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

COVID-19 Disease Clinical Trial

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-Randomized, Double-blind, Active Controlled and Open-label, Single-arm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05329220
• Other study ID #: ABNCoV2-03
• Status: Completed
• Phase: Phase 3
• Start date: August 31, 2022
• Est. completion date: October 5, 2023

Study information

• Verified date: October 2023
• Source: Bavarian Nordic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4223
• Est. completion date: October 5, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19 Disease

Intervention

Biological:
• ABNCoV2
ABNCoV2 100µg single dose
• Comirnaty
Comirnaty

Locations

Country	Name	City	State
Belgium	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)	Gent
Belgium	Office of Marc De Meulemeester	Gozée
Denmark	Aalborg Universitetshospital	Aalborg
Denmark	Aarhus Universitetshospital	Aarhus
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	Bispebjerg Hospital, Afdeling for Lunge- og Infektionssygdomme	Kobenhavn
Denmark	Odense Universitetshospital, Q, Infektionsmedicinsk Afdeling	Odense
Denmark	Sjællands Universitetshospital	Roskilde
United States	Atlanta Center for Medical Research - CenExel ACMR	Atlanta	Georgia
United States	Tekton Research	Austin	Texas
United States	Tekton Research	Beaumont	Texas
United States	Meridian Clinical Research	Binghamton	New York
United States	Achieve Clinical Research LLC d/b/a Accel Research Sites	Birmingham	Alabama
United States	Tekton Research	Chamblee	Georgia
United States	ClinSearch, LLC	Chattanooga	Tennessee
United States	Meridian Clinical Research, LLC	Cincinnati	Ohio
United States	Columbus Regional Research Institute at Talbotton	Columbus	Georgia
United States	Global Medical Research	Dallas	Texas
United States	Accel Research Site - NeuroStudies.net, LLC	Decatur	Georgia
United States	Emerging Medical Research, LLC	Durham	North Carolina
United States	Tekton Research	Edmond	Oklahoma
United States	AES - DRS - Synexus Clinical Research US, Inc.	Evansville	Indiana
United States	Carolina Institute for Clinical Research	Fayetteville	North Carolina
United States	Tekton Research	Fort Collins	Colorado
United States	Ventavia Research Group	Fort Worth	Texas
United States	CBH Health - CenExel CBH	Gaithersburg	Maryland
United States	Meridian Clinical Research , LLC	Grand Island	Nebraska
United States	Ventavia Research Group	Houston	Texas
United States	Clinical Site Partners	Leesburg	Florida
United States	Meridian Clinical Research LLC	Lincoln	Nebraska
United States	Wr-Pri, Llc	Los Alamitos	California
United States	Accel Research Sites	Maitland	Florida
United States	Arizona Clinical Trials	Mesa	Arizona
United States	Clinical Site Partners	Miami	Florida
United States	Suncoast Research Associates LLC	Miami	Florida
United States	Suncoast Research Group LLC	Miami	Florida
United States	PRI, LLC - Newport Beach - M3 WR	Newport Beach	California
United States	Meridian Clinical Research	Omaha	Nebraska
United States	Quality Clinical Research, Inc.	Omaha	Nebraska
United States	FOMAT Medical Research	Oxnard	California
United States	Meridian Clinical Research - Family Practice	Portsmouth	Virginia
United States	M3 Wake Research, Inc	Raleigh	North Carolina
United States	Sundance Clinical Research	Saint Louis	Missouri
United States	Medical Center For Clinical Research	San Diego	California
United States	Women's Healthcare Research Corporation	San Diego	California
United States	Mount Vernon Clinical Research, LLC	Sandy Springs	Georgia
United States	Meridian Clinical Research, LLC	Savannah	Georgia
United States	Meridian Clinical Research	Sioux City	Iowa
United States	DM Clinical Research	Sugar Land	Texas
United States	TrueBlue Clinical Research	Tampa	Florida
United States	Tucson Neuroscience Research - M3 WR	Tucson	Arizona
United States	Clinical Site Partners	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bavarian Nordic

Countries where clinical trial is conducted

United States,  Belgium,  Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-inferiority, or superiority in terms of neutralizing antibodies against the SARS-CoV-2 index virus (Wuhan wild type isolate), in Part A Cohort 1 and 2	To assess non-inferiority, or superiority, of vaccination with ABNCoV2 compared to Comirnaty in terms of neutralizing antibodies against the SARS-CoV-2 index virus (Wuhan wild type isolate), 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).; - Geometric mean titer (GMT) of neutralizing antibodies against the SARS-CoV-2 index virus at 2 weeks after trial vaccination, in each Part A cohort	2 weeks after vaccination
Secondary	Non-inferiority, or superiority, in terms of neutralizing antibodies against SARS-CoV-2 variants of concern (VOCs).	To assess in Part A cohorts the non-inferiority, or superiority, of vaccination with ABNCoV2 compared to Comirnaty in terms of neutralizing antibodies against SARS-CoV-2 variants of concern (VOCs) circulating at time of the trial.; - GMT of neutralizing antibodies against the SARS-CoV-2 VOCs circulating at time of the trial, at 2 weeks after trial vaccination, in the Part A cohort(s) in which the primary endpoint success criterion is met	2 weeks after vaccination
Secondary	Neutralizing antibody titers against the SARS-CoV-2 index virus after vaccination with ABNCoV2	To assess neutralizing antibody titers against the SARS-CoV-2 index virus after vaccination with ABNCoV2 in the immunogenicity subsets of Part B Cohort 1 and Cohort 2.; - GMTs of neutralizing antibodies against the SARS-CoV-2 index virus at 2 weeks after trial vaccination in subjects receiving ABNCoV2 in the immunogenicity subsets of Part B Cohort 1 and Cohort 2.	2 weeks after vaccination
Secondary	Safety and tolerability of the ABNCoV2 vaccine as measured by the incidence of solicited and unsolicited adverse events occurring during or after the trial vaccination.	Part A: For all subjects receiving ABNCoV2 compared to those receiving Comirnaty, the percent who report the below: Parts A and B: For all subjects receiving ABNCoV2, the percent who report the below: Serious adverse events (SAEs) or adverse events of special interest (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 adverse events (AEs) assessed as related to trial vaccine in the 8 day period starting with the day of vaccination.; SAEs, AESIs or medically attended AEs (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.	During active trial phase (defined as the period from the trial vaccination up to and including the end of active trial phase (EAP) visit at 28 to 35 days after trial vaccination) or during entire trial period for SAE/AESI/MAAE