Improved Novel VaccIne CombinaTion InflUenza Study
Improved Novel VaccIne CombinaTion InflUenza Study
A Phase IIb randomised, participant-blinded, placebo-controlled, multi-centre phase IIb
 efficacy study in 2030 volunteers aged 65 and over. The study will assess the safety and
 efficacy of the co-administration of a viral vectored vaccine, MVA- NP+M1, and the annual
 recommended licensed inactivated influenza vaccine (IIV). Within the main cohort 100
 participants will be recruited to an immunology sub-cohort.
The efficacy of current seasonal influenza vaccines is limited in the face of antigenic
 mismatch between circulating viral strains and those in the given vaccine. Additionally
 vaccination in older adults, a major target group for vaccination, prevents
 laboratory-confirmed influenza in only 30-40% compared to 70-90% in young adults. The
 hypothesis in this Phase IIb efficacy study is that a new vaccine MVA-NP+M1 with licensed
 inactivated influenza vaccine (IIV) in the older age group will be able to induce immune
 responses that protect individuals against influenza illness, severity of symptoms and reduce
 viral shedding, thereby increasing the protection conferred by seasonal influenza vaccine
 alone. A total of 2030 participants who are 65 years of age or over and eligible for annual
 seasonal influenza vaccination and provide informed consent will be recruited to the study.
 Potential volunteers will be mailed an invitation to take part by their GPs or recruited by
 local advertisements. Participants will be randomised to receive either MVA- NP+M1 with
 licensed IIV or saline placebo with licensed IIV. In the first 28 days after vaccination,
 participants will record adverse events using an electronic or paper diary. The participants
 will be contacted by telephone 1 day and 7 days post-vaccination to enquire about any serious
 adverse events and support follow up. During influenza season participants will record weekly
 whether or not they have had an influenza like illness (ILI). For every ILI episode
 experienced, the participants will record the severity of their symptoms daily. Among the
 participants, a total of 100 volunteers (50 in each group) will be recruited into an
 immunology sub-cohort. They will have blood samples collected on the day of vaccination, 1
 week, 3 weeks and 26 weeks post-vaccination for monitoring of laboratory adverse events and
 immunogenicity purposes.
Inclusion Criteria:

 -  Volunteer is willing and has capacity to provide written informed consent for
 participation in the trial (in the Investigator's opinion).

 -  Male or female adults, aged 65 years and above

 -  Able and willing (in the Investigator's opinion) to comply with all study requirements

 -  Willing to allow the investigators to discuss the volunteer's medical history with
 their General Practitioner

 -  Eligible to receive seasonal influenza vaccine

 Exclusion Criteria:

 -  Any history of anaphylaxis in reaction to vaccination or history of allergic reactions
 likely to be exacerbated by any component of the vaccine (e.g. egg allergy)

 -  Ongoing terminal illness with a life expectancy estimated to be approximately <6
 months.

 -  Continuous use of oral anticoagulants, such as coumarins and related anticoagulants
 (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran
 and edoxaban)

 -  Any other significant disease, disorder or finding (including blood test results),
 which, in the opinion of the Investigators, would either put the volunteer at risk
 because of participation in the study, or may influence the result of the study

 -  Participation in another clinical trial of an investigational medicinal product in the
 30 days preceding enrolment, or planned use during the study period

 -  Prior receipt of an investigational vaccine likely to impact on interpretation of the
 trial data

 -  Receipt of annual seasonal influenza vaccine prior to enrolment (for the same
 influenza season volunteers are recruited in)

 -  Not willing to comply with study procedures