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Pertussis Immunization Programs in Low Income Countries (PERILIC)

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ClinicalTrials.gov Identifier: NCT02983487
Recruitment Status : Recruiting
First Posted : December 6, 2016
Last Update Posted : August 9, 2018
Sponsor:
Collaborators:
Institut Pasteur, Cambodia
Institut Pasteur de Madagascar
Agence de Médecine Préventive, France
Information provided by (Responsible Party):
Institut Pasteur

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.

Condition or disease Intervention/treatment
Bordetella Pertussis, Whooping Cough Procedure: Nasopharyngeal sampling Procedure: Blood Sampling

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 3500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pertussis Immunization Programs in Low Income Countries
Actual Study Start Date : January 22, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Nasopharyngeal sample by aspiration or swabbing

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
Nasopharyngeal sample by aspiration or swabbing

Procedure: Blood Sampling
Blood sample by the tip of a finger (fingerprick)

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
Blood sample by the tip of a finger (fingerprick)




Primary Outcome Measures :
  1. Proportion of biologically confirmed cases of pertussis in patients under 6 months old admitted into hospital with clinical signs corresponding to whooping cough syndrome. [ Time Frame: November 2018 ]
    Primary Outcome of WP1a (Cohort 1)

  2. 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. [ Time Frame: November 2018 ]
    Primary Outcome of WP1b (Cohort 2)

  3. Proportion of cases tested positive given by the presence of an anti-pertussis toxin IgG level >100 IU/mL in the serum. [ Time Frame: November 2018 ]
    Primary Outcome of WP2 (Cohort 3)


Secondary Outcome Measures :
  1. Estimation of the relative risk of the disease occurring in the contact patients based on their immunization status and age groups [ Time Frame: April 2019 ]

Biospecimen Retention:   Samples Without DNA
Nasopharyngeal sample; Blood sample


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02983487


Contacts
Contact: Sandra CORRE, PM +33145688059 sandra.corre@pasteur.fr
Contact: Mohand AIT AHMED, Clinical PM +33144389302 mohand.ait-ahmed@pasteur.fr

Locations
Cambodia
Institut Pasteur of Cambodia Recruiting
Phnom Penh, Cambodia
Contact: Laurence BORAND    +85512333671    lborand@pasteur-kh.org   
Principal Investigator: Moniboth DUCH, MD         
Principal Investigator: Kimsroin KIM, MD         
Principal Investigator: Ka TENG, MD         
Principal Investigator: Thona SAR, MD         
Principal Investigator: Kong SOK, MD         
Principal Investigator: Vantha TE, MD         
Principal Investigator: Sopheaktra SROS, MD         
Principal Investigator: Peuv TCHEA, MD         
Principal Investigator: Tek Chheng EAP, MD         
Principal Investigator: Laurence BORAND, PhD         
Madagascar
Institut Pasteur de Madagascar Recruiting
Antananarivo, Madagascar
Contact: Jean Marc COLLARD, PhD    +261322900808    jmcollard@pasteur.mg   
Contact: Aina HARIMANANA, MD, PhD    +261202241272 ext 135    aharim@pasteur.mg   
Principal Investigator: Annick ROBINSON, MD, PhD         
Principal Investigator: Aina HARIMANANA, MD, PhD         
Principal Investigator: Mbola RAKOOMAHEFA, MD         
Togo
Agence de Médecine Préventive Completed
Dapaong, Togo
Sponsors and Collaborators
Institut Pasteur
Institut Pasteur, Cambodia
Institut Pasteur de Madagascar
Agence de Médecine Préventive, France
Investigators
Principal Investigator: Fabien TAIEB, MD, MSc, MPH Institut Pasteur
Study Chair: Nicole GUISO, PhD Institut Pasteur

Additional Information:
Publications:
Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT02983487     History of Changes
Other Study ID Numbers: 2015-055
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Institut Pasteur:
Bordetella Pertussis
Whooping Cough
vaccine

Additional relevant MeSH terms:
Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs