Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site: COVPN 3004 Boost
Project Number3UM1AI148689-03S8
Former Number5UM1AI148689-03
Contact PI/Project LeaderKOTLOFF, KAREN L.
Awardee OrganizationUNIVERSITY OF MARYLAND BALTIMORE
Description
Abstract Text
Novavax CoVPN 3004 Adult and Pediatric Booster Administration
Project Summary/Abstract:
Novavax Adult and Pediatric booster
To date, 485 adult and 29 pediatric participants have received the initial series of vaccinations, had associated
follow-up visits, and participated in a blinded cross-over. We estimate 380 adult and 29 pediatric participants
will be invited to receive booster dose of vaccine and participate in associated follow-up visits. Blood and other
protocol-required specimens collected at theses visits will be processed, stored, and shipped per protocol.
Data will be entered, and data queries will be resolved in a timely manner.
Surveillance for illness visits will continue and with the advent of new variants, it is expected illness visits will
increase following major holidays with a gradual reduction to follow.
Public Health Relevance Statement
Novavax CoVPN 3004 Adult and Pediatric Booster Administration
Narrative:
Novavax Adult and Pediatric booster
While the Pfizer and Moderna mRNA-based COVID-19 vaccines have received EUA for adult participants and
EUA for children 12-<18 years of age, and are widely available for public receipt, the Novavax NVX-CoV2373
vaccine offers a simpler, more well-established vaccine platform with a strong safety and efficacy profile. In
addition, the vaccine is easy to manufacture and requires only refrigeration storage making it easier to store
and distribute. Therefore, the evaluation of this vaccine is of great public health importance in the fight against
COVID-19.
NIH Spending Category
No NIH Spending Category available.
Project Terms
18 year oldAdolescentAdultBlindedBloodCOVID-19COVID-19 Prevention NetworkCOVID-19 vaccineCenters for Disease Control and Prevention (U.S.)ChildChildhoodClassificationDataDoseEvaluationGenesHolidaysIncidenceMessenger RNAParticipantProcessProtocols documentationPublic HealthRefrigerationSARS-CoV-2 positiveSARS-CoV-2 variantSafetySeriesShipsSpecimenTimeVaccinationVaccinesVariantVisitbasebooster vaccineclinical research sitefight againstfollow-upinterestsevere COVID-19symptomatic COVID-19vaccine evaluationvaccine platformvariants of concern
National Institute of Allergy and Infectious Diseases
CFDA Code
855
DUNS Number
188435911
UEI
Z9CRZKD42ZT1
Project Start Date
22-August-2022
Project End Date
30-November-2023
Budget Start Date
22-August-2022
Budget End Date
30-November-2023
Project Funding Information for 2022
Total Funding
$1,382,804
Direct Costs
$895,019
Indirect Costs
$487,785
Year
Funding IC
FY Total Cost by IC
2022
National Institute of Allergy and Infectious Diseases
$1,382,804
Year
Funding IC
FY Total Cost by IC
Sub Projects
No Sub Projects information available for 3UM1AI148689-03S8
Publications
Publications are associated with projects, but cannot be identified with any particular year of the project or fiscal year of funding. This is due to the continuous and cumulative nature of knowledge generation across the life of a project and the sometimes long and variable publishing timeline. Similarly, for multi-component projects, publications are associated with the parent core project and not with individual sub-projects.
No Publications available for 3UM1AI148689-03S8
Patents
No Patents information available for 3UM1AI148689-03S8
Outcomes
The Project Outcomes shown here are displayed verbatim as submitted by the Principal Investigator (PI) for this award. Any opinions, findings, and conclusions or recommendations expressed are those of the PI and do not necessarily reflect the views of the National Institutes of Health. NIH has not endorsed the content below.
No Outcomes available for 3UM1AI148689-03S8
Clinical Studies
No Clinical Studies information available for 3UM1AI148689-03S8
News and More
Related News Releases
No news release information available for 3UM1AI148689-03S8
History
No Historical information available for 3UM1AI148689-03S8
Similar Projects
No Similar Projects information available for 3UM1AI148689-03S8