GSK launches iNTS-TCV vaccine Phase 2 study with Wellcome after five years of support from CARB-X
(BOSTON: November 5, 2026) – 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.
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.”
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.
CARB-X is funded by federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under agreement number 75A50122C00028 and by awards from Wellcome (WT224842), the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Gates Foundation, Germany’s Federal Ministry of Research, Technology and Space (BMFTR), the Novo Nordisk Foundation, the Public Health Agency of Canada, (PHAC), Italy’s Ministry of Economy and Finance (MEF), Japan’s Ministry of Health, the European Commission’s DG Health Emergency Preparedness and Response Authority (DG HERA), and KfW Development Bank. The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in HHS, provides support in the form of in-kind services through access to a suite of preclinical services for product development. The content of this publication is solely the responsibility of the authors and does not necessarily represent the official views of any CARB-X funders.
CARB-X Contact: Marissa Novel, carbxpr@bu.edu
About CARB-X
CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) is the world’s leading non-profit partnership accelerating the research and development of innovative products to prevent, diagnose and treat bacterial infections and address the global threat of antimicrobial resistance. CARB-X pairs non-dilutive funding with comprehensive technical and scientific support, resulting in supported projects being five timesmore likely to advance into clinical development than comparable projects that did not receive CARB-X support. Since 2016, CARB-X has supported 124 R&D projects in 15 countries, and CARB-X product developers have made significant progress: 29 projects have already advanced into or completed clinical trials. Its portfolio strategically focuses on the pathogens and syndromes responsible for the greatest burden of bacterial disease globally, including those disproportionately affecting low- and middle-income countries. All CARB-X-funded product developers are contractually obligated to develop a Stewardship and Access Plan for their product, outlining strategies to ensure responsible stewardship and appropriate access in low- and middle-income countries. CARB-X is headquartered at Boston University and funded by a consortium of governments and foundations that all recognize the urgent global public health threat posed by antimicrobial resistance. https://carb-x.org/
About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.
About Biological E Limited
Biological E. Limited is a leading Indian vaccines and pharmaceutical company with over 70 years of experience in advancing global public health. Supplying vaccines to more than 140 countries, the company maintains a portfolio of 15 WHO-Prequalified vaccines and operates world-class manufacturing facilities that meet international regulatory standards. Biological E. offers end-to-end capabilities spanning vaccine development, technology transfer, process optimization, commercial manufacturing, regulatory support, and global distribution. As a trusted partner to governments, multilateral organizations, and biopharmaceutical innovators, Biological E. is committed to accelerating equitable access to high-quality, affordable healthcare solutions worldwide. Find out more at www.biologicale.com / www.bebiosol.com
About Wellcome
Wellcome supports science to solve the urgent health challenges facing everyone. We support discovery research into life, health and wellbeing, and we’re taking on three worldwide health challenges: mental health, infectious disease and climate and health.
About BARDA and NIAID
The U.S. Department of Health and Human Services works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The Administration for Strategic Preparedness and Response leads the nation’s medical and public health preparedness for, response to and recovery from disaster and other public health emergencies. Within ASPR, the Biomedical Advanced Research and Development Authority (BARDA) invests in innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures needed to combat health security threats. BARDA is one of the leading public sector funders of advanced development of antimicrobial therapeutics and diagnostics worldwide, having invested more than $2.7 billion in antimicrobial products since 2010. This investment has supported the development of over 190 antimicrobial products and led to the U.S. Food and Drug Administration (FDA) approval of six new antibiotics and FDA 510(k) clearance of 10 diagnostics.
As part of HHS, NIH is the primary U.S. federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses.
About the German Federal Ministry of Research, Technology, and Space (BMFTR)
Research and innovation are the foundations for our future. The promotion of science and research by BMFTR represents an important contribution to securing Germany’s prosperity. Research is a German Federal Government policy priority, which is reflected in the development of the funding it is making available to these fields.
About the Global AMR Innovation Fund (GAMRIF)
The Global AMR Innovation Fund (GAMRIF) is a One Health aid fund that supports research and development around the world to reduce the threat of antimicrobial resistance (AMR) in humans, animals and the environment for the benefit of people in low- and middle-income countries (LMICs). GAMRIF core objectives are to develop innovative One Health solutions to tackle AMR; increase availability of context-specific, accessible, and affordable innovations for LMICs; establish international research partnerships with industry, academia, and governments; and collaborate with and leverage additional funding from other global donors.
About the Novo Nordisk Foundation
Established in Denmark in 1924, the Novo Nordisk Foundation is an enterprise foundation with philanthropic objectives. The vision of the Foundation is to improve people’s health and the sustainability of society and the planet. The Foundation’s mission is to progress research and innovation in the prevention and treatment of cardiometabolic and infectious diseases as well as to advance knowledge and solutions to support a green transformation of society. www.novonordiskfonden.dk/en
About the Ministry of Economy and Finance of Italy
The Italian Ministry of Economy and Finance (MEF) performs the functions and tasks incumbent on the State in matters of economic and financial policy, budgeting, public investment planning and public debt management. The Ministry’s activities include coordinating and monitoring public spending and its trends, tax policies and the tax system and state assets. Moreover, the Ministry represents the Italian Government in the main European and international economic and financial fora, performs functions related to global governance and international financial cooperation, maintains relations with international economic, monetary, and financial institutions (such as the IMF, OECD, and Multilateral Development Banks), and negotiates and concludes international agreements and treaties with economic and financial content.
About the Japan’s Ministry of Health, Labour and Welfare (MHLW)
MHLW is a ministry of the Government of Japan whose missions are to improve and promote social welfare, social security, and public health in order to secure and improve the livelihoods of the people and contribute to economic development. Recognizing the urgent global public health threat posed by AMR, MHLW has been supporting various domestic and international efforts to advance research and development of antimicrobials. MHLW has committed to providing contributions to CARB-X from 2024 to 2026.
About the Health Emergency Preparedness and Response Authority (DG HERA)
The European Commission’s Health Emergency Preparedness and Response Authority (DG HERA) is responsible for ensuring the availability and accessibility of medical countermeasures needed to respond to cross-border health threats and emergencies. It plays a central role in strengthening the EU’s preparedness and resilience against antimicrobial resistance and other health threats, by enhancing threat intelligence, accelerating innovation, boosting manufacturing capacity and ensuring availability, and equitable access to and distribution of medical countermeasures.
About KfW Development Bank
KfW is one of the world’s leading promotional banks and a key implementing partner of the German Federal Government. It finances and manages programmes that foster sustainable economic and social development and strengthen global health security, including through support for public–private partnerships and innovation in medical countermeasures.
About Boston University
Founded in 1839, Boston University is an internationally recognized institution of higher education and research. With nearly 37,000 students, it is one of the largest private residential universities in the United States. BU consists of 17 schools and colleges, along with the Faculty of Computing & Data Sciences and a number of multi-disciplinary centers and institutes integral to the University’s research and teaching mission. In 2012, BU joined the Association of American Universities (AAU), a consortium of leading research universities in the United States and Canada. For further information, please contact Meridith St. Jean at stjean28@bu.edu. www.bu.edu