Document text
Principal Investigator: Peter B. Gilbert
Organization: FRED HUTCHINSON CANCER CENTER
Fiscal Year: 2022
Award: $419,442
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 COVID-19 vaccine efficacy trial entitled “A
parallel-group, Phase III, multi-stage, modified double-blind, multi-armed study to assess the efficacy, safety,
and immunogenicity of two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (monovalent and bivalent)
for prevention against COVID-19 in adults 18 years of age 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 National Institutes of Health (NIH) led
rapid constitution of the CoVPN, partnering 5 NIH supported clinical trial networks, to create an enhanced
network of physician-scientists at 145 United States (US) and 71 international clinical trial sites in 17 countries
dedicated to developing globally effective vaccines for SARS-CoV-2. Due to its extensive experience
implementing global HIV vaccine trials over the last 20 years, the HIV Vaccine Trials Network (HVTN) LOC
was selected as the LOC for CoVPN vaccine trials.
This Phase 3, multi-stage, modified double-blind, placebo-controlled, multi-armed study will test the
efficacy, safety and immunogenicity of Sanofi-Pasteur SARS-CoV2 prefusion Spike delta TM with AS03
adjuvant, monovalent D614 (monovalent vaccine) & SARS-CoV2 prefusion Spike delta TM with AS03
adjuvant, bivalent D614/B.1.351 (bivalent vaccine), to modify COVID-19 disease in adults 18 years of age and
older. Participants will be recruited from clinical trial sites across the US and globally using data analytics
to target high risk individuals with a diverse racial and ethnic profile.
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 using qualified and validated assays for diagnosis and immune monitoring.
Specific aims of this study are to assess the clinical efficacy of the investigational CoV2 preS dTM recombinant
protein adjuvanted with AS03 – both monovalent and bivalent (“study vaccines”) in naïve adults for the
prevention of symptomatic COVID-19 occurring > 14 days after the second injection; to assess the safety
of the study vaccines compared to placebo throughout the study; to assess, in participants who are SARS-
CoV-2 naïve, the clinical efficacy of the CoV2 preS dTM-AS03 vaccines for prevention of the following
occurring > 14 days after the second injection: prevention of SARS-CoV-2 infection, prevention of severe
COVID-19; to describe the frequency & spectrum of disease in episodes of symptomatic COVID-19 in
SARS-CoV-2 non-naïve adults in each study group.
This efficacy trial will tell us much about the ability of two recombinant vaccines, targeting two of the
most common SARS-CoV-2 variants, to induce strong adaptive protective responses. After the Novavax
vaccine, this is the second large scale recombinant protein vaccine to be tested for efficacy and it is the first
trial to use a bivalent vaccine including the B.1.351 variant of concern. If successful, this will be an important
vaccine that can be scaled up rapidly and deployed throughout the world. The results of this trial will be used to
assess registration of this vaccine product and will also provide crucial information to inform future
generations of COVID-19 vaccines.
Terms: <18 year old><18 years of age><2019 novel corona virus><2019 novel coronavirus><2019-nCoV><2019-nCoV vaccine><2019-nCoV variant><2019-nCoV variant forms><2019-nCoV variant strains><21+ years old><Abdominal Typhus><Address><Adjuvant><Adult><Adult Human><Antigens><Assay><B.1.351><Bioassay><Biologic Assays><Biological Assay><Biometrics><Biometry><Biostatistics><COVID crisis><COVID disease severity><COVID epidemic><COVID pandemic><COVID severity><COVID-19><COVID-19 Prevention Network><COVID-19 crisis><COVID-19 disease severity><COVID-19 epidemic><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 infection><COVID-19 outbreak><COVID-19 pandemic><COVID-19 public health crisis><COVID-19 screening><COVID-19 severity><COVID-19 vaccine><COVID-19 variant><COVID-19 variant forms><COVID-19 variant strains><COVID-19 virus><COVID19><COVID19 crisis><COVID19 disease severity><COVID19 epidemic><COVID19 global health crisis><COVID19 global pandemic><COVID19 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