• Login
    View Item 
    •   UMB Digital Archive
    • UMB Open Access Articles
    • UMB Open Access Articles
    • View Item
    •   UMB Digital Archive
    • UMB Open Access Articles
    • UMB Open Access Articles
    • View Item
    JavaScript is disabled for your browser. Some features of this site may not work without it.

    Browse

    All of UMB Digital ArchiveCommunitiesPublication DateAuthorsTitlesSubjectsThis CollectionPublication DateAuthorsTitlesSubjects

    My Account

    LoginRegister

    Statistics

    Display statistics

    A Deferred-Vaccination Design to Assess Durability of COVID-19 Vaccine Effect After the Placebo Group Is Vaccinated

    • CSV
    • RefMan
    • EndNote
    • BibTex
    • RefWorks
    Author
    Follmann, Dean
    Fintzi, Jonathan
    Fay, Michael P
    Janes, Holly E
    Baden, Lindsey R
    El Sahly, Hana M
    Fleming, Thomas R
    Mehrotra, Devan V
    Carpp, Lindsay N
    Juraska, Michal
    Benkeser, David
    Donnell, Deborah
    Fong, Youyi
    Han, Shu
    Hirsch, Ian
    Huang, Ying
    Huang, Yunda
    Hyrien, Ollivier
    Luedtke, Alex
    Carone, Marco
    Nason, Martha
    Vandebosch, An
    Zhou, Honghong
    Cho, Iksung
    Gabriel, Erin
    Kublin, James G
    Cohen, Myron S
    Corey, Lawrence
    Gilbert, Peter B
    Neuzil, Kathleen M
    Show allShow less

    Date
    2021-04-13
    Journal
    Annals of Internal Medicine
    Publisher
    American College of Physicians
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.7326/M20-8149
    Abstract
    Multiple candidate vaccines to prevent COVID-19 have entered large-scale phase 3 placebo-controlled randomized clinical trials, and several have demonstrated substantial short-term efficacy. At some point after demonstration of substantial efficacy, placebo recipients should be offered the efficacious vaccine from their trial, which will occur before longer-term efficacy and safety are known. The absence of a placebo group could compromise assessment of longer-term vaccine effects. However, by continuing follow-up after vaccination of the placebo group, this study shows that placebo-controlled vaccine efficacy can be mathematically derived by assuming that the benefit of vaccination over time has the same profile for the original vaccine recipients and the original placebo recipients after their vaccination. Although this derivation provides less precise estimates than would be obtained by a standard trial where the placebo group remains unvaccinated, this proposed approach allows estimation of longer-term effect, including durability of vaccine efficacy and whether the vaccine eventually becomes harmful for some. Deferred vaccination, if done open-label, may lead to riskier behavior in the unblinded original vaccine group, confounding estimates of long-term vaccine efficacy. Hence, deferred vaccination via blinded crossover, where the vaccine group receives placebo and vice versa, would be the preferred way to assess vaccine durability and potential delayed harm. Deferred vaccination allows placebo recipients timely access to the vaccine when it would no longer be proper to maintain them on placebo, yet still allows important insights about immunologic and clinical effectiveness over time.
    Keyword
    deferred vaccination
    placebo group
    COVID-19 Vaccines
    Identifier to cite or link to this item
    http://hdl.handle.net/10713/15459
    ae974a485f413a2113503eed53cd6c53
    10.7326/M20-8149
    Scopus Count
    Collections
    UMB Open Access Articles
    UMB Coronavirus Publications

    entitlement

    Related articles

    • Assessing Durability of Vaccine Effect Following Blinded Crossover in COVID-19 Vaccine Efficacy Trials.
    • Authors: Follmann D, Fintzi J, Fay MP, Janes HE, Baden L, Sahly HE, Fleming TR, Mehrotra DV, Carpp LN, Juraska M, Benkeser D, Donnell D, Fong Y, Han S, Hirsch I, Huang Y, Huang Y, Hyrien O, Luedtke A, Carone M, Nason M, Vandebosch A, Zhou H, Cho I, Gabriel E, Kublin JG, Cohen MS, Corey L, Gilbert PB, Neuzil KM
    • Issue date: 2020 Dec 14
    • A randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of SARS-CoV-2 vaccine (inactivated, Vero cell): a structured summary of a study protocol for a randomised controlled trial.
    • Authors: Akova M, Unal S
    • Issue date: 2021 Apr 13
    • Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of treating Healthcare Professionals with the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac - PROFISCOV: A structured summary of a study protocol for a randomised controlled trial.
    • Authors: Palacios R, Patiño EG, de Oliveira Piorelli R, Conde MTRP, Batista AP, Zeng G, Xin Q, Kallas EG, Flores J, Ockenhouse CF, Gast C
    • Issue date: 2020 Oct 15
    • Assessing vaccine durability in randomized trials following placebo crossover.
    • Authors: Fintzi J, Follmann D
    • Issue date: 2021 Nov 30
    • COVID-19 vaccine trials: The use of active controls and non-inferiority studies.
    • Authors: Fleming TR, Krause PR, Nason M, Longini IM, Henao-Restrepo AM
    • Issue date: 2021 Jun
    DSpace software (copyright © 2002 - 2023)  DuraSpace
    Quick Guide | Policies | Contact Us | UMB Health Sciences & Human Services Library
    Open Repository is a service operated by 
    Atmire NV
     

    Export search results

    The export option will allow you to export the current search results of the entered query to a file. Different formats are available for download. To export the items, click on the button corresponding with the preferred download format.

    By default, clicking on the export buttons will result in a download of the allowed maximum amount of items.

    To select a subset of the search results, click "Selective Export" button and make a selection of the items you want to export. The amount of items that can be exported at once is similarly restricted as the full export.

    After making a selection, click one of the export format buttons. The amount of items that will be exported is indicated in the bubble next to export format.