IBC Meeting Minutes

Institution:

Papillion Research Center/Avacare

Meeting Date:

December 11, 2025

Meeting Time

11:00 AM Central Time

Meeting Type:

Virtual Platform Teleconference (Remote)

Open to the Public

embers in Attendance:

Member

Voting

Member Type

Bavaret, Tammy

Yes

Chair: Biosafety Expert/HGT Expert

Reed, Craig

Yes

Core Member: Biosafety Expert/HGT Expert

Rastein, Daniel

Yes

Core Member: Biosafety Expert/HGT Expert

Boesch, Brandon

Yes

Local Unaffiliated Member

Diederich, Heather

No

Site Contact

 

Invited Members Not in Attendance:

Member

Voting

Member Type

Crowder, Ken

Yes

Local Unaffiliated Member

 

 

Guests:

Kalili, Nicole

Staff:

Hemmelgarn, Marian

 

Call to Order: The IBC Chair called the meeting to order at 11:02 AM. A quorum was present as defined in the Sabai IBC Charter. 

Conflicts of Interest: The IBC Chair reminded all members present to identify any conflicts of interest (COI). No COI was declared by any voting member of the IBC for any of the items on the agenda.

Public Comments: No public comments were made prior to or at the meeting.

Review of Prior Business: None

Previous Meeting Minutes: Minutes from 1/31/25 were approved by the IBC with no changes.

New Business:

PI:

Doehner, Tamara MD

Sponsor:

Bavarian Nordic A/S

Protocol:

WEV-MVA-002

A Two-Stage, Randomized, Double-Blind, Dose Ranging Phase 2 Trial in Healthy Adult Participants to Investigate Optimal Dose and Dosing Regimen, and to Evaluate Safety and Immunogenicity of the Recombinant MVA BN WEV Vaccine

Review Type:

Annual Review

NIH Guidelines Section:

III-C-1

 

 

 

Trial Summary: WEV-MVA-002 is a placebo-controlled Phase 2 dose-ranging study sponsored by Bavarian Nordic A/S designed to assess the safety, reactogenicity and immunogenicity of MVA-BN-WEV in healthy adult participants (≥18 to ≤50 years of age). MVA-BN-WEV (also known as MVA-mBN396) is a recombinant multivalent vaccine candidate intended for active immunization against disease induced by Venezuelan equine encephalitis virus (VEEV) and eastern equine encephalitis virus (EEEV) in persons at high risk of exposure. The investigational product (IP) is administered by intramuscular (IM) injection.

Biosafety Containment Level (BSL): The study agent MVA-BN-WEV is derived from a modified vaccinia virus Ankara (MVA) poxvirus. Poxviruses (excluding Monkeypox virus and restricted poxviruses) are classified as Risk-Group 2 agents under the NIH Guidelines; therefore, BSL2 is the recommended containment level.

 

Risk Assessment and Discussion:

  • The Committee reviewed the clinical trial Sponsor’s study documents and the Sabai-generated comprehensive study-specific Risk Assessment which collectively provided a thorough description of the recombinant or synthetic nucleic acid molecules (investigational product/s) and the proposed clinical research activities involving the IP.

    • In summary, the primary risks in this clinical trial include potential occupational exposure from accidental needlestick, spills, and splashes of the IP during preparation and/or administration procedures. These potential risks are mitigated through a combination of relevant staff training, safe clinical practices (including Standard Precautions and sharps safety) and use of appropriate PPE (as prescribed in the Risk Assessment and documented in the IBC submission package).

     

    • The Site confirmed that only study personnel who have been educated on the potential biohazards and the precautions to be taken when working with the IP will handle the IP or any materials contaminated by the IP.
    • The Site confirmed that study personnel are sufficiently trained in the practices and techniques required to safely work with the IP.
    • The Site confirmed that staff members receive Bloodborne Pathogens training.
    • Occupational Health Recommendations: None
    • The Committee had no additional significant comments or recommendations regarding the description of the potential risks and occupational exposure hazards associated with handling the IP in this clinical trial, or the proposed mitigation strategies, as detailed in the Risk Assessment.

       

  • The Committee reviewed the Site’s facility details, relevant study-specific procedures and practices, the Annual Review Report, and other applicable information provided by the Site for the purposes of the IBC review.
    • The Site verified that the information provided by the Chair was accurate.
    • The Site confirmed the accuracy of the Annual Review Report.
    • The Committee noted that the Site map did not show a door to the Lab. The Site confirmed that the lab has a door as seen in the Site photos.

 

Motion: A motion of Full Approval for the study at BSL-2 was passed by unanimous vote.

 

  • Contingencies stated by the Committee: None
  • Stipulations stated by the Committee: None

 

Review of Incidents: Nothing to report.

IBC Training: Nothing to report.

Reminder of IBC Approval Requirements.

Adjournment: The IBC Chair adjourned the meeting at 11:32 AM

Post-Meeting Pre-Approval Note: None