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AzTrials

COVID-19Phase 1/2NCT04368988

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

A Phase 1/2 study testing SARS-CoV-2 rS - Phase 1, SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 1 and SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 1 in people with COVID-19, run by Novavax at 18 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 84 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
SARS-CoV-2 rS - Phase 1, SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 1 and SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 1
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,419 participants
Where
18 sitesin 2 countries
Study dates
25 May 2020to 1 Jun 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 84 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.

Who cannot join

  • 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.
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  • 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).
  • 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 locations and contacts

18 sites in 2 countries.

18 sites in 2 countries

Australia10 sites

  • Paratus Clinical Research - Western Sydney - Phase 2

    Blacktown, New South Wales, 2148

  • Paratus Clinical Research - Canberra - Phase 2

    Bruce, Australian Capital Territory, 2617

  • Barwon Health - Phase 2

    Geelong, Victoria, 3220

  • Q Pharm Pty Limited - Phase 1

    Herston, Queensland, 4006

  • Paratus Clinical Research - Central Coast - Phase 2

    Kanwal, New South Wales, 2259

  • Australian Clinical Research Network - Phase 2

    Maroubra, New South Wales, 2035

  • Center for Clinical Studies - Phase 1 and Phase 2

    Melbourne, Victoria, 3181

  • University of the Sunshine Coast, Health Hub Morayfield - Phase 2

    Morayfield, Queensland, 4506

  • Scientia Clinical Research Limited - Phase 2

    Randwick, New South Wales, 2031

  • University of the Sunshine Coast - Phase 2

    Sippy Downs, Queensland, 4556

Other trials in Australia

United States8 sites

  • Synexus Clinical Research US, Inc. - Cincinnati - Phase 2

    Cincinnati, Ohio, 45236

  • Rapid Medical Research Inc - ERN-PPDS - Phase 2

    Cleveland, Ohio, 44122

  • Central Kentucky Research Associates Inc - Phase 2

    Lexington, Kentucky, 40509

  • Advanced Clinical Research - Meridian - ERN-PPDS - Phase 2

    Meridian, Idaho, 83642

  • Alliance for Multispecialty Research, LLC - Phase 2

    Newton, Kansas, 67114

  • Meridian Clinical Research-(Rockville Maryland) - Platinum - PPDS - Phase 2

    Rockville, Maryland, 20854

  • Meridian Clinical Research-(Savannah Georgia) - Platinum - PPDS - Phase 2

    Savannah, Georgia, 31406

  • Alliance for Multispecialty Research, LLC - Phase 2

    Wichita, Kansas, 67207

Other trials in United States

About this study

Official title: 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

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.

Conditions
COVID-19
Being tested
SARS-CoV-2 rS - Phase 1, SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 1, Normal saline solution (NSS), Placebo - Phase 1, Normal saline solution (NSS), Placebo - Phase 2, SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 1
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SARS-CoV-2 rS - Phase 1Biological

    Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS (0.6 mL) on Days 0 and 21.

  • SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 1Biological

    Also called NVX-CoV2373

    Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS mixed with Matrix-M adjuvant (0.6 mL) on Days 0 and 21.

  • Normal saline solution (NSS), Placebo - Phase 1Other

    Also called Sodium chloride solution for injection, 0.9%

    Alternating intramuscular (deltoid) injections of placebo (0.6 mL) on Days 0 and 21.

  • Normal saline solution (NSS), Placebo - Phase 2Other

    Also called Sodium chloride solution for injection, 0.9%

    Intramuscular (deltoid) injections of placebo (0.5 mL).

  • SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 1Biological

    Also called NVX-CoV2373

    Intramuscular (deltoid) injection of SARS-CoV-2 rS mixed with Matrix-M adjuvant (0.6 mL) on Day 0.

  • Normal saline solution (NSS), Placebo, Day 21 - Phase 1Other

    Also called Sodium chloride solution for injection, 0.9%

    Intramuscular injection of placebo (0.6 mL) in alternate deltoid on Day 21.

  • SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 2Biological

    Also called NVX-CoV2373

    Intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL).

