Pertussis Immunization Programs in Low Income Countries

NCT02983487 | Completed

• 1 other identifier: 2015-055
• Study Type: observational
• Target: 3,587
• Locations: 3 countries
• Sites: 3

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

Keywords

Bordetella Pertussis; Whooping Cough; vaccine

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 WP1a (Cohort 1)

  November 2018

• 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

• 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 Outcomes (1)

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

  April 2019

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 aspiration or 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 aspiration or 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

Nasopharyngeal sample by aspiration or 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:

• 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)
• 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.

You may not qualify if:

• Cohort 3 (WP2)

Sponsors & Collaborators

• Institut Pasteur: lead
• Institut Pasteur, Cambodia: collaborator
• Institut Pasteur de Madagascar: collaborator
• Agence de Médecine Préventive, France: collaborator

Study Sites (3)

Institut Pasteur of Cambodia

Phnom Penh, Cambodia

Location

Institut Pasteur de Madagascar

Antananarivo, Madagascar

Location

Agence de Médecine Préventive

Dapaong, Togo

Location

Related Publications (8)

• 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, Taieb F. Pertussis in Low and Medium Income Countries: A Pragmatic Approach. Adv Exp Med Biol. 2019;1183:137-149. doi: 10.1007/5584_2019_409.

  PMID: 31342458 BACKGROUND

• Noel G, Badmasti F, Nikbin VS, Zahraei SM, Madec Y, Tavel D, Ait-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.

  PMID: 32870922 BACKGROUND

• 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.

  PMID: 34144678 BACKGROUND

• 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;106:134-139. doi: 10.1016/j.ijid.2021.03.054. Epub 2021 Mar 22.

  PMID: 33766688 RESULT

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

• 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: November 17, 2016
• First Posted: December 6, 2016
• Study Start: January 22, 2017
• Primary Completion: July 25, 2019
• Study Completion: December 31, 2019
• Last Updated: April 1, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1); TO (1); CA (1)