hVIVO has announced positive result for the primary endpoint, following completion of analysis of samples by NIAID and additional results from the Phase IIb viral challenge study of FLU-v, (Study 004, NCT03180801).
FLU-v is being developed by Imutex, hVIVO’s 49% joint venture with the SEEK Group.
Following additional analysis of the samples from the study by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, hVIVO reports that the study’s primary endpoint achieved a statistically significant result.
One dose of FLU-v produced a highly statistically significant reduction in the primary endpoint of Mild to Moderate Influenza Disease (MMID), comprising a positive signal of influenza infection and at least one influenza symptom, compared with placebo (p=0.035)
A statistically significant additional endpoint has been achieved (p=0.006) from further data analysed by the NIAID from FLU-v 004, which confirmed the result for the primary endpoint and has the potential to become the primary regulatory endpoint for Phase III
These results together with the previously reported highly statistically significant reduction in symptoms endpoint (p=0.023) and performing better than placebo in a number of other key endpoints is evidence of the vaccine’s protective effect
hVIVO executive chairman Trevor Phillips said: “We are pleased to finally be in a position to report a positive primary endpoint outcome for this Phase IIb challenge study resulting from the NIAID’s additional analysis of samples taken during the study.
“These results follow an announcement in March 2018 confirming that key secondary endpoints in symptom reduction had achieved statistical significance and indicating that the NIAID would be conducting further sample analyses to assess the primary endpoint outcome, as the initial analysis, using results from a less sensitive assay for the presence of influenza virus, had showed the primary endpoint only trended to statistical significance.”
SEEK CEO Gregory Stoloff said: “NIAID has been conducting further and a more sensitive viral detection analysis on the FLU-v challenge study results as previously communicated.
“Our FLU-v vaccine has now demonstrated in two different Phase IIb studies, a statistically enhanced immune response which has translated into a statistical reduction in the number of people getting sick and severity of influenza symptoms which remains a significant burden to public health globally.”
A challenge study conducted by hVIVO using the NIAID virus, methods and analysis as a result of a collaboration between SEEK and NIAID.
A randomised, double-blind, placebo-controlled single-centre trial in collaboration with to assess the efficacy and safety of two different formulation and dosing regimens of FLU-v vaccine administered in healthy adults. In this trial, 123 subjects (aged 18-60 years) were assigned to either placebo or treatment arms.
The primary endpoint was to assess the incidence of MMID which is defined as evidence of viral shedding in nasopharyngeal swab samples and the presence of at least one symptom.
The development of a universal influenza vaccine has become a worldwide public health priority in both industrialised and low-and middle-income countries. A large number of government, academic, public and private organisations (such as, for example, WHO, BARDA, NIH, FDA and EMA) are supportive of development of such a vaccine.
These global stakeholders have indicated the benefits of vaccines that induce broad immunity so as to prime the population against newly emerging influenza viruses or other respiratory viruses of pandemic potential.
FLU-v is intended to address a number of key issues associated with current annual influenza vaccines whose effectiveness varies from year to year, which need to be redesigned every year, are available in limited quantities due to manufacturing cost, complexity and lead times and which offer limited protection over pandemic influenza.
A synthetic universal flu vaccine offering long lasting protection across a broad spectrum of influenza which could be given to a much broader population would be a significant step forward, and a potential future blockbuster in terms of sales.
Source: Company Press Release