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A Study Looking at the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults at Risk for SARS-CoV-2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04611802
Recruitment Status : Recruiting
First Posted : November 2, 2020
Last Update Posted : January 20, 2021
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Novavax

Brief Summary:
This is a study to evaluate the effectiveness, immune response, and safety of a coronavirus disease 2019 (COVID-19) vaccine called SARS-CoV-2 rS with Matrix-M1 adjuvant in adults 18 years of age and older in the United States and Mexico. A vaccine causes the body to have an immune response that may help prevent the infection or reduce the severity of symptoms. An adjuvant is something that can make a vaccine work better. This study will look at the protective effect, body's immune response, and safety of SARS-CoV-2 rS with Matrix-M1 adjuvant in the study population. Participants in the study will randomly be assigned to receive SARS-CoV-2 rS with Matrix-M1 adjuvant or placebo. Each participant in the study will receive a total of 2 intramuscular injections over the course of the study. Up to 30,000 participants will take part in the study.

Condition or disease Intervention/treatment Phase
SARS-CoV Infection Covid19 Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant Other: Placebo Phase 3

Detailed Description:

To obtain contact information for a study center near you, please visit:

https://www.novavax.com/PREVENT-19?utm_source=ctgov&utm_medium=link

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M1™ Adjuvant in Adult Participants ≥ 18 Years
Actual Study Start Date : December 27, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SARS-CoV-2 rS/Matrix-M1 Adjuvant
2 doses of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated), 1 dose each on Days 0 and 21.
Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant
Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Days 0 and 21.
Other Name: NVX-CoV2373

Placebo Comparator: Placebo
2 doses of Placebo (Saline), 1 dose each on Days 0 and 21.
Other: Placebo
Alternating intramuscular (deltoid) injections of placebo (0.5 mL) on Days 0 and 21.
Other Name: Sodium chloride 0.9% (BP, sterile)




Primary Outcome Measures :
  1. Participants with Symptomatic Mild, Moderate, or Severe Coronavirus Disease 2019 (COVID-19) [ Time Frame: Day 28 to Day 750 ]
    Number of participants with first occurrence of positive (+) polymerase chain reaction (PCR)-confirmed SARS-CoV-2 illness with symptomatic mild, moderate, or severe COVID-19, with each symptom lasting for at least 2 consecutive days, with onset from Day 28 (7 days after second vaccination dose) through the length of the study.


Secondary Outcome Measures :
  1. Participants with Symptomatic Moderate or Severe COVID-19 [ Time Frame: Day 28 to Day 750 ]
    Number of participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness with symptomatic moderate or severe COVID-19, with each symptom lasting for at least 2 consecutive days, with onset from Day 28 (7 days after second vaccination dose) through the length of the study.

  2. Participants with Any Symptomatic COVID-19 [ Time Frame: Day 28 to Day 750 ]
    Number of participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness with any symptomatic COVID-19, with each symptom lasting for at least 2 consecutive days, with onset from Day 28 (7 days after second vaccination dose) through the length of the study.

  3. Neutralizing Antibody Activity Expressed as Geometric Mean Titers (GMTs) [ Time Frame: Day 0 to Day 105 ]
    Neutralizing antibody activity as detected by microneutralization assay (MN) as expressed as GMTs at Days 0, 35 and Month 3.

  4. Neutralizing Antibody Activity Expressed as Geometric Mean Fold Rises (GMFRs) [ Time Frame: Day 0 to Day 105 ]
    Neutralizing antibody activity as detected by MN as expressed as GMFRs at Days 0, 35 and Month 3.

  5. Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMTs [ Time Frame: Day 0 to Day 105 ]
    Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by enzyme-linked immunosorbent assay (ELISA) expressed as GMTs at Days 0, 35 and Month 3.

  6. Serum IgG Antibody Levels Expressed as GMFRs [ Time Frame: Day 0 to Day 105 ]
    Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Days 0, 35 and Month 3.

  7. Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Assay Expressed as GMTs [ Time Frame: Day 0 to Day 105 ]
    Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMTs at Days 0, 35 and Month 3.

  8. hACE2 Receptor Binding Inhibition Assay Expressed as GMFRs [ Time Frame: Day 0 to Day 105 ]
    Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMFRs at Days 0, 35 and Month 3.

  9. Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMTs at Later Time Points [ Time Frame: Day 165 to Day 750 ]
    Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs at Months 6, 12, 18, and 24.

  10. Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMFRs at Later Time Points [ Time Frame: Day 165 to Day 750 ]
    Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Months 6, 12, 18, and 24.

  11. hACE2 Receptor Binding Inhibition Assay Expressed as GMTs at Later Time Points [ Time Frame: Day 165 to Day 750 ]
    Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMTs at Months 6, 12, 18, and 24.

  12. hACE2 Receptor Binding Inhibition Assay Expressed as GMFRs at Later Time Points [ Time Frame: Day 165 to Day 750 ]
    Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMFRs at Months 6, 12, 18, and 24.

  13. Neutralizing Antibody Activity Expressed as GMTs at Later Time Points [ Time Frame: Day 165 to Day 750 ]
    Neutralizing antibody activity as detected by MN as expressed as GMTs at Months 6, 12, 18, and 24.

  14. Neutralizing Antibody Activity Expressed as GMFRs at Later Time Points [ Time Frame: Day 165 to Day 750 ]
    Neutralizing antibody activity as detected by MN as expressed as GMFRs at Months 6, 12, 18, and 24.