Study groups in NCT04368988
Study groupRoleWhat they receive
Placebo - Phase 1Placebo comparator2 doses of Placebo (Saline), 1 dose each on Days 0 and 21.
Receives: Other: Normal saline solution (NSS), Placebo - Phase 1
SARS-CoV-2 rS - 25 μg without Matrix-M - Phase 1Experimental2 doses of SARS-CoV-2 rS - 25 μg, 1 dose each on Days 0 and 21.
Receives: Biological: SARS-CoV-2 rS - Phase 1
SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M - Phase 1Experimental2 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.
Receives: Biological: SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 1
SARS-CoV-2 rS - 25 μg + 50 μg Matrix-M - Phase 1Experimental2 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.
Receives: Biological: SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 1
SARS-CoV-2 rS - 25 μg + 50 μg Matrix-M then Placebo - Phase 1Experimental1 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.
Receives: Biological: SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 1; Other: Normal saline solution (NSS), Placebo, Day 21 - Phase 1
Placebo - Phase 2Placebo comparator3 doses of Placebo (Saline), 1 dose each on Days 0, 21, and 189.
Receives: Other: Normal saline solution (NSS), Placebo - Phase 2
SARS-CoV-2 rS - 5/5 μg + 50 μg Matrix-M - Phase 2Experimental2 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.
Receives: Other: Normal saline solution (NSS), Placebo - Phase 2; Biological: SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 2
SARS-CoV-2 rS - Alternating 5/5 μg + 50 μg Matrix-M - Phase 2Experimental1 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.
Receives: Other: Normal saline solution (NSS), Placebo - Phase 2; Biological: SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 2
SARS-CoV-2 rS - 25/25 μg + 50 μg Matrix-M - Phase 2Experimental2 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.
Receives: Other: Normal saline solution (NSS), Placebo - Phase 2; Biological: SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 2
SARS-CoV-2 rS - 25 μg + 50 μg Matrix-M - Phase 2Experimental1 dose of SARS-CoV-2 rS - 25 μg + 50 μg Matrix-M (co-formulated) on Day 0 then 2 doses of Placebo, 1 dose each on Days 21 and 189.
Receives: Other: Normal saline solution (NSS), Placebo - Phase 2; Biological: SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 2
SARS-CoV-2 rS - 5/5/5 μg + 50 μg Matrix-M - Phase 2Experimental3 doses of SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M (co-formulated), 1 dose each on Day 0, Day 21, and Day 189.
Receives: Biological: SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 2
SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M - Phase 2Experimental1 dose of SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M (co-formulated) on Day 0 then 2 doses of Placebo, 1 dose each on Days 21 and 189.
Receives: Other: Normal saline solution (NSS), Placebo - Phase 2; Biological: SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participants with Solicited Adverse Events (AEs) - Phase 1

    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.

    Measured: 28 days

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

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

    Measured: 28 days

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

    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 21.

    Measured: 21 days

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

    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.

    Measured: 35 days

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

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

    Measured: 35 days

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

    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.

    Measured: 35 days

  7. Serum IgG Antibody Levels Expressed as GMEUs - Phase 2

    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.

    Measured: Day 35

  8. Serum IgG Antibody Levels Expressed as GMFRs - Phase 2

    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.

    Measured: Day 35

  9. Serum IgG Antibody Levels Expressed as SCRs - Phase 2

    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.

    Measured: Day 35

  10. Participants with Solicited Adverse Events (AEs) - Phase 2

    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.

    Measured: 28 days

  11. Participants with Unsolicited AEs - Phase 2

    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.

    Measured: 35 days

Secondary outcomes (43)

  1. Participants with Unsolicited AEs - Phase 1

    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.

    Measured: 49 days

  2. Participants with Abnormal Vital Signs - Phase 1

    Percentage of participants with vital sign abnormalities on the day of vaccination by severity scoring immediately following vaccination.

    Measured: 21 days

  3. Changes from Baseline in Body Temperature - Phase 1

    Mean changes from baseline in body temperature by treatment group and visit.

    Measured: 189 days

  4. Changes from Baseline in Blood Pressure - Phase 1

    Mean changes from baseline in blood pressure by treatment group and visit.

    Measured: 189 days

  5. Changes from Baseline in Pulse Rate - Phase 1

    Mean changes from baseline in pulse rate by treatment group and visit.

    Measured: 189 days

  6. Participants with MAAEs - Phase 1

    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.

    Measured: 105 days

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

    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.

    Measured: 386 days

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

    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.

    Measured: 189 days

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

    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.

    Measured: 189 days

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

    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.

    Measured: 189 days

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

    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.

    Measured: 189 days

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

    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.

    Measured: 189 days

  13. ACE2 Receptor Binding Inhibition Assay Expressed as GMFRs - Phase 1

    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.

    Measured: 189 days

  14. ACE2 Receptor Binding Inhibition Assay Expressed as SCRs - Phase 1

    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.

    Measured: 189 days

  15. ACE2 Receptor Binding Inhibition Assay Expressed as SRRs - Phase 1

    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.

