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A 2-Part, Phase 1/2, Randomized, Observer-Blinded Study To Evaluate The Safety And Immunogenicity Of A SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Or Without MATRIX-M Adjuvant In Healthy Subjects

Trial Profile

A 2-Part, Phase 1/2, Randomized, Observer-Blinded Study To Evaluate The Safety And Immunogenicity Of A SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Or Without MATRIX-M Adjuvant In Healthy Subjects

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 11 Sep 2020

At a glance

  • Drugs NVX CoV 2373 (Primary) ; Matrix M
  • Indications COVID 2019 infections
  • Focus Adverse reactions; First in man; Pharmacodynamics
  • Sponsors Novavax
  • Most Recent Events

    • 08 Sep 2020 Planned number of patients changed from 1500 to 1631.
    • 08 Sep 2020 Planned End Date changed from 31 Jul 2021 to 18 Nov 2021.
    • 08 Sep 2020 Planned primary completion date changed from 31 Dec 2020 to 1 Dec 2020.

Trial Overview

Purpose

2019nCoV-101 is a 2-part, randomized, observer-blinded, placebo-controlled, Phase 1/2 trial. Part 1 (Phase 1) of the study is designed to evaluate the safety and immunogenicity of SARS-CoV-2 rS nanoparticle vaccine with or without Matrix-M adjuvant in 131 healthy participants ≥ 18 to 59 (inclusive) years of age at 2 sites in Australia. An interim analysis of Part 1 safety and immunogenicity will be performed prior to optional expansion to Part 2. Part 2 (Phase 2) of the study is designed to evaluate the immunogenicity, safety, and preliminary efficacy of a single construct of SARS-CoV-2 rS nanoparticle vaccine with Matrix-M adjuvant in up to 1,500 healthy participants ≥ 18 to 84 (inclusive) years of age at up to 40 sites across Australia and/or the United States.

Primary Endpoints

Participants with Solicited Adverse Events (AEs) - Phase 1

description: Percentage of participants with solicited AEs (local, systemic) for 7 days following each primary vaccination (Days 0, 21) by severity score, duration, and peak intensity.
time_frame: 28 days

Safety Laboratory Values (Serum Chemistry, Hematology) - Phase 1

description: Safety laboratory values (serum chemistry, hematology) by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination.
time_frame: 28 days

Serum Immunoglobulin G (IgG) Antibody Levels Expressed as Geometric Mean Titers (GMTs) - Phase 1

description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by enzyme-linked immunosorbent assay (ELISA) expressed as GMTs through Day 35.
time_frame: 35 days

Serum IgG Antibody Levels Expressed as Geometric Mean Fold Rises (GMFRs) - Phase 1

description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs through Day 35.
time_frame: 35 days

Serum IgG Antibody Levels Expressed as Seroconversion Rates (SCRs) - Phase 1

description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs through Day 35. SCR is the proportion of participants with ≥4-fold rises in ELISA units.
time_frame: 35 days

Serum IgG Antibody Levels Expressed as GMTs - Phase 2

description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs for the two-dose regimens by dose at Day 35 regardless of baseline immune status and stratified by baseline immune status.
time_frame: Day 35

Serum IgG Antibody Levels Expressed as GMFRs - Phase 2

description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs for the two-dose regimens by dose at Day 35 regardless of baseline immune status and stratified by baseline immune status.
time_frame: Day 35

Serum IgG Antibody Levels Expressed as SCRs - Phase 2

description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs (≥4-fold rises) for the two-dose regimens by dose at Day 35 regardless of baseline immune status and stratified by baseline immune status.
time_frame: Day 35

Serum IgG Antibody Levels Expressed as SCRs - Phase 2

description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs (≥4-fold rises) for the two-dose regimens by dose at Day 35 regardless of baseline immune status and stratified by baseline immune status.
time_frame: Day 35

Participants with Solicited Adverse Events (AEs) - Phase 2

description: Percentage of participants with solicited AEs (local, systemic) for 7 days following each primary vaccination (Days 0 and 21) by severity score, duration, and peak intensity. Unsolicited AEs (eg, treatment-emergent, serious, suspected unexpected serious, those of special interest, all medically attended adverse events [MAAEs]) through the 35 days by Medical Dictionary for Regulatory Activities (MedDRA) classification, severity score, and relatedness.
time_frame: 28 days

Participants with Solicited Adverse Events (AEs) - Phase 2

description: Percentage of participants with solicited AEs (local, systemic) for 7 days following each primary vaccination (Days 0 and 21) by severity score, duration, and peak intensity. Unsolicited AEs (eg, treatment-emergent, serious, suspected unexpected serious, those of special interest, all medically attended adverse events [MAAEs]) through the 35 days by Medical Dictionary for Regulatory Activities (MedDRA) classification, severity score, and relatedness.
time_frame: 28 days

Participants with Unsolicited AEs - Phase 2

description: Percentage of participants with unsolicited AEs (eg, treatment-emergent, serious, suspected unexpected serious, those of special interest, all medically attended adverse events [MAAEs]) through the 35 days by Medical Dictionary of Regulatory Activities (MedDRA) classification, severity score, and relatedness.
time_frame: 35 days

Other Endpoints

Participants with Unsolicited AEs - Phase 1

description: Percentage of participants with unsolicited AEs (eg, treatment-emergent, serious, suspected unexpected serious, those of special interest, all MAAEs) through the first 49 days by MedDRA classification, severity score, and relatedness.
time_frame: 49 days

Participants with Abnormal Vital Signs - Phase 1

description: Percentage of participants with vital sign abnormalities on the day of vaccination by severity scoring immediately following vaccination.
time_frame: 21 days

Changes from Baseline in Body Temperature - Phase 1

description: Mean changes from baseline in body temperature by treatment group and visit.
time_frame: 189 days

