Post Pandemic Pneumococcal Carriage Among Children and Adults

Post-Pandemic Genomic Epidemiology of Pneumococcal Carriage Among Children and Adults in the General US Population

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.

Study Overview

• Status: Recruiting
• Conditions: Pneumococcal Carriage

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 900

Contacts and Locations

• Study Contact: Name: Amoy Fraser, PhD, CCRP, PMP; Phone Number: 4072668742; Email: Amoy.Fraser@UCF.edu
• Study Contact Backup: Name: Erica Martin, B.S.; Phone Number: 4072668742; Email: erica.martin@ucf.edu

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32827
      • Recruiting
      • University of Central Florida
      • Contact: Amoy Fraser, PhD, CCRP, PMP; Phone Number: 4072668742; Email: Amoy.Fraser@UCF.edu
      • Contact: Britney-Ann Wray, BS, CCRP, CTBS; Phone Number: 4072668742; Email: britney-ann.wray@ucf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Children, ages 7 to 59 months (less than 5 years)
• Adults, ages 50 and older
• Ability to provide informed consent (from parents for children participants)
• ability to read and speak in English
• Agree to comply with study procedures (complete online data questionnaire and provide a nasopharyngeal collection).

Exclusion Criteria:

• Have been on an antibiotic in the last 2 weeks
• Have a respiratory infection that would make an nasopharyngeal collection improbable
• Have underlying developmental or chronic conditions impacting immune or respiratory function (e.g., immunocompromised, cystic fibrosis, cerebral palsy, paralysis)
• Adults unable to consent, individuals who are not yet adults, and prisoners will be excluded from this study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Central Florida
• Collaborators: Merck Sharp & Dohme Corporation
• Investigators: Principal Investigator: Taj Azarian, PhD, University of Central Florida

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Children; Epidemiology; Genomic; Pandemic; Streptococcus pneumoniae; Nasopharyngeal; Pneumococcal Carriage
• Other Study ID Numbers: STUDY00006081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No