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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples for pertussis antibody testing | 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
10-18 years old
Exclusion Criteria:
Inclusion criteria:
Exclusion criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manar SMAGUL, MD | Contact | +77017444681 | manarka@mail.ru | |
| Gauhar NUKENOVA, MD | Contact | +77714007784 | gnukenova@mail.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientific and Practical Center of Sanitary and Epidemiological Expertise and Monitoring | Recruiting | Almaty | 050008 | Kazakhstan |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 9, 2020 | Feb 25, 2021 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 9, 2020 | Mar 1, 2021 | ICF_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Statistical Analysis Plan | Oct 9, 2020 | Mar 1, 2021 | SAP_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Survey | Oct 9, 2020 | Mar 1, 2021 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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This study will be a cross-sectional serosurvey of anti-PT levels in a sample of the population. The study will be conducted in the cities of Aktobe, Karaganda, Taldykorgan, and Shymkent. Enrollment will be done in health centers and pediatric hospitals.
|
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |