SWAT Team Description: The Clinical Development and Operations SWAT team collaborates on initiatives related to clinical operations (incl.  supporting trial site readiness and setting up a clinical trial site network, providing information on COVID-19 CTA and EC requirements for specific regions), vaccine safety (incl. AESIs / case definitions, post roll-out vaccine safety surveillance), vaccine science (incl. development of strategic documents on key topics such as standard CT elements, adaptive trial design, Correlate of Protection, alternative/supportive evidence, optimization options) and maternal immunization. 

Co-Leads: Peter Dull (BMGF), Jakob Cramer (CEPI)


       

Clinical Science

Workshops & Meetings

The Clinical Development SWAT Team is holding regular webinars (one per month) to discuss current topics in COVID-19 vaccine development. Material of past workshops can be found below.     

COVID-19 Vaccine Development in an Increasingly Seropositive World
Workshop on 27 Oct 2021: Workshop Full Report | Workshop Complete Materials    

Fractional Dosing Platform Trial Approach
Meeting on 10 Sep 2021: Meeting Materials

Connecting COVID-19 primary and booster vaccination goals: historical precedents, immunologic considerations and approaches to meeting regulatory and policy requirements complexity
Workshop on 5 Aug 2021: Workshop Full Report |  Workshop Complete Materials    

Booster and Mix & Match COVID-19 Vaccine Strategies - Planning Ahead in an Environment of Increasing Complexity
Workshop on 3 Jun 2021: Workshop Full Report |  Workshop Complete Materials                        

Multivalent COVID-19 vaccines to help address emergence of variants: CMC and Clinical implications    
Workshop on 14 Apr 2021: Workshop Full Report | Workshop Complete Materials  |  Discussion Forum | 

SARS-CoV-2 variants - Practical considerations for accelerated clinical development in light of current regulatory guidance     
Workshop held on 25 Mar 2021: Workshop Full Report  |  Workshop Complete Materials  |  Discussion Forum  |  Workshop Q&A

Immune Correlates, SARS-CoV-2 variants and ‘mix & match’: How vaccine developer approaches might be impacted by emerging data
Workshop held on 25 Feb 2021: Workshop Full Report  |  Workshop Complete Materials  |  Discussion Forum

Emerging Challenges to the Development of COVID-19 Vaccines 
Workshop held on 28 Jan 2021: Workshop Full Report   |  Workshop Complete Materials  |  Discussion Forum

COVID-19 Infection & Transmission
Workshop held on 17 Dec 2020: Workshop Full Report   |  Workshop Complete Materials  | Discussion Forum

COVID-19 Correlates of Protection
Workshop held on 19 Nov 2020: Workshop Full Report |  Workshop Complete materials | Workshop Q&A

Early Efficacy from Covid-19 Phase 3 Vaccine Studies: Ethical, Operational, & Scientific Considerations
Workshop Held on 28 Oct 2020: Workshop Full Report  |  Workshop Complete Materials

COVID-19 Efficacy Trial Design Considerations & Early Learnings from Ongoing Studies 
Workshop Held on 24 Sept 2020:  Workshop Full Report  |  Workshop Complete Materials

 

Summary Documents and Publications

These documents provide a summary of key points from the COVID-19 literature, guidelines and other documents from experts on the subject matter, including from national and multilateral organizations and authorities. Due to the rapidly evolving situation, they may not include all the latest evidence and updates are likely to be made in the future. It's purpose is to support organizations and institutions involved in the development of COVID-19 vaccines. These neither constitute an official guidance nor are a substitute for the same and readers are encouraged to also refer to official guidance from regulatory or other responsible agencies.                                                                                                                                            

  1. Comparative Immunogenicity Trials of Novel Candidate COVID-19 Vaccines in a Seropositive Population | 23 March 2022 | Prepared by: CEPI COVID-19 Clinical Working Group  

  2. Considerations for Within-platform Immuno-bridging for Monovalent, Modified SARS-CoV-2-Strain, COVID-19 Candidate Vaccines in primed individuals V.1.0 | 16 December 2021 | Prepared by: CEPI COVID-19 Clinical Working Group

  3. Single Dose COVID Vaccination Irrespective of Baseline Serostatus V.2 | 18 June 2021 | Prepared by: CEPI COVID-19 Clinical Working Group

  4. Meeting Report: 'IABS/CEPI Platform technology webinar: Is it possible to reduce the vaccine development time?'  | 15 April 2021  | Joris Vandeputte et al. 

