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COVID-19 DiseasePhase 3NCT05329220

ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2

A Phase 3 study testing ABNCoV2 and Comirnaty in people with COVID-19 Disease, run by Bavarian Nordic at 57 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This trial is composed of a randomized, double-blind, active controlled component (Part A) and an open-label, single-arm component (Part B) conducted in parallel. Part A is designed to compare vaccination with a single 100 µg dose of ABNCoV2 to a single 30 µg adult booster dose of Comirnaty (active control) in adult… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19 Disease
What is being tested?
ABNCoV2 and Comirnaty
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,205 participants
Where
57 sitesin 3 countries
Study dates
30 Aug 2022to 5 Oct 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years at screening.
  • Documented, previous completion of a primary vaccination regimen with locally authorized SARS-CoV-2 vaccine(s) or completion of primary plus 1 boost vaccination, with last vaccination at least 3 months before screening. "Locally authorized" SARS-CoV-2 vaccines are those that have received market approval or emergency use authorization in the country of enrollment.
  • Absence of acute medical illness, significant physical exam findings, or laboratory abnormalities, as determined by the investigator.
  • Informed consent, provided by the subject prior to performance of any trial-specific procedures; the subject has read, signed, and dated an informed consent form (ICF), having been advised of the risks and benefits of the trial in a language understood by the subject.
  • Body mass index (BMI) ≥18.5 and <40.
  • For female subjects of childbearing potential (WOCBP) and male subjects who are sexually active with a WOCBP, agreement to use an effective method of birth control from at least 30 days prior to administration of the vaccine until 30 days after the vaccination. A woman is considered of childbearing potential unless post-menopausal (defined as ≥12 months without a menstrual period at screening) or surgically sterilized (bilateral oophorectomy, bilateral tubal ligation, hysterectomy). Acceptable contraception methods are restricted to abstinence (only acceptable if refraining from heterosexual intercourse during the period of 30 days prior to administration of the vaccine until 30 days after the vaccination), double barrier contraceptives, vasectomy, intrauterine contraceptive devices, or licensed hormonal products.
  • For WOCBP, a negative serum pregnancy test at screening.
  • Negative tests for human immunodeficiency virus antibody (anti HIV), hepatitis B surface antigen (HBsAG), and antibody to hepatitis C virus (HCV).

Who cannot join

  • History of COVID 19 infection within the last 3 months before screening.
  • Previous vaccination with a SARS-CoV-2 vaccine other than those mentioned in inclusion criterion #2.
  • Positive test for SARS-CoV-2 infection at screening.
  • Breastfeeding with intent to continue.
  • Acute or chronic medical condition that, in the opinion of the investigator, would render the trial procedures unsafe or would interfere with the evaluation of the responses.
  • History of myocarditis or pericarditis.
Show all 23Show fewer
  • History of or active autoimmune disease. History of Guillain-Barré syndrome or Reye's syndrome. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
  • Known or suspected impairment of immunologic functions including, but not limited to, known immunodeficiency syndrome.
  • History of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision at least 6 months prior to screening that is considered to have achieved cure. Subjects with history of skin cancer must not be vaccinated at the previous tumor site.
  • Laboratory parameters (such as complete blood count, serum biochemistry including aspartate aminotransferase [AST], alanine amino transferase [ALT], alkaline phosphokinase [ALP], bilirubin, or creatinine values), pulse rate, or blood pressure outside normal range at screening and deemed clinically relevant by the investigator.
  • Clinically significant mental disorder not adequately controlled by medical treatment.
  • Active or recent history (within 6 months before screening) of chronic alcohol abuse, or illicit drug abuse.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • History of anaphylaxis or severe allergic reaction to any vaccine.
  • History of any vaccinations or plan to receive any vaccinations with a live vaccine within 30 days prior to or after trial vaccination.
  • History of any vaccinations or plan to receive any vaccinations with a non-live vaccine within 14 days prior to or after trial vaccination.
  • Recent blood donation (including platelets, plasma and red blood cells) within 4 weeks prior to screening, or planned blood donations during the active phase of the trial.
  • Chronic systemic administration (defined as more than 14 days) of >5 mg prednisone (or equivalent)/day, or any other immune-modifying drugs during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after vaccination. The use of topical, inhaled, ophthalmic and nasal glucocorticoids is allowed.
  • History of organ transplantation, whether or not accompanied by chronic immunosuppressive therapy.
  • Administration or planned administration of immunoglobulins and/or any blood products during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after vaccination. Receipt of packed red blood cells given for an emergency indication in an otherwise healthy person, and not required as ongoing treatment is not exclusionary (for example packed red blood cells given in emergency during an elective surgery).
  • Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the administration of trial vaccine, or planned administration of such a drug or vaccine throughout the trial.
  • Involvement in this trial as site personnel.
  • Known bleeding disorder that, in the opinion of the investigator, would contraindicate intramuscular injection.

Trial locations and contacts

57 sites in 3 countries.

