Candidate enrollment begins for a universal mRNA influenza vaccine clinical trial

16 May 2023

Written by Amy White

Researchers at the National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center (VRC; MD, USA), part of the National Institutes of Health, have set into motion a clinical trial of an experimental influenza vaccine and have begun enrolling volunteers at Duke University (NC, USA) for its Phase I trial.

The Phase I trial will explore the safety of the experimental vaccine and its ability to induce an immune response. The trial will take on up to 50 healthy participants aged 18 – 49 years and will split these individuals into three study groups, where they will be vaccinated with 10, 25 and 50 micrograms of the vaccine respectfully. After the assessment of the data determining the optimum dosage, 10 additional participants will be enrolled to receive and monitor the optimum dosage. The trial will also include a group of participants who will receive the current seasonal influenza vaccine, which will allow researchers to compare the immunogenicity and safety of the candidate vaccine and available seasonal vaccines. Participants will be regularly evaluated to assess the vaccine’s safety and efficacy over time and will receive follow-up appointments up to a year after the study.

Although annual seasonal flu vaccines are available, influenza kills thousands of people in the United States each year. Seasonal flu vaccines are useful tools for minimizing the spread and severity of influenza but do not provide immunity against all strains of flu. Therefore, each year before flu season starts, experts must predict which strains will be common in the upcoming months and select three or four strains to include in the next seasonal vaccine. This then puts pressure on vaccine manufacturers to produce and distribute the vaccine whilst the dominant strains of the virus could be changing in unexpected ways, which can lead to decreased efficacy of the vaccine. A universal flu vaccine would solve these issues by protecting its recipients against a variety of strains and potentially providing long-term immunity against influenza.

You may also be interested in:

Acting NIAID Director, Hugh Auchincloss stated:

“A universal influenza vaccine would be a major public health achievement and could eliminate the need for both annual development of seasonal influenza vaccines, as well as the need for patients to get a flu shot each year […] Moreover, some strains of the influenza virus have significant pandemic potential. A universal flu vaccine could serve as an important line of defense against the spread of a future flu pandemic.”

A similar universal influenza vaccine being developed by researchers at NIAID’s VRC has already shown positive results in Phase I of its clinical trials. By developing and assessing various platforms for a universal flu vaccine, there is a higher chance researchers will find one that is safe and provides stronger immunity against a variety of strains which will hopefully lead to fewer vaccinations needed each year.

Source: National Institutes of Health press release, www.nih.gov/news-events/news-releases/clinical-trial-mrna-universal-influenza-vaccine-candidate-begins