Special Access Program IMVAMUNE®

NCT ID: NCT03472014

Last Updated: 2020-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-22
• Study Completion Date: 2014-11-14

Brief Summary

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

Conditions

Vaccination

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

IMVAMUNE®

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

Group Type: EXPERIMENTAL

IMVAMUNE®

Intervention Type: BIOLOGICAL

IMVAMUNE® liquid -frozen, containing 1 x 10E8 TCID50 MVA-BN® per 0.5 mL dose

Interventions

IMVAMUNE®

IMVAMUNE® liquid -frozen, containing 1 x 10E8 TCID50 MVA-BN® per 0.5 mL dose

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bavarian Nordic

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary Fujimoto, MD

Role: PRINCIPAL_INVESTIGATOR

Palo Alto Medical Foundation

Locations

Palo Alto Medical Foundation

Palo Alto, California, United States

Countries

United States

Other Identifiers

POX-MVA-03x

Identifier Type: -

Identifier Source: org_study_id