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NCT05925127 | COMPLETED | COVID-19

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

Novavax

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 \[Omicron XBB.1.5 subvariant vaccine with Matrix-M adjuvant\]).

Condition or disease

COVID-19

Intervention/treatment

NVX-CoV2373 (5μg)

NVX-CoV2601 (5μg)

NVX-CoV2601(5μg)

NVX-CoV2601 (35μg)

NVX-CoV2601(35μg)

NVX-CoV2601(50μg)

Bivalent BA.4/5

Phase

PHASE2

PHASE3

Detailed Description:

The ongoing COVID-19 pandemic has reached a stage where it is necessary to stablish the framework for periodic national vaccination campaigns.The present study aims to investigate the safety and immunogenicity of different booster dose levels of monovalent and bivalent vaccines in adults ≥ 50 years of age who have already been immunized with ≥ 3 doses of a COVID-19 prototype or bivalent licensed mRNA vaccine. The Boosters of investigational products will be administered ≥ 90 days after the participants received their third dose of a COVID-19 prototype or bivalent licensed mRNA vaccine. Approximately 1,980 participants ≥ 50 years of age who have received a regimen of ≥ 3 doses of a coronavirus disease 2019(COVID-19) vaccine (the last vaccine could have been a bivalent licensed mRNA vaccine) will be included in this study. The last COVID-19 vaccine dose should have been administered ≥ 90 days prior to Day 0. Approximately 1,800 participants will be randomly assigned in a 1:2:2:2:2:1 ratio to receive NVX-CoV2373 or NVC-CoV2601 in a double-blinded fashion into 1 of 6 monovalent vaccine groups (vaccine groups A to G). Following completion of enrollment into the 6 monovalent vaccine groups, 180 participants will be enrolled in vaccine group G to receive a bivalent licensed mRNA vaccine in an open-label fashion.

Study Type : INTERVENTIONAL
Estimated Enrollment : 994 participants
Masking : DOUBLE
Primary Purpose : PREVENTION
Official Title : A Phase 2/3, Randomized, Double-Blind Study to Evaluate the Safety and Immunogenicity of Different Booster Dose Levels of Monovalent SARS-CoV-2 rS Vaccines in Adults ≥ 50 Years Previously Vaccinated With COVID-19 mRNA Vaccines
Actual Study Start Date : 2023-10-16
Estimated Primary Completion Date : 2024-05-21
Estimated Study Completion Date : 2024-05-21

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • 1. Adults ≥ 50 years of age at screening.
  • 2. Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
  • 3. 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.
  • 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 initial study vaccination.
  • 5. Agrees to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.
  • 6. 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.
Exclusion Criteria
  • 1. 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.
  • 2. Participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to study vaccination.
  • 3. Received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine within 30 days prior to first study vaccination.
  • 4. Any known allergies to products contained in the investigational product. 5. Any history of anaphylaxis to any prior vaccine.
  • 6. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy.
  • 7. 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.
  • 8. 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.
  • 9. 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).
  • 10. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study.
  • 11. 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.
  • 12. 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).
  • 13. 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).
  • 14. Participants with a history of myocarditis or pericarditis.
Phase 2/3 Heterologous Boosting Study With Different Dose Levels of Monovalent SARS-CoV-2 rS Vaccines

