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COVID-19Phase 4COVID-19NCT07086222

Efficacy and Safety of NVX-CoV2705

A Phase 4 study testing NVX-CoV2705 in people with COVID-19 and Sars-CoV-2 Infection, run by Novavax at 99 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a Phase 4, post-market US study, evaluating the efficacy and safety of a single dose of the NVX-CoV2705 Omicron JN.1 COVID-19 vaccine. Approximately 6,500 healthy adults aged 50 to under 65 will be randomized to receive either the vaccine or a placebo, with follow-up for 180 days. Read more about this study

Who is it for?
Ages 50 to 65 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19, Sars-CoV-2 Infection
What is being tested?
NVX-CoV2705
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6,500 participants
Where
99 sitesUnited States
Study dates
20 Nov 2025to 9 Oct 2026
Phase
Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • To be included in this study, each individual must satisfy all of the following criteria:
  • Adults 50 to < 65 years of age at time of study vaccination (Day 0) who are not considered to be at high risk of severe COVID-19.
  • Participants unvaccinated to SARS-CoV-2 or participants previously vaccinated with a COVID-19 vaccine ≥ 90 days prior to study vaccination.
  • Participant or legally acceptable representative is 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 90 days after vaccination OR agree to consistently use a medically acceptable method of contraception listed below from ≥ 28 days prior to enrollment and through 90 days after vaccination.
  • Condoms (male or female) with spermicide (if acceptable in country)
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  • 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.
  • Agrees not to 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.

Who cannot join

  • If an individual meets any of the following criteria, he or she is ineligible for this study:
  • Is considered to be at high risk of severe COVID-19 due to underlying medical conditions or risk factors that demonstrated a conclusive increase in risk for at least one severe COVID-19 outcome, as described by the Centers for Disease Control and Prevention (CDC) .
  • Unstable acute illness at the time of vaccination.
  • Participation at the time of study enrollment or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
  • Current participation in any other COVID-19 prevention clinical trial.
  • Known history of COVID-19 infection within 90 days of study vaccination.
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  • Any known history of allergies to products contained in the investigational product in the participant's lifetime.
  • Any known history of anaphylaxis to any prior vaccine in the participant's lifetime.
  • Known history of myocarditis or pericarditis in the participant's lifetime.
  • Chronic administration (defined as > 14 continuous days) of immunosuppressant, systemic glucocorticoids, 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, inhaled, or intranasal glucocorticoids is permitted. Topical tacrolimus and ocular cyclosporin are permitted.
  • Received immunoglobulin or blood-derived products within 90 days prior to study vaccination (Day 0).
  • Participants who are pregnant, or who plan to become pregnant within 90 days following study vaccination.
  • 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, clinical research organization [CRO], and study site personnel involved in the conduct or planning of the study).

Trial locations and contacts

99 sites in 1 country.

99 sites in 1 country

United States99 sites

  • IMA Clinical Research - Albuquerque

    Albuquerque, New Mexico, 87109

  • North Alabama Research Center

    Athens, Alabama, 35611

  • CenExel Atlanta GA

    Atlanta, Georgia, 30331

  • Lynn Institute of Denver

    Aurora, Colorado, 80012

  • Avacare

    Austin, Texas, 78705

  • TrialMed - Austin

    Austin, Texas, 78744

  • Howland Allergy & Asthma PLLC dba Orion Clinical Research

    Austin, Texas, 78759

  • Velocity Clinical Research - Binghampton

    Binghamton, New York, 13905

  • TrialMed - Birmingham

    Birmingham, Alabama, 35211

  • Accellacare of Bristol

    Bristol, Tennessee, 37620

  • Rochester Clinical Research

    Buffalo, New York, 14217

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania, 17011

  • DelRicht Research @ Newton Family Medicine

    Charleston, South Carolina, 29407

  • Charlottesville Medical Research Center, LLC

    Charlottesville, Virginia, 22911

  • WR Clinsearch, LLC

    Chattanooga, Tennessee, 37421

  • Centricity Research

    Columbus, Georgia, 31904

  • Hawthorne Health - Concord

    Concord, North Carolina, 28025

  • Zenos Clinical Research

    Dallas, Texas, 75230

  • DSI Research - Northridge

    Dayton, Ohio, 45414

  • K2 Medical Research - East Providence

    East Providence, Rhode Island, 02914

  • TrialMed

    Evansville, Indiana, 47714

  • Profound Research LLC at Millennium Affiliated Physicians

    Farmington Hills, Michigan, 48334

  • Piedmont Research Partners

    Fort Mill, South Carolina, 29707

  • Avacare

    Fort Worth, Texas, 76135

  • Hawthorne Health - Gadsden

    Gadsden, Alabama, 35901

  • SIMED Health, LLC / SIMED Research

    Gainesville, Florida, 32607

  • DelRicht Research at Gulfport Memorial

    Gulfport, Mississippi, 39503

  • Indago Research and Health Center, Inc.