Changes from Baseline in Blood Pressure - Phase 1

description: Mean changes from baseline in blood pressure by treatment group and visit.
time_frame: 189 days

Changes from Baseline in Pulse Rate - Phase 1

description: Mean changes from baseline in pulse rate by treatment group and visit.
time_frame: 189 days

Participants with MAAEs - Phase 1

description: Percentage of participants with MAAEs, defined as AEs that lead to an unscheduled visit to a healthcare practitioner, through Day 105 by MedDRA classification, severity score, and relatedness.
time_frame: 105 days

Participants with Related MAAEs; Serious Adverse Events (SAEs); and Adverse Events of Special Interest (AESI) - Phase 1

description: Percentage of participants with MAAEs assessed as related to study vaccine, SAEs, and AESIs until the end of the study (EOS) by MedDRA classification and severity score. All SAEs and AESI, defined as potential immune-mediated medical conditions or AEs relevant to COVID-19, by MedDRA classification, severity score, and relatedness.
time_frame: 386 days

Assessment of Serum IgG Antibody Levels Expressed as GMTs at Multiple Time Points - Phase 1

description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs at multiple time points through Day 189.
time_frame: 189 days

Assessment of Serum IgG Antibody Levels Expressed as GMFRs at Multiple Time Points - Phase 1

description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at multiple time points through Day 189.
time_frame: 189 days

Assessment of Serum IgG Antibody Levels Expressed as SCRs at Multiple Time Points - Phase 1

description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs (proportion of participants with ≥2-fold and ≥4-fold rises in antibody levels) at multiple time points through Day 189.
time_frame: 189 days

Assessment of Serum IgG Antibody Levels Expressed by Seroresponse Rates (SRRs) at Multiple Time Points - Phase 1

description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SRRs (proportion of participants with rises in ELISA units exceeding the 95th percentile of placebo participants) at multiple time points through Day 189.
time_frame: 189 days

Angiotensin-Converting Enzyme 2 (ACE2) Receptor Binding Inhibition Assay Expressed as GMTs - Phase 1

description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as GMTs at multiple time points through Day 189.
time_frame: 189 days

ACE2 Receptor Binding Inhibition Assay Expressed as GMFRs - Phase 1

description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as GMFRs at multiple time points through Day 189.
time_frame: 189 days

ACE2 Receptor Binding Inhibition Assay Expressed as SCRs - Phase 1

description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as SCRs at multiple time points through Day 189.
time_frame: 189 days

ACE2 Receptor Binding Inhibition Assay Expressed as SRRs - Phase 1

description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as SRRs at multiple time points through Day 189.
time_frame: 189 days

Neutralizing Antibody Activity Expressed as GMTs - Phase 1

description: Neutralizing antibody activity as detected by microneutralization assay (MN) expressed as GMTs at multiple time points through Day 49.
time_frame: 49 days

Neutralizing Antibody Activity Expressed as GMFRs - Phase 1

description: Neutralizing antibody activity as detected by MN expressed as GMFRs at multiple time points through Day 49.
time_frame: 49 days

Neutralizing Antibody Activity Expressed as SCRs - Phase 1

description: Neutralizing antibody activity as detected by MN expressed as SCRs at multiple time points through Day 49.
time_frame: 49 days

Neutralizing Antibody Activity Expressed as SRRs - Phase 1

description: Neutralizing antibody activity as detected by MN expressed as SRRs at multiple time points through Day 49.
time_frame: 49 days

Assessment of Cell-Mediated (T helper 1 [Th1]/T helper 2 [Th2]) Pathways - Phase 1

description: Cell-mediated (Th1/Th2) pathways as measured by whole blood (flow cytometry) and/or in vitro peripheral blood mononuclear cell (PBMC) stimulation (eg, enzyme-linked immunospot [ELISpot], cytokine staining) with SARS-CoV-2 rS protein(s) through Day 28.
time_frame: 28 days

Assessment of Serum IgG Antibody Levels Expressed as GMTs - Phase 2

description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs for the single-dose regimens compared to the two-dose regimens and to placebo through Day 35 regardless of baseline immune status and stratified by baseline immune status.
time_frame: 35 days

Assessment of Serum IgG Antibody Levels Expressed as GMFRs - Phase 2

description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs for the single-dose regimens compared to the two-dose regimens and to placebo through Day 35 regardless of baseline immune status and stratified by baseline immune status.
time_frame: 35 days

Assessment of Serum IgG Antibody Levels Expressed as SCRs (≥ 4-fold change) - Phase 2

description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs (≥ 4-fold change) for the single-dose regimens compared to the two-dose regimens and to placebo through Day 35 regardless of baseline immune status and stratified by baseline immune status.
time_frame: 35 days

Assessment of Serum IgG Antibody Levels Expressed as GMTs at Multiple Time Points - Phase 2

description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs at multiple time points through Day 217 for the single-dose regimens compared to the two-dose regimens and to placebo, stratified by baseline immune response.
time_frame: 217 days

Assessment of Serum IgG Antibody Levels Expressed as GMFRs at Multiple Time Points - Phase 2

description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at multiple time points through Day 217 for the single-dose regimens compared to the two-dose regimens and to placebo, stratified by baseline immune response.
time_frame: 217 days

Assessment of Serum IgG Antibody Levels Expressed as SCRs (≥ 4-fold change) at Multiple Time Points - Phase 2

description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs (≥ 4-fold change) at multiple time points through Day 217 for the single-dose regimens compared to the two-dose regimens and to placebo, stratified by baseline immune response.
time_frame: 217 days

ACE2 Receptor Binding Inhibition Assay Expressed as GMTs - Phase 2

description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as GMTs at multiple time points through Day 217 for the single-dose regimens compared to the two-dose regimens and to placebo.
time_frame: 217 days

