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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

Latest Information Update: 29 May 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

    • 25 May 2020 According to a Novavax media release, first patient has been enrolled in this study.
    • 11 May 2020 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.
    • 11 May 2020 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.

Trial Overview

Purpose

This Phase I study will assess dosage amount and number of vaccinations of NVX-CoV2373 (COVID-19 vaccine) in healthy volunteers. This study will be conducted in two parts. The Phase 1 portion is a randomized, observer-blinded, placebo-controlled trial designed to evaluate the immunogenicity and safety of NVX-CoV2373, both adjuvanted with Matrix-M and unadjuvanted. The protocol's two-dose trial regimen assesses two dose sizes (5 and 25 micrograms) with Matrix-M and without.
The Phase 2 portion would assess immunity, safety and COVID-19 disease reduction in a broader age range.

Primary Endpoints

Subjects with solicited AEs - Phase 1

description: Numbers and percentages (with 95% CIs) of subjects with solicited AEs (local, systemic) for 7 days following each primary vaccination (Days 0, 21) by severity score, duration, and peak intensity. In the case of no reactogenicity, a toxicity score of zero (0) will be applied.
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 IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) - Phase 1

description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA at Day 21 and Day 35. Derived/calculated endpoints based on these data will include geometric mean ELISA units, geometric mean fold rise, and seroconversion rate (proportion of subjects with ≥4-fold rises in ELISA units).
time_frame: 35 days

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections prevention -

Subjects

  • Subject Type patients
  • Number

    Planned: 131

  • Sex male & female
  • Age Group 18-59 years; adult

Patient Inclusion Criteria

Inclusion Criteria (Phase 1): - Healthy adult males or females between 18 and 59 years of age, inclusive, at screening (Phase 1). Healthy status will be determined by the investigator based on medical history, clinical laboratory results, vital sign measurements, and physical examination at screening. - The subject has a body mass index 17 to 40 kg/m2, inclusive, at screening. - Willing and able to give informed consent prior to study enrollment and comply with study procedures. - Female subjects 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 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

(Phase 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 JNC 8 guidelines; b) congestive heart failure by NYHA functional classification of greater or equal to II; c) chronic obstructive pulmonary disease by 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 (ELISA or PCR) at screening or prior to first vaccination (if available). - 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 4 months 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). NOTE: The use of ≤325 mg of aspirin per day as prophylaxis is permitted, but the use of other platelet aggregation inhibitors, thrombin inhibitors, Factor Xa inhibitors, or warfarin derivatives is exclusionary, regardless of bleeding history, because these imply treatment or prophylaxis of known cardiac or vascular disease. - 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 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 : 31 Dec 2020

  • End Dates

    Planned : 31 Jul 2021

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase I
  • 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 with 50 μg Matrix-M

SARS-CoV-2 rS - 25 μg with 50 μg Matrix-M
Biological: SARS-CoV-2 rS (Phase 1: Study vaccinations will comprise 2 IM injections at a 21-day interval (Day 0 and Day 21), ideally in alternate deltoids with the study treatment.)
Other: Matrix-M Adjuvant (Phase 1: Study vaccinations will comprise 2 IM injections at a 21-day interval (Day 0 and Day 21), ideally in alternate deltoids with the study treatment assigned.) Other Name: Adjuvant

SARS-CoV-2 rS - 25 μg with 50 μg Matrix-M followed by Placebo

SARS-CoV-2 rS - 25 μg with 50 μg Matrix-M followed by Placebo
Biological: SARS-CoV-2 rS (Phase 1: Study vaccinations will comprise 2 IM injections at a 21-day interval (Day 0 and Day 21), ideally in alternate deltoids with the study treatment.)
Other: Matrix-M Adjuvant (Phase 1: Study vaccinations will comprise 2 IM injections at a 21-day interval (Day 0 and Day 21), ideally in alternate deltoids with the study treatment assigned.) Other Name: Adjuvant
Other: NSS Saline Placebo (Phase 1: Study vaccinations will comprise 2 IM injections at a 21-day interval (Day 0 and Day 21), ideally in alternate deltoids with the study treatment assigned (ie, saline).)

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

SARS-CoV-2 rS - 25 μg without Matrix-M
Biological: SARS-CoV-2 rS (Phase 1: Study vaccinations will comprise 2 IM injections at a 21-day interval (Day 0 and Day 21), ideally in alternate deltoids with the study treatment.)

SARS-CoV-2 rS - 5 μg with 50 μg Matrix-M

SARS-CoV-2 rS - 5 μg with 50 μg Matrix-M
Biological: SARS-CoV-2 rS (Phase 1: Study vaccinations will comprise 2 IM injections at a 21-day interval (Day 0 and Day 21), ideally in alternate deltoids with the study treatment.)
Other: Matrix-M Adjuvant (Phase 1: Study vaccinations will comprise 2 IM injections at a 21-day interval (Day 0 and Day 21), ideally in alternate deltoids with the study treatment assigned.) Other Name: Adjuvant

Placebo

Placebo - Saline
Other: NSS Saline Placebo (Phase 1: Study vaccinations will comprise 2 IM injections at a 21-day interval (Day 0 and Day 21), ideally in alternate deltoids with the study treatment assigned (ie, saline).)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Biljana Georgievska
61 3 8593 9817
B.Georgievska@nucleusnetwork.com.au
show details
Investigational Research Site 1, Investigational Research Site 2 Australia

Centres

Centre Name Location Trial Centre Country
Investigational Research Site 1 Herston, Queensland Australia
Investigational Research Site 2 Melbourne, Victoria Australia
Novavax
-
-

Trial History

Event Date Event Type Comment
29 May 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 29 May 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 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. Novavax. Novavax to commence COVID-19 vaccine trial with Nucleus Network. Media-Rel 2020;.

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

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

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

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

    Media Release
  6. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  7. Novavax. Novavax Reports First Quarter 2020 Financial Results. Media-Rel 2020;.

    Media Release
  8. 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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