Phase 2/3 Heterologous Boosting Study With Different Dose Levels of Monovalent SARS-CoV-2 rS Vaccines

NCT05925127 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 2019nCoV-205
• Study Type: interventional
• Target: 994
• Locations: 1 country
• Sites: 50

Brief Summary

This is a Phase 2/3, randomized, double-blind study to evaluate the safety and immunogenicity of different booster dose levels of the monovalent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle (SARS-CoV-2 rS) vaccines with Matrix-M™ adjuvant (NVX-CoV2373 \[prototype Wuhan vaccine with Matrix-M adjuvant\] or NVX-CoV2601 \[Omicron XBB.1.5 subvariant vaccine with Matrix-M adjuvant\]).

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Immunogenicity index-Neutralizing antibody expressed as geometric mean titer ratio[GMTR ]against the Omicron subvariant XBB.1.5

  Neutralizing antibody To determine if the combination of antigen and adjuvant levels of NVX-CoV2601 GMTR against the Omicron subvariant XBB.1.5 superior(LB of the 95% CI for GMTR \> 1.0) to that elicited by NVX-CoV2373

  Day 28

• Immunogenicity index-Neutralizing antibody expressed as seroresponse rates (SRRs)against the Omicron subvariant XBB.1.5

  Neutralizing antibody SRR against the Omicron XBB.1.5 subvariant elicited by NVXCoV2601 is non-inferior (NI)to the SRR elicited by NVX-CoV2373in participants ≥ 50 years of age previously vaccinated with ≥ 3 doses of a COVID-19 prototype or bivalent licensed mRNA vaccine.

  Day 28

Secondary Outcomes (10)

• Neutralizing antibody expressed as geometric mean titer ratio[GMTR ]against the Omicron subvariant XBB.1.5

  Day 28

• Immunogenicity index- IgG antibody Anti-S expressed as geometric mean Elisa units GMEUs (EU/mL)

  Day 0 to 180

• Immunogenicity index- Neutralizing antibody titers of post-booster by baseline anti-SARS-CoV-2 NP

  Day-28

• Immunogenicity index- Serum IgG levels to SARS-CoV-2 S protein at Day 28 of post-booster

  Day-28

• Safety Index-Incidence, duration, and severity of solicited local and systemic AEs expressed as GMT

  7 days

Study Arms (7)

Group-A Monovalent NVX-CoV2373 (5 μg)

EXPERIMENTAL

The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant

Biological: NVX-CoV2373 (5μg)

Group-B Monovalent NVX-CoV2601 (5 μg)

EXPERIMENTAL

Monovalent NVX-CoV2601 (5 μg of antigen with 50 μg of Matrix-M adjuvant)

Biological: NVX-CoV2601 (5μg)

Group-C Monovalent NVX-CoV2601 (5 μg)

EXPERIMENTAL

Monovalent NVX-CoV2601 (5 μg of antigen with 75 μg of Matrix-M adjuvant)

Biological: NVX-CoV2601(5μg)

Group-D Monovalent NVX-CoV2601 (35 μg)

EXPERIMENTAL

Monovalent NVX-CoV2373 (35 μg of antigen with 50 μg of Matrix-M adjuvant)

Biological: NVX-CoV2601 (35μg)

Group-E Monovalent NVX-CoV2601(35)

EXPERIMENTAL

Monovalent NVX-CoV2601 (35 μg of each antigen with a 75 μg of Matrix-M adjuvant)

Biological: NVX-CoV2601(35μg)

Group-F Monovalent NVX-CoV2601 (50 μg)

EXPERIMENTAL

Monovalent NVX-CoV2601 (50 μg of each antigen with a 100 μg of Matrix-M adjuvant)

Biological: NVX-CoV2601(50μg)

Group-G Bivalent XBB.1.5

EXPERIMENTAL

Bivalent XBB.1.5 Omicron subvariant/prototype COVID-19 licensed mRNA vaccine

Biological: Bivalent BA.4/5

Interventions

NVX-CoV2373 (5μg) BIOLOGICAL

Coformulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant: supplied as a solution for preparation for injection, at a concentration of 10 μg/mL and 100 μg adjuvant per mL, respectively

Group-A Monovalent NVX-CoV2373 (5 μg)

NVX-CoV2601 (5μg) BIOLOGICAL

The vaccination regimen will comprise one IM injection on Day 0 at a dose of 5 µg of antigen with 50 µg Matrix-M adjuvant.

