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Principal Investigator: Karen L. Kotloff
Organization: UNIVERSITY OF MARYLAND BALTIMORE
Fiscal Year: 2021
Award: $509,201
Funding agency: National Institute of Allergy and Infectious Diseases
Project Summary/Abstract
The University of Maryland School of Medicine (UMSOM) Center for Vaccine Development and Global Health
(CVD) has been an established VTEU site since 1974. The goal of the VTEUs is to initiate innovative concepts
for clinical research and implement clinical site protocols for evaluating vaccines, other preventive biologics,
therapeutics, diagnostics, and devices for the treatment and prevention of infectious diseases, and CVD is
uniquely poised to accomplish this goal. CVD’s expert and accomplished investigative team has
complementary skill sets in all areas necessary to address the NIAID priority areas, with established
management plans to effectively allocate work and conduct multiple projects simultaneously. In the past 17
months, a key area of interest at NIAID has been discovery of safe and effective protective measures,
including vaccines, for persons at risk of COVID-19. This proposal describes the implementation of a critical
protocol in that arena, namely the Pediatric expansion of the phase 3 pivotal efficacy study of the Novavax
recombinant spike protein vaccine with M Matrix adjuvant. The project’s primary objectives are (1) to evaluate
the efficacy of a 2-dose regimen of SARS-CoV-2 rS adjuvanted with Matrix-M1 compared to placebo against
PCR-confirmed symptomatic COVID-19 illness diagnosed ≥ 7 days after completion of the second injection in
the initial set of vaccinations of adolescent participants 12 to < 18 years of age; and (2) to describe the
safety experience for the vaccine versus placebo in adolescent participants (12 to <18 years of age) based on
solicited short-term reactogenicity by toxicity grade for 7 days following each vaccination (Days 0 and 21) after
the initial set of vaccinations. Multiple additional objectives are also being evaluated. The design is a Phase 3,
randomized, observer-blinded, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of
SARS-CoV-2 rS with Matrix-M1 adjuvant in adult participants ≥ 18 years of age (Adult Main Study) with a
Pediatric Expansion (This proposal is for the Pediatric Expansion). In the Pediatric Expansion, adolescent
participants 12 to 17 years of age will be enrolled without stratification. Participants are followed for 2 years for
safety, tolerability, efficacy, and immune responses. The expected sample size will be 3000 adolescents: 2000
will receive vaccine first and 1000 will receive placebo first. After 6 months, there will be a double-blind cross
over. This study is expected to contribute the data necessary to allow for authorization of this vaccine in 12 to
17 year-olds in the US.
Terms: <17 year old><17 years of age><18 year old><18 years of age><2019 novel corona virus><2019 novel coronavirus><2019-nCoV><2019-nCoV S protein><2019-nCoV spike glycoprotein><2019-nCoV spike protein><2019-nCoV vaccine><21+ years old><Address><Adjuvant><Adolescent><Adolescent Youth><Adult><Adult Human><Area><Authorization><Authorization documentation><Biologic Therapy><Biological Response Modifier Therapy><Biological Therapy><Blinded><COVID-19><COVID-19 Prevention Network><COVID-19 S protein><COVID-19 spike glycoprotein><COVID-19 spike protein><COVID-19 vaccine><COVID-19 virus><COVID19><COVID19 S protein><COVID19 spike glycoprotein><COVID19 spike protein><COVID19 vaccine><COVID19 virus><CV-19><CV19><Childhood><Clinical Research><Clinical Study><CoV-2><CoV2><CoVPN><Communicable Diseases><Data><Devices><Diagnosis><Diagnostic><Dose><Double-Blind Method><Double-Blind Study><Double-Blinded><Double-Masked Method><Double-Masked Study><Emerging Communicable Diseases><Emerging Infectious Diseases><Enrollment><Epidemic><Evaluation><Goals><Health><Immune response><Immunological response><Infectious Disease Pathway><Infectious Diseases><Infectious Disorder><Injections><International><Maryland><Measures><NIAID><National Institute of Allergy and Infectious Disease><Novavax COVID-19 vaccine><Novavax S protein vaccine><Novavax coronavirus disease 2019 vaccine><Participant><Permission><Personal Satisfaction><Persons><Phase><Placebos><Prevention><Preventive><Proteins><Protocol><Protocols documentation><Randomized><Recombinants><Regimen><Risk><SARS corona virus 2><SARS-CoV-2><SARS-CoV-2 S protein><SARS-CoV-2 rS><SARS-CoV-2 spike glycoprotein><SARS-CoV-2 spike protein><SARS-CoV-2 vaccine><SARS-CoV2><SARS-CoV2 S protein><SARS-CoV2 spike glycoprotein><SARS-CoV2 spike protein><SARS-CoV2 vaccine><SARS-associated corona virus 2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-coronavirus-2 vaccine><SARS-related corona virus 2><SARS-related coronavirus 2><SARSCoV2><Safety><Sample Size><Severe Acute Respiratory Distress Syndrome CoV 2><Severe Acute Respiratory Distress Syndrome Corona Virus 2><Severe Acute Respiratory Distress Syndrome Coronavirus 2><Severe Acute Respiratory Syndrome CoV 2><Severe Acute Respiratory Syndrome CoV 2 vaccine><Severe Acute Respiratory Syndrome-associated coronavirus 2><Severe Acute Respiratory Syndrome-related coronavirus 2><Severe acute respiratory syndrome associated corona virus 2><Severe acute respiratory syndrome corona virus 2><Severe acute respiratory syndrome coronavirus 2><Severe acute respiratory syndrome coronavirus 2 S protein><Severe acute respiratory syndrome coronavirus 2 spike glycoprotein><Severe acute respiratory syndrome coronavirus 2 spike protein><Severe acute respiratory syndrome coronavirus 2 vaccine><Severe acute respiratory syndrome related corona virus 2><Sham Treatment><Site><Stratification><Testing><Toxic effect><Toxicities><Universities><Vaccination><Vaccines><Virus><Work><Wuhan coronavirus><adulthood><age 17 years><age 18 years><aged><base><biological therapeutic><biological treatment><biotherapeutics><biotherapy><clinical research site><clinical site><corona virus disease 2019><corona virus disease 2019 vaccine><coronavirus disease 2019><coronavirus disease 2019 S protein><coronavirus disease 2019 prevention network><coronavirus disease 2019 spike glycoprotein><coronavirus disease 2019 spike protein><coronavirus disease 2019 vaccine><coronavirus disease 2019 virus><design><designing><develop a vaccine><development of a vaccine><efficacy analysis><efficacy assessment><efficacy evaluation><efficacy examination><efficacy study><eighteen year old><eighteen years of age><enroll><evaluate efficacy><evaluate vaccines><examine efficacy><experience><global health><hCoV19><host response><immune system response><immunogenicity><immunoresponse><innovate><innovation><innovative><interest><juvenile><juvenile human><medical college><medical schools><nCoV2><pediatric><placebo controlled study><prevent><preventing><programs><randomisation><randomization><randomly assigned><school of medicine><seventeen year old><seventeen years of age><sham therapy><skills><symptomatic COVID-19><symptomatic COVID19><symptomatic coronavirus disease 2019><tool><vaccine against 2019-nCov><vaccine against SARS-CoV-2><vaccine against SARS-CoV2><vaccine against SARS-coronavirus-2><vaccine against Severe Acute Respiratory Syndrome CoV 2><vaccine against Severe acute respiratory syndrome coronavirus 2><vaccine development><vaccine evaluation><vaccine for novel coronavirus><vaccine formulation><vaccine screening><vaccine testing><well-being><wellbeing>