A strategic model for developing vaccines against neglected diseases: An example of industry collaboration for sustainable development

Figures & data

Figure 1. Distribution of research and development funding by neglected disease between 2009 and 2019. Data were taken from the G-Finder 2019 and 2020 reports.^4,5.

R&D, research and development; HIV/AIDS, human immunodeficiency virus infection/acquired immune deficiency syndrome. Note:“Platform technologies” includes general diagnostic platforms, adjuvants and immunomodulators, vaccine/drug delivery technologies and devices; “other” includes leprosy, cryptococcal meningitis, snakebite envenoming, hepatitis B, Buruli ulcer, trachoma, leptospirosis, rheumatic fever, mycetoma, and multi-disease vector control products.

Figure 2. The GVGH operating model.

Table 1. Phase 1 and 2 clinical trials conducted with GVGH vaccine candidates.

NCT number	Phase	Study title	Population (country)	Schedule for GVGH vaccine
Vaccine against S. Typhi
NCT01123941	1	Safety and immunogenicity of Vi-CRM197 vaccine against S. Typhi in adults	Adults aged 18–40 y (Belgium)	1 dose
NCT01193907	2	Safety and immunogenicity of three formulations of Vi-CRM197 vaccine against S. Typhi in adults	Adults aged 18–40 y (Belgium)	1 dose
NCT01229176	2	Safety and immunogenicity of Vi-CRM197 vaccine against S. Typhi in adults, children, older infants and infants	Adults aged 18–45 y Children aged 24–59 months Infants aged 9–12 months Infants aged 6–8 weeks (India, Pakistan)	1 dose 2 doses, 8 weeks apart 2 doses, 8 weeks apart 3 doses, 4 weeks apart
NCT01437267	2	Safety and immunogenicity of Vi-CRM197 vaccine against S. Typhi in children, older infants and infants	Children aged 24–59 months Infants aged 9–12 months Infants aged 6–8 weeks (Philippines)	2 doses, 8 weeks apart 2 doses, 8 weeks apart 3 doses, 4 weeks apart
NCT01438996	2 (extension of NCT01193907)	Extension study to evaluate the booster response induced by Vi-CRM197 in adults	Adults aged 18–42 y (Belgium)	1 dose
Vaccine against S. sonnei
NCT02017899	1	A phase 1, dose escalation study, to evaluate a new Shigella sonnei vaccine in healthy adults	Adults aged 18–45 y (France)	3 doses, 4 weeks apart
NCT02034500	1	Evaluate a new Shigella sonnei vaccine administered either by intradermal, intranasal or intramuscular route in healthy adults	Adults aged 18–45 y (United Kingdom)	3 doses, 4 weeks apart
NCT03089879	1 (extension of NCT02017899)	A study to evaluate safety and immunogenicity of 1 booster dose of 1790GAHB vaccine in healthy adults previously primed with 3 doses of 1790GAHB vaccine compared to 1 vaccination of 1790GAHB in either subjects who received placebo in the same study or naïve adults not part of the parent study	Adults aged 22–50 y (France)	1 dose, 2–3 y post-priming
NCT02676895	2	A study of the safety and immune response of 2 doses of a new Shigella vaccine in Kenyan adults	Adults aged 18–45 y (Kenya)	2 doses, 4 weeks apart
NCT03527173	2b (human challenge study)	A study to evaluate the efficacy, safety and immunogenicity of a vaccine against Shigella sonnei in healthy adults	Adults aged 18–50 y (United States)	2 doses, 4 weeks apart
Vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a
NCT05073003	1	A study on the safety and immune responses to the GVGH altSonflex1-2-3 vaccine against shigellosis in adults, children, and infants – Stage 1 in adults	Adults aged 18–50 y (Belgium)	2 doses, 3 and 6 months apart

GVGH, GSK Vaccines Institute for Global Health; NCT, national clinical trial; GMMA, generalized modules for membrane antigens.

Figure 3. Milestones of the GVGH operating model as applied to the development of the typhoid conjugate vaccine.

Chapman N, Doubell A, Barnsley P, Goldstein M, Oversteegen L, Chowdhary V, Rugarabamu G, Ong M, Borri J, Hynen A, Policy Cures Research, et al. G-Finder 2019. Uneven progress 2019. http://s3-ap-southeast-2.amazonaws.com/policy-cures-website-assets/app/uploads/2020/02/11150341/G-Finder2019.pdf.

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Chapman N, Doubell A, Tuttle A, Barnsley P, Goldstein M, Oversteegen L, Chowdhary V, Borri J, Hynen A, Kearney M. Policy Cures Research. G-Finder 2020. Neglected disease research and development: Where to now? 2020. http://policy-cures-website-assets.s3.ap-southeast-2.amazonaws.com/wp-content/uploads/2021/04/15055816/G-FINDER-2020_Final-Report.pdf.

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