ACE2 Receptor Binding Inhibition Assay Expressed as GMFRs - Phase 2

description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as GMFRs at multiple time points through Day 217 for the single-dose regimens compared to the two-dose regimens and to placebo.
time_frame: 217 days

ACE2 Receptor Binding Inhibition Assay Expressed as SCRs - Phase 2

description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as SCRs (≥ 4-fold change) at multiple time points through Day 217 for the single-dose regimens compared to the two-dose regimens and to placebo.
time_frame: 217 days

Neutralizing Antibody Activity Expressed as GMTs - Phase 2

description: Neutralizing antibody activity as detected by MN expressed as GMTs at Days 35 and 217 relative to baseline in a subset of subjects by absolute titers and change from baseline.
time_frame: 217 days

Neutralizing Antibody Activity Expressed as GMFRs - Phase 2

description: Neutralizing antibody activity as detected by MN expressed as GMFRs at Days 35 and 217 relative to baseline in a subset of subjects by absolute titers and change from baseline.
time_frame: 217 days

Neutralizing Antibody Activity Expressed as SCRs (≥ 4-fold change) - Phase 2

description: Neutralizing antibody activity as detected by MN expressed as SCRs (≥ 4-fold change) at Days 35 and 217 relative to baseline in a subset of subjects by absolute titers and change from baseline.
time_frame: 217 days

Assessment of Serum IgG Antibody Levels Expressed as GMTs - Phase 2 Boost

description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs at Days 189 and 217 for boosting assessment with either placebo or active boost.
time_frame: 217 days

Assessment of Serum IgG Antibody Levels Expressed as GMFRs - Phase 2 Boost

description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Days 189 and 217 for boosting assessment with either placebo or active boost.
time_frame: 217 days

Participants with MAAEs - Phase 2

description: All MAAEs, defined as AEs that lead to an unscheduled visit to a healthcare practitioner, through Day 217 by MedDRA classification, severity score, and relatedness.
time_frame: 217 days

Participants with Related MAAEs; SAEs; and AESIs - Phase 2

description: Percentage of participants with MAAEs assessed as related to study vaccine, SAEs, and AESIs until the end of the study (EOS) by MedDRA classification and severity score. All SAEs and AESI, defined as potential immune-mediated medical conditions or AEs relevant to COVID-19, by MedDRA classification, severity score, and relatedness.
time_frame: 357 days

Participants with Abnormal Vital Signs - Phase 2

description: Percentage of participants with vital sign abnormalities on the day of vaccination by severity scoring immediately following vaccination. Descriptive statistics (mean, standard deviation, change from baseline) by treatment group, by visit.
time_frame: 21 days

Changes from Baseline in Body Temperature - Phase 2

description: Mean changes from baseline in body temperature by treatment group and visit.
time_frame: 189 days

Changes from Baseline in Blood Pressure - Phase 2

description: Mean changes from baseline in blood pressure by treatment group and visit.
time_frame: 189 days

Changes from Baseline in Pulse Rate - Phase 2

description: Mean changes from baseline in pulse rate by treatment group and visit.
time_frame: 189 days

Participants with SARS-CoV-2 Positivity - Phase 2

description: Percentage of participants with SARS-CoV-2 positivity as diagnosed by qualitative polymerase chain reaction (PCR) following COVID-19 symptoms assessment from Day 28 through 6 months with severity classification, overall and by age strata (18-59, 60-84 years).
time_frame: 161 days

Assessment of SARS-CoV-2 by Qualitative PCR - Phase 2

description: Assessment of SARS-CoV-2 by qualitative PCR based on routine screening by self- collection (nasal mid-turbinate or saliva) from Day 28 through 6 months without symptomatology to further describe epidemiologic evolution of the pandemic and potential effect of vaccination.
time_frame: 161 days

Assessment of Cell-Mediated (Th1/Th2) Pathways - Phase 2

description: Assessment of cell-mediated (Th1/Th2) pathways as measured by whole blood (flow cytometry) and/or in vitro PBMC stimulation (eg, ELISpot, cytokine staining) with SARS-CoV-2 rS protein(s) through Day 28.
time_frame: 28 days [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections prevention -

Subjects

  • Subject Type patients
  • Number

    Planned: 1631

  • Sex male & female
  • Age Group 18-84 years; adult; elderly

Patient Inclusion Criteria

Inclusion Criteria (Part 1): - Healthy adult males or females between 18 and 59 years of age, inclusive, at screening. Healthy status will be determined by the investigator based on medical history, clinical laboratory results, vital sign measurements, and physical examination at screening. - The participant has a body mass index 17 to 35 kg/m2, inclusive, at screening. - Willing and able to give informed consent prior to study enrollment and comply with study procedures. - Female participants of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months or documented plasma follicle-stimulating hormone (FSH) level ≥40 mIU/mL]) must agree to be heterosexually inactive from at least 21 days prior to enrollment and through 6 months after the last vaccination OR agree to consistently use any of the described methods of contraception from at least 21 days prior to enrollment and through 6 months after the last vaccination.

