The WHV138 Safety Review Board (SMB) successfully met on July 26, 2022, together with sponsor as well as protocol leadership representatives for the trial’s first periodic safety review. The board chair, Dr. Marnie Elizaga, together with board members, Dr. Michael Keefer and Dr. Yunda Huang, reviewed cumulative safety data – unblinded as to treatment arm – from trial initiation up until everyone from Group 2 received at least their first vaccination. Since there were no major safety concerns identified, the trial will continue as planned. Thanks to the highly experienced clinical team who is running WHV138 very competently, the milestone for the next periodic safety review is approaching quickly. Thus, the second of a total of three SMB meetings will likely be held in mid-September. Overall, the trial is progressing well and on track to administer the last volunteer’s final vaccination by the end of this year, with the final safety follow-up visit anticipated to be in late fall of 2023.