    Hialeah, Florida, 33012

  • Hawthorne Health - Horsham

    Horsham, Pennsylvania, 19044

  • TrialdMed - Huntsville

    Huntsville, Alabama, 35802

  • 310 Clinical Research

    Inglewood, California, 90301

  • Health Awareness, LLC

    Jupiter, Florida, 33458

  • AMR Kansas City

    Kansas City, Missouri, 64114

  • Summit-Halls Family Practice

    Knoxville, Tennessee, 37938

  • Velocity Clinical Research - San Diego

    La Mesa, California, 91942

  • Excel Clinical Research

    Las Vegas, Nevada, 89109

  • TrialMed - Las Vegas

    Las Vegas, Nevada, 89113

  • AMR Clinical - Las Vegas

    Las Vegas, Nevada, 89119

  • Hawthorne Health - Lebanon

    Lebanon, Tennessee, 37087

  • Alliance for Multispecialty Research, L.L.C.

    Lexington, Kentucky, 40509

  • Velocity Clinical Research, Lincoln

    Lincoln, Nebraska, 68510

  • Hawthorne Health - Lindenwold

    Lindenwold, New Jersey, 08021

  • Accellacare of Duly

    Lombard, Illinois, 60148

  • Velocity Clinical Research, Medford

    Medford, Oregon, 97504

  • TrialMed - Melbourne

    Melbourne, Florida, 32934

  • Velocity Clinical Research, Boise

    Meridian, Idaho, 83642

  • SMS Clinical Research LLC

    Mesquite, Texas, 75149

  • Acevedo Clinical Research Associates

    Miami, Florida, 33142

  • Research Institute Of South Florida, Inc.

    Miami, Florida, 33173

  • Clinical Research Consulting, LLC

    Milford, Connecticut, 06460

  • Clinical Research Institute, Inc

    Minneapolis, Minnesota, 55402

  • Boeson Research

    Missoula, Montana, 59804

  • AMR Mobile

    Mobile, Alabama, 36608

  • Monroe Pharmaceutical Research

    Monroe, North Carolina, 28112

  • International Clinical Research - Tennessee

    Murfreesboro, Tennessee, 37130

  • Trial Management Associates (TMA ) Headlands LLC

    Myrtle Beach, South Carolina, 29572

  • DelRicht Research @ Touro Medical Center

    New Orleans, Louisiana, 70115

  • Health Research of Hampton Roads, Inc

    Newport News, Virginia, 23606

  • Velocity Clinical Research

    Norfolk, Nebraska, 68701

  • Lynn Institute of Norman

    Norman, Oklahoma, 73072

  • Accellacare Duly Health and Care

    Oak Lawn, Illinois, 60453

  • Profound Research LLC at Seaside Medical Group

    Oceanside, California, 92058

  • Lynn Health Institute - OKC

    Oklahoma City, Oklahoma, 73112

  • Velocity Clinical Research, Omaha

    Omaha, Nebraska, 68134

  • DelRicht Research @ Concierge and Direct Primary Care

    Overland Park, Kansas, 66209

  • ACRC Trials

    Plano, Texas, 75093

  • Research Your Health

    Plano, Texas, 75093

  • Boeson Research - Utah

    Provo, Utah, 84604

  • Rochester Clinical Research, LLC

    Rochester, New York, 14609

  • DelRicht Research @ Matthew Mintz Clinic

    Rockville, Maryland, 20852

  • Accellacare of Rocky Mount

    Rocky Mount, North Carolina, 27804

  • Accellacare Research of Salisbury

    Salisbury, North Carolina, 28144

  • University of Utah

    Salt Lake City, Utah, 84108

  • J. Lewis Research, Inc. / Foothill Family Clinic

    Salt Lake City, Utah, 84109

  • Flourish San Antonio - Clinical

    San Antonio, Texas, 78229

  • TrialMed - San Antonio

    San Antonio, Texas, 78229

  • California Research Foundation

    San Diego, California, 92123

  • Headlands Research Scottsdale

    Scottsdale, Arizona, 85260

  • Velocity Clinical Research, Seattle

    Seattle, Washington, 98105

  • Velocity Clinical Research, Sioux City

    Sioux City, Iowa, 51106

  • Great Lakes Research Institute, LLC

    Southfield, Michigan, 48075

  • Sundance Clinical Research

    St Louis, Missouri, 63141

  • Hawthorne Health - Staten

    Staten Island, New York, 10309

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • Sugar Lakes Family Practice, P.A.

