ABSTRACT
This supplement request is for a Phase 3, randomized, observer-blind, placebo-controlled study
to evaluate the efficacy, safety and immunogenicity, of a SARS-CoV-2 recombinant spoke
protein nanoparticle vaccine (SARS-CoV-2 rS) with Matric-M1TM adjuvant in adult participants
over 18 years of age who have no known history of SARS-CoV-2 infection but whose locations
or circumstances put them at appreciable risk of acquiring COVID-19 and/or SARS-CoV-2
infection. This request also relates to other COVID 19 activities.
Public Health Relevance Statement
NARRATIVE
This supplement request is to prepare for and implement a COVID-19 Phase 3 vaccine clinical
trial and for other COVID 19 activities.
NIH Spending Category
No NIH Spending Category available.
Project Terms
18 year old2019-nCoVAdjuvantAdultCOVID-19EvaluationLocationNovavax COVID-19 vaccineParticipantPhaseProteinsRandomizedRecombinantsRecording of previous eventsRiskSARS-CoV-2 infectionSafetyVaccine Clinical TrialVaccinesblindefficacy evaluationimmunogenicitynanoparticleplacebo controlled study
National Institute of Allergy and Infectious Diseases
CFDA Code
855
DUNS Number
051113330
UEI
FXKMA43NTV21
Project Start Date
23-December-2020
Project End Date
30-November-2022
Budget Start Date
23-December-2020
Budget End Date
30-November-2022
Project Funding Information for 2021
Total Funding
$2,614,800
Direct Costs
$1,634,250
Indirect Costs
$980,550
Year
Funding IC
FY Total Cost by IC
2021
National Institute of Allergy and Infectious Diseases
$2,614,800
Year
Funding IC
FY Total Cost by IC
Sub Projects
No Sub Projects information available for 3UM1AI148575-02S4
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 3UM1AI148575-02S4
Patents
No Patents information available for 3UM1AI148575-02S4
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 3UM1AI148575-02S4
Clinical Studies
No Clinical Studies information available for 3UM1AI148575-02S4
News and More
Related News Releases
No news release information available for 3UM1AI148575-02S4
History
No Historical information available for 3UM1AI148575-02S4
Similar Projects
No Similar Projects information available for 3UM1AI148575-02S4