Clinical trial NCT03472014: Special Access Program IMVAMUNE®
Official title: A Special Access Program for the Prophylactic Vaccination With IMVAMUNE® for Personnel Working Directly With or in the Vicinity of Replicating Vaccinia Virus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaccination
Lead sponsor: Bavarian Nordic
Sponsor class: INDUSTRY
First posted: 2018-03-21
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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


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.

Primary outcomes:
measure: ELISA Seropositivity Rate
timeFrame: up to Week 7
Secondary outcomes:
measure: ELISA Seroconversion Rate
timeFrame: Week 7
measure: ELISA GMT
timeFrame: up to Week 7
measure: Serious Adverse Events
timeFrame: up to 32 weeks
measure: Related Grade >=3 Adverse Events
timeFrame: within 29 days after any vaccination
measure: Non-serious AEs
timeFrame: within 29 days after any vaccination
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation
state: California
Study officials:
affiliation: Palo Alto Medical Foundation
name: Gary Fujimoto, MD
role: PRINCIPAL_INVESTIGATOR
References: