A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.

NCT05975060 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 2019nCoV-313
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 30

Brief Summary

This is a Phase 2/3 open-label study to evaluate the safety and immunogenicity of a booster dose of the XBB.1.5 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccine (SARS-CoV-2 rS) adjuvanted with Matrix-M™ in previously mRNA COVID-19 vaccinated adult participants ≥18 years of age and baseline SARS CoV-2 seropositive COVID-19 vaccine naïve participants ≥18 years of age.

Conditions

COVID-19

Keywords

COVID-19, XBB.1.5

Outcome Measures

Primary Outcomes (4)

• Part 1: Pseudovirus neutralization (inhibitory dilution at a concentration of 50%; ID 50 ) to the NVX-CoV2601 vaccine

  Pseudovirus neutralization (inhibitory dilution at a concentration of 50%; ID 50 ) to the NVX-CoV2601 vaccine assessed at Day 28 following study vaccination.

  Day 28

• Part 1: Seroresponse Rates (SRRs) in ID 50 titers to the NVXCoV2601 vaccine

  SRRs (proportion of seroconverted participants) in ID 50 titers to the NVXCoV2601 vaccine assessed at Day 28 following the study vaccination.

  Day 28

• Part 2: SRRs in ID 50 titers to the XBB.1.5 Omicron subvariant

  SRRs (proportion of seroconverted participants) in ID 50 titers to the XBB.1.5 Omicron subvariant assessed at Day 28 following study vaccination.

  Day 28

• Part 2: ID 50 (Geometric Mean Titers) GMTs to the XBB.1.5 Omicron subvariant

  ID 50 GMTs to the XBB.1.5 Omicron subvariant assessed at Day 28 following study vaccination.

  Day 28

Secondary Outcomes (12)

• Part 1: Pseudovirus neutralization (inhibitory dilution at a concentration of 50%; ID50) to the NVX-CoV2601 vaccine

  Day 28

• Part 1: ID 50 GMTs to the XBB.1.5 Omicron subvariant

  Day 0 to Day 180

• Part 1: ID 50 geometric mean fold rise (GMFR) to the XBB.1.5 Omicron subvariant at relevant time points (Days 28 and 180) from baseline (Day 0).

  Day 0 to Day 180

• Part 1: SRRs in ID 50 titer concentrations to the XBB.1.5 Omicron subvariant at relevant time points.

  Day 28 to Day 180

• Part 1: Anti-S immunoglobulin G (IgG) geometric mean concentrations (GMCs, EU/mL) to the NVX-CoV2601 vaccine at relevant time points

  Day 0 to Day 180

Study Arms (2)

Group-A XBB.1.5 Vaccine (Booster)

EXPERIMENTAL

The Monovalent \[5 μg/50 μg\] NVX-CoV2601 XBB.1.5 Vaccine (Booster)

Biological: XBB.1.5 Vaccine (Booster)

Group-B The monovalent XBB.1.5 Vaccine (Single Dose).

ACTIVE COMPARATOR

Group-B The monovalent \[5 μg/50 μg\] NVX-CoV2601 XBB.1.5 Vaccine (Single Dose).

Biological: XBB.1.5 Vaccine (single dose)

Interventions

XBB.1.5 Vaccine (Booster) BIOLOGICAL

Omicron sub variant XBB.1.5 SARS-CoV-2 rS /Matrix-M Adjuvant the monovalent \[5 μg/50 μg\] NVX-CoV2601) XBB.1.5 Vaccine (Booster)

Also known as: Omicron sub variant XBB.1.5 vaccine( booster) SARS-CoV-2 rS /Matrix-M Adjuvant

Group-A XBB.1.5 Vaccine (Booster)

XBB.1.5 Vaccine (single dose) BIOLOGICAL

Omicron sub variant XBB.1.5 SARS-CoV-2 rS /Matrix-M Adjuvant the monovalent \[5 μg/50 μg\] NVX-CoV2601) XBB.1.5 Vaccine ( single dose)

Also known as: Omicron sub variant XBB.1.5 vaccine(single dose) SARS-CoV-2 rS /Matrix-M Adjuvant

Group-B The monovalent XBB.1.5 Vaccine (Single Dose).

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults ≥ 18 years of age at time of study vaccination.
• Part 1: Previously vaccinated with ≥ 3 doses of the Moderna and/or Pfizer /BioNTech prototype monovalent and/or BA.4/5 containing bivalent COVID-19 vaccines with the last dose administered ≥ 90 days prior to study vaccination.
• Part 2: Clinical history of COVID-19-like disease during the previous year.
• 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 in-active 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.
• Condoms (male or female) with spermicide (if acceptable in country)
• Diaphragm with spermicide
• Cervical cap with spermicide
• Intrauterine device
• Oral or patch contraceptives
• Norplant®, Depo-Provera®, or other in country regulatory approved contraceptive method that is designed to protect against pregnancy.
• Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle NOTE: Periodic abstinence (eg, calendar, ovulation, sympto-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
• Is medically stable, as determined by the investigator (based on review of health status, vital signs \[to include body temperature\], medical history, and physical examination \[to include body weight\]). Vital signs must be within medically acceptable ranges prior to study vaccination.
• Agrees to not participate in any research involving receipt of investigational products (drug/biologic/device) including other SARS-CoV-2 prevention or treatment trials for the duration of the study.
• NOTE: For participants who become hospitalized with COVID-19, participation in investigational treatment studies is permitted.

