Pertussis Immunization Programs in Low Income Countries - Ivory Coast

NCT03388034 | Completed

• 1 other identifier: 2017-056
• Study Type: observational
• Target: 789
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Bordetella Pertussis, Whooping Cough

Outcome Measures

Primary Outcomes (3)

• 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 Cohort 1 (WP1a)

  December 2019

• Identification of the contaminator of the index case

  Primary Outcome of Cohort 2 (WP1b)

  December 2019

• Estimation of the protection period induced by the primo-vaccination in children between 3 and 15 yo

  Primary Outcome of Cohort 3 (WP2)

  December 2019

Secondary Outcomes (1)

• Estimation of the relative risk of the disease occurring in the contact patients based on their immunization status and age groups

  June 2020

Study Arms (3)

Index case (WP1a)

Infant under 6 months old with clinical signs of whooping cough syndrome. Nasopharyngeal sampling: A nasopharyngeal sample collected from each nostril by swabbing

Procedure: Nasopharyngeal sampling

Control case (WP1b)

Contact cases of infant with a positive diagnosis for whooping cough. Nasopharyngeal sampling: A nasopharyngeal sample collected from each nostril by swabbing Blood sampling: A blood sample collected by fingerprick

Procedure: Nasopharyngeal sampling; Procedure: Blood Sampling

Seroepidemiological cohort (WP2)

Children between 3 and 15 years old with complete primo-vaccination against B.Pertussis Blood sampling: A blood sample collected by fingerprick

Procedure: Blood Sampling

Interventions

Nasopharyngeal sampling PROCEDURE

A nasopharyngeal sample collected from each nostril by swabbing

Control case (WP1b); Index case (WP1a)

Blood Sampling PROCEDURE

Blood sample by the tip of a finger (fingerprick)

Control case (WP1b); Seroepidemiological cohort (WP2)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cohort 1 (WP1a): Infants under 6 months old coming to hospital with clinical signs of whooping cough syndrome. Cohort 2 (WP1b): Contact cases of confirmed infants included in the WP1a module Cohort 3 (WP2): Children from 3 to 15 years old included, without underlying illness, with complete pertussis primo-vaccination

You may qualify if:

• Infants under 6 months old
• Presenting clinical signs of a whooping cough syndrome
• Written consent obtained from a parent/guardian of the child
• People in regular and prolonged contact (\>3h per day) with the index case for at least 15 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.
• Child aged between 3 and 15 yo
• Up to date first pertussis vaccination (vaccination booklet or official register)
• 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.

Sponsors & Collaborators

• Institut Pasteur: lead
• Institut Pasteur of Cote d'Ivoire: collaborator
• Sanofi Pasteur, a Sanofi Company: collaborator

Study Sites (5)

Centre de Santé Urbain à base Communautaire (CSU-Com) d'Angré

Abidjan, Côte d’Ivoire

Location

CHU d'Angré

Abidjan, Côte d’Ivoire

Location

Hôpital Général de Port-Bouët

Abidjan, Côte d’Ivoire

Location

Hôpital Général de Yopougon Attié

Abidjan, Côte d’Ivoire

Location

Institut Pasteur de Côte d'Ivoire

Abidjan, Côte d’Ivoire

Location

Related Publications (6)

• Guiso N, Wirsing von Konig 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.

  PMID: 27224518 BACKGROUND

• Tubiana S, Belchior E, Guillot S, Guiso N, Levy-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.

  PMID: 25955837 BACKGROUND

• 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.

  PMID: 25020131 BACKGROUND

• Heininger U, Andre P, Chlibek R, Kristufkova Z, Kutsar K, Mangarov A, Meszner Z, Nitsch-Osuch A, Petrovic V, Prymula R, Usonis V, Zavadska D. Comparative Epidemiologic Characteristics of Pertussis in 10 Central and Eastern European Countries, 2000-2013. PLoS One. 2016 Jun 3;11(6):e0155949. doi: 10.1371/journal.pone.0155949. eCollection 2016.

  PMID: 27257822 BACKGROUND

• Guiso N, Levy C, Romain O, Guillot S, Werner A, Rondeau MC, Bechet S, Cohen R. Whooping cough surveillance in France in pediatric private practice in 2006-2015. Vaccine. 2017 Oct 27;35(45):6083-6088. doi: 10.1016/j.vaccine.2017.09.072. Epub 2017 Sep 30.

  PMID: 28974408 BACKGROUND

• von Koenig CHW, Guiso N. Global burden of pertussis: signs of hope but need for accurate data. Lancet Infect Dis. 2017 Sep;17(9):889-890. doi: 10.1016/S1473-3099(17)30357-2. Epub 2017 Jun 13. No abstract available.

  PMID: 28623145 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasopharyngeal sample; Blood sample

MeSH Terms

Conditions

Whooping Cough

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Fabien TAIEB, MD, MSc, MPH

  Institut Pasteur

  PRINCIPAL INVESTIGATOR

• Man-Koumba SOUMAHORO, PhD

  Institut Pasteur of Cote d'Ivoire

  PRINCIPAL INVESTIGATOR

• Nicole GUISO, PhD

  Institut Pasteur

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 2, 2018
• Study Start: April 11, 2019
• Primary Completion: July 21, 2021
• Study Completion: July 21, 2021
• Last Updated: April 1, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CÔ (5)