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A public health value proposition for prospective Shigella vaccines
Shigella is the leading bacterial cause of diarrhea among children in low- and middle-income countries (LMICs), but no licensed Shigella vaccines exist yet. PATH conducted a series of studies to understand the public health value of prospective Shigella vaccines, with several themes emerging. First, the potential health impact and economic value of Shigella vaccines appear greater than previously estimated, due to Shigella’s increasingly recognized contribution to growth faltering in children, leading to potentially profound effects on wage earning as adults, and Shigella’s growing antimicrobial resistance (AMR). In addition, despite significant awareness of Shigella among LMIC stakeholders, the attractiveness and prioritization of Shigella vaccines appear highly dependent on the magnitude of impact on diarrheal disease, stunting, and AMR. Finally, Shigella-containing combination vaccines are likely to markedly increase attractiveness to LMIC decision-makers, but their development, licensure, and policy recommendation pathways face considerable obstacles.
These findings may help guide investment decisions by donors and Shigella vaccine developers to better meet LMIC needs, influence vaccine formulation, clinical trial designs, and endpoints, or help inform global policy guidance and national vaccine introduction decisions. These results indicate that, under certain scenarios, there may be a substantial market for Shigella vaccines.
Inventprise’s expanded-coverage pneumococcal vaccine enters the clinic
Biotechnology company Inventprise recently announced that a Phase 1/2 clinical study of its 25-valent pneumococcal conjugate vaccine (PCV) candidate began in Halifax, Canada. This first-in-human study is an important step in the efforts to develop an affordable, expanded-coverage PCV. Sponsored by Inventprise and conducted in collaboration with PATH and the Canadian Immunization Research Network, the Phase 1/2 study is evaluating the vaccine candidate’s safety and ability to induce an immune response in adults, young children, and infants, sequentially.
As a leading cause of deadly childhood pneumonia, sepsis, meningitis, and debilitating otitis media, the pneumococcus bacterium is responsible for an estimated 300,000 deaths per year in children younger than five years of age worldwide. Current PCVs approved for infants are lifesaving tools and cover 10 to 15 pneumococcal varieties (or serotypes), but do not yet include some serotypes that remain threats. The Inventprise PCV could increase the number of serotypes included to 25—expanding the potential to prevent disease from several deadly and emerging serotypes not yet addressed by existing PCVs. 
Thailand-produced COVID-19 vaccine enters late-stage clinical development
The Thai Government recently announced that the NDV-HXP-S COVID-19 vaccine candidate (HXP-GPOVac) produced by state-owned vaccine manufacturer Government Pharmaceutical Organization (GPO) has advanced into Phase 3 clinical evaluation as a booster dose in Nakhon Phanom Province, Thailand. The vaccine is based on innovative technology that uses inactivated Newcastle disease virus (NDV) expressing a stabilized spike protein of SARS-CoV-2 called HexaPro (HXP-S) to induce an immune response against COVID-19. HXP-GPOVac has a positive safety and immunogenicity profile from Phase 1 and 2 clinical studies. The vaccine is made in chicken eggs in much the same way as traditional influenza vaccines in widespread use and can be produced affordably in the same facilities. As a locally produced vaccine, it could be an affordable booster option for Thailand that helps reduce imported vaccine costs and supports vaccine supply security.
International collaboration has been central to this vaccine candidate’s advancement. The Icahn School of Medicine at Mount Sinai developed the recombinant NDV vaccine technology and provided the master seed virus to GPO for rapid production scale up; the University of Texas at Austin developed HexaPro; and PATH has served as consortium facilitator and technical advisor to GPO and other NDV-HXP-S manufacturers in Vietnam and Brazil.
Register and submit an abstract for the Microneedles 2023 conference
Registration and abstract submissions are now open for the 7th International Conference on Microneedles (Microneedles 2023), which will be held in-person on May 15 to 17, 2023 in Seattle, Washington. Co-hosted by PATH and Merck, Microneedles 2023 provides a unique international forum for academics and industry involved in the design, development, application and clinical translation of microneedle technology for vaccine and drug delivery and diagnostic applications. The conference will include presentations from leaders in the field and early-career researchers, as well as opportunities for networking. Individuals interested in presenting their original work at Microneedles 2023 may submit an abstract for inclusion as either an oral or poster presentation. The primary deadline for abstract submissions is January 27, 2023, and late-breaking abstracts are due by March 13, 2023. Early-bird pricing for registration and sponsorship opportunities are also available. |
