Special Access Program IMVAMUNE®

NCT03472014 | Completed Phase 4 Results FDA Drug

• 1 other identifier: POX-MVA-03x
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vaccination

Outcome Measures

Primary Outcomes (1)

• ELISA Seropositivity Rate

  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.

  up to Week 7

Secondary Outcomes (5)

• ELISA Seroconversion Rate

  Week 7

• ELISA GMT

  up to Week 7

• Serious Adverse Events

  up to 32 weeks

• Related Grade >=3 Adverse Events

  within 29 days after any vaccination

• Non-serious AEs

  within 29 days after any vaccination

Study Arms (1)

IMVAMUNE®

EXPERIMENTAL

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

Biological: IMVAMUNE®

Interventions

IMVAMUNE® BIOLOGICAL

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

IMVAMUNE®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Bavarian Nordic: lead

Study Sites (1)

Palo Alto Medical Foundation

Palo Alto, California, 94301, United States

Location

MeSH Terms

Interventions

smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic

Results Point of Contact

• Title: Program Lead, Clinical Operations
• Organization: Bavarian Nordic A/S

info@bavarian-nordic.com

+45 3326

Study Officials

• Gary Fujimoto, MD

  Palo Alto Medical Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 21, 2018
• Study Start: April 22, 2010
• Primary Completion: November 14, 2014
• Study Completion: November 14, 2014
• Last Updated: August 19, 2020
• Results First Posted: August 19, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)