Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults

A Randomized, Observer-Blinded, Phase 3 Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults

This is a randomized, Phase 3 study comparing the immunogenicity and safety of 3 different lots of Novavax vaccine with Matrix-M™ adjuvant (NVX-CoV2373).The study will enroll approximately 900 previously vaccinated adults 18 to 49 years of age, inclusive.

Study Overview

• Status: Completed
• Conditions: COVID-19; SARS-CoV-2 Infection
• Intervention / Treatment: Drug: NVX-Cov2373

Detailed Description

This is a randomized, Phase 3 study comparing the immunogenicity and safety of 3 different lots of Novavax vaccine with Matrix-M™ adjuvant (NVX-CoV2373). The study will enroll approximately 900 previously vaccinated adults 18 to 49 years of age, inclusive. Participants will be screened at baseline with the goal of enrolling approximately 900 previously vaccinated participants. Participants will be randomized 1:1:1 to receive 1 dose of the vaccine from 1 of 3 different lots, given on Day 1, at a dose level of 5 µg of antigen with 50 µg of Matrix-M adjuvant. All participants will remain on study for immunogenicity and safety data collection through 28 days following the vaccination.

• Study Type: Interventional
• Enrollment (Actual): 911
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90806
      • Long Beach Clinical Trial Services Inc.
    • Sacramento, California, United States, 95864
      • Benchmark Research
  • Florida
    • DeLand, Florida, United States, 32720
      • Accel Clinical Research
    • Hollywood, Florida, United States, 33024
      • Research Centers of America
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Lake City, Florida, United States, 32055
      • Multi-Specialty Research Associates, Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Cen/Excel ACMR
    • Savannah, Georgia, United States, 31406
      • Meridian Clinical Research
    • Stockbridge, Georgia, United States, 30281
      • CRA Headlands
  • Idaho
    • Boise, Idaho, United States, 83642
      • Velocity Clinical Research
  • Iowa
    • Sioux City, Iowa, United States, 51106
      • Meridian Clinical Research
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Meridian Clinical Research
  • Mississippi
    • Gulfport, Mississippi, United States, 39503
      • MedPharmics
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Sundance Clinical Research
  • Nebraska
    • Norfolk, Nebraska, United States, 68701
      • Meridian Clinical Research
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research
  • New York
    • Endwell, New York, United States, 13760
      • Meridian Clinical Research
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research
  • North Carolina
    • Charlotte, North Carolina, United States, 28208
      • OnSite Clinical Solutions, LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • CTI Clinical Research Center
    • Cleveland, Ohio, United States, 44122
      • Velocity Clinical Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Yukon, Oklahoma, United States, 73099
      • Tekton Research
  • Oregon
    • Grants Pass, Oregon, United States, 97527
      • Velocity Clinical Research
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Velocity Clinical Research
  • Texas
    • Austin, Texas, United States, 78705
      • Benchmark Research
    • Austin, Texas, United States, 78747
      • Tekton Research
    • Houston, Texas, United States, 76135
      • Benchmark Research
    • Plano, Texas, United States, 75093
      • Research Your Health
    • San Antonio, Texas, United States, 78229
      • Tekton Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

To be included in this study, each individual must satisfy all of the following criteria:

1. Adults 18 to 49 years of age, inclusive, at screening
2. Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
3. 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 the end of study (EOS) visit OR agree to consistently use a medically acceptable method of contraception from at least 28 days prior to enrollment and through the EOS visit.
4. 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 study vaccination

5. Agree to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.

   Note: For participants who become hospitalized with coronavirus disease 2019 (COVID-19), participation in investigational treatment studies is permitted.

6. Documented receipt of either 2 or 3 doses of the investigational Novavax vaccine with Matrix-M adjuvant (NVX- CoV2373); OR documented receipt of a full course of an FDA-authorized/approved COVID-19 vaccine; OR documented receipt of a full course of heterologous COVID-19 vaccines mentioned above. The most recent dose must have been administered at least 6 months prior to study vaccination.

Exclusion Criteria:

Participants meeting any of the following criteria will be excluded from the study.