Patient Exclusion Criteria

(Part 1): - Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care, inclusive of changes in medication in the past 2 months indicating that chronic illness/disease is not stable (at the discretion of the investigator). This includes any current workup of undiagnosed illness that could lead to a new condition. - Chronic disease inclusive of: a) hypertension uncontrolled for age according to the Eighth Joint National Committee (JNC 8) guidelines; b) congestive heart failure by New York Heart Association (NYHA) functional classification of greater or equal to II; c) chronic obstructive pulmonary disease by Global Initiative for Obstructive Lung Disease (GOLD) classification of greater or equal to 2; d) recent (within 6 months prior to first study vaccination) exacerbation of coronary artery disease as manifested by cardiac intervention, addition of new cardiac medications for control of symptoms, or unstable angina; e) asthma (diagnosed by spirometry showing reversibility of disease and must meet at least the Step 1 classification with current prescription/use of medications to control symptoms); f) diabetes requiring use of medicine (insulin or oral) or not controlled with diet. - Participation in research involving an investigational product (drug/biologic/device) within 45 days prior to first study vaccination. - History of a confirmed diagnosis of SARS or COVID-19 disease (confirmed by a specific test for each disease) or known exposure to a SARS-CoV-2 positive confirmed close contact (eg, family member, housemate, daycare provider, aged parent requiring care), at the discretion of the investigator. - Currently working in an occupation with a high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel). - Currently taking any product (investigational or off-label) for prevention of COVID-19 disease. - Positive rapid test for SARS-CoV-2 (either ELISA IgG or PCR) at screening or prior to first vaccination. Testing may be repeated during the screening period if exposure to SARS-CoV-2 is suspected, at the discretion of the investigator. - Received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine within 4 weeks prior to first study vaccination. - Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital). - Chronic administration (defined as more than 14 continuous days) of immunosuppressant, systemic glucocorticosteroids, or other immune-modifying drugs within 90 days prior to first study vaccination; or anticipation of the need for immunosuppressive treatment within 6 months after last vaccination. - Received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination. - Any acute illness concurrent or within 14 days prior to first study vaccination (medical history and/or physical examination) or documented temperature of >38°C during this period. This includes respiratory or constitutional symptoms consistent with SARS-CoV-2 (COVID-19) exposure (ie, cough, sore throat, difficulty breathing). - Known disturbance of coagulation (iatrogenic or congenital). - Evidence of Hepatitis B or C or HIV by laboratory testing. - A positive test result for drugs of abuse (except a positive test result associated with prescription medication that has been reviewed and approved by the investigator) or alcohol at screening. - Any neurological disease or history of significant neurological disorder (eg, meningitis, seizures, multiple sclerosis, vasculitis, migraines, Guillain-Barré syndrome [genetic/congenital or acquired]). - Active cancer (malignancy) within 5 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma, at the discretion of the investigator) - Vital sign (blood pressure, pulse, temperature) abnormalities of toxicity grade >1. - Clinical laboratory abnormalities of toxicity grade >1 for selected serum chemistry and hematology parameters - Any known allergies to products contained in the investigational product or latex allergy. - Women who are pregnant, breastfeeding or who plan to become pregnant during the study. - History of alcohol abuse or drug addiction within 1 year prior to the first study vaccination. - Any condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the study vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting). - Study team member or first-degree relative of any study team member (inclusive of sponsor, PPD, and site personnel involved in the study). Inclusion Criteria (Part 2): - Healthy adult males or females between 18 and 84 years of age, inclusive, at screening who are of legal adult age in their local jurisdiction. Healthy status will be determined by the investigator based on medical history, clinical laboratory results, vital sign measurements, and physical examination at screening. - The participant has a body mass index 17 to 35 kg/m2, inclusive, at screening. - Willing and able to give informed consent prior to study enrollment and comply with study procedures. - Female participants of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months or documented plasma FSH level ≥40 mIU/mL]) must agree to be heterosexually inactive from at least 21 days prior to enrollment and through 6 months after the last vaccination OR agree to consistently use any of the following methods of contraception from at least 21 days prior to enrollment and through 6 months after the last vaccination. Exclusion Criteria (Part 2): - Participants who are having any current workup of undiagnosed illness within the last 8 weeks, which is either participant-reported or has been clinician-assessed, that could lead to a new condition diagnosis. - Participation in research involving an investigational product (drug/biologic/device) within 45 days prior to first study vaccination. - History of a confirmed diagnosis of SARS or history of a confirmed diagnosis of COVID-19 disease resulting in medical intervention. - Received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine within 4 weeks prior to first study vaccination. - Have clinically significant chronic cardiovascular, endocrine, gastrointestinal/ hepatic, renal, neurological, respiratory, or other medical disorders not excluded by other exclusion criteria, that are assessed by the Investigator as being clinically unstable within the prior 4 weeks evidenced by: a) hospitalization for the condition, including day surgical interventions, b) new significant organ function deterioration, c) needing addition of new treatments or major dose adjustments of current treatments. - Diabetes mellitus requiring insulin therapy (either type 1 or type 2 diabetes mellitus). - Chronic obstructive pulmonary disease with a history of an acute exacerbation of any severity in the prior year. - Any history of congestive heart failure. - Any history of chronic kidney disease (the presence of impaired or reduced kidney function lasting at least 3 months). Clinical validation of potential cases of chronic kidney disease should be conducted. - Evidence of unstable coronary artery disease as manifested by cardiac intervention, addition of new cardiac medications for control of symptoms, or unstable angina in the past 3 months. - History of chronic neurological disorders that have required prior specialist physician review for diagnosis and management (such as multiple sclerosis, dementia, transient ischemic attacks, Parkinson's disease, degenerative neurological conditions, neuropathy, and epilepsy) or a history of stroke or previous neurological disorder within 12 months with residual symptoms. Participants with a history of migraine or chronic headaches or nerve root compression that have been stable on treatment for the last 4 weeks are not excluded. - Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital). - Chronic administration (defined as more than 14 continuous days) of immunosuppressants, systemic glucocorticosteroids reaching an immunosuppressive dose, or other immune-modifying drugs within 90 days prior to first study vaccination. - Received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination. - Known disturbance of coagulation (iatrogenic or congenital). - Active cancer (malignancy) within 5 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma, at the discretion of the investigator). - Any known allergies to products contained in the investigational product or latex allergy. - Women who are breastfeeding or who plan to become pregnant during the study. - History of alcohol abuse or drug addiction within one year prior to the first study vaccination. - Any condition that, in the opinion of the investigator, would pose a health risk to the subject if enrolled or could interfere with evaluation of the study vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting). - Study team member or first-degree relative of any study team member (inclusive of sponsor, PPD, and site personnel involved in the study

