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

NCT05329220 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: ABNCoV2-03
• Study Type: interventional
• Target: 4,205
• Locations: 3 countries
• Sites: 57

Brief 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 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.

Conditions

COVID-19 Disease

Outcome Measures

Primary Outcomes (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).

  2 weeks after the single trial vaccination occurring on Day 1

Secondary Outcomes (3)

• 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

  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]

  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.

  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.

Study Arms (2)

ABNCoV2 100μg single dose

EXPERIMENTAL

ABNCoV2 100μg single dose

Biological: ABNCoV2

Comirnaty

ACTIVE COMPARATOR

Comirnaty

Biological: Comirnaty

Interventions

ABNCoV2 BIOLOGICAL

ABNCoV2 100μg single dose

ABNCoV2 100μg single dose

Comirnaty BIOLOGICAL

Comirnaty

Comirnaty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• History of COVID 19 infection within the last 3 months before screening.
• 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.

Sponsors & Collaborators

• Bavarian Nordic: lead

Study Sites (57)

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

Birmingham, Alabama, 35216, United States

Location

Arizona Clinical Trials

Mesa, Arizona, 85210, United States

Location

Tucson Neuroscience Research - M3 WR

Tucson, Arizona, 85710, United States

Location

Wr-Pri, Llc

Los Alamitos, California, 90720, United States

Location

PRI, LLC - Newport Beach - M3 WR

Newport Beach, California, 92660, United States

Location

FOMAT Medical Research

Oxnard, California, 93030, United States

Location

Women's Healthcare Research Corporation

San Diego, California, 92111, United States

Location

Medical Center For Clinical Research

San Diego, California, 92120, United States

Location

Tekton Research

Fort Collins, Colorado, 80525, United States

Location

Clinical Site Partners

Leesburg, Florida, 34748, United States

Location

Accel Research Sites

Maitland, Florida, 32751, United States

Location

Suncoast Research Group LLC

Miami, Florida, 33135, United States

Location

Suncoast Research Associates LLC

Miami, Florida, 33173, United States

Location

Clinical Site Partners

Miami, Florida, 33186, United States

Location

TrueBlue Clinical Research

Tampa, Florida, 33609, United States

Location

Clinical Site Partners

Winter Park, Florida, 32789, United States

Location

Atlanta Center for Medical Research - CenExel ACMR

Atlanta, Georgia, 30331, United States

Location

Tekton Research

Chamblee, Georgia, 30341, United States

Location

Columbus Regional Research Institute at Talbotton

Columbus, Georgia, 31904, United States

Location

Accel Research Site - NeuroStudies.net, LLC

Decatur, Georgia, 30030, United States

Location

Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, 30328, United States

Location

Meridian Clinical Research, LLC

Savannah, Georgia, 31406, United States

Location

AES - DRS - Synexus Clinical Research US, Inc.

Evansville, Indiana, 47714, United States

Location

Meridian Clinical Research

Sioux City, Iowa, 51106, United States

Location

CBH Health - CenExel CBH

Gaithersburg, Maryland, 20877, United States

Location

Sundance Clinical Research

St Louis, Missouri, 63141, United States

Location

Meridian Clinical Research , LLC

Grand Island, Nebraska, 68803, United States

Location

Meridian Clinical Research LLC

Lincoln, Nebraska, 68510, United States

Location

Quality Clinical Research, Inc.

Omaha, Nebraska, 68114, United States

Location

Meridian Clinical Research

Omaha, Nebraska, 68134, United States

Location

Meridian Clinical Research

Binghamton, New York, 13901, United States

Location

Emerging Medical Research, LLC

Durham, North Carolina, 27704, United States

Location

Carolina Institute for Clinical Research

Fayetteville, North Carolina, 28303, United States

Location

M3 Wake Research, Inc

Raleigh, North Carolina, 27612, United States

Location

Meridian Clinical Research, LLC

Cincinnati, Ohio, 45219, United States

Location

Tekton Research

Edmond, Oklahoma, 73013, United States

Location

ClinSearch, LLC

Chattanooga, Tennessee, 37421, United States

Location

Tekton Research

Austin, Texas, 78745, United States

Location

Tekton Research

Beaumont, Texas, 77706, United States

Location

Global Medical Research

Dallas, Texas, 75224, United States

Location

Ventavia Research Group

Fort Worth, Texas, 76104, United States

Location

Ventavia Research Group

Houston, Texas, 77008, United States

Location

DM Clinical Research

Sugar Land, Texas, 77478, United States

Location

Meridian Clinical Research - Family Practice

Portsmouth, Virginia, 23703, United States

Location

Instituut voor Tropische Geneeskunde

Antwerp, 2000, Belgium

Location

Centrum voor de evaluatie van vaccinaties

Edegem, 2650, Belgium

Location

Private Practice Dr Jean Benoit Martinot

Erpent, 5101, Belgium

Location

Centrum voor vaccinologie (CEVAC)

Ghent, 9000, Belgium

Location

Office of Marc De Meulemeester

Gozée, 6534, Belgium

Location

Aalborg Universitetshospital

Aalborg, 9000, Denmark

Location

Aarhus Universitetshospital

Aarhus, 8200, Denmark

Location

Bispebjerg Hospital, Afdeling for Lunge- og Infektionssygdomme

Copenhagen, 2400, Denmark

Location

Regionshospitalet Gødstrup, Medicinsk afdeling, Klinik for Infektionssygdomme

Herning, 7400, Denmark

Location

Nordsjællands Hospital, Hillerød, Lunge- og Infektionsmedicinsk Afdeling

Hillerød, 3400, Denmark

Location

Hvidovre Hospital, Infektionsmedicinsk afd.

Hvidovre, 2650, Denmark

Location

Odense Universitetshospital, Q, Infektionsmedicinsk Afdeling

Odense, 5000, Denmark

Location

Sjællands Universitetshospital

Roskilde, 4000, Denmark

Location

MeSH Terms

Interventions

ABNCoV2 vaccine; BNT162 Vaccine

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Results Point of Contact

• Title: Bavarian Nordic Call Center
• Organization: Bavarian Nordic A/S

medical.information_us@bavarian-nordic.com

1-844-422-8274

Study Officials

• Leo James, MD

  Bavarian Nordic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 14, 2022
• Study Start: August 30, 2022
• Primary Completion: March 15, 2023
• Study Completion: October 5, 2023
• Last Updated: February 24, 2025
• Results First Posted: February 24, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (44); BE (5); DK (8)