57 sites in 3 countries

United States44 sites

  • Atlanta Center for Medical Research - CenExel ACMR

    Atlanta, Georgia, 30331

  • Tekton Research

    Austin, Texas, 78745

  • Tekton Research

    Beaumont, Texas, 77706

  • Meridian Clinical Research

    Binghamton, New York, 13901

  • Achieve Clinical Research LLC d/b/a Accel Research Sites

    Birmingham, Alabama, 35216

  • Tekton Research

    Chamblee, Georgia, 30341

  • ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • Meridian Clinical Research, LLC

    Cincinnati, Ohio, 45219

  • Columbus Regional Research Institute at Talbotton

    Columbus, Georgia, 31904

  • Global Medical Research

    Dallas, Texas, 75224

  • Accel Research Site - NeuroStudies.net, LLC

    Decatur, Georgia, 30030

  • Emerging Medical Research, LLC

    Durham, North Carolina, 27704

  • Tekton Research

    Edmond, Oklahoma, 73013

  • AES - DRS - Synexus Clinical Research US, Inc.

    Evansville, Indiana, 47714

  • Carolina Institute for Clinical Research

    Fayetteville, North Carolina, 28303

  • Tekton Research

    Fort Collins, Colorado, 80525

  • Ventavia Research Group

    Fort Worth, Texas, 76104

  • CBH Health - CenExel CBH

    Gaithersburg, Maryland, 20877

  • Meridian Clinical Research , LLC

    Grand Island, Nebraska, 68803

  • Ventavia Research Group

    Houston, Texas, 77008

  • Clinical Site Partners

    Leesburg, Florida, 34748

  • Meridian Clinical Research LLC

    Lincoln, Nebraska, 68510

  • Wr-Pri, Llc

    Los Alamitos, California, 90720

  • Accel Research Sites

    Maitland, Florida, 32751

  • Arizona Clinical Trials

    Mesa, Arizona, 85210

  • Suncoast Research Group LLC

    Miami, Florida, 33135

  • Suncoast Research Associates LLC

    Miami, Florida, 33173

  • Clinical Site Partners

    Miami, Florida, 33186

  • PRI, LLC - Newport Beach - M3 WR

    Newport Beach, California, 92660

  • Quality Clinical Research, Inc.

    Omaha, Nebraska, 68114

  • Meridian Clinical Research

    Omaha, Nebraska, 68134

  • FOMAT Medical Research

    Oxnard, California, 93030

  • Meridian Clinical Research - Family Practice

    Portsmouth, Virginia, 23703

  • M3 Wake Research, Inc

    Raleigh, North Carolina, 27612

  • Women's Healthcare Research Corporation

    San Diego, California, 92111

  • Medical Center For Clinical Research

    San Diego, California, 92120

  • Mount Vernon Clinical Research, LLC

    Sandy Springs, Georgia, 30328

  • Meridian Clinical Research, LLC

    Savannah, Georgia, 31406

  • Meridian Clinical Research

    Sioux City, Iowa, 51106

  • Sundance Clinical Research

    St Louis, Missouri, 63141

  • DM Clinical Research

    Sugar Land, Texas, 77478

  • TrueBlue Clinical Research

    Tampa, Florida, 33609

  • Tucson Neuroscience Research - M3 WR

    Tucson, Arizona, 85710

  • Clinical Site Partners

    Winter Park, Florida, 32789

Other trials in United States

Denmark8 sites

  • Aalborg Universitetshospital

    Aalborg, 9000

  • Aarhus Universitetshospital

    Aarhus, 8200

  • Bispebjerg Hospital, Afdeling for Lunge- og Infektionssygdomme

    Copenhagen, 2400

  • Regionshospitalet Gødstrup, Medicinsk afdeling, Klinik for Infektionssygdomme

    Herning, 7400

  • Nordsjællands Hospital, Hillerød, Lunge- og Infektionsmedicinsk Afdeling

    Hillerød, 3400

  • Hvidovre Hospital, Infektionsmedicinsk afd.

    Hvidovre, 2650

  • Odense Universitetshospital, Q, Infektionsmedicinsk Afdeling

    Odense, 5000

  • Sjællands Universitetshospital

    Roskilde, 4000

Other trials in Denmark

Belgium5 sites

  • Instituut voor Tropische Geneeskunde

    Antwerp, 2000

  • Centrum voor de evaluatie van vaccinaties

    Edegem, 2650

  • Private Practice Dr Jean Benoit Martinot

    Erpent, 5101

  • Centrum voor vaccinologie (CEVAC)

    Ghent, 9000

  • Office of Marc De Meulemeester

    Gozée, 6534

Other trials in Belgium

About this study

Official title: Evaluation of the Immunogenicity, Safety, and Tolerability of a Single Dose of ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2: a Phase 3 Trial in Two Parts

This trial is composed of a randomized, double-blind, active controlled component (Part A) and an open-label, single-arm component (Part B) conducted in parallel.

Part A is designed to compare vaccination with a single 100 µg dose of ABNCoV2 to a single 30 µg adult booster dose of Comirnaty (active control) in adult subjects who either previously completed primary vaccination (Cohort 1) or have already received 1 booster dose (Cohort 2) of SARS-CoV-2 locally authorized vaccine(s), and whose last locally authorized SARS-CoV-2 vaccination was at least 3 months prior to the screening visit. Subjects will be randomized in a 1:1 ratio to receive either ABNCoV2 or Comirnaty.

