Institution:
Alliance for Multispecialty Research – Newton
Meeting Date:
March 11, 2026
Meeting Time
1:00 PM Central Time
Meeting Type:
Virtual Platform Teleconference (Remote)
Open to the Public
Members in Attendance:
Member
Voting
Member Type
Rastein, Daniel
Yes
Core Member: Biosafety Expert/HGT Expert
Wang, Anthony
Yes
Core Member: Biosafety Expert/HGT Expert
Phillips, Dawn
Yes
Local Unaffiliated Member
Phillips, Justin
No
Site Contact
Invited Members Not in Attendance:
Member
Voting
Member Type
Thome, Cindy
Yes
Local Unaffiliated Member
Guests:
Mueller, Marissa
Staff:
Bavaret, Tammy (Administrative Chair); Smith, Jennifer
Call to Order: The IBC Chair called the meeting to order at 1:00 PM. 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 3/12/25 were approved by the IBC with no changes.
New Business:
PI:
Holdeman, Troy
Sponsor:
Blue Lake Biotechnology Inc.
Protocol:
BLB-201-002
A Phase 1/2a Trial of the Safety, Tolerability, and Immunogenicity of PIV5-vectored RSV Vaccine (BLB-201) in RSV Seronegative and Seropositive Infants and Children
Review Type:
Annual Review
NIH Guidelines Section:
III-C-1
Trial Summary: BLB-201-002 is a Phase I/IIa, randomized, placebo-controlled trial sponsored by Blue Lake Biotechnology Inc. and designed to evaluate the safety, tolerability, and immunogenicity of CPI-RSV-F (BLB-201) as a Respiratory Syncytial Virus (RSV) vaccine in seropositive and seronegative infants (8 to 24 months of age) and children (18 to 59 months of age). CPI-RSV-F is a live recombinant parainfluenza virus 5 (PIV5) expressing the fusion protein from RSV. The investigational product (IP) is administered by intranasal administration.
Biosafety Containment Level (BSL): The study agent CPI-RSV-F consists of a recombinant version of a parainfluenza virus type 5 containing more than 2/3 of the native genome. To date, PIV5 has not been associated with human disease and therefore reasonably meets the definition of a Risk Group 1 organism for which Biosafety Level 1 may potentially be considered. However, due to the communicability of the agent to both humans and a wide range of animals, potential pathogenicity of the agent in canine populations, and special considerations for restricting access to animals where the study agent is handled, Biosafety Level 2 containment may also be considered. This agent is administered in a clinical setting requiring compliance with OSHA Bloodborne Pathogen Standard.
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 splashes and/or aerosols of the IP during preparation and/or administration procedures and needlesticks due to the use of needles during preparation. 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.
In response to a question from the Committee, the Site confirmed that they have not had any issues with either the old or new administration device.
Motion: A motion of
Full Approval
for the study at
BSL-1 plus Standard Precautions
was passed by unanimous vote. There were no votes against and no abstentions.
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 1:35 PM.
Post-Meeting Pre-Approval Note: None
IBC- Finalized Minutes, AMR Newton, March 11, 2026
