RNS 14.7M influenza contract1 Jun 2022 08:03
"Following completion of the challenge agent manufacturing, the
characterisation study will identify a dose of the flu challenge agent that
causes a safe and reliable infection in healthy volunteers. The study, which
is sponsored by hVIVO, is expected to start in Q3 2022, subject to the
relevant regulatory approvals, and will enrol volunteers recruited from the
Company's clinical trial volunteer recruitment arm, FluCamp
(https://flucamp.com/) .
As part of the study, hVIVO Labs will develop and validate challenge agent
specific assays for the new flu challenge agent to US Food and Drug
Administration (FDA), European Medicines Agency (EMA) and International
Council for Harmonisation of Technical Requirements for Pharmaceuticals for
Human Use (ICH) standards. This includes quantitative polymerase chain
reaction (qPCR) for viral load determination, viral infectivity assay and
serological assays for antibody level determination.
Following completion of the characterisation study, hVIVO will conduct a human
challenge study, expected to commence in Q1 2023. The study will enable the
Company to determine the efficacy of a number of different vaccine candidates
for the reduction in incidence of symptomatic flu infection and disease
severity in healthy volunteers. This will help select which of the candidates
to progress further into later stage clinical trials. The vaccine study can be
initiated, subject to receipt of the relevant regulatory approvals, as soon as
the Company completes the infectivity and safety data review from the
characterisation study and establishes the best challenge agent dose for safe
volunteer inoculation.
"
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