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

Active Cooperative Agreement Awarded Last action

Award ID
U01AI172733
Recipient
Awarding agency
Obligated
$3,226,121

Award facts

Assistance listing
93.855 Allergy and Infectious Diseases Research
Completion date 66% complete
Place of performance
Rochester, NY 14621, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

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.

Transactions

Action Obligated Date
Amendment $787,426
Amendment $794,229
Amendment $822,233
Original award $822,233

Subawards

Subrecipient Amount Awarded
Subrecipient not on record Pittsford Pediatric Associates serves as a clinical trial site. $120,000
Subrecipient not on record Long Pond Pediatrics serves as a clinical trial site. $120,000
Subrecipient not on record Westside Pediatric Group serves as a clinical trial site. $120,000
Subrecipient not on record Panorama Pediatric Group serves as a clinical trial site. $320,000
Rochester Institute Of Technology The purpose of this subaward is to provide biostatistical services to the U01 data. $62,465
The Children's Hospital Corporation Dr. Malley will be responsible for the immunological assays to be conducted during the trial, namely the measurement of antibody responses to the whole cell… $70,575

Quick answers

Who received award U01AI172733?

U01AI172733 was awarded to The Rochester General Hospital by National Institute of Allergy and Infectious Diseases (National Institutes of Health) on March 15, 2024.

How much is award U01AI172733 worth?

$3,226,121 has been obligated on U01AI172733.

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