Part B is designed to collect ABNCoV2 safety and tolerability data from a larger population of adult subjects, as well as additional immunogenicity data from a subset. Part B involves vaccination with the same single 100 µg dose of ABNCoV2 in the same population of adult subjects as the randomized component, and subjects will similarly be enrolled into 2 cohorts according to whether they have completed primary vaccination only or primary plus booster vaccination.

Being tested
ABNCoV2, Comirnaty

What participants receive

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

  • ABNCoV2Biological

    ABNCoV2 100μg single dose

  • ComirnatyBiological

    Comirnaty

Study groups in NCT05329220
Study groupRoleWhat they receive
ABNCoV2 100μg single doseExperimentalABNCoV2 100μg single dose
Receives: Biological: ABNCoV2
ComirnatyActive comparatorComirnaty
Receives: Biological: Comirnaty

What is being measured

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

  1. Neutralizing Antibody Titers Against the SARS-CoV-2 Index Virus (Wuhan Wild Type Isolate) at 2 Weeks After Trial Vaccination

    The primary endpoint was SARS-CoV-2 index virus (Wuhan wild type isolate) neutralizing antibodies assessed at 2 weeks after trial vaccination, for subjects in the Immunogenicity Analysis Sets in Part A Cohort 1 (adult subjects who previously completed primary vaccination at least 3 months prior to the screening visit) and Part A Cohort 2 (adult subjects who have completed primary vaccination and have received 1 booster vaccination).

    Measured: 2 weeks after the single trial vaccination occurring on Day 1

Secondary outcomes (3)

  1. Neutralizing Antibody Titers Against the SARS-CoV-2 Variants of Concern (Omicron Variants BA.4/BA.5 and XBB.1.5) at 2 Weeks After Trial Vaccination

    The secondary endpoint was SARS-CoV-2 variants of concern (Omicron Variant BA.4/BA.5 and XBB.1.5) pseudovirus or virus neutralizing antibodies assessed at 2 weeks after trial vaccination, for subjects in the Immunogenicity Analysis Sets in Part A Cohort 1 (adult subjects who previously completed primary vaccination at least 3 months prior to the screening visit) and Part A Cohort 2 (adult subjects who have completed primary vaccination and have received 1 booster vaccination.

    Measured: 2 weeks after the single trial vaccination occurring on Day 1

  2. Neutralizing Antibody Titers Against the SARS-CoV-2 Index Virus (Wuhan Wild Type Isolate) at 2 Weeks After Trial Vaccination [Time Frame: 2 Weeks After the Single Trial Vaccination Occurring on Day 1]

    The secondary endpoint was SARS-CoV-2 index virus (Wuhan wild type isolate) neutralizing antibodies assessed at 2 weeks after trial vaccination, for subjects in the Immunogenicity Analysis Sets in Part B Cohort 1 (adult subjects who previously completed primary vaccination at least 3 months prior to the screening visit) and Part B Cohort 2 (adult subjects who have completed primary vaccination and have received 1 booster vaccination).

    Measured: 2 weeks after the single trial vaccination occurring on Day 1

  3. Safety and Tolerability of the ABNCoV2 Vaccine as Measured by the Frequency of Solicited and Unsolicited Adverse Events Occurring During or After the Trial Vaccination.

    The number and percent of subjects who report:

    • SAEs or AESIs assessed as related to trial vaccine during the entire trial period, which includes both the active trial phase and follow-up.
    • Grade 3 or higher AEs assessed as related to trial vaccine in the 8 day period starting with the day of vaccination.
    • SAEs, AESIs or MAAEs, regardless of relationship, during the active trial phase.
    • SAE, AESI or MAAEs, regardless of relationship, during the entire trial period.
    • Grade 3 or higher AEs assessed as related to trial vaccine during the active trial phase.
    • Solicited local AEs in the 8 day period starting with the day of vaccination.
    • Solicited general AEs in the 8 day period starting with the day of vaccination.

    Solicited event grading based on FDA 2007 Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials, where Grade 1 is Mild and Grade 4 is Life-Threatening and the worst outcome.

    Measured: Active trial period is from vaccination until 28 to 35 days after vaccination. Entire trial period is from vaccination until 182 to 196 days after vaccination. Solicited events are reported if occurring within 8 days following vaccination.

Timeline

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

  1. First posted14 Apr 2022
  2. Study start30 Aug 2022
  3. Primary completion15 Mar 2023
  4. Study completion5 Oct 2023

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
4,205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05329220
Sponsor's protocol ID
ABNCoV2-03
Status last verified
Dec 2024
First submitted
25 Mar 2022
Last updated
24 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABNCoV2 and Comirnaty in people with COVID-19 Disease, run by Bavarian Nordic at 57 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Denmark, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neutralizing Antibody Titers Against the SARS-CoV-2 Index Virus (Wuhan Wild Type Isolate) at 2 Weeks After Trial Vaccination (time frame: 2 weeks after the single trial vaccination occurring on Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05329220.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.

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