion
December 31, 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 12, 2015
Actual (reported)December 31, 2016
Actual (reported)December 31, 2016
Actual (reported)June 13, 2017
Actual (reported)June 23, 2017
Actual (reported)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
A group of culture positive whooping cough patients.
B. pertussis strains has been collected from the nasopharynx of the patients during the clinical visit
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Study population consists of pertussis culture positive patients from nine European countries. From this population, B. pertussis clinical isolates are collected and studied.
University of Turku
Turku, 20014, Finland
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.
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.
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.
Qiushui He, MD, PhD
University of Turku
265 participants (actual enrollment reported by the registry).
First Submitted
June 13, 2017
First Posted
June 23, 2017
Study Start
October 12, 2015
Actual (reported)Pertussis Challenge Study in Adults Vaccinated With BPZE1
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
Primary Completion
December 31, 2016
Actual (reported)Study Completion
December 31, 2016
Actual (reported)Last Updated
June 23, 2017
Record last verified: 2017-06
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