# 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

> **NIH NIH U01** · ROCHESTER GENERAL HOSPITAL (NY) · 2024 · $822,233

## Abstract

Abstract. While new, higher-valency pneumococcal conjugate vaccines( PCVs), PCV15 and PCV20,
will include important serotypes, their impact and cost-effectiveness will likely be less than what was
achieved with introduction of PCV7, PCV10 and PCV13 because, in recent years, prevalent serotypes
causing infections have changed and continue to change. Here we propose a clinical study,
vaccinating children with a low cost-to-produce, serotype-independent, killed, non-capsulated avirulent
whole-cell Streptococcus pneumoniae (wSp) vaccine that elicits Th17 cell-mediated immunity and
antibodies against all pneumococcal serotyypes, and which has been tested in adults and toddlers.
Nasopharyngeal (NP) colonization is a prerequisite to pneumococcal diseases and transmission. We
will evaluate the efficacy of wSp vaccination in young children on pneumococcal NP colonization at
times of health and onset of acute otitis media. Notably, prevention of pneumococcal NP colonization
may be a surrogate for prevention by wSp of pneumococcal infections. In addition, we will confirm the
safety and immunogenicity of wSp. Demonstration of a reduction of NP colonization, safety,
immunogenicity of wSp would engage the scientific and public health community and
commercialization support for additional licensure studies to next test for protection against various
pneumococcal diseases, to determine whether wSp could complement PCVs or even replace PCVs
as an inexpensive, serotype-independent vaccine.

## Key facts

- **NIH application ID:** 10703986
- **Project number:** 1U01AI172733-01A1
- **Recipient organization:** ROCHESTER GENERAL HOSPITAL (NY)
- **Principal Investigator:** MICHAEL E PICHICHERO
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $822,233
- **Award type:** 1
- **Project period:** 2024-03-15 → 2028-02-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10703986

## Citation

> US National Institutes of Health, RePORTER application 10703986, 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 (1U01AI172733-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10703986. Licensed CC0.

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