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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19 Disease
• Intervention / Treatment: Biological: ABNCoV2; Biological: Comirnaty

• Study Type: Interventional
• Enrollment (Actual): 4205
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2000
    • Instituut voor Tropische Geneeskunde
  • Edegem, Belgium, 2650
    • Centrum voor de evaluatie van vaccinaties
  • Erpent, Belgium, 5101
    • Private Practice Dr Jean Benoit Martinot
  • Gent, Belgium, 9000
    • Centrum voor vaccinologie (CEVAC)
  • Gozée, Belgium, 6534
    • Office of Marc De Meulemeester
• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg Universitetshospital
  • Aarhus, Denmark, 8200
    • Aarhus Universitetshospital
  • Herning, Denmark, 7400
    • Regionshospitalet Gødstrup, Medicinsk afdeling, Klinik for Infektionssygdomme
  • Hillerød, Denmark, 3400
    • Nordsjællands Hospital, Hillerød, Lunge- og Infektionsmedicinsk Afdeling
  • Hvidovre, Denmark, 2650
    • Hvidovre Hospital, Infektionsmedicinsk afd.
  • Kobenhavn, Denmark, 2400
    • Bispebjerg Hospital, Afdeling for Lunge- og Infektionssygdomme
  • Odense, Denmark, 5000
    • Odense Universitetshospital, Q, Infektionsmedicinsk Afdeling
  • Roskilde, Denmark, 4000
    • Sjællands Universitetshospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Achieve Clinical Research LLC d/b/a Accel Research Sites
  • Arizona
    • Mesa, Arizona, United States, 85210
      • Arizona Clinical Trials
    • Tucson, Arizona, United States, 85710
      • Tucson Neuroscience Research - M3 WR
  • California
    • Los Alamitos, California, United States, 90720
      • Wr-Pri, Llc
    • Newport Beach, California, United States, 92660
      • PRI, LLC - Newport Beach - M3 WR
    • Oxnard, California, United States, 93030
      • Fomat Medical Research
    • San Diego, California, United States, 92120
      • Medical Center for Clinical Research
    • San Diego, California, United States, 92111
      • Women's Healthcare Research Corporation
  • Colorado
    • Fort Collins, Colorado, United States, 80525
      • Tekton Research
  • Florida
    • Leesburg, Florida, United States, 34748
      • Clinical Site Partners
    • Maitland, Florida, United States, 32751
      • Accel Research Sites
    • Miami, Florida, United States, 33135
      • Suncoast Research Group LLC
    • Miami, Florida, United States, 33173
      • Suncoast Research Associates LLC
    • Miami, Florida, United States, 33186
      • Clinical Site Partners
    • Tampa, Florida, United States, 33609
      • Trueblue Clinical Research
    • Winter Park, Florida, United States, 32789
      • Clinical Site Partners
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research - CenExel ACMR
    • Chamblee, Georgia, United States, 30341
      • Tekton Research
    • Columbus, Georgia, United States, 31904
      • Columbus Regional Research Institute at Talbotton
    • Decatur, Georgia, United States, 30030
      • Accel Research Site - NeuroStudies.net, LLC
    • Sandy Springs, Georgia, United States, 30328
      • Mount Vernon Clinical Research, LLC
    • Savannah, Georgia, United States, 31406
      • Meridian Clinical Research, LLC
  • Indiana
    • Evansville, Indiana, United States, 47714
      • AES - DRS - Synexus Clinical Research US, Inc.
  • Iowa
    • Sioux City, Iowa, United States, 51106
      • Meridian Clinical Research
  • Maryland
    • Gaithersburg, Maryland, United States, 20877
      • CBH Health - CenExel CBH
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Sundance Clinical Research
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Meridian Clinical Research , LLC
    • Lincoln, Nebraska, United States, 68510
      • Meridian Clinical Research LLC
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research, Inc.
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research
  • New York
    • Binghamton, New York, United States, 13901
      • Meridian Clinical Research
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • Emerging Medical Research, LLC
    • Fayetteville, North Carolina, United States, 28303
      • Carolina Institute for Clinical Research
    • Raleigh, North Carolina, United States, 27612
      • M3 Wake Research, Inc
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Meridian Clinical Research, LLC
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Tekton Research
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • ClinSearch, LLC
  • Texas
    • Austin, Texas, United States, 78745
      • Tekton Research
    • Beaumont, Texas, United States, 77706
      • Tekton Research
    • Dallas, Texas, United States, 75224
      • Global Medical Research
    • Fort Worth, Texas, United States, 76104
      • Ventavia Research Group
    • Houston, Texas, United States, 77008
      • Ventavia Research Group
    • Sugar Land, Texas, United States, 77478
      • DM Clinical Research
  • Virginia
    • Portsmouth, Virginia, United States, 23703
      • Meridian Clinical Research - Family Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABNCoV2 100μg single dose	Biological: ABNCoV2; ABNCoV2 100μg single dose
Active Comparator: Comirnaty	Biological: Comirnaty; Comirnaty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2 weeks after the single trial vaccination occurring on Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks after the single trial vaccination occurring on Day 1
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).	2 weeks after the single trial vaccination occurring on Day 1
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.	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.

Collaborators and Investigators

• Sponsor: Bavarian Nordic
• Investigators: Study Director: Leo James, MD, Bavarian Nordic

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2022
• Primary Completion (Actual): March 15, 2023
• Study Completion (Actual): October 5, 2023

Study Registration Dates

• First Submitted: March 25, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ABNCoV2-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No