Trial Details

Identifiers

Identifier Owner
NCT04368988 ClinicalTrials.gov: US National Institutes of Health
2019nCoV101 -

Organisations

  • Sponsors Novavax
  • Affiliations Novavax

Trial Dates

  • Initiation Dates

    Planned : 15 May 2020

    Actual : 25 May 2020

  • Primary Completion Dates

    Planned : 01 Dec 2020

  • End Dates

    Planned : 18 Nov 2021

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase I/II
  • Location Australia; USA
  • Focus Adverse reactions; First in man; Pharmacodynamics

Interventions

Drugs Route Formulation
Matrix M Intramuscular Injection
NVX CoV 2373Primary Drug Intramuscular Injection

SARS-CoV-2 rS - 25 μg without Matrix-M - Phase 1

2 doses of SARS-CoV-2 rS - 25 μg, 1 dose each on Days 0 and 21. Biological: SARS-CoV-2 rS - Phase 1 (Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS (0.6 mL) on Days 0 and 21.)

SARS-CoV-2 rS - 25 μg + 50 μg Matrix-M - Phase 1

2 doses of SARS-CoV-2 rS - 25 μg + 50 μg Matrix-M (mixed together for each injection), 1 dose each on Days 0 and 21. Biological: SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 1 (Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS mixed with Matrix-M adjuvant (0.6 mL) on Days 0 and 21.) Other Name: NVX-CoV2373

SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M - Phase 1

2 doses of SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M (mixed together for each injection), 1 dose each on Days 0 and 21. Biological: SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 1 (Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS mixed with Matrix-M adjuvant (0.6 mL) on Days 0 and 21.) Other Name: NVX-CoV2373

Placebo - Phase 1

2 doses of Placebo (Saline), 1 dose each on Days 0 and 21. Other: Normal saline solution (NSS), Placebo - Phase 1 (Alternating intramuscular (deltoid) injections of placebo (0.6 mL) on Days 0 and 21.) Other Name: Sodium chloride solution for injection, 0.9%

Placebo - Phase 2

3 doses of Placebo (Saline), 1 dose each on Days 0, 21, and 189. Other: Normal saline solution (NSS), Placebo - Phase 2 (Alternating intramuscular (deltoid) injections of placebo (0.5 mL) on Days 0, 21, and 189.) Other Name: Sodium chloride solution for injection, 0.9%

SARS-CoV-2 rS - 25 μg + 50 μg Matrix-M then Placebo - Phase 1

1 dose of SARS-CoV-2 rS - 25 μg + 50 μg Matrix-M (mixed together for injection), on Day 0 followed by 1 dose of Placebo on Day 21. Biological: SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 1 (Intramuscular (deltoid) injection of SARS-CoV-2 rS mixed with Matrix-M adjuvant (0.6 mL) on Day 0.) Other Name: NVX-CoV2373 Other: Normal saline solution (NSS), Placebo, Day 21 - Phase 1 (Intramuscular injection of placebo (0.6 mL) in alternate deltoid on Day 21.) Other Name: Sodium chloride solution for injection, 0.9%

SARS-CoV-2 rS - 25/25 μg + 50 μg Matrix-M - Phase 2

2 doses of SARS-CoV-2 rS - 25 μg + 50 μg Matrix-M (co-formulated), 1 dose each on Days 0 and 21, followed by 1 dose of Placebo on Day 189. Biological: SARS-CoV-2 rS/Matrix-M Adjuvant, Days 0 and 21 - Phase 2 (Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Days 0 and 21.) Other Name: NVX-CoV2373 Other: Normal saline solution (NSS), Placebo, Day 189 - Phase 2 (Intramuscular injection of placebo (0.5 mL) in alternating deltoid on Day 189.) Other Name: Sodium chloride solution for injection, 0.9%

SARS-CoV-2 rS - 5/5 μg + 50 μg Matrix-M - Phase 2

2 doses of SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M (co-formulated), 1 dose each on Days 0 and 21, followed by 1 dose of Placebo on Day 189. Biological: SARS-CoV-2 rS/Matrix-M Adjuvant, Days 0 and 21 - Phase 2 (Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Days 0 and 21.) Other Name: NVX-CoV2373 Other: Normal saline solution (NSS), Placebo, Day 189 - Phase 2 (Intramuscular injection of placebo (0.5 mL) in alternating deltoid on Day 189.) Other Name: Sodium chloride solution for injection, 0.9%

SARS-CoV-2 rS - Alternating 25/5 μg + 50 μg Matrix-M - Phase 2

1 dose of SARS-CoV-2 rS - 25 μg + 50 μg Matrix-M (co-formulated) on Day 0 then 1 dose of Placebo on Day 21 followed by 1 dose of SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M (co-formulated) on Day 189. Biological: SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 2 (Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 0.) Other Name: NVX-CoV2373 Other: Normal saline solution (NSS), Placebo, Day 21 - Phase 2 (Intramuscular injection of placebo (0.5 mL) in alternating deltoid on Day 21.) Other Name: Sodium chloride solution for injection, 0.9% Biological: SARS-CoV-2 rS/Matrix-M Adjuvant - Day 189 - Phase 2 (Intramuscular injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) in alternating deltoid on Day 189.) Other Name: NVX-CoV2373

SARS-CoV-2 rS - Alternating 5 μg + 50 μg Matrix-M - Phase 2

1 dose of SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M (co-formulated) on Day 0 then 1 dose of Placebo on Day 21 followed by 1 dose of SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M (co-formulated) on Day 189. Biological: SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 2 (Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 0.) Other Name: NVX-CoV2373 Other: Normal saline solution (NSS), Placebo, Day 21 - Phase 2 (Intramuscular injection of placebo (0.5 mL) in alternating deltoid on Day 21.) Other Name: Sodium chloride solution for injection, 0.9% Biological: SARS-CoV-2 rS/Matrix-M Adjuvant - Day 189 - Phase 2 (Intramuscular injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) in alternating deltoid on Day 189.) Other Name: NVX-CoV2373