Also known as: Omicron XBB.1.5

Group-B Monovalent NVX-CoV2601 (5 μg)

NVX-CoV2601(5μg) BIOLOGICAL

The vaccination regimen will comprise one IM injection on Day 0 at a dose of 5 µg of antigen with 75 µg Matrix-M adjuvant.

Also known as: Omicron XBB.1.5

Group-C Monovalent NVX-CoV2601 (5 μg)

NVX-CoV2601 (35μg) BIOLOGICAL

The vaccination regimen will comprise one IM injection on Day 0 at a dose of 35 µg of antigen with 50 µg Matrix-M adjuvant.

Also known as: Omicron XBB.1.5

Group-D Monovalent NVX-CoV2601 (35 μg)

NVX-CoV2601(35μg) BIOLOGICAL

The vaccination regimen will comprise one IM injection on Day 0 at a dose of 35 µg of antigen with 75 µg Matrix-M adjuvant.

Also known as: Omicron XBB.1.5

Group-E Monovalent NVX-CoV2601(35)

NVX-CoV2601(50μg) BIOLOGICAL

The vaccination regimen will comprise one IM injection on Day 0 at a dose of 50 µg of antigen with 100 µg Matrix-M adjuvant

Also known as: Omicron XBB.1.5

Group-F Monovalent NVX-CoV2601 (50 μg)

Bivalent BA.4/5 BIOLOGICAL

The bivalent BA.4/5 (or recommended mRNA vaccine at the time of the conduct of this study) Omicron subvariant/prototype licensed mRNA vaccine will be procured and stored per the manufacturer's instructions. For this vaccine group, treatment will be administered open label as a single IM injection

Also known as: Omicron Subvariant/Prototype Licensed mRNA Vaccine

Group-G Bivalent XBB.1.5

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 50 years of age at screening.
• Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
• Female 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 \[defined as amenorrhea ≥ 12 consecutive months\]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study OR agree to consistently use a medically acceptable method of contraception listed below from ≥ 28 days prior to enrollment and through the end of the study.
• 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 initial study vaccination.
• Agrees to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.
• Have previously received ≥ 3 doses of a COVID-19 prototype or bivalent licensed mRNAvaccine with the last dose having been given ≥ 90 days previously prior to first study booster.

You may not qualify if:

• Received COVID-19 vaccines other than a COVID-19 prototype or bivalent licensed mRNA vaccine in the past, inclusive of clinical trial COVID-19 vaccines.
• Participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to study vaccination.
• Received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine within 30 days prior to first study vaccination.
• Any known allergies to products contained in the investigational product. 5. Any history of anaphylaxis to any prior vaccine.
• \. 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 study vaccination. NOTE: An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical or intranasal glucocorticoids is permitted. Topical tacrolimus and ocular cyclosporin are permitted. Use of inhaled glucocorticoids is prohibited.
• \. 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 therapy within 3 years prior to study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator).
• \. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study.
• \. Suspected or known history of alcohol abuse or drug addiction within 2 years 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 study 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, contract 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 (50)

