The National Institutes of Health (NIH) has announced the initiation of a phase 1 clinical trial assessing the safety, tolerability, and efficacy of a “universal” influenza vaccine candidate, H1ssF_3928, in healthy adult patients.
In order to provide longer-lasting protection against multiple influenza subtypes, scientists at the National Institute of Allergy and Infectious Diseases (NIAID) are aiming to create a “universal” influenza vaccine. This vaccine, H1ssF_3928, consists only of the hemagglutinin (HA) stem region and does not include the HA head region, like previous influenza vaccines do.
“The stem is more constant than the head among influenza strains, and thus less likely to need to be updated every season. Many scientists predict that targeting the HA stem without the distraction of the HA head could induce broader and longer lasting immunity,” according to an NIH press release. Because of this, H1ssF_3928 aids in teaching the body to develop immune responses to a diverse number of influenza subtypes.
The trial, which is being conducted at the NIH Clinical Center in Bethesda, Maryland, will include at least 53 healthy patients 18 to 70 years old. One week following vaccination, the patients will record their body temperature as well as any symptoms on a diary card. Additionally, blood samples will be drawn to determine anti-influenza antibodies levels at the clinic at various time points throughout the trial.
Over 12 to 15 months, the patients will be seen for a total of 9 to 11 follow-up visits. Data analysis will include determining how age and previous exposure to influenza variants affects a patient’s immune response; patients will be stratified into 4 groups based on age: 18-40 years old, 41-49 years old, 50-59 years old, and 60-70 years old.
Enrollment for the trial is expected to be complete by the end of 2019 and initial results may be reported as early as the beginning of 2020.
More information regarding the trial can be found on ClinicalTrials.gov.