1. History of laboratory-confirmed (by polymerase chain reaction [PCR] or rapid antigen test)COVID-19 infection ≤ 4 months prior to randomization.
2. Current participation in research involving receipt of an investigational product (drug/biologic/device).
3. Any known allergies or history of anaphylaxis to the active substance or any of the other ingredients contained in the investigational product.
4. Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) or therapy that causes clinically significant immunosuppression.
5. Received any vaccine ≤ 90 days prior to study vaccination, except for influenza vaccine which may be received 4 days prior to study vaccine, or rabies vaccine which may be received at any time if medically indicated.
6. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to study vaccination, except for rabies immunoglobulin which may be given if medically indicated.
7. Active cancer (malignancy) on chemotherapy that is judged to cause significant immunocompromise within 1 year prior to first study vaccination (with the exception of malignancy cured via excision, at the discretion of the investigator).
8. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the EOS visit.
9. Suspected or known history of alcohol abuse or drug addiction within 3 months prior to the study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance.
10. 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 (including neurologic or psychiatric conditions likely to impair the quality of safety reporting).
11. Study team member or immediate family member of any study team member (inclusive of Sponsor, clinical research organization [CRO], and study site personnel involved in the conduct or planning of the study).
12. Participants with a history of myocarditis or pericarditis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lot 1; 1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1.	Drug: NVX-Cov2373; Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1; Other Names: SARS-CoV-2 rS/Matrix-M Adjuvant
Experimental: Lot 2; 1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1.	Drug: NVX-Cov2373; Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1; Other Names: SARS-CoV-2 rS/Matrix-M Adjuvant
Experimental: Lot 3; 1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1.	Drug: NVX-Cov2373; Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1; Other Names: SARS-CoV-2 rS/Matrix-M Adjuvant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Immunoglobulin G (IgG) Antibody Levels to the SARS-CoV-2 Spike Protein Expressed as Geometric Mean ELISA Unit [GMEUs]	Serum Immunoglobulin G (IgG) geometric mean ELISA unit concentrations (GMEU/mL) to the SARS-CoV-2 spike protein at Day 29 in each treatment arm.	Baseline (Day 1) and Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum IgG Antibody Levels to the SARS-CoV-2 Spike Protein Expressed as Seroconversion Rate (SCR)	Proportion of participants in each treatment arm who achieve seroconversion (≥ 4-fold increase from baseline) in IgG concentrations to the SARS-CoV-2 spike protein at Day 29.	Day 29
Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) Expressed as Geometric Mean Titer [GMT]	Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) of 3 Lots of NVX-CoV2373 at Day 1 and Day 29	Baseline (Day 1) to Day 29
Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) Expressed as SCR	Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) of 3 Lots of NVX-CoV2373 at Day 29	Day 29
hACE2 Receptor Binding Inhibition Antibody Titers Specific for the SARS-CoV-2 Spike Protein (Wuhan) Expressed as GMT	hACE2 Receptor Binding Inhibition Antibody Titers Specific for the SARS-CoV-2 Spike Protein (Wuhan) the 3 Lots of NVX-CoV2373 at Day 1 to Day 29	Baseline (Day 1) to Day 29
Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Antibody Titers Specific for the SARS-CoV-2 Spike Protein (Wuhan) Expressed as SCR	Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Antibody Titers Specific for the SARS-CoV-2 Spike Protein (Wuhan) the 3 Lots of NVX-CoV2373 at Day 29	Day 29
Number of Participants With Medically Attended Adverse Event(s) (MAAEs), Adverse Event(s) of Special Interest (AESIs), and Serious Adverse Event(s) (SAEs)	Number of participants Medically Attended Adverse Event(s) (MAAEs), Adverse event(s) of Special Interest (AESIs), and Serious Adverse Event(s) (SAEs)	Day 1 to Day 29
Incidence and Severity of MAAEs Through Day 29	Incidence, duration, severity, and relationship of MAAEs through Day 29 (ie, 28 days after vaccine dose)	Day 29
Number of Participants With Unsolicited Treatment-Emergent Adverse Events by COVID-19	Number of Participants with Unsolicited Treatment-Emergent Adverse Events by COVID-19 throughout the study at Day 29	Day 29

Collaborators and Investigators

• Sponsor: Novavax
• Investigators: Study Director: Clinical Development, Novavax, Inc.

Publications and helpful links

General Publications

• Raiser F, Davis M, Adelglass J, Cai MR, Chau G, Cloney-Clark S, Eickhoff M, Kalkeri R, McKnight I, Plested J, Zhu M, Dunkle LM; 2019nCoV-307 study team. Immunogenicity and safety of NVX-CoV2373 as a booster: A phase 3 randomized clinical trial in adults. Vaccine. 2023 Sep 22;41(41):5965-5973. doi: 10.1016/j.vaccine.2023.07.056. Epub 2023 Aug 30.

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2022
• Primary Completion (Actual): August 17, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: July 14, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Coronavirus; COVID-19
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronaviridae Infections; Nidovirales Infections; COVID-19; Coronavirus Infections; NVX-CoV2373 adjuvated lipid nanoparticle
• Other Study ID Numbers: 2019nCoV-307

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No