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

NCT05463068 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 2019nCoV-307
• Study Type: interventional
• Target: 911
• Locations: 1 country
• Sites: 30

Brief Summary

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.

Conditions

COVID-19; SARS-CoV-2 Infection

Keywords

Coronavirus; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Serum IgG Antibody Levels to the SARS-CoV-2 Spike Protein Expressed as Seroconversion Rate (SCR)

  Day 29

• Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) Expressed as Geometric Mean Titer [GMT]

  Baseline (Day 1) to Day 29

• Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) Expressed as SCR

  Day 29

• hACE2 Receptor Binding Inhibition Antibody Titers Specific for the SARS-CoV-2 Spike Protein (Wuhan) Expressed as GMT

  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

  Day 29

Study Arms (3)

Lot 1

EXPERIMENTAL

1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1.

Drug: NVX-Cov2373

Lot 2

EXPERIMENTAL

1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1.

Drug: NVX-Cov2373

Lot 3

EXPERIMENTAL

1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1.

Drug: NVX-Cov2373

Interventions

NVX-Cov2373 DRUG

Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1

Also known as: SARS-CoV-2 rS/Matrix-M Adjuvant

Lot 1; Lot 2; Lot 3

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• To be included in this study, each individual must satisfy all of the following criteria:
• Adults 18 to 49 years of age, inclusive, at screening
• 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 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.
• 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
• 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.
• 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.

You may not qualify if:

• Participants meeting any of the following criteria will be excluded from the study.
• History of laboratory-confirmed (by polymerase chain reaction \[PCR\] or rapid antigen test)COVID-19 infection ≤ 4 months prior to randomization.
• Current participation in research involving receipt of an investigational product (drug/biologic/device).
• Any known allergies or history of anaphylaxis to the active substance or any of the other ingredients contained in the investigational product.
• Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) or therapy that causes clinically significant immunosuppression.
• 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.
• 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.
• 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).
• Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the EOS visit.
• 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.
• 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).
• 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).
• Participants with a history of myocarditis or pericarditis.

Sponsors & Collaborators

• Novavax: lead

Study Sites (30)

Long Beach Clinical Trial Services Inc.

Long Beach, California, 90806, United States

Location

Benchmark Research

Sacramento, California, 95864, United States

Location

Accel Clinical Research

DeLand, Florida, 32720, United States

Location

Research Centers of America

Hollywood, Florida, 33024, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Multi-Specialty Research Associates, Inc.

Lake City, Florida, 32055, United States

Location

Cen/Excel ACMR

Atlanta, Georgia, 30331, United States

Location

Meridian Clinical Research

Savannah, Georgia, 31406, United States

Location

CRA Headlands

Stockbridge, Georgia, 30281, United States

Location

Velocity Clinical Research

Boise, Idaho, 83642, United States

Location

Meridian Clinical Research

Sioux City, Iowa, 51106, United States

Location

Meridian Clinical Research

Baton Rouge, Louisiana, 70809, United States

Location

MedPharmics

Gulfport, Mississippi, 39503, United States

Location

Sundance Clinical Research

St Louis, Missouri, 63141, United States

Location

Meridian Clinical Research

Norfolk, Nebraska, 68701, United States

Location

Meridian Clinical Research

Omaha, Nebraska, 68134, United States

Location

Meridian Clinical Research

Endwell, New York, 13760, United States

Location

Rochester Clinical Research

Rochester, New York, 14609, United States

Location

OnSite Clinical Solutions, LLC

Charlotte, North Carolina, 28208, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

Velocity Clinical Research

Cleveland, Ohio, 44122, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Tekton Research

Yukon, Oklahoma, 73099, United States

Location

Velocity Clinical Research

Grants Pass, Oregon, 97527, United States

Location

Velocity Clinical Research

East Greenwich, Rhode Island, 02818, United States

Location

Benchmark Research

Austin, Texas, 78705, United States

Location

Tekton Research

Austin, Texas, 78747, United States

Location

Benchmark Research

Houston, Texas, 76135, United States

Location

Research Your Health

Plano, Texas, 75093, United States

Location

Tekton Research

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• 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.

  PMID: 37652823 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

NVX-CoV2373 adjuvated lipid nanoparticle

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Novavax Customer Service Center
• Organization: Novavax Inc.

Clinicaltrials@novavax.com

1-844-Novavax (668-2829)

Study Officials

• Clinical Development

  Novavax, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 18, 2022
• Study Start: July 11, 2022
• Primary Completion: August 17, 2022
• Study Completion: September 1, 2022
• Last Updated: April 17, 2026
• Results First Posted: April 17, 2026

Record last verified: 2026-04

Locations

US (30)