An Open Label Phase 2 Trial to Evaluate the Safety, Tolerability and Immunogenicity of the ABNCoV2 Vaccine in SARS-CoV-2 Seronegative and Seropositive Adult Subjects.
- Conditions
- COVID-19 diseaseMedDRA version: 23.1Level: PTClassification code 10084457Term: COVID-19 immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2021-001393-31-DE
- Lead Sponsor
- Bavarian Nordic A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 210
1.Subjects =18 years of age at SCR.
2.Seronegative (Group 1): negative qualitative test for SARS-CoV-2 antibodies at SCR.
Seropositive (Group2) and Group 3): Previous COVID-19 disease or previously completed vaccination regimen with an authorized SARS-CoV-2 vaccine at least 90 days before planned trial vaccination, and a positive qualitative test for SARS-CoV-2 antibodies at SCR.Authorized” SARS-CoV-2 vaccine refers to authorization status at SCR, i.e.,subjects can be eligible if they previously received investigational vaccines that have since been authorized for emergency use or granted full market licensure. Receipt of a single dose of an authorized COVID-19 vaccine regimen in subjects with a previous diagnosis of COVID-19 or a mix/match series of 2 doses of any authorized COVID-19 vaccine will be considered as a completed vaccination.
3.General good health, without acute medical illness, physical exam findings, or laboratory abnormalities, as determined by the investigator.
4.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.Female subjects of childbearing potential (WOCBP) and male subjects who are sexually active with a WOCBP must agree to the use of 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 SCR) or surgically sterilized (bilateral oophorectomy, bilateral tubal ligation, hysterectomy). Acceptable contraception methods are restricted to abstinence (abstinence only acceptable if refraining from heterosexual intercourse during the entire 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.WOCBP must have a negative serum pregnancy test at SCR.
8.Negative human immunodeficiency virus antibody test (anti HIV), negative hepatitis B surface antigen (HBsAG) and negative antibody to hepatitis C virus (HCV).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 105
1.Group 1 only: History of COVID-19 infection or previous vaccination with a licensed or candidate SARS-CoV-2 vaccine, or positive qualitative test for SARS-CoV-2 antibodies at SCR. Groups 2 and 3 only: History of COVID-19 infection and subsequent receipt of more than one licensed or candidate SARS-CoV-2 vaccine.
2.Positive test for SARS-CoV-2 infection at SCR.
3.Pregnant or breastfeeding women.
4.Subject has an 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.
5.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.
6.Known or suspected impairment of immunologic functions including, but not limited to, known immunodeficiency syndrome.
7.History of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision at least 6 months prior to SCR that is considered to have achieved cure. Subjects with history of skin cancer must not be vaccinated at the previous tumor site.
8.Laboratory parameters (such as complete blood count, serum biochemistry including aspartate aminotransferase [AST], alanine amino transferase [ALT], alkaline phosphokinase [AP], bilirubin, or creatinine values), pulse rate, blood pressure, or electrocardiogram (ECG) outside normal range at SCR and deemed clinically relevant by the investigator.
9.Clinically significant mental disorder not adequately controlled by medical treatment.
10.Active or recent history (within 6 months before SCR) of chronic alcohol abuse, intravenous drug abuse, or nasal drug abuse.
11.History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
12.History of anaphylaxis or severe allergic reaction to any vaccine.
13.Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior to or after trial vaccination.
14.Having received any vaccinations or planned vaccinations with an inactivated vaccine within 14 days prior to or after trial vaccination.
15.Recent blood donation (including platelets, plasma and red blood cells) within 4 weeks prior to SCR, or planned blood donations any time during the trial.
16.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 the last vaccination. The use of topical, inhaled, ophthalmic and nasal glucocorticoids is allowed.
17.Post organ transplant subjects, whether or not receiving chronic immunosuppressive therapy.
18.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 the last 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).
19.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.
20.Clinical trial si
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess SARS-CoV-2 specific humoral immune responses of the ABNCoV2 vaccine in initially SARS-CoV-2 seronegative and seropositive subjects.;Secondary Objective: To assess the safety and tolerability of the ABNCoV2 vaccine in adult seropositive and seronegative subjects.;Primary end point(s): SARS-CoV-2 neutralizing antibody titers at 2 weeks after the last vaccination, i.e., after the second vaccination in initially seronegative subjects and after the single boost vaccination in initially seropositive subjects.<br>;Timepoint(s) of evaluation of this end point: 2 weeks after the last vaccination
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Subjects reporting any SAEs or AESIs assessed as related to trial vaccine within 8 days after vaccination.<br><br>Subjects reporting any Grade 3 or higher AEs assessed as related to trial vaccine within 8 days after vaccination. <br>;Timepoint(s) of evaluation of this end point: within 8 days after vaccination.<br><br>