Clinical trial NCT04779853: Seroprevalence of Pertussis Among Healthy Children and Adolescents in Kazakhstan
Official title: Seroprevalence of Pertussis Among Healthy Children and Adolescents in Kazakhstan: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pertussis
Keywords: pertussis
seroprevalence
immunity
antibodies
Kazakhstan
vaccination
Lead sponsor: Scientific and practical center of sanitary and epidemiological expertise and monitoring
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 520
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Exclusion Criteria:

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

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

Primary outcomes:
measure: The anti-PT IgG and Ig A concentrations (in IU/ml) in the population sample.
timeFrame: 25.01.2021-17.10.2021
Secondary outcomes:
measure: The prevalence of recent Bp infection in the test in the selected population sample stratified by demographic and socio-economic criteria, vaccination history, and risk of infection.
timeFrame: 25.01.2021-17.10.2021
Other outcomes:
measure: • Adherence to vaccination status defined as the. number and timeliness of doses received and potential exposure to booster vaccination as well as the concordance with the Kazakh vaccination status.
timeFrame: 25.01.2021-17.10.2021
Locations:
city: Almaty
country: Kazakhstan
facility: Scientific and Practical Center of Sanitary and Epidemiological Expertise and Monitoring
Study officials:
References: