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| Name | Class |
|---|---|
| Merck Sharp & Dohme Corporation | UNKNOWN |
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The PI propose to conduct a genomic epidemiology study of pneumococcal carriage among children and adults in a large metropolitan city. These data will allow PI to assess the post-pandemic population structure, investigate the phylogenetic relationship between isolates from children and adults, and compare pneumococcal populations across diverse geographic areas.
The SARS-CoV-2 pandemic profoundly impacted human health directly and indirectly. As such, elucidating pre- and post-pandemic trends in the epidemiology and population genomics of human respiratory pathogens including those such as the bacteria Streptococcus pneumoniae, a human commensal and the causative agent of invasive pneumococcal disease (IPD), merits study.
Nasopharyngeal samples will be processed at the PIs Laboratory to identify S. pneumoniae. If present, the isolate will undergo bacterial whole genome sequencings and population dynamic analysis. Carriage prevalence and serotype composition will be compared to extant studies and pneumococcal genomic data will be analyzed in the context of samples from the US and abroad.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children | This is a non-interventional study with data collection online, chart review, and biospecimen collection (nasopharyngeal swab). The swab will then be used for biomarker discovery. Findings will be compared and analyzed between the children and adult groups. | ||
| Adults | This is a non-interventional study with data collection online, chart review, and biospecimen collection (nasopharyngeal swab). The swab will then be used for biomarker discovery. Findings will be compared and analyzed between the children and adult groups. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pneumococcal carriage prevalence and distribution of serotypes among children and adults calculated from the results of S. pneumoniae isolation using qPCR. | 22 months |
| Measure | Description | Time Frame |
|---|---|---|
| Phylogenetic relationship of pneumococcal isolates collected among child and adult populations using whole-genome sequencing libraries. | 22 months | |
| Putative transmission networks between children and adult populations from online questionnaires. | 22 months |
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Inclusion Criteria:
Exclusion Criteria:
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The PI seeks to recruit 450 children 7-59 months of age and 450 adults 50 years or older over a 16-month period. Children will be equally distributed between 7-23 months and 24-59 months and adults equally distributed in the age ranges: 50-64 years, 65-74 years, and 75 years or older.
Pregnant women may choose to be in the study. The study procedures do not pose a risk to the safety of the unborn child or the woman.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amoy Fraser, PhD, CCRP, PMP | Contact | 4072668742 | amoy.fraser@ucf.edu | |
| Erica Martin, B.S. | Contact | 4072668742 | erica.martin@ucf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Taj Azarian, PhD | University of Central Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Central Florida | Recruiting | Orlando | Florida | 32827 | United States |
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Biospecimens from participants of the study will be coded and de-identified by the clinical research coordinators and will be accompanied by corresponding clinical data collected at the time of biospecimen collection. De-identified biospecimens will be stored at -80°C indefinitely.
Data received with the biospecimens and from the analyses generated in the study will be stored electronically on a dedicated password protected server at the Burnett School of Biomedical Sciences and accessed only through UCF computers. Access to this data will be limited to the research personnel involved in the analyses.
Biospecimens will be accessed only by authorized personnel working in the PIs laboratory.