11 Feb Carlos Martin/ University of Zaragoza

The Global roadmap for research and development for TB vaccines and the corresponding Background document are both very comprehensive, well-structured and clear. They address main actions and priorities currently being considered among the TB vaccine development community (from stakeholders to regulators, manufacturers and researchers). As public academic institution, the University of Zaragoza, patent owner of the vaccine candidate MTBVAC, we consider important to include the following four key points in the text of the roadmap document and one point in the background document, as we indicate in continuation:

1) Roadmap document, Page 11, last paragraph: Please add: “A clinically feasible aerosol route could facilitate the universal administration of licensed new TB vaccines for second-stage TB eradication mass vaccination campaigns.”

2) Roadmap document, Page 12: Table 1.3 Improve vaccine formulation and delivery:

Please add a new key action:
Clinical evaluation for safety and immunogenicity should be facilitated for clinically feasible, well-optimized and preclinically characterized mucosal delivery of new TB vaccines to the lungs for those candidates whose safety and efficacy by a parenteral route (e.g. intradermal or intramuscular route) has been previously established in clinic.

3) Roadmap document, Page 14: Table 2.2 “Comparison of vaccine candidates within and across animal models:

Please add a new point:
Safety, efficacy and immunogenicity should be demonstrated in at least three different animal species of accepted TB-relevance (e.g., mice, including immunocomprimised mice for safety and attenuation, guinea pigs and non-human primates), using BCG as reference gold standard comparator, prior to moving to clinical evaluation”.

4) Roadmap document, Page 19:
Add to last paragraph: Alternative delivery of new vaccines, like the aerosol route, with prior clinically demonstrated safety and immunogenicity, could be used for second-stage TB eradication programmes in post-licensure studies of new TB vaccines.

5) Background document, Page 17, Non-human primate models, last paragraph: Please add: ” It is important that NHP studies with new candidates in clinical development, mimic clinical trial designs as recently published with a candidate TB vaccine in advanced clinical development.” Please add references: “MTBVAC vaccination protects rhesus macaques against aerosol challenge with M. tuberculosis and induces immune signatures analogous to those observed in clinical studies.” White AD, et al., NPJ Vaccines. 2021 Jan 4;6(1):4. doi: 10.1038/s41541-020-00262-8.
See Pdf version of the publication.