One step closer to the world’s first hepatitis C vaccine

A new Danish-led research initiative is taking major steps toward solving one of the biggest gaps in global public health: a vaccine against hepatitis C. Backed by a DKK 15.7 million Grand Solutions Grant from Innovation Fund Denmark, the HCVIVA project (Hepatitis C Virus Inactivated Vaccine Advancement) aims to advance a promising vaccine candidate toward industrial production and first-in-human clinical trials.

HCV among WHO’s top vaccine priorities

Hepatitis C virus (HCV) poses a major global health challenge, with around 50 million people chronically infected and at risk of severe liver disease including cancer. Every year around 1 million people are infected and HCV causes an estimated 250,000 deaths globally – yet no vaccine exists.

The World Health Organization has classified HCV as a top-priority virus requiring a vaccine to help eliminate viral hepatitis as a public health threat. So far, only a handful of vaccine candidates have reached human trials, and none have been successfully marketed.

Multidisciplinary collaboration with broad expertise

The HCVIVA project unites a multidisciplinary group of experts from both academia and industry led by Professor Judith Gottwein from the Department of Immunology and Microbiology (ISIM) at UCPH and the Department of Infectious Diseases at Hvidovre Hospital.

“We have brought together a strong group of academic and industrial partners whose expertise covers all aspects of the vaccine development pipeline. This is essential to achieving our goal of bringing the HCVIVA vaccine candidate to market and making it broadly available where it is needed,” says Professor Judith Gottwein.

Beside UCPH, partners include Hvidovre Hospital, Statens Serum Institut (SSI), vaccine manufacturer AJ Vaccines, biotech company Nuvonis and NGO European Vaccine Initiative.

Building on long-standing research in CO-HEP

Alongside Judith Gottwein, key scientific collaborators at ISIM are Professor Jens Bukh and PhD Anna Offersgaard. Within the Copenhagen Hepatitis C Program (CO-HEP), these researchers have worked closely for years on hepatitis C virology and immunology, generating results that now enable the development of their vaccine candidate through HCVIVA.

“HCV is difficult to make a vaccine against because there are many different viral variants, and the viral envelope proteins have a structure that hides important epitopes for induction of broadly neutralizing antibodies. However, we have overcome this challenge by exposing such epitopes on recombinant viral particles, leading to the development of an innovative inactivated HCV vaccine candidate that could be a key tool to limit the spread of HCV,” says Professor Judith Gottwein.

The vaccine candidate builds on more than a decade of research into recombinant HCV and broadly neutralizing antibodies. It has already shown promising immune responses in preclinical animal studies. The HCVIVA project now aims to further develop the candidate, paving the way for pharmaceutical production and human testing within four to six years after the innovation project concludes.

Further HCV research backed by DFF grant

In addition to the Innovation Fund Denmark grant, Professor Judith Gottwein received a DKK 5.3 million Research Project 2 grant from the Independent Research Fund Denmark (DFF) in late 2024 for the project Targeting antibody responses to conserved neutralizing epitopes of hepatitis C virus using innovative vaccine antigens.

Leveraging recent advances in AI-based protein design and new insights into HCV envelope protein structure, this project aims to design novel HCV vaccine antigens using subunit and virus-like particle (VLP) vaccine platforms. The goal is to explore how these protein-based antigens can be optimized to induce protective, broadly neutralizing antibody responses.

The project relies on a strong Danish partnership involving key researchers from ISIM: Professor Adam Sander, Professor Jens Bukh, Professor Jan Pravsgaard Christensen, Professor Søren Buus, Associate Professor Lea Barfod and PhD Anna Czarnota, as well as Associate Professor Gabriel Pedersen with main affiliation at SSI.

If successful, these projects could lead to a safe and effective hepatitis C vaccine that significantly reduces reinfection rates among high-risk groups, lowers healthcare costs, and prevents serious liver diseases such as cirrhosis and cancer. Thus, these projects could make a major impact on global health in the fight against the ongoing HCV epidemic.