Bordetella Pertussis, Whooping Cough Clinical Trial
Official title:
EUpertstrain 4 Study of Bordetella Pertussis Isolates
Verified date | June 2017 |
Source | University of Turku |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 265 |
Est. completion date | December 31, 2016 |
Est. primary completion date | December 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Finland | University of Turku | Turku |
Lead Sponsor | Collaborator |
---|---|
University of Turku | GlaxoSmithKline, Sanofi Pasteur, a Sanofi Company |
Finland,
Advani A, Hallander HO, Dalby T, Krogfelt KA, Guiso N, Njamkepo E, von Könnig 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. — View Citation
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. — View Citation
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. Epub 2012 Aug 22. — View Citation
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. — View Citation
Caro V, Njamkepo E, Van Amersfoorth SC, Mooi FR, Advani A, Hallander HO, He Q, Mertsola J, Riffelmann M, Vahrenholz C, Von König 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. — View Citation
Heikkinen E, Xing DK, Olander RM, Hytönen 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. — View Citation
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. — View Citation
van Amersfoorth SC, Schouls LM, van der Heide HG, Advani A, Hallander HO, Bondeson K, von König 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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