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

NCT ID: NCT05329220

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 4205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-30
• Study Completion Date: 2023-10-05

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

ABNCoV2 100μg single dose

ABNCoV2 100μg single dose

Group Type: EXPERIMENTAL

ABNCoV2

Intervention Type: BIOLOGICAL

ABNCoV2 100μg single dose

Comirnaty

Comirnaty

Group Type: ACTIVE_COMPARATOR

Comirnaty

Intervention Type: BIOLOGICAL

Comirnaty

Interventions

ABNCoV2

ABNCoV2 100μg single dose

Intervention Type: BIOLOGICAL

Comirnaty

Comirnaty

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bavarian Nordic

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leo James, MD

Role: STUDY_DIRECTOR

Bavarian Nordic

Locations

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

Birmingham, Alabama, United States

Arizona Clinical Trials

Mesa, Arizona, United States

Tucson Neuroscience Research - M3 WR

Tucson, Arizona, United States

Wr-Pri, Llc

Los Alamitos, California, United States

PRI, LLC - Newport Beach - M3 WR

Newport Beach, California, United States

FOMAT Medical Research

Oxnard, California, United States

Women's Healthcare Research Corporation

San Diego, California, United States

Medical Center For Clinical Research

San Diego, California, United States

Tekton Research

Fort Collins, Colorado, United States

Clinical Site Partners

Leesburg, Florida, United States

Accel Research Sites

Maitland, Florida, United States

Suncoast Research Group LLC

Miami, Florida, United States

Suncoast Research Associates LLC

Miami, Florida, United States

Clinical Site Partners

Miami, Florida, United States

TrueBlue Clinical Research

Tampa, Florida, United States

Clinical Site Partners

Winter Park, Florida, United States

Atlanta Center for Medical Research - CenExel ACMR

Atlanta, Georgia, United States

Tekton Research

Chamblee, Georgia, United States

Columbus Regional Research Institute at Talbotton

Columbus, Georgia, United States

Accel Research Site - NeuroStudies.net, LLC

Decatur, Georgia, United States

Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, United States

Meridian Clinical Research, LLC

Savannah, Georgia, United States

AES - DRS - Synexus Clinical Research US, Inc.

Evansville, Indiana, United States

Meridian Clinical Research

Sioux City, Iowa, United States

CBH Health - CenExel CBH

Gaithersburg, Maryland, United States

Sundance Clinical Research

St Louis, Missouri, United States

Meridian Clinical Research , LLC

Grand Island, Nebraska, United States

Meridian Clinical Research LLC

Lincoln, Nebraska, United States

Quality Clinical Research, Inc.

Omaha, Nebraska, United States

Meridian Clinical Research

Omaha, Nebraska, United States

Meridian Clinical Research

Binghamton, New York, United States

Emerging Medical Research, LLC

Durham, North Carolina, United States

Carolina Institute for Clinical Research

Fayetteville, North Carolina, United States

M3 Wake Research, Inc

Raleigh, North Carolina, United States

Meridian Clinical Research, LLC

Cincinnati, Ohio, United States

Tekton Research

Edmond, Oklahoma, United States

ClinSearch, LLC

Chattanooga, Tennessee, United States

Tekton Research

Austin, Texas, United States

Tekton Research

Beaumont, Texas, United States

Global Medical Research

Dallas, Texas, United States

Ventavia Research Group

Fort Worth, Texas, United States

Ventavia Research Group

Houston, Texas, United States

DM Clinical Research

Sugar Land, Texas, United States

Meridian Clinical Research - Family Practice

Portsmouth, Virginia, United States

Instituut voor Tropische Geneeskunde

Antwerp, , Belgium

Centrum voor de evaluatie van vaccinaties

Edegem, , Belgium

Private Practice Dr Jean Benoit Martinot

Erpent, , Belgium

Centrum voor vaccinologie (CEVAC)

Ghent, , Belgium

Office of Marc De Meulemeester

Gozée, , Belgium

Aalborg Universitetshospital

Aalborg, , Denmark

Aarhus Universitetshospital

Aarhus, , Denmark

Bispebjerg Hospital, Afdeling for Lunge- og Infektionssygdomme

Copenhagen, , Denmark

Regionshospitalet Gødstrup, Medicinsk afdeling, Klinik for Infektionssygdomme

Herning, , Denmark

Nordsjællands Hospital, Hillerød, Lunge- og Infektionsmedicinsk Afdeling

Hillerød, , Denmark

Hvidovre Hospital, Infektionsmedicinsk afd.

Hvidovre, , Denmark

Odense Universitetshospital, Q, Infektionsmedicinsk Afdeling

Odense, , Denmark

Sjællands Universitetshospital

Roskilde, , Denmark

Countries

United States; Belgium; Denmark

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ABNCoV2-03

Identifier Type: -

Identifier Source: org_study_id