Human Clinical Trial of mRNA Universal Influenza Vaccine Begins

Although still in its early stages, the race to develop the first safe and effective mRNA-based influenza vaccine is gaining momentum.

In the latest move, a Phase 1 clinical trial has begun at Duke University in Durham, North Carolina to test the safety and immune response of H1ssF-3928 mRNA-LNP developed by the National Institute of Allergy and Infectious Diseases (NIAID) vaccine. are doing. Research Center (VRC).

Approximately 50 participants aged 18-49 years will be divided into three groups, each receiving 10, 25, and 50 micrograms of active agent. Once the optimal dose is determined, he will additionally administer this measured jab to 10 participants. As there are additional groups receiving the current quadrivalent seasonal influenza vaccine, researchers have prepared a comparative data set that considers the immune response and safety of readily available influenza vaccines.

Study participants are then evaluated periodically over 12 months to see how the drug’s immune response works and to assess short- and long-term safety.

The number varies depending on which seasonal influenza strains are circulating, but Centers for Disease Control and Prevention During the worst period from 2010 to 2020, the virus is estimated to have caused up to 710,000 hospitalizations and 52,000 deaths annually in the United States. Worldwide, the flu kills 650,000 people each year.

“A universal flu vaccine would be a major public health achievement that could eliminate the need to develop a seasonal flu vaccine each year, and the need for patients to receive annual flu vaccinations,” said Hugh Oh, Acting NIAID Director. Dr. Chincross said. . “In addition, some influenza viruses have significant pandemic potential. Universal influenza vaccines may serve as an important line of defense against the spread of future influenza pandemics.”

This trial follows the initial NIAID Vaccine Research Center study of the safety and immune response of H1ssF (H1 hemagglutinin-stabilized stemferritin) nanoparticle vaccines.of Phase 1 trial, from April 2019 to March 2020, 52 participants aged 18 to 70 years had a broad antibody response.The results of the exam were published in a magazine last month. Scientific translational medicine.

The H1ssF vaccine targets the influenza protein hemagglutinin. The “head” portion of this protein changes as the virus evolves into different strains, whereas the protein stem changes much slower and remains largely constant throughout influenza mutations. Researchers believe that here lies the key to a long-lasting and effective universal preventive vaccine.

of new attempt with the ultimate goal of combining H1ssF nanoparticle vaccines and messenger RNA (mRNA) as a platform to achieve more efficient and targeted immune responses.

“During flu season, the flu virus drifts and makes small but significant changes that reduce the efficacy of current vaccines,” said Chief Medical Officer and head of the Duke Vaccines and Clinical Trials Unit. Dr. Emmanuel Walter said. “We hope this vaccine can provide protection against such changes.”

The H1ssF-3928 mRNA-LNP vaccine is not the only flu vaccine available at this stage of development. CureVac and GSK has initiated a Phase 1/2 combination trial of a multivalent modified mRNA seasonal influenza vaccine. Pfizer and BioNTech Begin Phase 3 The company developed a quadrivalent nucleoside-modified messenger RNA (modRNA) vaccine last September and administered the drug to 25,000 adults aged 18 and older in the United States. Their approach is yet another, targeting four known influenza strains recommended by the World Health Organization (WHO).they also started Phase 1 trial Influenza vaccination combined with COVID-19 Omicron BA.4/BA.5 vaccine.

However, last month contemporary recognized A Phase 3 trial of the company’s vaccine mRNA-1010 “failed to obtain a sufficient number of cases to declare early success in an interim efficacy analysis.” Continuing from 2021, disappointing test results.

sauce: National Institute of Allergy and Infectious Diseases