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Posted By: Lawrence Herman, MPA, PA-C
April 09, 2019
The National Institutes of Health have begun the first clinical trial of an innovative universal influenza vaccine candidate. A Phase I trial will examine the vaccine’s safety and tolerability as well as its ability to induce an immune response in 53 healthy volunteers. The experimental vaccine, known as H1ssF_3928, was developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID).
The H1ssF_3928 vaccine focuses on the part of the influenza virus that has little-to-no variability between subtypes, thereby making protective antibodies more durable and solving a significant public health issue that has the potential to kill thousands annually and millions during a pandemic.
The trial design will enroll the first five healthy volunteers aged 18 to 40 years, who will then receive a smaller 20 mcg dose to evaluate initial safety. Subsequently, the trial will enroll 48 additional healthy volunteers, aged 18 to 70 years, who will receive two 60 mcg doses 16 weeks apart. Blood samples will be drawn periodically over as long as 15 months to assess anti-influenza antibody immune response. Assessing vaccine efficacy based upon previous influenza response is important.
The team at NIAID used the stem—the component that remains relatively consistent from strain to strain—of an H1N1 influenza virus to create the candidate vaccine. Each year there tends to be a “shift and drift” associated with the influenza virus, making an effective vaccine against all strains problematic. There are 18 known HA subtypes and 11 known NA subtypes, but only H1N1 and H3N2 circulate among people seasonally. Significantly, H5N1, H7N9, and other strains have caused a handful of deadly outbreaks and have the potential to cause a pandemic.
While only a first step, this is exciting news. The universal influenza vaccine remains years away but this may be the Holy Grail that we have been searching for. Stay tuned!
- National Institutes of Health. NIH begins first-in-human trial of a universal influenza vaccine candidate. www.nih.gov/news-events/news-releases/nih-begins-first-human-trial-universal-influenza-vaccine-candidate. Accessed April 5, 2019.