  15. Description of Course, Treatment and Severity of COVID-19 [ Time Frame: Day 28 to Day 750 ]
    Description of course, treatment and severity of COVID-19 reported after a PCR-confirmed case via the Endpoint Form.

  16. Reactogenicity Incidence and Severity [ Time Frame: Day 0 to Day 27 ]
    Reactogenicity incidence and severity (mild, moderate or severe) recorded by all participants on their electronic patient-reported outcome diary application (eDiary) on days of vaccination and subsequent 6 days (total 7 days after each vaccine injection).

  17. Incidence and Severity of Medically Attended Adverse Events (MAAEs) Through Day 49. [ Time Frame: Day 0 to Day 49 ]
    Number of participants with mild, moderate, or severe MAAEs through Day 49.

  18. Incidence and Severity of Unsolicited Adverse Events (AEs) Through Day 49. [ Time Frame: Day 0 to Day 49 ]
    Number of participants with mild, moderate, or severe AEs through Day 49.

  19. Incidence and Severity of MAAEs Attributed to Study Vaccine Through Month 12. [ Time Frame: Day 0 to Day 375 ]
    Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine through Month 12.

  20. Incidence and Severity of Serious Adverse Events (SAEs) Through Month 12. [ Time Frame: Day 0 to Day 375 ]
    Number of participants with mild, moderate, or severe SAEs through Month 12.

  21. Incidence and Severity of Adverse Events of Special Interest (AESIs) Through Month 12. [ Time Frame: Day 0 to Day 375 ]
    Number of participants with mild, moderate, or severe AESIs through Month 12.

  22. Incidence and Severity of SAEs from Month 12 to Month 24. [ Time Frame: Day 360 to Day 750 ]
    Number of participants with mild, moderate, or severe SAEs from Month 12 to Month 24.

  23. Incidence and Severity of MAAEs Attributed to Study Vaccine from Month 12 to Month 24. [ Time Frame: Day 360 to Day 750 ]
    Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine from Month 12 to Month 24.

  24. Incidence and Severity of AESIs from Month 12 to Month 24. [ Time Frame: Day 360 to Day 750 ]
    Number of participants with mild, moderate, or severe AESIs attributed to study vaccine from Month 12 to Month 24.

  25. Deaths Due to Any Cause [ Time Frame: Day 0 to Day 750 ]
    Number of participants who died during the study due to any cause.

  26. Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Specific Time Points [ Time Frame: Day 0 to Day 750 ]
    Number of participants with antibodies to SARS-CoV-2 NP at Days 0 and 35, or Months 3, 6, 12, 18 and 24 to determine natural infection and to determine the incidence of asymptomatic infection acquired during study follow-up.

  27. Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Any Time Point [ Time Frame: Day 0 to Day 750 ]
    Number of participants with antibodies to SARS-CoV-2 NP, regardless of whether the infection was symptomatic.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults ≥ 18 years of age at screening who, by virtue of age, race, ethnicity or life circumstances, are considered at substantial risk of exposure to and infection with SARS-CoV-2.
  • Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
  • Participants of childbearing potential (defined as any participant 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]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through 3 months after the last vaccination OR agree to consistently use a medically acceptable method of contraception from at least 28 days prior to enrollment and through 3 months after the last vaccination.
  • Is medically stable, as determined by the investigator (based on review of health status, vital signs [to include body temperature], medical history, and targeted physical examination [to include body weight]). Vital signs must be within medically acceptable ranges prior to the first vaccination.
  • Agree to not participate in any other SARS-CoV-2 prevention trial during the study follow-up.

Exclusion Criteria:

  • Unstable acute or chronic illness. Criteria for unstable medical conditions include:

    1. Substantive changes in chronic prescribed medication (change in class or significant change in dose) in the past 2 months.
    2. Currently undergoing workup of undiagnosed illness that could lead to diagnosis of a new condition.
  • Participation in research involving an investigational product (drug/biologic/device) within 45 days prior to first study vaccination.
  • History of a previous laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19.
  • Received influenza vaccination or any other adult vaccine within 4 days prior to or within 7 days after either study vaccination.
  • Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy.
  • Chronic administration (defined as > 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to first study vaccination.
  • Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to first study vaccination.
  • Active cancer (malignancy) on therapy within 1 year prior to first study vaccination (with the exception of malignancy cured via excision, at the discretion of the investigator).
  • Any known allergies to products contained in the investigational product.
  • Participants who are breastfeeding, pregnant or who plan to become pregnant within 3 months following last study vaccination.
  • Any other 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 trial vaccine or interpretation of study results.
  • Study team member or first-degree relative of any study team member (inclusive of Sponsor, and study site personnel involved in the study).
  • Current participation in any other COVID-19 prevention clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04611802


Contacts
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Contact: Novavax CT.gov Call Center NOVAVAX (1-844-668-2829)

Locations
Show Show 115 study locations
Sponsors and Collaborators
Novavax
Department of Health and Human Services
Investigators
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Study Director: Lisa M Dunkle, MD Novavax, Inc.
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Responsible Party: Novavax
ClinicalTrials.gov Identifier: NCT04611802    
Other Study ID Numbers: 2019nCoV-301
First Posted: November 2, 2020    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novavax:
Coronavirus
Prevent-19
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases