Whole-cell pneumococcal vaccine to reduce nasal carriage in young children
Official title: A Phase II Study Evaluating the Safety and Efficacy of Whole-Cell Pneumococcal Vaccine (wSp) in Reducing Nasopharyngeal Colonization by Streptococcus pneumoniae in Young Children
Funded at Rochester General Hospital (Ny) · NIH-11325717 · Data updated 2026-11-12
This trial gives a low-cost, whole-cell pneumococcal vaccine to young children to help reduce bacteria living in the nose and lower the chance of ear and other pneumococcal infections.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Rochester General Hospital (Ny) NIH-funded |
| Lab location | 1 site (Rochester, United States) |
| Project start | March 15, 2024 |
| Project end | February 29, 2028 |
| Funding year | 2026 |
| Award (this year) | $787,426 |
| NIH project number | 5U01AI172733-03 |
| Project ID | NIH-11325717 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal participants are young children (toddlers and preschool-aged) who are healthy enough to receive routine vaccinations and whose caregivers consent to nasal swabs and follow-up visits.
✕Less likely to help
Adults, people with contraindications to vaccination, or children not at risk for pneumococcal exposure are unlikely to receive direct benefit from participating.
What this research studies
You or your child would receive a killed, non-capsulated whole-cell Streptococcus pneumoniae vaccine (wSp) that aims to trigger broad immune responses against many pneumococcal types. The study enrolls young children and collects nasal swabs during healthy visits and at the start of acute otitis media to measure bacterial colonization. Researchers will also monitor safety and measure immune responses after vaccination, building on prior testing in adults and toddlers. Reductions in nasal carriage during health or infections would suggest the vaccine could help prevent pneumococcal disease and transmission.
Why it matters
Potential benefit: If successful, this vaccine could lower nasopharyngeal carriage of pneumococcus in children and reduce rates of ear and other pneumococcal infections.
How similar studies have gone: Earlier trials reported that wSp is safe and produces immune responses in adults and toddlers, but using it to reduce nasal colonization in young children is a newer test.
Where this research is happening
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Rochester General Hospital (Ny)
Rochester, United States Active
Researchers
- Principal investigator: Pichichero, Michael E — Rochester General Hospital (Ny)
- Study coordinator: Pichichero, Michael E
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.