Bordetella Pertussis, Whooping Cough Clinical Trial
— PERILICOfficial title:
Pertussis Immunization Programs in Low Income Countries
NCT number | NCT02983487 |
Other study ID # | 2015-055 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 22, 2017 |
Est. completion date | December 31, 2019 |
Verified date | July 2021 |
Source | Institut Pasteur |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Due to waning of infectious as well as vaccine immunity and lack of vaccination boosters, a large number of adolescents and adults are no longer immunized against Bordetella pertussis, the agent of whooping cough and consequently may contract whooping cough. Furthermore, these populations represent a reservoir of the infectious agent from which the dissemination to non-immune infants is possible, causing severe illness, or even death, in this age group. Few studies have been carried out on whooping cough in developing countries (incidence, contaminator's age, etc.) and, specifically, none have assessed the duration of protection induced by the whole cell pertussis (wP) vaccine mainly presently used in these countries. However, data on the duration of vaccine induced protection are essential to determine i) the usefulness of vaccine boosters and ii) the target age group for these boosters. The aims of the present study are: - To evaluate the proportion of confirmed pertussis cases in infants presenting whooping cough syndrome (WP1a) - To evaluate the proportion of confirmed pertussis cases or healthy carriers among contact cases - To determine origin of the infant's contamination (WP1b) - To determine the duration of protection induced by the wP vaccines used in contact cases and the child population aged 3 to 15 yo (WP1b and WP2) - To bring new scientific evidences documenting the potential need for initiating boosters (WP1b and WP2) - To allow a comparison of the results with those obtained using the same methodology for the acellular pertussis vaccine and/or in other contexts. Potential implications for the use of pertussis vaccines in low and moderate income countries. - To increase local capabilities by the transfer of materials and expertise that will make the diagnosis of pertussis possible in the centres of reference and strengthen a pertussis monitoring network in the implicated countries. - To improve children's health through a better match of the vaccination schedule according to the reality of the situation.
Status | Completed |
Enrollment | 3587 |
Est. completion date | December 31, 2019 |
Est. primary completion date | July 25, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: Cohort 1 (WP1a) - Infants under 6 months old - Presenting clinical signs of a whooping cough syndrome - Written consent obtained from a parent/guardian of the child Cohort 2 (WP1b) - People in regular and prolonged contact (>1h per day) with the index case for at least 5 days before the signs of whooping cough occurred in the infected child, living (or not) in the same household. - For the adults, written consent obtained. - For minors under 7 yo: written consent obtained from a parent/guardian. - For minors over 7 yo: written consent obtained from parent/guardian and oral assent obtained from the child. Cohort 3 (WP2) - Child aged between 3 and 15 yo - Up to date first pertussis vaccination (vaccination booklet or official register) - Last pertussis vaccination done more than one year before inclusion - For minors under 7 yo: written consent obtained from parent/guardian. - For minors over 7 yo: written consent obtained from parent/guardian and oral assent obtained from the child. Exclusion Criteria: Cohort 3 (WP2) - Pertussis vaccination done more than one year before inclusion |
Country | Name | City | State |
---|---|---|---|
Cambodia | Institut Pasteur of Cambodia | Phnom Penh | |
Madagascar | Institut Pasteur de Madagascar | Antananarivo | |
Togo | Agence de Médecine Préventive | Dapaong |
Lead Sponsor | Collaborator |
---|---|
Institut Pasteur | Agence de Médecine Préventive, France, Institut Pasteur de Madagascar, Institut Pasteur, Cambodia |
Cambodia, Madagascar, Togo,
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Guiso N, Wirsing von König CH. Surveillance of pertussis: methods and implementation. Expert Rev Anti Infect Ther. 2016 Jul;14(7):657-67. doi: 10.1080/14787210.2016.1190272. Epub 2016 May 31. Review. — View Citation
Guiso N. Pertussis vaccination and whooping cough: and now what? Expert Rev Vaccines. 2014 Oct;13(10):1163-5. doi: 10.1586/14760584.2014.941816. Epub 2014 Jul 14. — View Citation
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Noel G, Badmasti F, Nikbin VS, Zahraei SM, Madec Y, Tavel D, Aït-Ahmed M, Guiso N, Shahcheraghi F, Taieb F. Transversal sero-epidemiological study of Bordetella pertussis in Tehran, Iran. PLoS One. 2020 Sep 1;15(9):e0238398. doi: 10.1371/journal.pone.0238398. eCollection 2020. — View Citation
Noel G, Borand L, Leng C, Keang C, Botr C, Dim B, Kerleguer A, Peng YS, Sreng N, Ork V, Ait-Ahmed M, Guiso N, Taieb F. Circulation of Bordetella pertussis in vaccinated Cambodian children: A transversal serological study. Int J Infect Dis. 2021 May;106:13 — View Citation
Noel G, Lotfi MN, Mirshahvalad S, Mahdi S, Tavel D, Zahraei SM, Ghanaie RM, Heidary T, Goudarzi A, Kazemi A, Karimi A, Nateghian A, Ait-Ahmed M, Guiso N, Shahcheraghi F, Taieb F. Hospital-based prospective study of pertussis in infants and close contacts in Tehran, Iran. BMC Infect Dis. 2021 Jun 18;21(1):586. doi: 10.1186/s12879-021-06266-6. — View Citation
Tubiana S, Belchior E, Guillot S, Guiso N, Lévy-Bruhl D; Renacoq Participants. Monitoring the Impact of Vaccination on Pertussis in Infants Using an Active Hospital-based Pediatric Surveillance Network: Results from 17 Years' Experience, 1996-2012, France. Pediatr Infect Dis J. 2015 Aug;34(8):814-20. doi: 10.1097/INF.0000000000000739. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of biologically confirmed cases of pertussis in patients under 6 months old admitted into hospital with clinical signs corresponding to whooping cough syndrome. | Primary Outcome of WP1a (Cohort 1) | November 2018 | |
Primary | Proportion of cases tested positive for B.Pertussis given by the presence of B. pertussis DNA in the nasopharyngeal sample or by the presence of an anti-pertussis toxin IgG level >100 IU/mL in the serum. | Primary Outcome of WP1b (Cohort 2) | November 2018 | |
Primary | Proportion of cases tested positive given by the presence of an anti-pertussis toxin IgG level >100 IU/mL in the serum. | Primary Outcome of WP2 (Cohort 3) | November 2018 | |
Secondary | Estimation of the relative risk of the disease occurring in the contact patients based on their immunization status and age groups | April 2019 |
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