December 8, 2023

It’s still early days, but the race to develop the first safe and effective mRNA-based flu vaccine is gaining momentum.

The latest move is a Phase 1 trial testing H1ssF-3928 mRNA-LNP developed by the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Safety and Immune Response Research Center (VRC) at Duke University in Durham, North Carolina. ).

Approximately 50 participants aged 18-49 will be divided into three groups and given 10, 25 and 50 micrograms of the active drug. Then after the optimal dose is determined, 10 other participants will receive this measured injection. There is an additional group that will receive the current quadrivalent seasonal influenza vaccine, so the researchers have a comparative dataset that takes into account the immune response and safety of off-the-shelf influenza vaccines.

Participants in the trial will then be evaluated periodically over 12 months to see how the drug’s immune response is performing and to assess its short- and long-term safety.

Although the amount varies with the circulating seasonal influenza strains, CDC Between 2010 and 2020, the virus has caused as many as 710,000 hospitalizations and 52,000 deaths each year in the United States, according to estimates. Worldwide, influenza kills as many as 650,000 people each year.

“A universal flu vaccine would be a major public health achievement that would eliminate the need to develop a seasonal flu vaccine each year, and the need for patients to get an annual flu shot,” said NIAID acting director Dr. Hugh Auchincloss. “Additionally, some flu viruses strains have significant pandemic potential. A universal influenza vaccine could serve as an important line of defense against the spread of future influenza pandemics.”

The trial follows a preliminary study of the safety and immune response of the H1ssF (H1 hemagglutinin-stabilized dry ferritin) nanoparticle vaccine at NIAID’s Vaccine Research Center.this phase one trial, generated broad antibody responses in 52 participants aged 18-70 from April 2019 to March 2020.The trial results were published last month in the journal Science Translational Medicine.

The H1ssF vaccine targets the influenza protein hemagglutinin. One part of the protein — the “head” — changes as the virus evolves into different strains, but the backbone of the protein changes much more slowly and remains fairly stable throughout the flu mutation. The researchers believe this is the key to developing a durable, effective universal preventive vaccine.

this new test Combining H1ssF nanoparticle vaccines with messenger RNA (mRNA) serves as a platform with the ultimate goal of delivering a more effective and targeted immune response.

“During flu season, influenza viruses can drift, undergoing small but significant changes that reduce the effectiveness of current vaccines,” said Dr. Emmanuel Walter, chief medical officer and director of Duke Vaccines and Trials. “We hope this vaccine will provide protection against these changes.”

The H1ssF-3928 mRNA-LNP vaccine is not the only potential flu vaccine at this stage. CureVac and GlaxoSmithKline has started a combined phase 1/2 trial of its multivalent, modified mRNA seasonal influenza vaccine. Pfizer and BioNTech Initiate Phase 3 Last September they developed a tetravalent nucleoside-modified messenger RNA (modRNA) vaccine, administering the drug to 25,000 adults aged 18 and older in the United States. Their method is another one, targeting four known strains of influenza recommended by the World Health Organization (WHO).they also started phase one trial The flu shot is combined with their COVID-19 Omicron BA.4/BA.5 vaccine.

However, last month, modern admission A phase 3 trial of its vaccine, mRNA-1010, “did not accumulate enough cases in the interim efficacy analysis to declare early success.” This follows disappointing trial results in 2021.

source: National Institute of Allergy and Infectious Diseases