Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) today announced that GSK’s global health vaccine program for a combined invasive nontyphoidal Salmonella and typhoid fever (iNTS‑TCV) has advanced into a Phase 2 clinical trial. The program is the first-ever CARB-X-supported vaccine candidate to reach this stage of advanced development.
The candidate is being developed to help prevent disease caused by invasive nontyphoidal Salmonella (iNTS) and typhoid fever—life-threatening bacterial infections that disproportionately affect young children in low- and middle-income countries (LMICs), particularly in South Asia, Southeast Asia, and sub-Saharan Africa.
There are currently no licensed vaccines against iNTS, which is associated with multidrug resistance and is listed among the WHO high-priority pathogens. The GSK candidate combines a new iNTS vaccine formulation with an existing typhoid conjugate vaccine (TCV), to increase the likelihood of uptake and sustained coverage for iNTS prevention.
The Phase 2 study is being funded with the support of Wellcome, a global philanthropy which co-founded CARB-X in 2016. The TCV component, which is WHO-Prequalified and eligible for procurement and financial support through Gavi, the Vaccine Alliance, is provided by Biological E. Limited. Biological E is an India-based vaccine innovator and manufacturer, and has supplied more than 5 billion doses of vaccines to more than 140 countries in the last decade through a portfolio of 15 WHO-Prequalified vaccines.
Marking a milestone
CARB‑X has supported GSK’s iNTS‑TCV program’s preclinical and Phase 1 development since 2021, providing $5.3 million in non‑dilutive funding and customized technical support to help advance the innovative vaccine candidate through early development and prepare it for continued clinical progress. The program’s transition into Phase 2 marks a milestone in efforts to address severe bacterial infections with high mortality rates, with iNTS case fatality estimated at approximately 15 percent, substantially higher than many other major febrile illnesses.
“Advancing the iNTS-TCV vaccine into Phase 2 trials represents an important step forward for potentially addressing a major unmet global health need,” said Richard Alm, Chief of R&D at CARB-X. “This milestone underscores the potential of prevention strategies to help reduce the burden of antimicrobial‑resistant infections while demonstrating the importance of global collaboration, including Wellcome’s funding of the Phase 2 trial and Biological E’s role as a vaccine partner, in advancing innovative solutions to patients living in high-burden areas.”
“Progressing this combined iNTS-TCV candidate into Phase 2 reflects our shared commitment to innovation and tackling high burden infectious diseases,” said Dr Harmony P. Garges, GSK’s Chief Global Health Officer. “Together, we are now focused on generating further clinical data for a vaccine that aims to protect children most at risk of iNTS-related diseases and typhoid fever, and help address the growing global threat of antimicrobial resistance.”
Unmet need
Pierre Balard, Research Lead for Vaccines in Wellcome’s Infectious Disease team, said: “Despite its significant burden in infants in sub-Saharan Africa, we still have no way of protecting those most at risk of iNTS disease. In the light of this unmet need, this trial is a promising step towards a much-needed vaccine in an area that has been chronically underfunded. For science to make a difference where it matters most, investment in long-term research and partnerships is essential.”
Recent research has shown that without vaccination, 9.2 million new iNTS cases are estimated to occur in children younger than the age of 5 across sub-Saharan Africa from 2022 to 2038. The Phase 2 study is vaccinating infants ages 6 weeks to 6 months at Medical Research Council Unit The Gambia to further evaluate the vaccine’s immunogenicity and safety against invasive Salmonella disease, building on results generated during earlier stages of development supported by CARB-X.
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