Late-stage clinical development of Chikungunya vaccines in endemic countries (CHIKV) and Controlled Human Infection Models for SARS-CoV2 and other beta coronaviruses (CHIM).

Grant number: 101126531

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Key facts

  • Disease

    COVID-19, Unspecified
  • Start & end year

    2023
    2028
  • Known Financial Commitments (USD)

    $74,900,000
  • Funder

    European Commission
  • Principal Investigator

    Breugelmans Gabrielle
  • Research Location

    Norway
  • Lead Research Institution

    COALITION FOR EPIDEMIC PREPAREDNESS INNOVATIONS
  • Research Priority Alignment

    N/A
  • Research Category

    Vaccines research, development and implementation

  • Research Subcategory

    Phase 4 clinical trial

  • Special Interest Tags

    N/A

  • Study Type

    Clinical

  • Clinical Trial Details

    Clinical Trial, Phase IV

  • Broad Policy Alignment

    Pending

  • Age Group

    Unspecified

  • Vulnerable Population

    Pregnant womenOther

  • Occupations of Interest

    Unspecified

Abstract

A Framework Partnership Agreement (FPA) between the Coalition for Epidemic Preparedness'ÄØInnovations (CEPI) and the European Union (EU) was signed in April 2019, to finance and coordinate the development of new medical countermeasures to prevent and contain infectious disease epidemics, which are of particular concern to low- and middle-income countries. As part of the FPA, a call for proposals (CfP) was launched jointly with the EU and supported the preclinical development of Rift Valley Fever Virus vaccines and the late-stage development of Chikungunya virus vaccines (CHIKV). While previous funding has led to the development of pre-licensure CHIK vaccines, in this current application we like to further advance our CHIK vaccine programme, and support CHIK vaccines that are near or have achieved regulatory licensure by supporting their clinical development into phase IV clinical trials to increase our understanding of the long-term safety, durability of protection, and effectiveness against virologically confirmed disease. Furthermore, we would like to expand the use indication by supporting clinical trials in vulnerable populations, including children, immunosuppressed and pregnant women.'ÄØ As part of this grant application, we also like to launch a CfP on Controlled Human Infection Models (CHIM). The overall objective of the CHIM proposal is to support research projects that increase knowledge in vaccine-induced mucosal immunity and advance the development of transmission-blocking vaccines against coronaviruses and other potential respiratory viral threats.'ÄØThe expected outcome of this CfP is to create a global network of experts conducting CHIM at a high level of consistency and reliability. This current grant application seeks to leverage 'Ǩ70M from Horizon Europe, which will be supplemented with 'Ǩ30M from CEPI making a pool of 'Ǩ100M. Awards will have a 36'Äì48-month duration and will be administered by the CEPI secretariat.