    Measured: 189 days

  16. Neutralizing Antibody Activity Expressed as GMTs - Phase 1

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

    Measured: 49 days

  17. Neutralizing Antibody Activity Expressed as GMFRs - Phase 1

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

    Measured: 49 days

  18. Neutralizing Antibody Activity Expressed as SCRs - Phase 1

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

    Measured: 49 days

  19. Neutralizing Antibody Activity Expressed as SRRs - Phase 1

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

    Measured: 49 days

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

    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.

    Measured: 28 days

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

    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.

    Measured: 35 days

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

    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.

    Measured: 35 days

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

    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.

    Measured: 35 days

  24. Assessment of Serum IgG Antibody Levels Expressed as GMEUs at Multiple Time Points - Phase 2

    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 357 for the single-dose regimens compared to the two-dose regimens and to placebo, stratified by baseline immune response.

    Measured: 357 days

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

    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 357 for the single-dose regimens compared to the two-dose regimens and to placebo, stratified by baseline immune response.

    Measured: 357 days

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

    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 357 for the single-dose regimens compared to the two-dose regimens and to placebo, stratified by baseline immune response.

    Measured: 357 days

  27. ACE2 Receptor Binding Inhibition Assay Expressed as GMTs - Phase 2

    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 357 for the single-dose regimens compared to the two-dose regimens and to placebo.

    Measured: 357 days

  28. ACE2 Receptor Binding Inhibition Assay Expressed as GMFRs - Phase 2

    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 357 for the single-dose regimens compared to the two-dose regimens and to placebo.

    Measured: 357 days

  29. ACE2 Receptor Binding Inhibition Assay Expressed as SCRs - Phase 2

    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 357 for the single-dose regimens compared to the two-dose regimens and to placebo.

    Measured: 357 days

  30. Neutralizing Antibody Activity Expressed as GMTs - Phase 2

    Neutralizing antibody activity as detected by MN expressed as GMTs at Days 35, 217, and 357 relative to baseline in a subset of subjects by absolute titers and change from baseline.

    Measured: 357 days

  31. Neutralizing Antibody Activity Expressed as GMFRs - Phase 2

    Neutralizing antibody activity as detected by MN expressed as GMFRs at Days 35, 217 and 357 relative to baseline in a subset of subjects by absolute titers and change from baseline.

    Measured: 357 days

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

    Neutralizing antibody activity as detected by MN expressed as SCRs (≥ 4-fold change) at Days 35, 217, and 357 relative to baseline in a subset of subjects by absolute titers and change from baseline.

    Measured: 357 days

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

    Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs at Days 189, 217, and 357 for all treatment groups and additionally at Day 371 and Day 546 for treatment groups B and C for boosting assessment with either placebo or active boost.

    Measured: 546 days

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

    Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Days 189, 217, and 357 for all treatment groups and additionally at Day 371 and Day 546 for treatment groups B and C for boosting assessment with either placebo or active boost.

    Measured: 546 days

  35. Participants with MAAEs - Phase 2

    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.

    Measured: 217 days

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

    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.

    Measured: 357 days

  37. Participants with Abnormal Vital Signs - Phase 2

    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.

    Measured: 21 days

  38. Changes from Baseline in Body Temperature - Phase 2

    Mean changes from baseline in body temperature by treatment group and visit.

    Measured: 189 days

  39. Changes from Baseline in Blood Pressure - Phase 2

    Mean changes from baseline in blood pressure by treatment group and visit.

    Measured: 189 days

  40. Changes from Baseline in Pulse Rate - Phase 2

    Mean changes from baseline in pulse rate by treatment group and visit.

    Measured: 189 days

  41. Participants with SARS-CoV-2 Positivity - Phase 2

    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).

    Measured: 161 days

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

    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.

    Measured: 161 days

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

    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.

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2020
  2. Study start25 May 2020
  3. Primary completion1 Jun 2022
  4. Study completion1 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,419 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04368988
Sponsor's protocol ID
2019nCoV-101
Status last verified
Apr 2023
First submitted
24 Apr 2020
Last updated
10 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bangaru S, Jackson AM, Copps J, Fernandez-Quintero ML, Torres JL, Richey ST, Nogal B, Sewall LM, Torrents de la Pena A, Rehman A, Guebre-Xabier M, Girard B, Das R, Corbett-Helaire KS, Seder RA, Graham BS, Edwards DK, Patel N, Smith G, Ward AB. Structural serology of polyclonal antibody responses to mRNA-1273 and NVX-CoV2373 COVID-19 vaccines. Cell Rep. 2025 Jul 22;44(7):115986. doi: 10.1016/j.celrep.2025.115986. Epub 2025 Jul 8.

