Comparison of high VS. Standard dose influenza vaccine in pediatric solid organ transplant recipients

Active Cooperative Agreement Awarded Last action

Award ID
U01AI167799
Recipient
Awarding agency
Obligated
$10,233,262

Award facts

Assistance listing
93.855 Allergy and Infectious Diseases Research
Completion date 70% complete
Place of performance
Nashville, TN 37203, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Influenza virus is a significant pathogen in pediatric solid organ transplant (SOT) recipients. However, these individuals respond poorly to standard-dose (SD) inactivated influenza vaccine (IIV). Recent studies have investigated two strategies to overcome poor immune responses in SOT recipients: (1) administration of high- dose (HD)-IIV compared to SD-IIV and (2) two doses of SD-IIV compared to one dose of SD-IIV in the same influenza season. One study compared HD-IIV VS. SD-IIV in adult SOT recipients and noted that HD-IIV was safe and more immunogenic; however, the median post-transplant period was 38 months. A phase i pediatric study comparing a single dose of HD-IIV VS. SD-IIV was safe with higher immunogenicity, but the study was limited by small sample size and median post-transplant vaccine administration was 26 months. In another phase II trial of adult SOT recipients, two doses of SD-IIV one month apart compared to one-dose of SD-IIV revealed modestly increased immunogenicity when given at a median of 18 months post-transplant. Therefore, these studies lack both evaluation in the early post-transplant period and substantive pediatric populations. Additionally, the administration of two-doses of HD-IIV in the same influenza season has not been evaluated in pediatric SOT recipients. Thus, the optimal immunization strategy for pediatric SOT recipients less than 24 months post-transplant is unknown. In addition, immunologic predictors and correlates of influenza vaccine immunogenicity in pediatric SOT recipients have not been well-defined. The central hypothesis of our proposal is that pediatric SOT recipients 1-23 months post-transplant who receive two doses of HD- quadrivalent inactivated influenza vaccine (QIV) will have similar safety but higher HAI geometric mean titers (gmts) to influenza antigens compared to pediatric SOT recipients receiving two doses of SD- QIV. To test this hypothesis and address the critical knowledge gaps outlined above, we propose to conduct a phase II, multi-center, randomized-controlled immunogenicity and safety trial comparing two doses of HD-QIV to two doses of SD-QIV in pediatric kidney, heart, and/or liver SOT recipients 1-23 months post-transplant. The results of this study will address significant knowledge gaps regarding influenza vaccine strategies and immune responses in pediatric SOT recipients and will guide vaccine recommendations in the early post- transplant period.

Transactions

Action Obligated Date
Amendment $1,631,637
Amendment $1,631,325
Amendment $1,669,617
Amendment $1,669,617
Amendment $1,815,533
Original award $1,815,533

Subawards

Subrecipient Amount Awarded
Research Institute At Nationwide Children's Hospital Comparison of High vs. Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant Recipients $63,200
The Leland Stanford Junior University $30,880
University Of Pittsburgh - Of The Commonwealth System Of Higher Education $26,200
Childrens Mercy Hospital $1,240
Baylor College Of Medicine $48,150
Childrens Healthcare Of Atlanta, Inc. $15,000
ANN & Robert H Lurie Childrens Hospital Of Chicago $46,500
The Children's Hospital Of Philadelphia $71,200
Childrens Hospital Medical Center $47,700
Emory University $23,475
Trustees Of Indiana University $79,250
Seattle Children's Hospital Comparison of High vs. Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant Re $70,400
University Of Pittsburgh - Of The Commonwealth System Of Higher Education Comparison of High vs. Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant Recipients $26,200
University Of Pittsburgh - Of The Commonwealth System Of Higher Education $127,200
Emory University $31,300
Baylor College Of Medicine $32,100
ANN & Robert H Lurie Childrens Hospital Of Chicago $30,918
Childrens Healthcare Of Atlanta, Inc. $3,000
Childrens Hospital Medical Center $119,696
Childrens Mercy Hospital $11,922
The Leland Stanford Junior University $30,880
ANN & Robert H Lurie Childrens Hospital Of Chicago $31,000
University Of Pittsburgh - Of The Commonwealth System Of Higher Education $39,300
Baylor College Of Medicine $48,052
ANN & Robert H Lurie Childrens Hospital Of Chicago $46,500
Emory University $39,125
Childrens Healthcare Of Atlanta, Inc. $8,000
University Of Pittsburgh - Of The Commonwealth System Of Higher Education $118,351
Childrens Hospital Medical Center $151,495
The Leland Stanford Junior University $46,920
Childrens Mercy Hospital $49,195
The Leland Stanford Junior University "Comparison of High vs. Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant Recipients " $46,665
Baylor College Of Medicine Comparison of High vs. Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant Recipients $48,052
University Of Pittsburgh - Of The Commonwealth System Of Higher Education $3,100
Childrens Hospital Medical Center $5,900
Emory University $31,300
Childrens Hospital Medical Center $146,870
Childrens Mercy Hospital $41,102
The Leland Stanford Junior University $30,925
Baylor College Of Medicine $32,002
University Of Pittsburgh - Of The Commonwealth System Of Higher Education $26,200
Show all 41

Quick answers

Who received award U01AI167799?

U01AI167799 was awarded to Vanderbilt University Medical Center by National Institute of Allergy and Infectious Diseases (National Institutes of Health) on June 9, 2023.

How much is award U01AI167799 worth?

$10,233,262 has been obligated on U01AI167799.

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