NCT02983487: PERILIC

Pertussis Immunization Programs in Low Income Countries

Completed Last updated 1 April 2022

What this trial tests

trial testing Nasopharyngeal sampling in Bordetella Pertussis, Whooping Cough in 3,587 participants. Completed in 31 December 2019.

Timeline

22 January 2017

Primary endpoint
25 July 2019

31 December 2019

Quick facts

Lead sponsor	Institut Pasteur
Status	Completed
Study type	OBSERVATIONAL
Enrollment	3,587
Start date	22 January 2017
Primary completion	25 July 2019
Estimated completion	31 December 2019
Sites	3 locations across Madagascar, Cambodia, Togo

Drugs / interventions tested

• Nasopharyngeal sampling
• Blood Sampling — full drug profile →

Conditions studied

• Bordetella Pertussis, Whooping Cough — all drugs for Bordetella Pertussis, Whooping Cough →

Sponsor

Institut Pasteur — full company profile →

Who can join

Eligibility, any sex, with Bordetella Pertussis, Whooping Cough. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. High circulation of pertussis in infants and close contacts in Antananarivo, the capital of Madagascar in Africa, and Cambodia in Asia.
   Noel G, Harimanana A, Borand L, Campana F, et al · · 2025 · cited 1× · PMID 40016639 · DOI 10.1186/s12879-025-10590-6
2. Seroprevalence of Diphtheria in Antananarivo, Madagascar, and Cambodia.
   Campana F, Noel G, Rajabizadeh M, Harimanana A, et al · · 2025 · PMID 40066087 · DOI 10.1093/ofid/ofaf091