Document text
Principal Investigator: Peter B. Gilbert
Organization: FRED HUTCHINSON CANCER RESEARCH CENTER
Fiscal Year: 2020
Award: $1,414,274
Funding agency: National Institute of Allergy and Infectious Diseases
Project Abstract
This proposal outlines the scientific agenda for the COVID-19 Prevention Network (CoVPN) Vaccines
Leadership Operations Center (LOC) for implementation of the first COVID-19 vaccine efficacy trial “A Phase
3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and
Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older.”
With the global COVID-19 pandemic, we recognize a significant need for vaccines that modify COVID-19 in
SARS-CoV-2 infected individuals. Addressing this gap, the HVTN has joined 4 other National Institute of
Health (NIH) clinical trial networks to form the CoVPN, an enhanced network dedicated to developing globally
effective vaccines for SARS-CoV-2. Due to its extensive experience implementing HIV vaccine trials, the HIV
Vaccine Trials Network (HVTN) LOC was selected to as the CoVPN vaccine LOC.
This trial, a phase 3, placebo-controlled, double-blinded study will test the efficacy of mRNA-1273 SARS-CoV-
2, a lipid co-formulated messenger ribonucleic acid (mRNA) vaccine encoding the SARS-CoV-2 spike protein
(S), to modify COVID-19 disease in adults 18 year of age and older. Participants will be recruited from clinical
trial sites across the US, using data analytics to target high risk individuals with a diverse racial and ethnic
profile. In addition, the CoVPN will use accessory community-based sites, staffed by clinical teams from the
home sites and employ mobile clinics to enroll individuals in new high risk settings (e.g., meat packing plants).
Participants will receive symptomatic screening for SARS-CoV-2 infection, and if they become infected will be
monitored with frequent clinical check-ins and remote monitoring of vital signs. Infected individuals who
progress to moderate-severe COVID-19 will be referred for hospitalization. All trial endpoint assays will be
done at CoVPN laboratories, using validated assays for diagnosis and immune monitoring.
Specific aims of this study are to demonstrate efficacy of mRNA-1273 SARS-CoV-2 to prevent COVID-19, to
evaluate the safety and reactogenicity of 2 injections given 28 days apart, the assess the ability to prevent
infection with SARS-CoV-2, the assess the ability to modify COVID-19 infection, to evaluate viral infection
kinetics, and to evaluate the vaccine induced immune response. This initial efficacy trial will tell us much about
the adaptive immune response in persons who receive a SARS-CoV-2 S protein based vaccine and about their
ability to modify the disease course of COVID-19. In addition, it will improve our understanding of the dynamics
and duration of these responses and will inform rational design and testing of preventive and therapeutic
monoclonal antibody interventions. Lastly, the results of this trial will be used to assess registration of this
vaccine product as well as to modify future COVID-19 vaccine trials planned over the next 12 months.
Terms: <18 year old><18 years of age><2019 novel coronavirus><2019-nCoV><21+ years old><Abdominal Typhus><Address><Adult><Adult Human><Age-Years><Assay><Bioassay><Biologic Assays><Biological Assay><Biometrics><Biometry><Biostatistics><COVID-19><COVID-19 epidemic><COVID-19 pandemic><COVID-19 vaccine><COVID19><COVID19 epidemic><COVID19 pandemic><COVID19 vaccine><Cause of Death><Cellular Assay><Cellular Immune Function><Clinic><Clinical><Clinical Trials><Clinical Trials Network><Cohort Studies><Communicable Diseases><Communities><Concurrent Studies><Data Analytics><Development><Diagnosis><Disease><Disease Outbreaks><Disorder><Double-Blind Method><Double-Blind Study><Double-Blinded><Double-Masked Method><Double-Masked Study><End Point Assay><Endpoint Assays><Enrollment><Enteric Fever><Exposure to><Eye><Eyeball><Future><Goals><HIV Vaccine Trials Network><HIV vaccine><HIV/AIDS Vaccines><HVTN><Health><Home><Home environment><Hospital Admission><Hospitalization><Immune><Immune Monitoring><Immune response><Immunes><Immunity><Immunologic Monitoring><Immunological Monitoring><Immunological response><Immunology><Immunomonitoring><Individual><Infection><Infection Control><Infection prevention><Infectious Disease Pathway><Infectious Diseases><Infectious Disorder><Injections><Intervention><Intervention Strategies><Kinetics><Knowledge><Laboratories><Lead><Leadership><Lipids><MAb Therapeutics><Malaria><Meat><Mediating><Monitor><Morbidity><Morbidity - disease rate><NIH><National Institutes of Health><Non-Polyadenylated RNA><Outbreaks><Paludism><Participant><Pb element><Persons><Phase><Placebos><Plants><Plasmodium Infections><Population><Preparation><Prevent infection><Prevention><Preventive><Proteins><Protocol><Protocols documentation><Quality Control><RNA><RNA Gene Products><Randomized><Randomized Clinical Trials><Research Methodology><Research Methods><Ribonucleic Acid><Risk><SARS-CoV-2><SARS-CoV2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related coronavirus 2><Safety><Sampling><Serologic><Serological><Severe acute respiratory syndrome coronavirus 2><Severities><Sham Treatment><Site><System><Testing><Therapeutic Monoclonal Antibodies><Typhoid><Typhoid Fever><United States National Institutes of Health><Vaccines><Validation><Viral Diseases><Virus><Virus Diseases><Wuhan coronavirus><adaptive immune response><adulthood><age 18 years><base><blind><cell assay><clinical trial analysis><corona virus disease 2019><corona virus disease 2019 epidemic><corona virus disease 2019 pandemic><corona virus disease 2019 vaccine><coronavirus disease 2019><coronavirus disease 2019 epidemic><coronavirus disease 2019 pandemic><coronavirus disease 2019 vaccine><design><designing><developmental><efficacy study><efficacy testing><efficacy trial><eighteen year old><eighteen years of age><enroll><experience><heavy metal Pb><heavy metal lead><high risk><host response><human immunodeficiency virus vaccine><immune function><immunogenicity><immunoresponse><improved><interventional strategy><monoclonal antibody drugs><mortality><operation><placebo controlled study><prevent><preventing><programs><quality assurance><racial and ethnic><racial diversity><racially diverse><randomisation><randomization><randomly assigned><recruit><response><screening><sham therapy><therapeutic mAbs><vaccination study><vaccination trial><vaccine study><vaccine trial><viral infection><virus infection><virus-induced disease>