Seroprevalence of Pertussis Among Healthy Children and Adolescents in Kazakhstan

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

520 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-25

Study Completion Date

2022-07-05

Brief Summary

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Seroprevalence of pertussis among older children and adolescents in Kazakhstan: A cross sectional study.

Justification: to describe the distribution of anti-pertussis toxin (PT) antibodies (IgA and IgG) in a population aged 10-18 years old according to sociodemographic characteristics, vaccination history, and risk factors of pertussis infection.

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Detailed Description

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Pertussis due to infection with Bordetella pertussis (B pertussis) is a well-known cause of persistent cough primarily affecting infants and young children. Repeated administration of the vaccine is often needed to reduce the disease burden and control its transmission. At this time, no data are available on the epidemiology of pertussis in adolescents and adults in Kazakhstan.

The aim of the present study is to estimate the prevalence of pertussis infection in different age groups in Kazakh children and adolescents using the anti-pertussis toxin (PT) antibodies (IgA and IgG) as specific marker of pertussis infection or vaccination. The serosurvey will be conducted in 4 different regions: Aktobe, Karaganda, Taldykorgan, and Shymkent.

Participants (≥ 10 years \& \< 19 years) attending the study centers will be asked to participate in the study. The adolescent participants and the parents/guardian(s) of all participants will be informed about the procedures and data handling. Written informed consent from one parent/guardian needs to be obtained by the physician before any blood samples can be taken.

Upon obtaining informed consent for participant parent/guardian, the study coordinator will complete an investigation form (IF) for each participant and collect serum samples. The specimens will be coded by a unique participant number and delivered to the laboratory in charge of the assay. The specimens will be used for serological analyses.

Conditions

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Pertussis

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pertussis antibodies testing will be conducted at the Reference Laboratory in NPCCEEM

serum samples will be taken and tested by enzyme-linked immunoassay (ELISA) using the SAVYON SeroPertussisTM kits (Savyon Diagnostics Ltd, Israel).

Blood samples for pertussis antibody testing

Intervention Type DIAGNOSTIC_TEST

Blood samples will be sent to the laboratories of the National Centers of Expertise within 24-48 hours of blood collection. The samples will be transferred to the reference laboratory of SPCSEEM in Almaty, Kazakhstan. Serum samples will be stored in the reference laboratory at a temperature of -20 C.

Interventions

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Blood samples for pertussis antibody testing

Blood samples will be sent to the laboratories of the National Centers of Expertise within 24-48 hours of blood collection. The samples will be transferred to the reference laboratory of SPCSEEM in Almaty, Kazakhstan. Serum samples will be stored in the reference laboratory at a temperature of -20 C.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

10-18 years old

* Informed consent obtained from parents or guardian(s) and assent from patient.
* Enrollment following a visit at the study center.
* Documented vaccination history

* 10-18 years old
* Informed consent obtained from parents or guardian(s) and assent from patient.
* Enrollment following a visit at the study center.
* Documented vaccination history

Exclusion Criteria

* ≤10 years and ≥ 19 years
* Pertussis immunization during the last 12 months
* No informed consent obtained from one parent or guardian.
* Immunocompromised patients
* Patients with acute infectious diseases

Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No