Results

Adverse events

Results from the phase I portion of a phase I/II trial showed that that NVX CoV 2373 with the Matrix-M adjuvant was well-tolerated with a reassuring safety profile. The reactogenicity events were generally mild. Tenderness and pain were the most frequent local symptoms reported post Dose 1 and the systemic events were individually less frequent with headache, fatigue and myalgia being reported most commonly. a greater reactogenicity was reported, following the second dose, although the majority of symptoms were reported as = Grade 1. The average duration of events was < 2 days. There were no severe (Grade 3) unsolicited adverse events through 28 days after dose 2. Most of the adverse events were mild and deemed not related to vaccination. No serious adverse events (SAEs) were reported [2] .

Immunogenicity

Results from the phase I portion of a phase I/II trial showed that that NVX CoV 2373 induced neutralization titers in all the volunteers. Both 5 µg and 25 µg adjuvanted doses generated peak geometric mean titer (GMT) greater than 1:3,300 (5 µg adjuvanted dose group peak GMT: 3,906 (95% CI: 2,556; 5,970). Post administration of a single dose of vaccine, all the volunteers developed anti-spike IgG antibodies, and many also developed wild-type virus neutralizing antibody responses. However after the second dose, all (100%) the volunteers developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID-19 disease. Also, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional. The adjuvant was dose-sparing, with the lower 5 µg dose of NVX-CoV2373 performing comparably with the 25 µg dose. In a subset of vounteers, and NVX CoV 2373 induced antigen-specific polyfunctional CD4+ T cell responses with a strong bias toward the Th1 phenotype (IFN-g, IL-2, and TNF-a) [2] .

Publications

  1. Novavax. Novavax Announces Positive Phase 1 Data for its COVID-19 Vaccine Candidate. Media-Rel 2020;.

    Media Release
  2. Novavax. Novavax Announces Publication of Phase 1 Data for COVID-19 Vaccine Candidate in The New England Journal of Medicine. Media-Rel 2020;.

    Media Release
  3. Keech C, Albert G, Cho I, Robertson A, Reed P, Neal S, et al. Phase 1-2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine. . N-Engl-J-Med 2020;.

    PubMed | CrossRef Fulltext

Authors

Author Total Publications First Author Last Author
Albert G 1 - -
Callahan K 1 - -
Cho I 1 - -
Cloney-Clark S 1 - -
Desai C 1 - -
Formica N 1 - -
Frieman MB 1 - -
Fries L 1 - -
Glenn GM 1 - 1
Griffin P 1 - -
Haupt RE 1 - -
Keech C 1 1 -
Lewis M 1 - -
Lickliter JD 1 - -
Logue J 1 - -
McGrath M 1 - -
Neal S 1 - -
Novavax 2 2 2
Patel N 1 - -
Piedra PA 1 - -
Plested JS 1 - -
Price-Abbott P 1 - -
Reed P 1 - -
Robertson A 1 - -
Shinde V 1 - -
Smith G 1 - -
Weston S 1 - -
Wilkinson B 1 - -
Zhou H 1 - -
Zhu M 1 - -

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Amber Leah Paratus Clinical Research - Canberra - Phase 2 Australia
Arianna Mahfoud
+61283470645 adrianna@acrn.com.au
show details
Australian Clinical Research Network - Phase 2 Australia
Ashlee Innes
+61484007388 ashlee.innes@paratusclinical.com
show details
Paratus Clinical Research - Canberra - Phase 2 Australia
Audra Weslowski
208-377-8653 aweslowski@velocityclinical.com
show details
Advanced Clinical Research - Meridian - ERN-PPDS - Phase 2 USA
Biljana Georgievska
61 3 8593 9817 B.Georgievska@nucleusnetwork.com.au
show details
Center for Clinical Studies - Phase 1 and Phase 2, Q Pharm Pty Limited - Phase 1 and Phase 2 Australia
Charlotte Lemech Scientia Clinical Research Limited - Phase 2 Australia
Courtney Heisey
816-835-3481 cheisey@mcrmed.com
show details
Meridian Clinical Research-(Rockville Maryland) - Platinum - PPDS - Phase 2 USA
Eugene Athan Barwon Health - Phase 2 Australia
Fiona Napier-Flood Paratus Clinical Research - Western Sydney - Phase 2 Australia
Gemma Blunt
+61286088668 gemma.blunt@paratusclinical.com
show details
Paratus Clinical Research - Western Sydney - Phase 2 Australia
Ira Berger Meridian Clinical Research-(Rockville Maryland) - Platinum - PPDS - Phase 2 USA
Jason Lickliter Center for Clinical Studies - Phase 1 and Phase 2 Australia
Jeanne Blevins
513-247-5594 jeanne.blevins@synexus-us.com
show details
Synexus Clinical Research US, Inc. - Cincinnati - Phase 2 USA
Joshua Kim Paratus Clinical Research - Central Coast - Phase 2 Australia
Joy Soper
859-264-8799 joy.soper@amrllc.com
show details
Central Kentucky Research Associates Inc - Phase 2 USA
Justin Phillips
316-283-7403 justin.phillips@amrllc.com
show details
Alliance for Multipsecialty Research, LLC - Phase 2 USA
Kathryn Ellis
+61342152878 kathryc@barwonhealth.org.au
show details
Barwon Health - Phase 2 Australia
Lisa Hoagland
216-682-0320 242 lisa.hoagland@rapidmedicalresearch.com
show details
Rapid Medical Research Inc - ERN-PPDS - Phase 2 USA
Lisa Nelson
610438008816 lisa.nelson@scientiaclinicalresearch.com.au
show details
Scientia Clinical Research Limited - Phase 2 Australia
Mark Adams Central Kentucky Research Associates Inc - Phase 2 USA
Mark Arya Australian Clinical Research Network - Phase 2 Australia
Mark Turner Advanced Clinical Research - Meridian - ERN-PPDS - Phase 2 USA
Mary Beth Manning Rapid Medical Research Inc - ERN-PPDS - Phase 2 USA
Meenakshi (Kavya) Natesan
316-689-6645 kavya.natesan@amrllc.com
show details
Alliance for Multispecialty Research, LLC - Phase 2 USA
Monica Harris
+61243479185 monica.harris@paratusclinical.com
show details
Paratus Clinical Research - Central Coast - Phase 2 Australia
Paul Bradley Meridian Clinical Research-(Savannah Georgia) - Platinum - PPDS - Phase 2 USA
Paul Griffin Q Pharm Pty Limited - Phase 1 and Phase 2 Australia
Paul Nugent Synexus Clinical Research US, Inc. - Cincinnati - Phase 2 USA
Richard Glover, II Alliance for Multipsecialty Research, LLC - Phase 2 USA
Sarah Piplica
+61754431033 spiplica@usc.edu.au
show details
University of the Sunshine Coast - Phase 2, University of the Sunshine Coast, Health Hub Morayfield - Phase 2 Australia
Scott Kitchener University of the Sunshine Coast, Health Hub Morayfield - Phase 2 Australia
Stephanie Ailey
405-227-7047 sailey@mcrmed.com
show details
Meridian Clinical Research-(Savannah Georgia) - Platinum - PPDS - Phase 2 USA
Susan Thackwray University of the Sunshine Coast - Phase 2 Australia
Terry Klein Alliance for Multispecialty Research, LLC - Phase 2 USA

