FLU-v is a novel peptide vaccine candidate.
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 is administered as a subcutaneous injection in the upper arm.
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-neutralising 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 centre, 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.