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

Bavarian Nordic A/S0 sites4,000 target enrollmentJuly 15, 2022

ConditionsCOVID-19 disease MedDRA version: 23.1Level: PTClassification code 10084457Term: COVID-19 immunisationSystem Organ Class: 10042613 - Surgical and medical procedures Therapeutic area: Diseases [C] - Virus Diseases [C02]

DrugsComirnaty 30 micrograms/dose concentrate for dispersion for injection

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: COVID-19 disease
Sponsor: Bavarian Nordic A/S
Enrollment: 4000
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 15, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Bavarian Nordic A/S

Eligibility Criteria

Inclusion Criteria

•1\. Age \=18 years at screening.
•2\. Documented, previous completion of a primary vaccination regimen with locally authorized SARS CoV 2 vaccine(s) or completion of primary plus 1 boost vaccination (see definition of completed primary vaccination regimen and completed primary plus boost vaccination in Section 1\.2\), 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.
•3\. Absence of acute medical illness, significant physical exam findings, or laboratory abnormalities, as determined by the investigator.
•4\. 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.
•5\. Body mass index (BMI) \=18\.5 and \<40\.
•6\. 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.
•7\. For WOCBP, a negative serum pregnancy test at screening.
•8\. Negative tests for human immunodeficiency virus antibody (anti\-HIV), hepatitis B surface antigen (HBsAG), and antibody to hepatitis C virus (HCV).
•Are the trial subjects under 18? no
•Number of subjects for this age range:

Exclusion Criteria

•1\. History of COVID\-19 infection within the last 3 months before screening.
•2\. Previous vaccination with a SARS\-CoV\-2 vaccine other than those mentioned in inclusion criterion \#2\.
•3\. Positive test for SARS\-CoV\-2 infection at screening.
•4\. Breastfeeding with intent to continue.
•5\. 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.
•6\. History of myocarditis or pericarditis.
•7\. 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.
•8\. Known or suspected impairment of immunologic functions including, but not limited to, known immunodeficiency syndrome.
•9\. 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.
•10\. 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, or electrocardiogram (ECG) outside normal range at screening and deemed clinically relevant by the investigator.