You may not qualify if:

• Received COVID-19 vaccines other than Moderna and/or Pfizer-BioNTech 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 (Day 0).
• Received influenza vaccination within 14 days prior to study vaccination, or any other vaccine within 30 days prior to study vaccination.
• Any known allergies to products contained in the investigational product.
• Any history of anaphylaxis to any prior vaccine.
• Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy.
• NOTE: Stable endocrine disorders (eg, thyroiditis, pancreatitis), including stable diabetes mellitus with no history of diabetic ketoacidosis are NOT excluded.
• Chronic administration (defined as \> 14 continuous days) of immunosuppressant, systemic glucocorti-coids, or other immune-modifying drugs within 90 days prior to study vaccination (Day 0).
• 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 any prohibited medication (see Section 7.4.1), immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to study vaccination (Day 0).
• Active cancer (malignancy) on chemotherapy within 3 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo malign 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 study vaccination 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 (includ-ing 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).

Sponsors & Collaborators

• Novavax: lead

Study Sites (30)

AMR

Mobile, Alabama, 36608, United States

Location

Benchmark Research

Sacramento, California, 95864, United States

Location

Lynn Institute of the Rockies

Colorado Springs, Colorado, 80918, United States

Location

AMR LLC-Miami

Coral Gables, Florida, 33134, United States

Location

AMR

Fort Myers, Florida, 33912, United States

Location

Health Awareness,LLC

Jupiter, Florida, 33458, United States

Location

Tekton Research

Lawrenceville, Georgia, 30046, United States

Location

Alliance for Multispecialty RSCH

Newton, Kansas, 67114, United States

Location

Tekton Research

Wichita, Kansas, 67218, United States

Location

AMR New Orleans

New Orleans, Louisiana, 70119, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

AMR

Kansas City, Missouri, 64114, United States

Location

Sundance Clinical Research

St Louis, Missouri, 63141, United States

Location

Velocity Clinical Research

Norfolk, Nebraska, 68701, United States

Location

AMR

Las Vegas, Nevada, 89119, United States

Location

AXCES Research

Albuquerque, New Mexico, 87109, United States

Location

Rochester Clinical Research

Rochester, New York, 14609, United States

Location

Tekton Research

Yukon, Oklahoma, 73099, United States

Location

DM Clinical Research

Philadelphia, Pennsylvania, 19147, United States

Location

AMR

Knoxville, Tennessee, 37909, United States

Location

Benchmark Research

Austin, Texas, 78705, United States

Location

Tekton Research

Austin, Texas, 78745, United States

Location

Tekton Research

Beaumont, Texas, 77706, United States

Location

Pan American clinical Research,LLC

Brownsville, Texas, 78520, United States

Location

Benchmark Research

Fort Worth, Texas, 76135, United States

Location

Research For Your Health

Plano, Texas, 75093, United States

Location

Tekton Research

San Antonio, Texas, 78229, United States

Location

AMR Layton Research Centre

Layton, Utah, 84041, United States

Location

Health Research of Hampton Roads

Newport News, Virginia, 23606, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (2)

• Alves K, Kouassi A, Plested JS, Kalkeri R, Smith K, Kaba M, Nelson J, Zhu M, Cloney-Clark S, Cai Z, Mallory RM, Noriega F; 2019nCoV-313 Study Investigators. Immunogenicity and safety of a monovalent Omicron XBB.1.5 SARS-CoV-2 recombinant spike protein vaccine in previously unvaccinated, SARS-CoV-2 seropositive participants: Primary day-28 analysis of a phase 2/3 open-label study. Vaccine. 2025 May 10;55:127046. doi: 10.1016/j.vaccine.2025.127046. Epub 2025 Apr 2.

  PMID: 40184816 DERIVED

• Alves K, Kotloff K, McClelland RS, Kouassi A, Plested JS, Kalkeri R, Zhu M, Cloney-Clark S, Cai Z, Smith K, Kaba M, Nelson J, Hammershaimb EA, Mallory RM, Noriega F; 2019nCoV-313 Study Investigators. Immunogenicity and safety of a monovalent omicron XBB.1.5 SARS-CoV-2 recombinant spike protein vaccine as a heterologous booster dose in US adults: interim analysis of a single-arm phase 2/3 study. Lancet Infect Dis. 2025 May;25(5):585-594. doi: 10.1016/S1473-3099(24)00670-4. Epub 2025 Jan 14.

  PMID: 39824198 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Immunization, Secondary

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

Intervention Hierarchy (Ancestors)

Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Clinical Development

  Novavax, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 3, 2023
• Study Start: September 7, 2023
• Primary Completion: November 15, 2023
• Study Completion: May 20, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

US (30)