A phase IIb study to determine the safety and efficacy of candidate INfluenza Vaccine MVA-NP+M1 in combination with licensed InaCTivated inflUenza vaccine in adultS aged 65 years and above (INVICTUS): a study protocol
Swayze H., Allen J., Folegatti P., Yu L-M., Gilbert S., Hill A., Ellis C., Butler CC.
<ns4:p>Seasonal influenza has a significant annual global impact. Current influenza vaccines work by inducing strain-specific antibodies against the highly polymorphic surface proteins of the influenza virus and need to be redesigned every year, increasing their cost and limiting availability. There is a demand for a more efficacious vaccine, particularly in older adults in which the current vaccines show poor efficacy. The aim is to investigate a novel vaccine, MVA-NP+M1, which targets T cell responses to the nucleoprotein and matrix 1 core proteins of the influenza virus A, which are highly conserved,<ns4:bold> </ns4:bold>and therefore may provide long protection against a broad range of influenza strains.</ns4:p><ns4:p> INVICTUS is a phase IIb study to determine the safety and efficacy of candidate <ns4:underline>IN</ns4:underline>fluenza <ns4:underline>V</ns4:underline>accine MVA-NP+M1 in combination with licensed <ns4:underline>I</ns4:underline>na<ns4:underline>CT</ns4:underline>ivated infl<ns4:underline>U</ns4:underline>enza vaccine in adult<ns4:underline>S</ns4:underline> aged 65 years and above is a randomised, participant-blinded, placebo-controlled, multi-centre phase IIb efficacy study planned for 2030 volunteers aged 65 and over, in primary care. The primary objective is to assess the efficacy of MVA-NP+M1 co-administered with licensed inactivated quadrivalent influenza vaccine in adults ≥65 years. Participants complete daily diaries to record solicited and unsolicited events in the first four weeks post vaccination, and influenza-like illness (ILI) symptoms and severity throughout the influenza season.</ns4:p><ns4:p> We hypothesise an improvement in the primary outcome, a reduction in the average number of days spent with moderate or severe influenza-like illness during periods of influenza circulation, in the group administered with MVA-NP+M1, compared to those in the control group.</ns4:p><ns4:p> <ns4:bold>Registration: </ns4:bold>ClinicalTrials.gov identifier <ns4:ext-link xmlns:ns3="http://www.w3.org/1999/xlink" ext-link-type="uri" ns3:href="https://clinicaltrials.gov/ct2/show/NCT03300362">NCT03300362</ns4:ext-link>.</ns4:p><ns4:p> <ns4:bold>Protocol version:</ns4:bold> INVICTUS Protocol v3.0, 08 June06 2018.</ns4:p>