PICR-b Nasopharyngeal S. Pneumoniae and Nasal S. Aureus Carriage Study

Study Overview
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Brief Summary
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Objective: PCV effects on S. pneumoniae and S. aureus carriage in a population based study. The major specific aims: To compare different PCV vaccination policies, by cross-sectional repeated surveillance of closely related populations living in regions with different vaccination policies. To compare the epidemiology, predictors and outcomes of antibiotic resistant S. aureus and S. pneumoniae in different regions of the PICR. Study design: Annual / Biannual cross-sectional surveillance of nasal S. aureus carriage and nasopharyngeal S. pneumoniae carriage in children and one of their parents.

Detailed Description
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Study design: Annual / Biannual cross-sectional surveillance of nasal S. aureus carriage and nasopharyngeal S. pneumoniae carriage in children and one of their parents. PICR districts: 1. Palestinian Authority (PA) - particularly: Bethlehem, Ramallah and Nabulus. 2. East Jerusalem (EJ) 3. Central Israel (IL) - particularly: Rishon Lezion, Bat Yam, Holon 4. Gaza strip (GZ) - 12 regions including cities/villages in central/northern Gaza. Study population: Child (age 0-5y) & Parent who attend clinics (for any reason). Exclusion criteria: Parent does not agree to sign informed consent Child or sibling (brother/sister) have already participated. Both healthy and ill children are screened. No specific exclusion other than the above. Only one child per family (younger child, if more than one available) and one parent (mother, if both are available). Sample size per year: IL: Central Israel (Hashfela District): 400 pairs of child+parent/surveillance EJ: East Jerusalem: 400 pairs of child+parent/surveillance PA: West Bank cities (Ramallah, Bethlehem & Nabulus): 600 pairs of child+parent/surveillance GZ: Gaza strip: 300 pairs of child+parent/surveillance Study Period: May-August annually 2009 - 2011 - (Part a). May-August biannually 2014-2016-2018-2020 Current study (Part b). Screening Procedure: Parent signs informed consent Put Barcode stickers on informed consent, questionnaire, swabs and daily list Fill questionnaire with parent. Fill physician questionnaire Nasal & nasopharyngeal swab of child and parent. Fill daily working table. Write the number of refusals (parents who refused) on daily table. Fill questionnaire FULLY (unmarked questions will not be analyzed) - put x on each question - whether YES or NO. Swabbing: First swab the child and then follow with the parent. First perform nasal swab (for S. aureus) using cotton-tip swab placed into Amies transport Media (Blue) and follow with nasopharyngeal swab ( for S. pneumoniae) using rayon-tipped aluminum shaft swab placed in Amies transport Media (Orange). Slightly wet the nasal swab with sterile saline. Swab both anterior nares. Nasopharyngeal swab of only through one nostril - gently, quickly and deep to nasopharynx - until you touch the nasopharyngeal wall. Swab transfer to lab: If swabs are stored overnight before transfer - keep in 40C (fridge). Within 24h swabs must reach the central laboratory (Dr. Regev-Yochay's Lab at Sheba Medical Center).

Official Title
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PICR-b Nasopharyngeal S. Pneumoniae and Nasal S. Aureus Carriage Study

Conditions
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Streptococcus Pneumoniae

Intervention / Treatment
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* Biological: PCV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any child younger than 5 years, visiting the participating clinics during the surveillance period Exclusion Criteria: Older than 5 years Previously participated in the study. Sibling has participated in the study. Parent does not agree to sign informed consent

Ages Eligible for Study
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Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Israel PCV13<br>Children and their parents living in central Israel and visiting primary pediatric clinics of Hashfela District, Macabbi Healthcare Services HMO, for any reason during the surveillance period each year. | Biological: PCV<br>* PCV7 was introduced in Israel (IL and EJ) in July 2009 PCV13 replaced PCV7 in IL and EJ on Oct 2010 PCV10 was introduced in PA in 2011<br>* Other names: PCV13;|
| East Jerusalem PCV13<br>Children and their parents living in East Jerusalem and visiting primary pediatric clinics of Jerusalem District, Macabbi Healthcare Services HMO, for any reason during the surveillance period each year. | Biological: PCV<br>* PCV7 was introduced in Israel (IL and EJ) in July 2009 PCV13 replaced PCV7 in IL and EJ on Oct 2010 PCV10 was introduced in PA in 2011<br>* Other names: PCV13;|
| Palestine PCV7 PCV10<br>Children and their parents living in major cities of the Palestinian Authority and visiting private primary pediatric clinics, for any reason during the surveillance period each year. | Biological: PCV<br>* PCV7 was introduced in Israel (IL and EJ) in July 2009 PCV13 replaced PCV7 in IL and EJ on Oct 2010 PCV10 was introduced in PA in 2011<br>* Other names: PCV13;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| S. pneumoniae carriage | S. pneumoniae carriage of children and parents by the different groups | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carriage of Vaccine-type S. pneumoniae | Carriage of Vaccine-type S. pneumoniae in children and parents by the different groups | 1 Day | 
| Carriage of antibiotic resistant S. pneumonia | Carriage of antibiotic resistant S. pneumonia in children and parents by the different groups | 1 Day | 
| Carriage of piliated S. pneumonia | Carriage of piliated S. pneumonia in children and parents by the different groups | 1 Day | 
| Carriage of MRSA | Carriage of MRSA in children and parents by the different groups | 1 Day | 
| S. aureus carriage | S. aureus carriage of children and parents by the different groups | 1 Day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCV effects, S. pneumoniae carriage, S. aureus carriage, Indirect vaccination effects, Palestinian-Israeli Collaborative Research (PICR)