Special Access Program IMVAMUNE®

Phase 4

Completed

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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
IMVAMUNE®	IMVAMUNE®	Two subcutaneous vaccinations with 0.5 mL IMVAMUNE® vaccine administered at a 4 week intervals

Primary Outcome Measures

Name	Time	Method
ELISA Seropositivity Rate	up to Week 7	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.

Secondary Outcome Measures

Name	Time	Method
Serious Adverse Events	up to 32 weeks	Incidence, relationship and intensity of any Serious Adverse Event (SAE).
Related Grade >=3 Adverse Events	within 29 days after any vaccination	Incidence of any Grade \>=3 Adverse Events possibly, probably or definitely related to the trial vaccine
ELISA GMT	up to Week 7	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'.
Non-serious AEs	within 29 days after any vaccination	Incidence of non-serious AEs
ELISA Seroconversion Rate	Week 7	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.