    PubMed 40632654

  • Alves K, Plested JS, Galbiati S, Chau G, Cloney-Clark S, Zhu M, Kalkeri R, Patel N, Smith K, Marcheschi A, Pfeiffer S, McFall H, Smith G, Glenn GM, Dubovsky F, Mallory RM; Novavax 2019nCoV-101 Study Group. Immunogenicity and safety of a fourth homologous dose of NVX-CoV2373. Vaccine. 2023 Jun 29;41(29):4280-4286. doi: 10.1016/j.vaccine.2023.05.051. Epub 2023 Jun 2.

    PubMed 37271706

  • Fries L, Formica N, Mallory RM, Zhou H, Plested JS, Kalkeri R, Moldovan I, Patel N, Albert G, Robinson M, Cho I, Chau G, Dubovsky F, Glenn GM; 2019nCoV-101 Study Group. Strong CD4+ T-Cell Responses to Ancestral and Variant Spike Proteins Are Established by NVX-CoV2373 Severe Acute Respiratory Syndrome Coronavirus 2 Primary Vaccination. J Infect Dis. 2023 Sep 15;228(6):734-741. doi: 10.1093/infdis/jiad163.

    PubMed 37210741

  • Mallory RM, Formica N, Pfeiffer S, Wilkinson B, Marcheschi A, Albert G, McFall H, Robinson M, Plested JS, Zhu M, Cloney-Clark S, Zhou B, Chau G, Robertson A, Maciejewski S, Hammond HL, Baracco L, Logue J, Frieman MB, Smith G, Patel N, Glenn GM; Novavax 2019nCoV101 Study Group. Safety and immunogenicity following a homologous booster dose of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373): a secondary analysis of a randomised, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2022 Nov;22(11):1565-1576. doi: 10.1016/S1473-3099(22)00420-0. Epub 2022 Aug 10.

    PubMed 35963274

  • Formica N, Mallory R, Albert G, Robinson M, Plested JS, Cho I, Robertson A, Dubovsky F, Glenn GM; 2019nCoV-101 Study Group. Different dose regimens of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373) in younger and older adults: A phase 2 randomized placebo-controlled trial. PLoS Med. 2021 Oct 1;18(10):e1003769. doi: 10.1371/journal.pmed.1003769. eCollection 2021 Oct.

    PubMed 34597298

  • Tian JH, Patel N, Haupt R, Zhou H, Weston S, Hammond H, Logue J, Portnoff AD, Norton J, Guebre-Xabier M, Zhou B, Jacobson K, Maciejewski S, Khatoon R, Wisniewska M, Moffitt W, Kluepfel-Stahl S, Ekechukwu B, Papin J, Boddapati S, Jason Wong C, Piedra PA, Frieman MB, Massare MJ, Fries L, Bengtsson KL, Stertman L, Ellingsworth L, Glenn G, Smith G. SARS-CoV-2 spike glycoprotein vaccine candidate NVX-CoV2373 immunogenicity in baboons and protection in mice. Nat Commun. 2021 Jan 14;12(1):372. doi: 10.1038/s41467-020-20653-8.

    PubMed 33446655

  • Guebre-Xabier M, Patel N, Tian JH, Zhou B, Maciejewski S, Lam K, Portnoff AD, Massare MJ, Frieman MB, Piedra PA, Ellingsworth L, Glenn G, Smith G. NVX-CoV2373 vaccine protects cynomolgus macaque upper and lower airways against SARS-CoV-2 challenge. Vaccine. 2020 Nov 25;38(50):7892-7896. doi: 10.1016/j.vaccine.2020.10.064. Epub 2020 Oct 23.

    PubMed 33139139

  • Keech C, Albert G, Cho I, Robertson A, Reed P, Neal S, Plested JS, Zhu M, Cloney-Clark S, Zhou H, Smith G, Patel N, Frieman MB, Haupt RE, Logue J, McGrath M, Weston S, Piedra PA, Desai C, Callahan K, Lewis M, Price-Abbott P, Formica N, Shinde V, Fries L, Lickliter JD, Griffin P, Wilkinson B, Glenn GM. Phase 1-2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine. N Engl J Med. 2020 Dec 10;383(24):2320-2332. doi: 10.1056/NEJMoa2026920. Epub 2020 Sep 2.

    PubMed 32877576

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SARS-CoV-2 rS - Phase 1, SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 1 and SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 1 in people with COVID-19, run by Novavax at 18 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants with Solicited Adverse Events (AEs) - Phase 1 (time frame: 28 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04368988, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.

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