    Sugar Land, Texas, 77479

  • MOORE Clinical Research

    Tampa, Florida, 33609

  • TrialMed - The Villages

    The Villages, Florida, 32162

  • Orange Grove Family Practice

    Tucson, Arizona, 85741

  • DelRicht Research @ Grassroots Healthcare

    Tulsa, Oklahoma, 74133

  • Bayview Research Group, LLC

    Valley Village, California, 91607

  • Velocity Clinical Research, Valparaiso

    Valparaiso, Indiana, 46383

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • Suburban Research Associates - West Chester Office

    West Chester, Pennsylvania, 19380

  • Integrated Clinical Trial Services

    West Des Moines, Iowa, 50265

  • Alliance Clinical - West Hills

    West Hills, California, 91303

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Paradigm Clinical Research Centers, LLC

    Wheat Ridge, Colorado, 80033

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas, 67207

  • Accellacare Research of Winston Salem

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Post-Marketing Study to Evaluate the Efficacy and Safety of an Omicron JN.1 Subvariant SARS-CoV-2 rS Vaccine Adjuvanted With Matrix-M® in Adults 50 to < 65 Years of Age Without High Risk Conditions for Severe COVID-19

This is a Phase 4, post-market US study, evaluating the efficacy and safety of a single dose of the NVX-CoV2705 Omicron JN.1 COVID-19 vaccine. Approximately 6,500 healthy adults aged 50 to under 65 will be randomized to receive either the vaccine or a placebo, with follow-up for 180 days.

Read the detailed description

This is a Phase 4, multicenter, randomized, double-blind, placebo-controlled, post-marketing study to evaluate the efficacy and safety of a single dose of an Omicron JN.1 subvariant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccine (SARS-CoV-2 rS) adjuvanted with Matrix-M (NVX-CoV2705) in adults 50 to < 65 years of age who are not considered to be at high risk of severe coronavirus disease 2019 (COVID-19). This study will be conducted in the United States (US).

Approximately 6,500 participants will be randomized in a 1:1 ratio via block randomization to receive a single intramuscular (IM) injection of NVX-CoV2705 or placebo (normal saline) on Day 0 and remain on study for efficacy and safety data collection through Day 180/end of study (EoS).

Being tested
NVX-CoV2705, Placebo
Keywords
COVID-19
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NVX-CoV2705Biological

    Also called Omicron JN.1 subvariant SARS-CoV-2 rS vaccine adjuvanted with Matrix-M

    NVX-CoV2705 vaccine in a 0.5 mL injection volume at an antigenic dose of 5 µg with 50 µg Matrix-M adjuvant

  • PlaceboBiological

    Placebo (normal saline) in a 0.5 mL injection volume.

Study groups in NCT07086222
Study groupRoleWhat they receive
NVX-CoV2705Experimentala single intramuscular (IM) injection of NVX-CoV2705 on Day 0
Receives: Biological: NVX-CoV2705
PlaceboPlacebo comparatora single intramuscular (IM) injection of placebo (normal saline) on Day 0
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. First episode of PCR-positive symptomatic COVID 19

    First episode of PCR-positive symptomatic COVID 19 from Day 0 (post vaccination) through Day 180/EoS

    Measured: Day 0 to Day 180

Secondary outcomes (2)

  1. First episode of PCR-positive symptomatic COVID 19

    First episode of PCR-positive symptomatic COVID 19 after completion of the injection through Day 180/EoS

    Measured: Day 42 to Day 180

  2. Participants with Medically attended adverse events (MAAEs), Serious adverse event (SAEs) and Adverse event of special interest (AESIs)

    Number of participants reported MAAEs attributable to study vaccine, SAEs, or AESIs through Day 180/EoS.

    Measured: Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2025
  2. Study start20 Nov 2025
  3. Primary completion9 Oct 2026
  4. Study completion9 Oct 2026

Why it stopped: The study was terminated early due to low COVID-19 incidence and high population immunity, limiting meaningful vaccine efficacy assessment. The decision was made in consultation with FDA/CBER and was unrelated to safety concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
6,500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07086222
Sponsor's protocol ID
2019nCoV-420
Acronym
COVID-19
Status last verified
Oct 2026
First submitted
17 Jul 2025
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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