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MONDAY, March 9, 2020 (HealthDay News) — Adjuvanted FLU-v, a broad-spectrum influenza vaccine, is immunogenic, according to a study published online March 10 in the Annals of Internal Medicine<\/i>.<\/p>\n
Olga Pleguezuelos, Ph.D., from SEEK in London, and colleagues compared the safety, immunogenicity, and exploratory efficacy of FLU-v in a randomized, double-blind, placebo-controlled phase 2b trial conducted among 175 healthy adults in the Netherlands. Participants were randomly assigned to receive either a subcutaneous injection of adjuvanted or nonadjuvanted FLU-v (A-FLU-v or NA-FLU-v) or adjuvanted or nonadjuvanted placebo (A-placebo or NA-placebo) in a 2:2:1:1 ratio.<\/p>\n
The researchers found that mild-to-moderate injection-site reactions had the highest incidence among adverse events. The difference in the median fold increase in secreted interferon-\u03b3 (IFN-\u03b3) was 38.2-fold at day 42 and 25.0-fold at day 180 between A-FLU-v and A-placebo. Comparing A-FLU-v and A-placebo, the differences in median fold increase were 4.5-fold for IFN-\u03b3-producing CD4+ T cells, 4.9-fold for tumor necrosis factor-\u03b1 (TNF-\u03b1), 7.0-fold for interleukin-2 (IL-2), and 1.7-fold for CD107a at day 42. The differences were 2.1-fold for IFN-\u03b3 and 5.7-fold for IL-2 at day 180, with no difference seen for TNF-\u03b1 or CD107a. There were no differences noted between NA-FLU-v and NA-placebo.<\/p>\n
“Further development is warranted for a single dose of A-FLU-v to be tested in a phase 3 setting with a larger cohort of vaccinees, where efficacy and safety can be further explored as primary end points,” the authors write.<\/p>\n
Two authors disclosed financial ties to SEEK, which developed the vaccine and partially funded the study.<\/p>\n
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