Bordetella Pertussis, Whooping CoughNCT03197597
EUpertstrain 4 Study of Bordetella Pertussis Isolates
An observational study of Bordetella Pertussis, Whooping Cough, run by University of Turku at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bordetella Pertussis, Whooping Cough
- What is being tested?
- Strain isolation from the nasopharynx
- How many people
- 265 participants
- Where
- 1 siteFinland
- Study dates
- 12 Oct 2015to 31 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- There is no strict exclusion criteria for this study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
- 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.
- Conditions
- Bordetella Pertussis, Whooping Cough
- Being tested
- Strain isolation from the nasopharynx
- Keywords
- B. pertussis, Acellular vaccination, Strain variation
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strain isolation from the nasopharynxOther
- pertussis strains has been collected from the nasopharynx of the patients during the clinical visit
| Study group | Role | What they receive |
|---|---|---|
| Strain isolation from the nasopharynx | A group of culture positive whooping cough patients. Receives: Other: Strain isolation from the nasopharynx |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start12 Oct 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Bordetella Pertussis, Whooping CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Sanofi Pasteur, a Sanofi Company
- Responsible party
- Principal investigator, Qiushui He, University of Turku
- Investigators
- Qiushui He, MD, PhD, Principal investigator, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197597
- Sponsor's protocol ID
- EUpert IV
- Status last verified
- Jun 2017
- First submitted
- 13 Jun 2017
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23175253Bouchez 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.
PubMed 19666155Barkoff 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.
PubMed 22914363Mooi 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.
PubMed 19751581Barkoff 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.
PubMed 24925807Caro 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.
PubMed 15994109Heikkinen 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.
PubMed 18816412van 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.
PubMed 15956406
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUpertstrain 4 Study of Bordetella Pertussis Isolates
- ClinicalTrials.gov ID
- NCT03197597
- Acronym / sponsor ID
- EUpert IV
- Conditions
- Bordetella Pertussis, Whooping Cough
- Keywords
- B. pertussis, Acellular vaccination, Strain variation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Sanofi Pasteur, a Sanofi Company
- Study start
- 12 Oct 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 23 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Strain isolation from the nasopharynx | – | Other: Strain isolation from the nasopharynxA group of culture positive whooping cough patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- There is no strict exclusion criteria for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strain isolation from the nasopharynxB. pertussis strains has been collected from the nasopharynx of the patients during the clinical visit | Other | Strain isolation from the nasopharynx |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
- Background: PubMed 23175253Advani 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.
- Background: PubMed 19666155Bouchez 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.
- Background: PubMed 22914363Barkoff 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.
- Background: PubMed 19751581Mooi 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.
- Background: PubMed 24925807Barkoff 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.
- Background: PubMed 15994109Caro 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.
- Background: PubMed 18816412Heikkinen 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.
- Background: PubMed 15956406van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qiushui He, MD, PhD principal investigator
University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bordetella Pertussis, Whooping Cough, run by University of Turku at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine antigen deficient (VAD) B. pertussis clinical isolates (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03197597, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2017.