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A trial platform to assess approved SARS-CoV-2 vaccines in immunocompromised patients: first sub-protocol for a pilot trial comparing the mRNA vaccines Comirnaty® and COVID-19 mRNA Vaccine Moderna®

Type of publication Peer-reviewed
Publikationsform Original article (peer-reviewed)
Author Speich Benjamin, Chammartin Frédérique, Smith Daniel, Stoeckle Marcel P., Amico Patrizia, Eichenberger Anna L., Hasse Barbara, Schuurmans Macé M., Müller Thomas, Tamm Michael, Dickenmann Michael, Abela Irene A., Trkola Alexandra, Hirsch Hans H., Manuel Oriol, Cavassini Matthias, Hemkens Lars G., Briel Matthias, Mueller Nicolas J., Rauch Andri, Günthard Huldrych F., Koller Michael T., Bucher Heiner C., Kusejko Katharina,
Project Improving the reporting in randomised clinical trials: How reliable are clinical trial registries and how efficient is the use of reporting checklists for peer reviewers?
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Original article (peer-reviewed)

Journal Trials
Volume (Issue) 22(1)
Page(s) 724 - 724
Title of proceedings Trials
DOI 10.1186/s13063-021-05664-0

Open Access

URL http://doi.org/10.1186/s13063-021-05664-0
Type of Open Access Publisher (Gold Open Access)

Abstract

AbstractBackgroundLate 2019, a new highly contagious coronavirus SARS-CoV-2 has emerged in Wuhan, China, causing within 2 months a pandemic with the highest disease burden in elderly and people with pre-existing medical conditions. The pandemic has highlighted that new and more flexible clinical trial approaches, such as trial platforms, are needed to assess the efficacy and safety of interventions in a timely manner. The two existing Swiss cohorts of immunocompromised patients (i.e., Swiss HIV Cohort Study (SHCS) and Swiss Transplant Cohort Study (STCS)) are an ideal foundation to set-up a trial platform in Switzerland leveraging routinely collected data. Within a newly founded trial platform, we plan to assess the efficacy of the first two mRNA SARS-CoV-2 vaccines that reached market authorization in Switzerland in the frame of a pilot randomized controlled trial (RCT) while at the same time assessing the functionality of the trial platform.MethodsWe will conduct a multicenter randomized controlled, open-label, 2-arm sub-study pilot trial of a platform trial nested into two Swiss cohorts. Patients included in the SHCS or the STCS will be eligible for randomization to either receiving the mRNA vaccine Comirnaty® (Pfizer/BioNTech) or the COVID-19 mRNA Vaccine Moderna®. The primary clinical outcome will be change in pan-lg antibody response (pan-Ig anti-S1-RBD; baseline vs. 3 months after first vaccination; binary outcome, considering ≥ 0.8 units/ml as a positive antibody response). The pilot study will also enable us to assess endpoints related to trial conduct feasibility (i.e., duration of RCT set-up; time of patient recruitment; patient consent rate; proportion of missing data). Assuming vaccine reactivity of 90% in both vaccine groups, we power our trial, using a non-inferiority margin such that a 95% two-sided confidence interval excludes a difference in favor of the reference group of more than 10%. A sample size of 380 (190 in each treatment arm) is required for a statistical power of 90% and a type I error of 0.025. The study is funded by the Swiss National Science Foundation (National Research Program NRP 78, “COVID-19”).DiscussionThis study will provide crucial information about the efficacy and safety of the mRNA SARS-CoV-2 vaccines in HIV patients and organ transplant recipients. Furthermore, this project has the potential to pave the way for further platform trials in Switzerland.Trial registrationClinicalTrials.govNCT04805125 . Registered on March 18, 2021
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