Special Access Program IMVAMUNE®

Study Overview
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Brief Summary
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Prophylactic smallpox vaccination for personnel actively working with or in the vicinity of replicating vaccinia virus

Official Title
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A Special Access Program for the Prophylactic Vaccination With IMVAMUNE® for Personnel Working Directly With or in the Vicinity of Replicating Vaccinia Virus

Conditions
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Vaccination

Intervention / Treatment
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* Biological: IMVAMUNE®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects, aged 18-65 years, who will work with or in the vicinity of a replicating vaccinia virus and who volunteer for the program. Subjects may be vaccinia-naïve or vaccinia-experienced. Women of child-bearing potential (WOCBP) must have a negative urine pregnancy test within 48 hours prior to vaccination. WOCBP must have used an acceptable method of contraception for at least 30 days prior to the first vaccination and must agree to use an acceptable method of contraception during the vaccination period until at least 28 days after the last vaccination. A woman is considered of child-bearing potential unless post-menopausal or surgically sterilized. (Acceptable contraception methods are restricted to barrier contraceptives which include Food and Drug Administration (FDA)-approved spermicides, intrauterine contraceptive devices, or licensed hormonal products.) Read, signed and dated Informed Consent Form. Exclusion Criteria: Pregnant or breast-feeding women. Uncontrolled serious infection i.e., not responding to antimicrobial therapy. History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded. Known or suspected 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. 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. History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor. History of allergies or reactions to eggs, egg products, or gentamycin. 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. Chronic administration (defined as more than 6 days) of systemic corticosteroids within 30 days of the first planned vaccination. Use of any investigational or non-registered drug or vaccine other than IMVAMUNE® within 30 days preceding the first vaccine dose.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMVAMUNE®<br>Two subcutaneous vaccinations with 0.5 mL IMVAMUNE® vaccine administered at a 4 week intervals | Biological: IMVAMUNE®<br>* IMVAMUNE® liquid -frozen, containing 1 x 10E8 TCID50 MVA-BN® per 0.5 mL dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ELISA Seropositivity Rate | Seropositivity rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seropositivity is defined as antibody titers ≥ detection limit (50). Percentages based on number of subjects with data available. | up to Week 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ELISA Seroconversion Rate | Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to the Screening titer for initially seropositive subjects. Percentages based on number of subjects with data available. | Week 7 | 
| ELISA GMT | Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'. | up to Week 7 | 
| Serious Adverse Events | Incidence, relationship and intensity of any Serious Adverse Event (SAE). | up to 32 weeks | 
| Related Grade >=3 Adverse Events | Incidence of any Grade >=3 Adverse Events possibly, probably or definitely related to the trial vaccine | within 29 days after any vaccination | 
| Non-serious AEs | Incidence of non-serious AEs | within 29 days after any vaccination |