Sumitomo and Japan Institute's universal flu vaccine starts trials

Sumitomo Pharma and Japan’s National Institutes of Biomedical Innovation, Health and Nutrition (NIBIOHN) have recently announced the commencement of Phase 1 clinical trials for a universal influenza vaccine, designated fH1/DSP-0546LP. This initiative aims to develop a vaccine capable of addressing seasonal influenza A strains, even in the event of viral mutations. The experimental vaccine is the result of a collaborative effort between Sumitomo and NIBIOHN.

The Phase 1 clinical trial is set to begin in Belgium, with the initial doses administered in July. The trials will be conducted by Sumitomo and will include subsequent phases, such as Phase 2, where an exposure test will be carried out. During this exposure test, participants will be deliberately infected with the influenza virus to evaluate the vaccine's efficacy.

Sumitomo's Representative Director and Senior Managing Executive Officer, Toru Kimura, explained that Europe is suitable for conducting exposure tests, which is why Belgium has been selected for these trials. The Phase 2 trials will also take place in Belgium, focusing on obtaining proof of concept by assessing if the vaccinated individuals are protected against the influenza virus upon exposure.

The vaccine, fH1/DSP-0546LP, utilizes a modified form of hemagglutinin, a glycoprotein present on the surface of the influenza virus, which plays a crucial role in the virus’s ability to infect host cells. By altering the structure of hemagglutinin, the vaccine exposes epitopes common to various influenza viruses, potentially allowing for a broader protective effect.

Additionally, the vaccine incorporates an adjuvant known as DSP-0546LP, which activates TLR7, a type of Toll-like receptor. Toll-like receptors are integral to the immune system’s response to viral RNA. The inclusion of DSP-0546LP aims to enhance the immune response and improve its duration, thus bolstering the vaccine’s effectiveness.

The trials will initially focus on subtypes of seasonal influenza A that share high antigenic similarity with the modified hemagglutinin used in the vaccine. However, the ultimate goal is to develop a vaccine capable of responding to all subtypes of seasonal influenza A.

Participants in the study will be divided into several groups: a placebo group, a group receiving only the antigen, and a group administered with only the adjuvant. Each group will include several dozen patients. The primary objective of these trials is to determine whether the fH1/DSP-0546LP vaccine can induce the production of antibodies that are effective against a broad spectrum of influenza viruses.

In conclusion, the development and testing of the fH1/DSP-0546LP vaccine mark a significant milestone in the quest for a universal flu vaccine. Sumitomo Pharma and NIBIOHN are progressing towards a solution that could potentially offer broader and more robust protection against seasonal influenza A, even in the face of viral mutations. The clinical trials in Belgium are a critical step in this journey, aiming to validate the vaccine’s ability to prevent influenza infections and pave the way for future advancements in flu prevention.