Seroprevalence of Pertussis Among Healthy Children and Adolescents in Kazakhstan

Pertussis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04779853
• Other study ID #: PER00075
• Status: Recruiting
• Start date: January 25, 2021
• Est. completion date: July 5, 2022

Study information

• Verified date: February 2021
• Source: Scientific and practical center of sanitary and epidemiological expertise and monitoring
• Contact: Manar SMAGUL, MD
• Phone: +77017444681
• Email: manarka[@]mail.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: July 5, 2022
• Est. primary completion date: October 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pertussis
• Whooping Cough

Intervention

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.

Locations

Country	Name	City	State
Kazakhstan	Scientific and Practical Center of Sanitary and Epidemiological Expertise and Monitoring	Almaty

Sponsors (1)

Lead Sponsor	Collaborator
Scientific and practical center of sanitary and epidemiological expertise and monitoring

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	• 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
Primary	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	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