Healthy subjects actively working with or in the vicinity of replicating Vaccinia virus will receive immunization IMVAMUNE to offer protection against accidential Vaccinia virus infection. MedDRA version: 12.1 Level: PT Classification code 10041197 Term: Smallpox MedDRA version: 12.1 Level: LLT Classification code 10066048 Term: Vaccinia
Conditions
Interventions
Product Name: IMVAMUNE®
Product Code: MVA-BN®
Pharmaceutical Form: Suspension for injection
Current Sponsor code: MVA-BN®
Other descriptive name: Modified Vaccinia Virus Ankara-Bavarian Nordic
Concent
Sponsors
Bavarian Nordic A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects who will work with or in the vicinity of replicating Vaccinia virus and are at-risk for contracting vaccinia infection during work and who volunteer for the program. 2. Health status will be assessed by medical history, physical examination and clinical laboratory tests. 3. Age: 18 to 60 (inclusive) years 4. Women of child-bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to each vaccination. 5. Women of child-bearing potential must agree to use an acceptable method of contraception during the vaccination period, and must continue to use it for at least 28 days after the last vaccination. 6. Read, signed and dated informed consent form (ICF) after being advised of the risks and benefits of the trial in a language understood by the subject prior to performance of any trial specific procedure. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or breast-feeding women. 2. History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject. 3. Present uncontrolled serious infection i.e., not responding to antimicrobial therapy. 4. History of or active autoimmune disease. 5. Known or by the clinical investigator suspected relevant impairment of immunologic function including, but not limited to, clinically significant liver disease; uncontrolled diabetes mellitus; moderate to severe kidney impairment or post organ transplant subjects which might interfere with the safety and/or immunogenicity of IMVAMUNE® vaccination. 6. History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. 7. History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other clinical relevant heart condition to the discretion of the investigator. 8. History of allergies or reactions to eggs, egg products, or gentamycin. 9. History of any anaphylactic shock or severe allergic reaction requiring immediate treatment. 10. Having received any vaccinations or planned vaccinations with a live vaccine within 28 days or a killed vaccine within 14 days prior to or after IMVAMUNE® vaccination. 11. Chronic administration (defined as more than 6 days) of systemic corticosteroids within 90 days of the first planned vaccination. 12. Use of any investigational or non-registered drug or vaccine within 30 days preceding the first IMVAMUNE® vaccine dose, or planned administration of such a drug during the trial period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Safety and reactogenicity of IMVAMUNE® vaccination in this study population. ;Main Objective: To provide potential provision of immunogenicity against infection with Vaccinia Virus by prophylactic, voluntary IMVAMUNE® vaccination for persons who work with or must be in the vicinity of replicating Vaccinia virus and therefore are at-risk for contracting vaccinia infection during work, for instance, laboratory workers and vaccine-production workers. ;Primary end point(s): Determination of immune response measured by a Vaccinia-specific Enzyme-linked immunosorbent assay (ELISA). Percentage of subjects with an ELISA response, i.e. either an appearance of antibody titers above the assay cut-off value for initially seronegative subjects, or an increase of the antibody titer compared to the baseline titer for subjects with a pre-existing antibody titer, at all individual blood sampling time-points. | — |
Countries
Germany
Outcome results
None listed