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Enrollment completed at BIDMC - February 16, 2021

Clinical Trials.gov Link:  NCT04611802

PI Name

Kathryn Stephenson, M.D., MPH

Study Contact Name/Beeper

Kathryn Stephenson- b3032

Clinical Research Center - crc@bidmc.harvard.edu

Project Title

A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-MI Adjuvant in Adult Participants ≥ 18 years

Sponsor

Novavax, Inc

Study Population 

Adults participants ≥ 18 years

*Novavax is specifically targeting populations with high risk of severe COVID-19 infection (e.g. Black & LatinX individuals, and those with Diabetes Mellitus, Hypertension, and/or obesity

Treatment Summary

 

2 IM injections (Day 0 & Day 21) with either SARS-CoV-2 rS + Matrix MI adjuvant or placebo

Project Summary

Study Overview: This is a phase 3, randomized, observer-blinded, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of a SARS-CoV-2 rS vaccine with matrix MI adjuvant in healthy adult participants 18 years and older. This study is being sponsored by the pharmaceutical company, Novavax, Inc. Approximately 30,000 participants will be enrolled at 130 sites worldwide, with approximately 70% of participants being enrolled in the United States. Participants in this study will receive 2 IM injections on day 0 and day 21 (+ 7 days). The dose level will be 5 mg SARS-CoV-2 rS adjuvanted with 50 mg Matrix- MI based on nonclinical and early clinical data. Blood samples for immunogenicity and epidemiological assessments will be collected from all participants prior to the first vaccination and at selected subsequent time points. Following each vaccination, participants will record any local or systemic symptoms they experience and their daily temperature in their eDiary application. At any point, if a participant experiences symptoms associated with SARS-CoV-2 infection, they will be instructed to obtain a nasal swab for PCR testing and to complete a symptom reporting instrument using their eDiary application. The study will consist of a screening visit, two vaccination visits, and six follow up visits. The entire study will be 24 months in duration.

Primary Objective: To evaluate the efficacy of a primary 2-dose regimen of SARS-CoV-2 rS adjuvanted with Matrix-MI compared to placebo against PCR-confirmed symptomatic COVID-19 illness diagnosed ≥ 7 days after completion of the second vaccine in adult participants ≥ 18 years

Scientific Rationale: Both nonclinical and early clinical data to date support continued clinical development of SARS-CoV-2 rS + Matrix-MI adjuvant as a potential vaccine against SARS-CoV-2 infection. In rodent and nonhuman primate challenge models, the study vaccine induced high titers of antibodies in a dose-dependent fashion, as measured against anti-spike protein and hACE2 receptor binding, and achieved neutralization of wild-type virus that exceeded magnitude of responses measured in human convalescent sera and provided protection against SARS-CoV-2 challenge. Results from a Day 35 interim analysis of a clinical study (2019nCoV-101) in healthy adult participants showed that the study vaccine was well tolerated and induced robust immune responses with high levels of neutralizing antibodies that closely correlated with anti-spike IgG. The benefit of the Matrix-MI adjuvant was clear in the greater magnitude of humoral and T cell responses, induction of functional antibodies, and dose-sparing.

Study Implementation Plan 

The estimated study launch is mid-October, pending contracts and study set-up. The study will be implemented first at BIDMC, utilizing the Clinical Research Center space. We have already received approval from Janet Mullington to proceed with this study. We also plan to launch this study at the BIDMC Chelsea clinic. We have already established a relationship with their staff for the Regeneron-2069 study and hope to build off this for the Novavax vaccine study. Partnering with the BIDMC Chelsea clinic is crucial as it will help build the diversity in the participant population, and ultimately meet secondary objectives of studying the vaccine’s efficacy in high risk populations (i.e. Black and LatinX communities). The long term study implementation goals include launching collaborations with additional Beth Israel Lahey organizations (i.e. Lahey Burlington, Cambridge Hospital)

Key Inclusion criteria  

  • Adult males or females ≥ 18 years at screening
  • Willing and able to give informed consent
  • Female participants of child-bearing age are willing to be heterosexually inactive or use a medically acceptable form of contraception from at least 28 days prior to enrolment through 3 months after the last vaccination
  • Are medically stable as determined by the investigator
  • Agree not to participate in any other SARS-CoV-2 prevention trial during study follow up

Key Exclusion Criteria 

  • Unstable acute or chronic illness (except for well-controlled HIV with undetectable RNA and CD4 count ≥ 200)
  • Participation in research involving an investigational product  within 45 days prior to first study vaccination
  • History of a confirmed diagnosis of SARS-CoV-2 infection or COVID-19

Co-enrollment in other trials permitted?

No

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