Centres

Centre Name Location Trial Centre Country
Advanced Clinical Research - Meridian - ERN-PPDS - Phase 2 Meridian, Idaho USA
Alliance for Multipsecialty Research, LLC - Phase 2 Newton, Kansas USA
Alliance for Multispecialty Research, LLC - Phase 2 Wichita, Kansas USA
Australian Clinical Research Network - Phase 2 Maroubra, New South Wales Australia
Barwon Health - Phase 2 Geelong, Victoria Australia
Center for Clinical Studies - Phase 1 and Phase 2 Melbourne, Victoria Australia
Central Kentucky Research Associates Inc - Phase 2 Lexington, Kentucky USA
Coalition for Epidemic Preparedness Innovations (CEPI)
-
-
Meridian Clinical Research-(Rockville Maryland) - Platinum - PPDS - Phase 2 Rockville, Maryland USA
Meridian Clinical Research-(Savannah Georgia) - Platinum - PPDS - Phase 2 Savannah, Georgia USA
Novavax
-
-
Paratus Clinical Research - Canberra - Phase 2 Bruce, Australian Capital Territory Australia
Paratus Clinical Research - Central Coast - Phase 2 Kanwal, New South Wales Australia
Paratus Clinical Research - Western Sydney - Phase 2 Blacktown, New South Wales Australia
Q Pharm Pty Limited - Phase 1 and Phase 2 Herston, Queensland Australia
Rapid Medical Research Inc - ERN-PPDS - Phase 2 Cleveland, Ohio USA
Scientia Clinical Research Limited - Phase 2 Randwick, New South Wales Australia
Synexus Clinical Research US, Inc. - Cincinnati - Phase 2 Cincinnati, Ohio USA
University of the Sunshine Coast - Phase 2 Sippy Downs, Queensland Australia
University of the Sunshine Coast, Health Hub Morayfield - Phase 2 Morayfield, Queensland Australia

