Pneumococcal Carriage Duration

NIS103487 Duration of Streptococcus Pneumoniae Carriage in U.S. Children Under Five: A Pilot Longitudinal Study

Streptococcus pneumoniae (SPN) remains a leading cause of respiratory disease in young children despite widespread vaccination. Understanding the duration of pneumococcal carriage, patterns of co-colonization, and the influence of viral infections and the respiratory microbiome is essential to evaluate next-generation pneumococcal vaccines and inform public health strategies. Current data on Streptococcus pneumoniae carriage dynamics are limited in U.S. pediatric populations. This study aims to generate updated estimates of Streptococcus pneumoniae colonization and explore microbial interactions using high-resolution longitudinal sampling and genomic methods.

Study Overview

• Status: Recruiting
• Conditions: Pneumococcal Carriage
• Intervention / Treatment: Other: Oropharyngeal (OP) swab

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Dr. Amoy Fraser, PhD; Phone Number: 407-266-8742; Email: Amoy.Fraser@UCF.edu
• Study Contact Backup: Name: Aniya Barclay, MS; Phone Number: 407-266-8742; Email: Aniya.Barclay@UCF.edu

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32827
      • Recruiting
      • University of Central Florida
      • Contact: Dr. Amoy Fraser, PhD; Phone Number: 407-266-8742; Email: Amoy.Fraser@UCF.edu
      • Contact: Aniya Barclay, MS; Phone Number: 407-266-8742; Email: Aniya.Barclay@UCF.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study will enroll 60 healthy children under 4 years of age (30 aged 0-1 year, 30 aged 2-4 years) residing in Orlando, Florida. Children must be free of chronic or immuno-compromising conditions. Participants will be recruited from the community, pediatric clinics, and existing registries.

Description

Inclusion Criteria:

• Are older than 28 days and under 4 years of age at the time of enrollment.

• Have a parent or legal guardian who:

  1. Provides written informed consent.
  2. Is able to read and speak English or Spanish.
  3. Agrees to comply with all study procedures, including completion of questionnaires and biweekly oropharyngeal (OP) swab collections from the child for a period of 12 months.

Exclusion Criteria:

• History of chronic medical conditions or immunocompromising conditions that may influence pneumococcal carriage or study participation, such as:
• cystic fibrosis
• cerebral palsy
• neuromuscular disorders
• congenital heart disease
• known congenital or acquired immunodeficiencies
• sickle cell disease
• undergoing immunosuppressive therapy (e.g., systemic corticosteroids ≥2 mg/kg/day for ≥14 days, chemotherapy, biologics)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Main Cohort; 60 healthy children under 4 years of age (30 children aged 0-1 years, 30 children aged 2-4 years) residing in Orlando, Florida.	Other: Oropharyngeal (OP) swab; At each study visit, a double-tipped OP swab will be collected by trained clinical research staff. All swabs will be collected using a standard protocol. There will be 26 total study visits over the course of one year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimate the age- and serotype-specific carriage duration of Streptococcus pneumoniae in children aged 0-4 years.	Respiratory samples will be tested to determine whether Streptococcus pneumoniae (pneumococcus) is present using standard laboratory methods and genetic testing. If found, the bacteria will be genetically analyzed to identify its type (serotype) and compare it with other strains. Researchers will measure when a child first becomes colonized, when the bacteria are cleared (after two negative tests), how long colonization lasts, and how quickly new colonization occurs. Genetic analysis will determine whether the same strain persists or a new strain is acquired.	One year
Estimate the age- and serotype-specific co-colonization rates of S. pneumoniae in children aged 0-4 years.	Respiratory samples will be tested to determine whether Streptococcus pneumoniae (pneumococcus) is present with other pneumococcal intra-subject lineages (ISL) using standard laboratory methods and genetic testing. If found, the bacteria will be genetically analyzed to identify the different types (serotype) and how many there are.	One year
Evaluate the feasibility and scalability of expanding the study to a larger sample size		One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine which viral and bacterial pathogens are present in respiratory specimens collected from enrolled children	Respiratory samples will be tested for common viruses and bacteria using advanced laboratory methods. Researchers will also record whether participants have symptoms or are carrying these bacteria without feeling sick. They will track when a participant first acquires a new respiratory virus (one that was not detected at the previous visit) and calculate how often new infections occur over time, including comparisons by age group.	One year
Assessment of study methodologies	Researchers will compare different laboratory methods ( to see how well they detect Streptococcus pneumoniae and identify its type. They will also evaluate whether collecting samples every two weeks or once a month provides better information on bacterial carriage, new infections, and missing data. The study will compare different methods for analyzing the respiratory microbiome (the community of bacteria in the airways) and use computer models to determine whether microbiome patterns can predict pneumococcal carriage. Finally, researchers will compare the costs and practicality of different sampling schedules, collection methods, and laboratory tests to help guide future studies.	One year
To identify carriage of pneumococcal serotypes among participants in the context of PCV vaccine history.	The PI will identify the carriage of vaccine serotypes (VT) included in the most recent PCV administered to each participant. This analysis will compare VT versus NVT carriage prevalence, stratified by age group, vaccine, and time since vaccination.	One year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: July 27, 2026
• First Submitted That Met QC Criteria: August 4, 2026
• First Posted (Actual): August 6, 2026

Study Record Updates

• Last Update Posted (Actual): August 6, 2026
• Last Update Submitted That Met QC Criteria: August 4, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Children; Pneumococcal Carriage
• Other Study ID Numbers: STUDY00008626

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No