Clinical trial NCT05329220: ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19 Disease
Lead sponsor: Bavarian Nordic
Sponsor class: INDUSTRY
First posted: 2022-04-14
Enrollment: 4205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Neutralizing Antibody Titers Against the SARS-CoV-2 Index Virus (Wuhan Wild Type Isolate) at 2 Weeks After Trial Vaccination
timeFrame: 2 weeks after the single trial vaccination occurring on Day 1
Secondary outcomes:
measure: 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
timeFrame: 2 weeks after the single trial vaccination occurring on Day 1
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]
timeFrame: 2 weeks after the single trial vaccination occurring on Day 1
measure: 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.
timeFrame: 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.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research LLC d/b/a Accel Research Sites
state: Alabama
city: Mesa
country: United States
facility: Arizona Clinical Trials
state: Arizona
city: Tucson
country: United States
facility: Tucson Neuroscience Research - M3 WR
state: Arizona
city: Los Alamitos
country: United States
facility: Wr-Pri, Llc
state: California
city: Newport Beach
country: United States
facility: PRI, LLC - Newport Beach - M3 WR
state: California
city: Oxnard
country: United States
facility: FOMAT Medical Research
state: California
city: San Diego
country: United States
facility: Women's Healthcare Research Corporation
state: California
city: San Diego
country: United States
facility: Medical Center For Clinical Research
state: California
city: Fort Collins
country: United States
facility: Tekton Research
state: Colorado
city: Leesburg
country: United States
facility: Clinical Site Partners
state: Florida
city: Maitland
country: United States
facility: Accel Research Sites
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group LLC
state: Florida
city: Miami
country: United States
facility: Suncoast Research Associates LLC
state: Florida
city: Miami
country: United States
facility: Clinical Site Partners
state: Florida
city: Tampa
country: United States
facility: TrueBlue Clinical Research
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research - CenExel ACMR
state: Georgia
city: Chamblee
country: United States
facility: Tekton Research
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute at Talbotton
state: Georgia
city: Decatur
country: United States
facility: Accel Research Site - NeuroStudies.net, LLC
state: Georgia
city: Sandy Springs
country: United States
facility: Mount Vernon Clinical Research, LLC
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research, LLC
state: Georgia
city: Evansville
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc.
state: Indiana
city: Sioux City
country: United States
facility: Meridian Clinical Research
state: Iowa
city: Gaithersburg
country: United States
facility: CBH Health - CenExel CBH
state: Maryland
city: Saint Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Grand Island
country: United States
facility: Meridian Clinical Research , LLC
state: Nebraska
city: Lincoln
country: United States
facility: Meridian Clinical Research LLC
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Binghamton
country: United States
facility: Meridian Clinical Research
state: New York
city: Durham
country: United States
facility: Emerging Medical Research, LLC
state: North Carolina
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research, Inc
state: North Carolina
city: Cincinnati
country: United States
facility: Meridian Clinical Research, LLC
state: Ohio
city: Edmond
country: United States
facility: Tekton Research
state: Oklahoma
city: Chattanooga
country: United States
facility: ClinSearch, LLC
state: Tennessee
city: Austin
country: United States
facility: Tekton Research
state: Texas
city: Beaumont
country: United States
facility: Tekton Research
state: Texas
city: Dallas
country: United States
facility: Global Medical Research
state: Texas
city: Fort Worth
country: United States
facility: Ventavia Research Group
state: Texas
city: Houston
country: United States
facility: Ventavia Research Group
state: Texas
city: Sugar Land
country: United States
facility: DM Clinical Research
state: Texas
city: Portsmouth
country: United States
facility: Meridian Clinical Research - Family Practice
state: Virginia
city: Antwerp
country: Belgium
facility: Instituut voor Tropische Geneeskunde
city: Edegem
country: Belgium
facility: Centrum voor de evaluatie van vaccinaties
city: Erpent
country: Belgium
facility: Private Practice Dr Jean Benoit Martinot
city: Gent
country: Belgium
facility: Centrum voor vaccinologie (CEVAC)
city: Gozée
country: Belgium
facility: Office of Marc De Meulemeester
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital
city: Herning
country: Denmark
facility: Regionshospitalet Gødstrup, Medicinsk afdeling, Klinik for Infektionssygdomme
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital, Hillerød, Lunge- og Infektionsmedicinsk Afdeling
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital, Infektionsmedicinsk afd.
city: Kobenhavn
country: Denmark
facility: Bispebjerg Hospital, Afdeling for Lunge- og Infektionssygdomme
city: Odense
country: Denmark
facility: Odense Universitetshospital, Q, Infektionsmedicinsk Afdeling
city: Roskilde
country: Denmark
facility: Sjællands Universitetshospital
Study officials:
affiliation: Bavarian Nordic
name: Leo James, MD
role: STUDY_DIRECTOR
References: