| Meeting Date: | June 11, 2025 at 1:00 PM Eastern Time |
| Meeting Place: | Teleconference (Remote) Meeting is open to the public |
| Members in Attendance: | Hauke, Caitlyn Helm, Allen Rastein, Daniel Ranger, Brian Cross, Stephanie |
| Members Not in Attendance: | Brigati, Jennifer |
| Guests: | None |
| Staff: | Hemmelgarn, Marian |
| Institution: | Alliance for Multispecialty Research, LLC – Knoxville |
Call to Order: The meeting was called to order at 1:00 PM. A quorum was present.
Conflicts of Interest: None declared by voting members of the IBC.
Meeting Minutes: Previous meeting minutes were reviewed and approved with no requested changes.
New Business:
| PI: | Smith, William B. MD, FACC |
| Sponsor: | ModernaTX, Inc. |
| Protocol: | mRNA-1195-P101 A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, 2-Part, Dose-Ranging Study of an EBV Candidate Vaccine, mRNA-1195, in Healthy Participants 18 through 55 Years of Age |
| Smith, William B. MD, FACC | |
| Review Type: | Annual Review |
| NIH Guidelines: | III-C |
Trial Summary: mRNA-1195-P101 is a Phase 1, randomized, observer-blind, placebo-controlled, dose-ranging study sponsored by ModernaTX, Inc. and designed to assess the safety and reactogenicity of mRNA-1195, an RNA-liposome vaccine candidate, to prevent infectious mononucleosis and potentially protect against Epstein-Barr virus (EBV) infection in healthy seronegative and seropositive adults 18 to 55 years of age.
Biosafety Containment Level per Risk Assessment: BSL-1 plus Standard Precautions
Comments:
- The Committee reviewed the Sponsor’s study documents and the comprehensive study-specific Risk Assessment which provided a thorough description of the recombinant or synthetic nucleic acid molecules (“investigational product [IP]”) and the proposed clinical research involving the IP.
- The Committee agreed that the potential risks and occupational exposure hazards associated with handling the IP in this clinical trial were well-described in the Risk Assessment.
- The Committee reviewed the Site’s facility details, study-specific procedures and practices, training records, 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.
- In response to a question from the Committee, the Site noted that the ethanol-based disinfectant is used as a standard daily cleaner in addition to the other listed disinfectants, and is EPA registered. The Committee noted that the disinfectant shown in the photo was expired but acknowledged that it is a representative photo. The Site confirmed that disinfectants are routinely checked for expiration.
Motion: A motion of Full Approval for the study at BSL-1 plus Standard Precautions was passed by majority vote. There were no abstentions on voting.
- Contingencies stated by the Committee: None
- Stipulations stated by the Committee: None
Reminder of IBC Approval Requirements.
Adjournment: 1:32 PM
Post-Meeting Pre-Approval Note: None