Trial History

Event Date Event Type Comment
11 Sep 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 11 Sep 2020
08 Sep 2020 Other trial event Planned number of patients changed from 1500 to 1631. Updated 11 Sep 2020
08 Sep 2020 Completion date Planned End Date changed from 31 Jul 2021 to 18 Nov 2021. Updated 11 Sep 2020
08 Sep 2020 Other trial event Planned primary completion date changed from 31 Dec 2020 to 1 Dec 2020. Updated 11 Sep 2020
02 Sep 2020 Results Results (n=83) published in the New England Journal of Medicine Updated 08 Sep 2020
02 Sep 2020 Results According to a Novavax media release, results from phase 1 portion were published in The New England Journal of Medicine. Updated 04 Sep 2020
02 Sep 2020 Results Results presented in the Novavax Media Release. Updated 04 Sep 2020
24 Aug 2020 Other trial event According to a Novavax media release, interim data from this study is anticipated in the fourth quarter of this year. Updated 25 Aug 2020
24 Aug 2020 Other trial event Planned number of patients changed from 131 to 1500, according to a Novavax media release. Updated 25 Aug 2020
24 Aug 2020 Other trial event According to a Novavax media release, the first volunteers have been enrolled in the Phase 2 portion of this study. The Phase 2 clinical trial expands on the age range of the Phase 1 portion by including older adults 60-84 years of age as approximately 50 percent of the trial population. Updated 25 Aug 2020
17 Aug 2020 Other trial event According to a Novavax media release, Phase 2 clinical trials will begin in August Updated 20 Aug 2020
17 Aug 2020 Other trial event According to a Novavax media release, data from phase 1 portion have been submitted to the U.S. Food and Drug Administration (FDA) and an independent safety monitoring committee.The company intends to initiate the Phase 2 portion of this trial in the U.S. and Australia in the near future. This trial will include approximately 1,500 subjects and will include older adults. Updated 20 Aug 2020
04 Aug 2020 Other trial event According to a Novavax media release, Conference call to be held and Detailed data slides will be posted on novavax.com. Updated 06 Aug 2020
04 Aug 2020 Other trial event According to a Novavax media release, data have been submitted for peer-review to a scientific journal and to an online preprint server at medRxiv.org. Updated 06 Aug 2020
04 Aug 2020 Results Results from phase I portion presented in the Novavax Media Release. Updated 06 Aug 2020
23 Jul 2020 Other trial event According to a Novavax media release, the company will announce phase I data consisting preliminary immunogenicity and safety results, during the first week of August and phase 2 portion to assess immunity, safety, and COVID-19 disease reduction is expected to begin shortly thereafter. Updated 28 Jul 2020
25 May 2020 Other trial event According to a Novavax media release, first patient has been enrolled in this study. Updated 26 May 2020
11 May 2020 Other trial event According to a Novavax media release, the Coalition for Epidemic Preparedness Innovations (CEPI) will invest up to $384 million of additional funding, on top of $4 million it invested in March, to advance clinical development of NVX-CoV2373. Updated 21 May 2020
11 May 2020 Other trial event According to a Novavax media release, phase I portion of this trial is starting this month in Australia and the Phase 2 portion conducted in multiple countries following successful Phase 1 top-line results that are expected in July. Updated 21 May 2020
11 May 2020 Other trial event According to a Novavax media release, recruitment for this trial began in May 2020. Updated 14 May 2020
11 May 2020 Status change - recruiting Status changed from not yet recruiting to recruiting, according to a Novavax media release. Updated 14 May 2020
08 May 2020 Other trial event New source identified and integrated (ClinicalTrial.gov: NCT04368988) Updated 08 May 2020
28 Apr 2020 Other trial event According to a 360 Biolabs media release, Novavax has selected Australian speciality laboratory 360biolabs, to conduct sample analysis for this clinical trial of its SARS-CoV-2 recombinant spike protein nanoparticle vaccine, NVX-CoV2373. Updated 20 Jul 2020
28 Apr 2020 Status change - not yet recruiting Status changed from planning to not yet recruiting. Updated 08 May 2020
16 Apr 2020 Other trial event According to a Novavax media release, Nucleus (multi-site phase I clinical trials provider) is due to commence Phase 1 testing for the NVX-CoV2373, at its Melbourne and Brisbane clinics within the coming weeks. Updated 17 Apr 2020
08 Apr 2020 Other trial event According to a Novavax media release, the company has planned to initiate this trial ahead of schedule in mid-May and expects preliminary immunogenicity and safety results to be available in July 2020. Updated 15 Apr 2020
11 Mar 2020 Other trial event According to a Novavax media release, the company began efforts to develop a novel vaccine to protect against COVID-19 in January.Initiation of Phase I clinical testing is expected in May or June 2020 (late spring of 2020).The company expects to utilize its proprietary Matrix-M adjuvant with its COVID-19 vaccine candidate to enhance immune responses. Updated 18 Mar 2020
11 Mar 2020 Other trial event According to a Novavax media release, the company recently announced that the Coalition for Epidemic Preparedness Innovations (CEPI) awarded an initial funding of $4 million to support its effort to develop a COVID-19 vaccine. CEPI and Novavax are having ongoing discussions on additional funding from CEPI to address Novavax costs through Phase 1. Updated 18 Mar 2020
02 Mar 2020 New trial record New trial record Updated 02 Mar 2020
26 Feb 2020 Other trial event According to a Novavax media release, this study will begin by the end of Spring 2020. Updated 02 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. Novavax. Novavax Announces Positive Phase 1 Data for its COVID-19 Vaccine Candidate. Media-Rel 2020;.

    Media Release
  3. Novavax. Novavax to commence COVID-19 vaccine trial with Nucleus Network. Media-Rel 2020;.

    Media Release
  4. Novavax. Novavax Initiates Phase 1/2 Clinical Trial of COVID-19 Vaccine. Media-Rel 2020;.

    Media Release
  5. Novavax, FUJIFILM. Novavax and FUJIFILM Diosynth Biotechnologies Initiate Large Scale Manufacturing of COVID-19 Vaccine Candidate. Media-Rel 2020;.

    Media Release
  6. Novavax. Novavax Advances Development of Novel COVID-19 Vaccine. Media-Rel 2020;.

    Media Release
  7. Novavax. Novavax Initiates Efficacy Trial of COVID-19 Vaccine in South Africa. Media-Rel 2020;.

    Media Release
  8. Novavax. Novavax Reports Fourth Quarter and Full Year 2019 Financial Results. Media-Rel 2020;.

    Media Release
  9. Novavax. Novavax Identifies Coronavirus Vaccine Candidate; Accelerates Initiation of First-in-Human Trial to Mid-May. Media-Rel 2020;.

    Media Release
  10. Novavax. Novavax Announces Publication of Phase 1 Data for COVID-19 Vaccine Candidate in The New England Journal of Medicine. Media-Rel 2020;.

    Media Release
  11. Novavax. Novavax Initiates Phase 2 Portion of Phase 1/2 Clinical Trial of COVID-19 Vaccine. Media-Rel 2020;.

    Media Release
  12. 360 Biolabs. 360biolabs supports the first Australian COVID-19 clinical vaccine trials. Media-Rel 2020;.

    Media Release
  13. Novavax. Novavax Reports First Quarter 2020 Financial Results. Media-Rel 2020;.

    Media Release
  14. Keech C, Albert G, Cho I, Robertson A, Reed P, Neal S, et al. Phase 1-2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine. . N-Engl-J-Med 2020;.

    PubMed | CrossRef Fulltext
  15. Novavax. Novavax to Receive up to $388 Million Funding from CEPI for COVID-19 Vaccine Development and Manufacturing. Media-Rel 2020;.

    Media Release
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