Location Details

NCT05925127

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Albama

ARS-Birmingham CRU

Birmingham, Albama, United States, 35216

Not yet recruiting

United States, Arizona

Tucson Neuroscience Research

Tucson, Arizona, United States, 85710

Not yet recruiting

United States, California

Velocity Clinical Research, Banning

Banning, California, United States, 99202

Not yet recruiting

United States, California

Velocity Clinical Research, Chula Vista

Chula Vista, California, United States, 91911

Not yet recruiting

United States, California

Velocity Clinical Research, San Diego

The table, California, United States, 91942

Not yet recruiting

United States, California

Artemis Institute for Clinical Research

Riverside, California, United States, 92503

Not yet recruiting

United States, California

Artemis - San Diego

San Diego, California, United States, 92103

Not yet recruiting

United States, California

WR-MCCR

San Diego, California, United States, 92120

Not yet recruiting

United States, Florida

Deland CRU

DeLand, Florida, United States, 32720

Not yet recruiting

United States, Florida

Health Awareness

Jupiter, Florida, United States, 33458

Not yet recruiting

United States, Florida

Wr-Msra, Llc

Lake City, Florida, United States, 32055

Not yet recruiting

United States, Florida

Professional Urgent Care Services

Largo, Florida, United States, 33777

Not yet recruiting

United States, Florida

Research Institute of South Florida

Miami, Florida, United States, 33173

Not yet recruiting

United States, Florida

Suncoast Research Associates, LLC

Miami, Florida, United States, 33173

Not yet recruiting

United States, Florida

Headlands Research Orlando LLC

Orlando, Florida, United States, 32819

Not yet recruiting

United States, Florida

Precision Clinical Research, LLC

Sunrise, Florida, United States, 33351

Not yet recruiting

United States, Florida

TrueBlue Clinical Research

Tampa, Florida, United States, 33609

Not yet recruiting

United States, Georgia

Neurostudies CRU

Decatur, Georgia, United States, 30030

Not yet recruiting

United States, Georgia

Velocity Clinical Research

Savannah, Georgia, United States, 31406

Not yet recruiting

United States, Georgia

CRA Headlands LLC

Stockbridge, Georgia, United States, 30281

Not yet recruiting

United States, Idaho

Velocity Clinical Research

Meridian, Idaho, United States, 83642

Not yet recruiting

United States, Iowa

Velocity Clinical Research

Sioux City, Iowa, United States, 51106

Not yet recruiting

United States, Louisiana

Velocity Clinical Research

Baton Rouge, Louisiana, United States, 70809

Not yet recruiting

United States, Louisiana

Velocity Clinical Research - Covington

Covington, Louisiana, United States, 70433

Not yet recruiting

United States, Louisiana

Velocity Clinical Research, Metairie

Metairie, Louisiana, United States, 70006

Not yet recruiting

United States, Massachusetts

Activmed Practices and Research, LLC

Methuen, Massachusetts, United States, 01844

Not yet recruiting

United States, Mississippi

Velocity Clinical Research, Gulfport

Gulfport, Mississippi, United States, 39503

Not yet recruiting

United States, Nebraska

Velocity Clinical Research

Grand Island, Nebraska, United States, 68803

Not yet recruiting

United States, Nebraska

Velocity Clinical Research

Norfolk, Nebraska, United States, 68701

Not yet recruiting

United States, Nebraska

Velocity Clinical Research

Omaha, Nebraska, United States, 68134

Not yet recruiting

United States, New Hampshire

Activmed Practices and Research, LLC

Portsmouth, New Hampshire, United States, 03801

Not yet recruiting

United States, New York

Velocity Clinical Research

Binghamton, New York, United States, 13905

Not yet recruiting

United States, North Carolina

Hypercore (Lucas Research)

New Bern, North Carolina, United States, 28562

Not yet recruiting

United States, North Carolina

M3 Wake Research Inc

Raleigh, North Carolina, United States, 27612

Not yet recruiting

United States, North Carolina

Trial Management Associates, LLC

Wilmington, North Carolina, United States, 28403

Not yet recruiting

United States, North Carolina

Javara Inc./Wake Forest Health Network, LLC

Winston-Salem, North Carolina, United States, 27157

Not yet recruiting

United States, Ohio

Velocity Clinical Research

Cincinnati, Ohio, United States, 45219

Not yet recruiting

United States, Ohio

Velocity Clinical Research

Cincinnati, Ohio, United States, 45246

Not yet recruiting

United States, Oklahola

Tekton Research

Edmond, Okholohan, United States, 73013

Not yet recruiting

United States, Oklahola

Lynn Health Science Institute

Ololama City, Okholohan, United States, 73112

Not yet recruiting

United States, Oregon

Velocity Clinical Research, Grants Pass

Grants Pass, Oregon, United States, 97527

Not yet recruiting

United States, Rhode Island

Velocity Clinical Research, Providence

East Greenwich, Rhode Island, United States, 02818

Not yet recruiting

United States, South Carolina

Velocity Clinical Research, Gaffney

Gaffney, South Carolina, United States, 29340

Not yet recruiting

United States, South Carolina

Coastal Carolina Research Center an ALCANZA Clinical Research company

North Charleston, South Carolina, United States, 29405

Not yet recruiting

United States, Texas

Central Texas Clinical Research, LLC

Austin, Texas, United States, 78705

Not yet recruiting

United States, Texas

Research Your Health

Plano, Texas, United States, 75093

Not yet recruiting

United States, Texas

Benchmark Research

San Angelo, Texas, United States, 76904

Not yet recruiting

United States, Utah

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, United States, 84088

Not yet recruiting

United States, Virginia

Health Research of Hampton Roads, Inc

Newport News, Virginia, United States, 23606

Not yet recruiting

United States, Virginia

Clinical Research Partners

Richmond, Virginia, United States, 23226