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)

Working Groups & Documents:   Clinical Operations   |   Clinical Science   |   Vaccine Safety   |   Maternal Immunization 


Clinical Operations

Vaccine Efficasy Workshop Held on 24 Sept 2020:  Workshop full report  |  Workshop complete materials

Operational Preparedness Database – COVID-19-specific information on Regulatory and Ethics requirements as well as other operational details by country

Trainings:

R&D Good Participatory Practice for COVID-19 clinical trials: a toolbox  |  Coronavirus disease (COVID-19) training: Online training

Good Participatory Practice:

Vaccine Development Landscape

WHO COVID-19 vaccine landscape   LSHTM Vaccine landscape

Clinical Trial Sites and Networks
COVAX and BMGF have separately provided bridge funding to experienced clinical trial sites around the world in preparation for an unprecedented number of concurrent Phase III clinical trials with new COVID-19 specific infrastructure, physical capacity, and staffing requirements. These sites were selected in partnership with product development partners, who are working to ensure that these sites are ready for Phase III COVID-19 vaccine trials. Site readiness will be confirmed by independent consultants using harmonized criteria. This dashboard provides a high level overview of study sites that have received supportive COVAX or BMGF funding to improve capacity  to conduct phase 3 efficacy studies for Covid-19 vaccines in coming months.  This dashboard will be updated regularly:

Dashboard of COVAX-Supported Sites Ready for Clinical Trials

Please find below a list of site networks which may be valuable contacts for COVID-19 trials. It should be noted, however, that neither COVAX nor CEPI can accept responsibility for the quality of the investigational sites and this is not to be understood as a recommendation of the networks or individual sites within the networks.

Epidemiology and Modelling

SeroTracker serology study data   IHME COVID predictive model

Regulatory and Ethics

Selected strategic and regulatory guidance documents on Covid-19 Clinical Trials: 

Africa:   AVAREF   |   WHO Africa

Europe: European Medicines Agency (EMA)

USA: Food and Drug Administration (FDA)  |   NIH- NIAID - ClinRegs   |   ACRO

WHO:  COVID-19 Vaccine PQnew  |  Coronavirus disease (COVID-2019) R&D   |   Guidance for managing ethical issues

CROs and Sponsors:

CEPI launched a call for Expression of Interest in April 2020 which aimed to identify organisations with capability and interest to act as sponsors or Contract Research Organisations (CROs) for clinical trials involving one or more COVID-19 vaccine candidates. A total of 84 organisations from 26 countries applied. CEPI has performed an in-depth evaluation of the received Expressions of Interest and has provided a summary to its COVID-19 developers. With advanced stage trials planned to start imminently, developers will have a repository of organisations from whom to seek assistance.

Please click below to find a list of all organisations who applied and who agreed to have their name and contact details shared on this webpage.

More details on CRO & Sponsor EOIs

This information is provided as a service to COVID-19 vaccine developers to facilitate clinical trials and does not represent an endorsement of any specific organization by CEPI.

 

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Clinical Science

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- 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 Wongrki Group | For questions, please write to: paul.oloo@cepi.net

2- 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 

3- 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 

4- 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 

5- 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.

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

7- 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  

8- COVID-19 Vaccines: Target Product Characteristics 

 
  Advanced Stage Clinical Trial Protocols:

  Moderna |  Pfizer |  Astra Zeneca  |  Janssen  |  PATHCollection of Protocols and Guidelines

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Vaccine Safety

Workshops:

1- Workshop Report: COVAX Vaccine Safety Working Group: Developer Needs Workshop | 21 Oct 2020 | By Dr Julia Granerod

Documents: 

1- Priority List of COVID-19 Adverse events of special interest: Quarterly update 1 | 9 Sept 2020 | By Barbara Law 

2- Consensus considerations on the assessment of the risk of disease enhancement with COVID-19 vaccines: Outcome of a Coalition for Epidemic Preparedness Innovations (CEPI)/Brighton Collaboration (BC) scientific working meeting. | March 12-13, 2020 

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Maternal Immunization

1- CEPI workshop on Maternal Immunization against Emerging Infectious Diseases | London 12-13 February 2020 

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