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

Last updated: December 9, 2024
Sponsor: Novavax
Overall Status: Completed

Phase

2/3

Condition

Covid-19

Treatment

Bivalent BA.4/5

NVX-CoV2601 (5μg)

NVX-CoV2601 (35μg)

Clinical Study ID

NCT05925127
2019nCoV-205
  • Ages 50-99
  • All Genders
  • Accepts Healthy Volunteers

Study 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]).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adults ≥ 50 years of age at screening.

  2. Willing and able to give informed consent prior to study enrollment and to complywith study procedures.

  3. Female participants of childbearing potential (defined as any participant who hasexperienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateraltubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea ≥ 12 consecutive months]) must agree to be heterosexually inactive from at least 28days prior to enrollment and through the end of the study OR agree to consistentlyuse a medically acceptable method of contraception listed below from ≥ 28 days priorto enrollment and through the end of the study.

  4. Is medically stable, as determined by the investigator (based on review of healthstatus, vital signs [to include body temperature], medical history, and targetedphysical examination [to include body weight]). Vital signs must be within medicallyacceptable ranges prior to the initial study vaccination.

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

  6. Have previously received ≥ 3 doses of a COVID-19 prototype or bivalent licensedmRNAvaccine with the last dose having been given ≥ 90 days previously prior to firststudy booster.

Exclusion

Exclusion Criteria:

  1. Received COVID-19 vaccines other than a COVID-19 prototype or bivalent licensed mRNAvaccine 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, orany other vaccine within 30 days prior to first study vaccination.

  4. Any known allergies to products contained in the investigational product. 5. Anyhistory of anaphylaxis to any prior vaccine.

  5. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital)requiring ongoing immunomodulatory therapy.

  6. Chronic administration (defined as > 14 continuous days) of immunosuppressant,systemic glucocorticoids, or other immune-modifying drugs within 90 days prior tostudy vaccination. NOTE: An immunosuppressant dose of glucocorticoid is defined as asystemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical orintranasal glucocorticoids is permitted. Topical tacrolimus and ocular cyclosporinare permitted. Use of inhaled glucocorticoids is prohibited.

  7. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to study vaccination, except for rabies immunoglobulin which may begiven if medically indicated.

  8. Active cancer (malignancy) on therapy within 3 years prior to study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigomaligna and uterine cervical carcinoma in situ without evidence of disease, at thediscretion of the investigator).

  9. Participants who are breastfeeding, pregnant, or who plan to become pregnant priorto the end of study.

  10. Suspected or known history of alcohol abuse or drug addiction within 2 years priorto the study vaccine dose that, in the opinion of the investigator, might interferewith protocol compliance.

  11. Any other condition that, in the opinion of the investigator, would pose a healthrisk to the participant if enrolled or could interfere with evaluation of the studyvaccine or interpretation of study results (including neurologic or psychiatricconditions likely to impair the quality of safety reporting).

  12. Study team member or immediate family member of any study team member (inclusive ofSponsor, contract research organization (CRO), and study site personnel involved inthe conduct or planning of the study).

  13. Participants with a history of myocarditis or pericarditis.

Study Design

Total Participants: 994
Treatment Group(s): 7
Primary Treatment: Bivalent BA.4/5
Phase: 2/3
Study Start date:
October 16, 2023
Estimated Completion Date:
May 21, 2024

Study 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.

Connect with a study center

  • ARS-Birmingham CRU

    Birmingham, Alabama 35216
    United States

    Site Not Available

  • Tucson Neuroscience Research

    Tucson, Arizona 85710
    United States

    Site Not Available

  • Velocity Clinical Research, Banning

    Banning, California 99202
    United States

    Site Not Available

  • Velocity Clinical Research, Chula Vista

    Chula Vista, California 91911
    United States

    Site Not Available

  • Velocity Clinical Research, San Diego

    La Mesa, California 91942
    United States

    Site Not Available

  • Artemis Institute for Clinical Research

    Riverside, California 92503
    United States

    Site Not Available

  • Artemis - San Diego

    San Diego, California 92103
    United States

    Site Not Available

  • WR-MCCR

    San Diego, California 92120
    United States

    Site Not Available

  • Deland CRU

    DeLand, Florida 32720
    United States

    Site Not Available

  • Health Awareness

    Jupiter, Florida 33458
    United States

    Site Not Available

  • Wr-Msra, Llc

    Lake City, Florida 32055
    United States

    Site Not Available

  • Professional Urgent Care Services

    Largo, Florida 33777
    United States

    Site Not Available

  • Health Awareness

    Miami, Florida 33458
    United States

    Site Not Available

  • Research Institute of South Florida

    Miami, Florida 33173
    United States

    Site Not Available

  • Suncoast Research Associates, LLC

    Miami, Florida 33173
    United States

    Site Not Available

  • Headlands Research Orlando LLC

    Orlando, Florida 32819
    United States

    Site Not Available

  • Precision Clinical Research, LLC

    Sunrise, Florida 33351
    United States

    Site Not Available

  • TrueBlue Clinical Research

    Tampa, Florida 33609
    United States

    Site Not Available

  • Neurostudies CRU

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Velocity Clinical Research

    Savannah, Georgia 31406
    United States

    Site Not Available

  • CRA Headlands LLC

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Velocity Clinical Research

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Velocity Clinical Research

    Sioux City, Iowa 51106
    United States

    Site Not Available

  • Velocity Clinical Research

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Velocity Clinical Research - Covington

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Velocity Clinical Research, Metairie

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Activmed Practices and Research, LLC

    Methuen, Massachusetts 01844
    United States

    Site Not Available

  • Velocity Clinical Research, Gulfport

    Gulfport, Mississippi 39503
    United States

    Site Not Available

  • Velocity Clinical Research

    Grand Island, Nebraska 68803
    United States

    Site Not Available

  • Velocity Clinical Research

    Norfolk, Nebraska 68701
    United States

    Site Not Available

  • Velocity Clinical Research

    Omaha, Nebraska 68134
    United States

    Site Not Available

  • Activmed Practices and Research, LLC

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Velocity Clinical Research

    Binghamton, New York 13905
    United States

    Site Not Available

  • Hypercore (Lucas Research)

    New Bern, North Carolina 28562
    United States

    Site Not Available

  • M3 Wake Research Inc

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Trial Management Associates, LLC

    Wilmington, North Carolina 28403
    United States

    Site Not Available

  • Javara Inc./Wake Forest Health Network, LLC

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Velocity Clinical Research

    Cincinnati, Ohio 45246
    United States

    Site Not Available

  • Tekton Research

    Edmond, Oklahoma 73013
    United States

    Site Not Available

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Velocity Clinical Research, Grants Pass

    Grants Pass, Oregon 97527
    United States

    Site Not Available

  • Velocity Clinical Research, Providence

    East Greenwich, Rhode Island 02818
    United States

    Site Not Available

  • Velocity Clinical Research, Gaffney

    Gaffney, South Carolina 29340
    United States

    Site Not Available

  • Coastal Carolina Research Center an ALCANZA Clinical Research company

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Central Texas Clinical Research, LLC

    Austin, Texas 78705
    United States

    Site Not Available

  • Research Your Health

    Plano, Texas 75093
    United States

    Site Not Available

  • Benchmark Research

    San Angelo, Texas 76904
    United States

    Site Not Available

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah 84088
    United States

    Site Not Available

  • Health Research of Hampton Roads, Inc

    Newport News, Virginia 23606
    United States

    Site Not Available

  • Clinical Research Partners

    Richmond, Virginia 23226
    United States

    Site Not Available

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