Pertussis Immunization Programs in Low Income Countries - Ivory Coast (PERILIC-IC)
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| ClinicalTrials.gov Identifier: NCT03388034 |
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Recruitment Status
:
Not yet recruiting
First Posted
: January 2, 2018
Last Update Posted
: January 2, 2018
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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 : | 1150 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Pertussis Immunization Programs in Low Income Countries - Ivory Coast |
| Estimated Study Start Date : | January 2018 |
| Estimated Primary Completion Date : | December 2019 |
| Estimated Study Completion Date : | December 2020 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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
A nasopharyngeal sample collected from each nostril by swabbing
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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
A nasopharyngeal sample collected from each nostril by swabbing
Procedure: Blood Sampling
Blood sample by the tip of a finger (fingerprick)
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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)
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- 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: December 2019 ]Primary Outcome of Cohort 1 (WP1a)
- Identification of the contaminator of the index case [ Time Frame: December 2019 ]Primary Outcome of Cohort 2 (WP1b)
- Estimation of the protection period induced by the primo-vaccination in children between 3 and 15 yo [ Time Frame: December 2019 ]Primary Outcome of Cohort 3 (WP2)
- Estimation of the relative risk of the disease occurring in the contact patients based on their immunization status and age groups [ Time Frame: June 2020 ]
Biospecimen Retention: Samples Without DNA
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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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
Inclusion Criteria (Cohort 1):
- Infants under 6 months old
- Presenting clinical signs of a whooping cough syndrome
- Written consent obtained from a parent/guardian of the child
Inclusion Criteria (Cohort 2):
- 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.
Inclusion Criteria (Cohort 3):
- 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):
- Pertussis vaccination done more than one year before inclusion
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): NCT03388034
| Contact: Fabien TAIEB, MD, MSc, MPH | +33(0)140613456 | fabien.taieb@pasteur.fr | |
| Contact: Mohand AIT AHMED, Clinical PM | +33(0)144389302 | mohand.ait-ahmed@pasteur.fr |
| Côte D'Ivoire | |
| Centre de Santé Urbain à base Communautaire (CSU-Com) d'Angré | Not yet recruiting |
| Abidjan, Côte D'Ivoire | |
| Contact: Flavie ACHI, MD | |
| Principal Investigator: Flavie ACHI, MD | |
| CHU d'Angré | Not yet recruiting |
| Abidjan, Côte D'Ivoire | |
| Contact: Flore AMON-TANO-DICK, MD | |
| Principal Investigator: Flore AMON-TANO-DICK, MD | |
| Hôpital Général de Port-Bouët | Not yet recruiting |
| Abidjan, Côte D'Ivoire | |
| Contact: Mariame DRAME-DEME, MD | |
| Principal Investigator: Mariame DRAME-DEME, MD | |
| Hôpital Général de Yopougon Attié | |
| Abidjan, Côte D'Ivoire | |
| Institut Pasteur de Côte d'Ivoire | Not yet recruiting |
| Abidjan, Côte D'Ivoire | |
| Contact: Man-Koumba SOUMAHORO, PhD + 225 03 53 04 36 mksoumahoro@pasteur.ci | |
| Principal Investigator: | Fabien TAIEB, MD, MSc, MPH | Institut Pasteur | |
| Principal Investigator: | Man-Koumba SOUMAHORO, PhD | Institut Pasteur de Côte d'Ivoire | |
| Study Chair: | Nicole GUISO, PhD | Institut Pasteur |
Additional Information:
Publications of Results:
Other Publications:
| Responsible Party: | Institut Pasteur |
| ClinicalTrials.gov Identifier: | NCT03388034 History of Changes |
| Other Study ID Numbers: |
2017-056 |
| First Posted: | January 2, 2018 Key Record Dates |
| Last Update Posted: | January 2, 2018 |
| Last Verified: | December 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
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Whooping Cough Bordetella Infections Gram-Negative Bacterial Infections Bacterial Infections Respiratory Tract Infections |
Infection Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |