ABSTRACT
This session will use examples from an mRNA-1273 phase 1 COVID-19 vaccine trial to explore reporting and operational considerations for vaccine trials in the pandemic setting. The session is composed of three talks from members of the Statistical and Data Coordinating Center for the mRNA-1273 phase 1 trial followed by two discussants and a question-and-answer session. The mRNA-1273 phase 1 trial evaluated the safety and immunogenicity of several doses of the mRNA- 1273 vaccine. Three age groups were enrolled (18-55, 56-70, and 71 years or older) and followed for safety and immunogenicity. At the time of this writing, subjects are completing Day 209. The results of this trial combined with the phase 2 trial were used to justify the 100 mg dose used in the phase 3 trial. The expectation is that all Day 209 follow-up will be completed and the results published by the time of the session in May 2021. The speakers and discussants will share knowledge gained from their roles and will address questions from the audience about the design and conduct of the trial as well as the process of reporting trial results. This session is highly relevant to the meeting theme and is expected to be of interest for a wide audience. Talk one will provide a brief background of the mRNA-1273 vaccine study platform and will highlight issues that arise at the start of the clinical trial process during an outbreak. Ava Manokian, Data Manager, will address considerations for adopting accelerated timelines and quickly getting a trial launched from concept to first subject enrollment. Talk two will focus on strategies for handling enrollment, data entry, and data cleaning during trials in outbreak settings. Semhal Selamawi, Data manager, will discuss how the changing COVID outbreaks, protocol changes to add dose levels and age cohorts, and the immediate need for clean data presented challenges to data management. Talk three will introduce the issues related to trial reporting. The pandemic setting raised difficult questions about disseminating the results of clinical trials. Kaitlyn Cross, Senior Biostatistician, will describe all the major reporting occurring during the trial and how the study group navigated the large numbers of reports required in a short time. Topics will also include different assays that are used and how they are handled. These three speakers will be followed by talks from two discussants who will provide additional perspectives on this vaccine study. Discussant one, Britta Flach, Director Advanced Clinical Testing, will provide a perspective on the challenges associated with running a lab, specimen receipt and analysis, and reporting results. Discussant two, Dr Mat Makowski, will discuss the challenges of working on this high-profile trial and how all the different pieces fit together from a logistics and analytical standpoint. Our expectation is that these talks will generate many questions;hence, the remainder of the session is devoted to a panel style question-and-answer session with the speakers and discussants.
ABSTRACT
[Figure: see text].