The TB vaccine development pathway - An innovative approach to accelerating global TB vaccine development.

Danielle Roordink, Ann Williams, Bernard Fritzell, Dominick J Laddy, Emmanuelle Gerdil, Anne Marie Graffin, Dereck Tait, Leo van der Pol, Ilona van den Brink, Marit Holleman, Jelle Thole, Gerald Voss, Maria Lempicki, Georges Thiry
Author Information
  1. Danielle Roordink: TuBerculosis Vaccine Initiative (TBVI), Lelystad, the Netherlands. Electronic address: Danielle.roordink@tbvi.eu.
  2. Ann Williams: TuBerculosis Vaccine Initiative (TBVI), Lelystad, the Netherlands.
  3. Bernard Fritzell: TuBerculosis Vaccine Initiative (TBVI), Lelystad, the Netherlands.
  4. Dominick J Laddy: IAVI, New York, USA.
  5. Emmanuelle Gerdil: TuBerculosis Vaccine Initiative (TBVI), Lelystad, the Netherlands.
  6. Anne Marie Graffin: TuBerculosis Vaccine Initiative (TBVI), Lelystad, the Netherlands.
  7. Dereck Tait: IAVI, Cape Town, South Africa.
  8. Leo van der Pol: TuBerculosis Vaccine Initiative (TBVI), Lelystad, the Netherlands.
  9. Ilona van den Brink: TuBerculosis Vaccine Initiative (TBVI), Lelystad, the Netherlands.
  10. Marit Holleman: TuBerculosis Vaccine Initiative (TBVI), Lelystad, the Netherlands.
  11. Jelle Thole: TuBerculosis Vaccine Initiative (TBVI), Lelystad, the Netherlands.
  12. Gerald Voss: TuBerculosis Vaccine Initiative (TBVI), Lelystad, the Netherlands.
  13. Maria Lempicki: IAVI, New York, USA.
  14. Georges Thiry: TuBerculosis Vaccine Initiative (TBVI), Lelystad, the Netherlands.

Abstract

Two proof of concept clinical trials with TB vaccines demonstrate that new approaches can prevent sustained TB infection in adolescents (BCG revaccination) and TB disease in adults (M72/ASO1) (Nemes et al., 2018; Tait et al., 2019) [1,2]. Both approaches are in late stage development and provide motivation and rationale to invest into a global TB vaccine pipeline. This pipeline needs to be diverse to address TB-specific challenges including variation in target populations, uncertainties in animal model predictivity and lack of immune correlates of protection. It requires that individual vaccine candidates must be advanced rationally and that the global pipeline must be managed in the most nimble and resource-efficient way, especially in the current constrained funding environment. The TB Vaccine Development Pathway is a webtool which has been developed as an offer to the field to provide a source of information and guidance covering vaccine development from discovery to implementation. It is underpinned by generic and TB vaccine-specific guidelines, regulatory frameworks and best practice, and was compiled by a multi-disciplinary team of scientific and technical experts with the input of the TB vaccine community. The Pathway is a unique tool to guide and accelerate the development of TB vaccine candidates and may be useful for other vaccine development fields.

Keywords

References

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MeSH Term

Drug Development
Humans
Immunization, Secondary
Mycobacterium tuberculosis
Retrospective Studies
Tuberculosis
Tuberculosis Vaccines

Chemicals

Tuberculosis Vaccines

Word Cloud

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