  5. Status Report on COVID-19 Vaccines Development | 14 April 2021 |  Arun Kumar et al.

  6. Long COVID: Implications for Clinical Development  |  Version 2.0 dated 29 Mar 2021  |  Prepared by: Paul Oloo for CEPI COVID-19 Clinical Working Group

  7. Identifying optimal symptoms combination for PCR trigger  |  25 Nov 2020 | Posted on medRxiv

  8. A Comparison of Vaccine Efficacy Elements in Advanced Stage Clinical Trial Protocols V3.0 | 19 Nov 2020 | Prepared by: Paul Oloo for CEPI COVID-19 Clinical Working Group 

  9. A Comparison of Study Population Inclusion and Exclusion Criteria reported in Advanced Stage Clinical Trial Protocols | 19 Nov 2020 | Prepared by: Paul Oloo for CEPI COVID-19 Clinical Working Group 

  10. CoVPN COVID-19 Vaccine Efficacy Trial Immune Correlates SAP | 9 Nov 2020

  11. Evaluating the Burden-of-Disease Endpoint to Assess Vaccine Efficacy  |  26 Oct 2020  |  Prepared by:Edde Loeliger and Bob Small for CEPI COVID-19 Clinical Working Group

  12. Early and Advanced Stage Clinical Development Core Elements- Comparison of the Guidance and Considerations   |  01 September 2020 | Prepared By: Paul Oloo for CEPI COVID-19 Clinical Working Group | For questions, please write to: paul.oloo@cepi.net

  13. Considerations for Inclusion of Risk Populations into COVID-19 Vaccine Efficacy Trials | 15 July 2020 | Paul Oloo & Edde Loeliger for CEPI COVID-19 Clinical Working Group 

  14. Core Elements for Advanced Stage Clinical Trials of COVID-19 Vaccine Candidates: Aspects to Consider  |  26 June 2020 | Amol Chaudhari for CEPI COVID-19 Clinical Working Group 

  15. Efficacy Endpoints in COVID-19 Vaccine Trials: SARS-CoV-2 Infection |  25 June 2020  | Amol Chaudhari & Edde Loeliger for CEPI COVID-19 Clinical Working Group 

  16. COVID-19 Efficacy Endpoints in Interventional Trials Version 2.0: What Constitutes an Incident Clinical Disease Case and What Triggers Diagnostic Work-Up  |  Retired as of 20 Oct 2020 | Edde Loeliger & Amol Chaudhari for CEPI COVID-19 Clinical Working Group  |  This document will no longer be updated and some of the information may not be current. The readers are encouraged to refer to the regulatory guidance by US FDA & the WHO PQ group in the meantime as well the publicly available clinical trial protocols of various developers. Further documents with specific focus on vaccine efficacy are being developed to address the emerging information and will be released shortly.

  17. Vaccine Efficacy Assessment for COVID-19 |  7 May 2020  |  By Edde Loeliger and Bob Small for CEPI COVID-19 Clinical Working Group 

  18. General Core Elements for Early Phase Clinical Trials of COVID-19 Vaccine Candidates: Aspects to Consider  |  16 April 2020  |  Amol Chaudhari for CEPI COVID-19 Clinical Working Group  

  19. COVID-19 Vaccines: Target Product Characteristics 

 
  Advanced Stage Clinical Trial Protocols:

  Moderna |  Pfizer |  Astra Zeneca  |  Janssen  |  Novavax  |  Curevac | Butantan Institute 

  PATHCollection of Protocols and Guidelines 

 

  Mutations and Variants

  See information on the GISAID and Agility projects. 

 

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