ARS-Birmingham CRU

Birmingham, Alabama, 35216, United States

Location

Tucson Neuroscience Research

Tucson, Arizona, 85710, United States

Location

Velocity Clinical Research, Banning

Banning, California, 99202, United States

Location

Velocity Clinical Research, Chula Vista

Chula Vista, California, 91911, United States

Location

Velocity Clinical Research, San Diego

La Mesa, California, 91942, United States

Location

Artemis Institute for Clinical Research

Riverside, California, 92503, United States

Location

Artemis - San Diego

San Diego, California, 92103, United States

Location

WR-MCCR

San Diego, California, 92120, United States

Location

Deland CRU

DeLand, Florida, 32720, United States

Location

Health Awareness

Jupiter, Florida, 33458, United States

Location

Wr-Msra, Llc

Lake City, Florida, 32055, United States

Location

Professional Urgent Care Services

Largo, Florida, 33777, United States

Location

Research Institute of South Florida

Miami, Florida, 33173, United States

Location

Suncoast Research Associates, LLC

Miami, Florida, 33173, United States

Location

Headlands Research Orlando LLC

Orlando, Florida, 32819, United States

Location

Precision Clinical Research, LLC

Sunrise, Florida, 33351, United States

Location

TrueBlue Clinical Research

Tampa, Florida, 33609, United States

Location

Neurostudies CRU

Decatur, Georgia, 30030, United States

Location

Velocity Clinical Research

Savannah, Georgia, 31406, United States

Location

CRA Headlands LLC

Stockbridge, Georgia, 30281, United States

Location

Velocity Clinical Research

Meridian, Idaho, 83642, United States

Location

Velocity Clinical Research

Sioux City, Iowa, 51106, United States

Location

Velocity Clinical Research

Baton Rouge, Louisiana, 70809, United States

Location

Velocity Clinical Research - Covington

Covington, Louisiana, 70433, United States

Location

Velocity Clinical Research, Metairie

Metairie, Louisiana, 70006, United States

Location

Activmed Practices and Research, LLC

Methuen, Massachusetts, 01844, United States

Location

Velocity Clinical Research, Gulfport

Gulfport, Mississippi, 39503, United States

Location

Velocity Clinical Research

Grand Island, Nebraska, 68803, United States

Location

Velocity Clinical Research

Norfolk, Nebraska, 68701, United States

Location

Velocity Clinical Research

Omaha, Nebraska, 68134, United States

Location

Activmed Practices and Research, LLC

Portsmouth, New Hampshire, 03801, United States

Location

Velocity Clinical Research

Binghamton, New York, 13905, United States

Location

Hypercore (Lucas Research)

New Bern, North Carolina, 28562, United States

Location

M3 Wake Research Inc

Raleigh, North Carolina, 27612, United States

Location

Trial Management Associates, LLC

Wilmington, North Carolina, 28403, United States

Location

Javara Inc./Wake Forest Health Network, LLC

Winston-Salem, North Carolina, 27157, United States

Location

Velocity Clinical Research

Cincinnati, Ohio, 45219, United States

Location

Velocity Clinical Research

Cincinnati, Ohio, 45246, United States

Location

Tekton Research

Edmond, Oklahoma, 73013, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Velocity Clinical Research, Grants Pass

Grants Pass, Oregon, 97527, United States

Location

Velocity Clinical Research, Providence

East Greenwich, Rhode Island, 02818, United States

Location

Velocity Clinical Research, Gaffney

Gaffney, South Carolina, 29340, United States

Location

Coastal Carolina Research Center an ALCANZA Clinical Research company

North Charleston, South Carolina, 29405, United States

Location

Central Texas Clinical Research, LLC

Austin, Texas, 78705, United States

Location

Research Your Health

Plano, Texas, 75093, United States

Location

Benchmark Research

San Angelo, Texas, 76904, United States

Location

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, 84088, United States

Location

Health Research of Hampton Roads, Inc

Newport News, Virginia, 23606, United States

Location

Clinical Research Partners

Richmond, Virginia, 23226, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

NVX-CoV2373 adjuvated lipid nanoparticle

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Development

  Novavax

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: June 29, 2023
• Study Start: October 16, 2023
• Primary Completion: May 21, 2024
• Study Completion: May 21, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

US (50)