Special Access Program IMVAMUNE®

Completed · Phase 4

Conditions studied: Vaccination

In brief

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

Key facts

Study ID

NCT03472014

Run by

Bavarian Nordic

People needed

22

Starts

2010-04-22

Expected to finish

2014-11-14

Last updated by the study team

2020-08-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Palo Alto Medical Foundation — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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