Status:
COMPLETED
Special Access Program IMVAMUNE®
Lead Sponsor:
Bavarian Nordic
Conditions:
Vaccination
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Prophylactic smallpox vaccination for personnel actively working with or in the vicinity of replicating vaccinia virus
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 22 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2014
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03472014
Start Date
April 22 2010
End Date
November 14 2014
Last Update
August 19 2020
Active Locations (1)
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1
Palo Alto Medical Foundation
Palo Alto, California, United States, 94301