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Evaluation of the Safety and Immunogenicity of a SARS-CoV-2 rS (COVID-19) Nanoparticle Vaccine With/Without Matrix-M Adjuvant

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ClinicalTrials.gov Identifier: NCT04368988
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Novavax

Tracking Information
First Submitted Date  ICMJE April 24, 2020
First Posted Date  ICMJE April 30, 2020
Last Update Posted Date May 27, 2020
Actual Study Start Date  ICMJE May 25, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2020)
  • Subjects with solicited AEs - Phase 1 [ Time Frame: 28 days ]
    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.
  • Safety Laboratory Values (serum chemistry, hematology) - Phase 1 [ Time Frame: 28 days ]
    Safety laboratory values (serum chemistry, hematology) by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination.
  • Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) - Phase 1 [ Time Frame: 35 days ]
    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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Safety and Immunogenicity of a SARS-CoV-2 rS (COVID-19) Nanoparticle Vaccine With/Without Matrix-M Adjuvant
Official Title  ICMJE 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
Brief Summary For Phase 1 only. Additional information will be provided if Phase 2 is implemented. 2019nCoV-101 is a 2-part, randomized, observer-blinded, placebo-controlled, Phase 1/2 trial designed to evaluate the immunogenicity and safety of SARS-CoV-2 rS nanoparticle vaccine with or without Matrix-M adjuvant in healthy participants ≥ 18 to 59 (inclusive) years of age. The study will be conducted in 2 parts. In Part 1, at least 1 and up to two SARS-CoV-2 rS constructs will be evaluated in up to 2 cohorts, which may be enrolled in parallel. An interim analysis of Part 1 safety and immunogenicity data will be performed prior to an optional expansion to Part 2.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo - Saline
    Intervention: Other: NSS Saline Placebo
  • Experimental: SARS-CoV-2 rS - 25 μg without Matrix-M
    SARS-CoV-2 rS - 25 μg without Matrix-M
    Intervention: Biological: SARS-CoV-2 rS
  • Experimental: SARS-CoV-2 rS - 5 μg with 50 μg Matrix-M
    SARS-CoV-2 rS - 5 μg with 50 μg Matrix-M
    Interventions:
    • Biological: SARS-CoV-2 rS
    • Other: Matrix-M Adjuvant
  • Experimental: SARS-CoV-2 rS - 25 μg with 50 μg Matrix-M
    SARS-CoV-2 rS - 25 μg with 50 μg Matrix-M
    Interventions:
    • Biological: SARS-CoV-2 rS
    • Other: Matrix-M Adjuvant
  • Experimental: 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
    Interventions:
    • Biological: SARS-CoV-2 rS
    • Other: Matrix-M Adjuvant
    • Other: NSS Saline Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 28, 2020)
131
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Biljana Georgievska 61 3 8593 9817 B.Georgievska@nucleusnetwork.com.au
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04368988
Other Study ID Numbers  ICMJE 2019nCoV-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novavax
Study Sponsor  ICMJE Novavax
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novavax
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP