Flu-v Influenza Description
FLU-v is a novel peptide vaccine candidate.
FLU-v is designed to prompt a response not by antibodies but by a separate arm of the immune system—cellular immunity. Cellular immune responses include activity by white blood cells called cytotoxic T lymphocytes (CTLs). Recent research has shown that influenza-specific CTLs can seek out and remove virus-infected cells before and after flu symptoms arise.
The FLU-v vaccine is designed to stimulate the production of these flu-specific CTLs by targeting several proteins inside the virus that do not vary much from strain to strain, meaning that CTL responses against them may be effective against many virus strains.
Flu-v Influenza Indication
Flu-v is a synthetic universal flu vaccine candidate offering long-lasting protection across a broad spectrum of influenza viruses.
Flu-v Influenza Dosage
Flu-v is administered as a subcutaneous injection in the upper arm.
Flu-v Influenza Clinical Trials
Clinical Trial NCT01226758: Influenza Vaccine Challenge Study in Healthy Subjects
The purpose of this research is to study the safety, tolerability, and effectiveness of the investigational influenza vaccine in healthy volunteers infected with an attenuated influenza A virus.
Clinical Trial NCT02962908: A Randomised, Double-blind, Placebo-controlled Phase IIb Trial to Test FLU-v Vaccine
FLU-v is a vaccine that aims to protect against a wide range of flu viruses. The purpose of this study is to measure the immune responses induced by the FLU-v vaccine. This study will look at how safe FLU-v is when administered and how successful it is to prevent flu or reduce the flu symptoms' severity.
Clinical Trial NCT03180801: Efficacy of FLU-v in an H1N1 Influenza Human Challenge Model -- Last Update Posted on August 5, 2020.
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 pre-clinical and clinical studies.
The FLU-v vaccine administered with and without adjuvant has been demonstrated to be safe in previous trials. 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. However, 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. Also, immunological endpoints will be addressed as exploratory endpoints.