Seroprevalence of Pertussis Among Healthy Children and Adolescents in Kazakhstan

Seroprevalence of Pertussis Among Healthy Children and Adolescents in Kazakhstan: A Cross-Sectional Study

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.

Study Overview

• Status: Unknown
• Conditions: Pertussis
• Intervention / Treatment: Diagnostic test: Blood samples for pertussis antibody testing

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.

• Study Type: Observational
• Enrollment (Anticipated): 520

Contacts and Locations

Study Locations

• Kazakhstan
  • Almaty, Kazakhstan, 050008
    • Recruiting
    • Scientific and Practical Center of Sanitary and Epidemiological Expertise and Monitoring
    • Contact: Manar SMAGUL, MD; Phone Number: +77017444681; Email: manarka@mail.ru
    • Contact: NUKENOVa, MD; Phone Number: +77714007784; Email: gnukenova@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The anti-PT IgG and Ig A concentrations (in IU/ml) in the population sample.	To estimate the prevalence of recent infection Bp infection, using increased anti-PT antibody levels as markers of Bp infection in the serology test.	25.01.2021-17.10.2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	To evaluate the risk factors associated with higher seroprevalence of pertussis.	25.01.2021-17.10.2021

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
• 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.	• To evaluate the compliance with recommended vaccination schedule in study participants	25.01.2021-17.10.2021

Collaborators and Investigators

• Sponsor: Scientific and practical center of sanitary and epidemiological expertise and monitoring

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2021
• Primary Completion (ANTICIPATED): October 17, 2021
• Study Completion (ANTICIPATED): July 5, 2022

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (ACTUAL): March 3, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: vaccination; pertussis; immunity; antibodies; Kazakhstan; seroprevalence
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Whooping Cough; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: PER00075

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No