Vaccine Info

Flu-v Influenza Vaccine

Flu-v Influenza Description

FLU-v is a novel peptide vaccine candidate.

Flu-v Influenza Indication

Flu-v is a synthetic universal flu vaccine candidate offering long-lasting protection across a broad spectrum of influenza which could be given to a much broader population.

Flu-v Influenza Dosage

Flu-v is administered as a subcutaneous injection in the upper arm.

Flu-v Influenza Clinical Trials

  • Clinical Trial NCT03180801: Efficacy of FLU-v in an H1N1 Influenza Human Challenge Model
    • FLU-v, a novel peptide vaccine, aims to provide a broad-spectrum response using peptide antigens matching immunogenic regions of conserved viral proteins found inside the viral capsid.
    • These antigens have been shown to induce cytotoxic T-cell responses and non-neutralizing antibodies in both pre-clinical and clinical studies.
    • The FLU-v vaccine administered with and without adjuvant has been demonstrated to be safe in previous trials, and the addition of adjuvant Montanide ISA-51 was shown to produce superior immunological responses compared to non-adjuvanted FLU-v.
    • Data from a previous phase IIb study conducted as part of the UNISEC consortium suggest that the cellular and/or humoral responses resulting from vaccination with adjuvanted FLU-v may reduce influenza symptom severity and duration, although the study was not powered to assess these efficacy measures.
    • Presently, efficacy will be evaluated as a primary endpoint alongside safety as part of a single-center, placebo-controlled, phase IIb viral challenge study, using influenza A 2009 H1N1 human virus, in suitable healthy subjects aged 18-60 years.
    • Two dosing regimens will be explored. In addition, immunological endpoints will be addressed as exploratory endpoints.
Updated
07/30/2020 - 14:18