Efficacy of MVA-NP+M1 in the Influenza H3N2 Human Challenge Model

Inclusion Criteria

• Healthy males and females aged ≥18 and ≤55 years of age at the point of enrolment.
• Non-smokers or those who stopped smoking ≥ 3 months prior to screening 1 visit.
• Willingness to remain in isolation for the duration of the study.
• A female participant is eligible for this study if she is not pregnant or breast feeding and 1 of the following:
• Of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year).
• Of childbearing potential but has been and agrees to continue practicing highly effective contraception or abstinence (if this is the preferred and usual lifestyle of the participant) from 6 months prior to vaccination to 6 months after administration of the influenza challenge virus. Highly effective methods of contraception include 1 or more of the following:

i. male partner who is sterile (vasectomised) prior to the female participants entry into the study and is the sole sexual partner for the female participant; ii. hormonal (oral, intravaginal, transdermal, implantable or injectable); iii. an intrauterine hormone-releasing system (IUS); iv. an intrauterine device (IUD) with a documented failure rate of 32.

• Presence of any significant acute or chronic, uncontrolled medical (or psychiatric) illness including a history of chronic respiratory illness.
• History of seasonal hay fever or a clinically significant seasonal allergic rhinitis (SAR), including the use of symptomatic prescription only medication and non-prescription medication.
• History or evidence of autoimmune disease or known immunodeficiency of any cause - with the exception of atopic dermatitis/eczema and atopic rhinitis.
• Any history of anaphylaxis in reaction to vaccination or history of allergic reactions likely to be exacerbated by any component of the vaccine.
• History of lung disease (Asthma, COPD).
• Current smokers or those who stopped smoking 40.
• Participants that are an employee or family member of the Investigator or study site personnel may not be enrolled.
• Any other finding that, in the opinion of the Investigator, deems the participant unsuitable for the study.

EXCLUSION (CHALLENGE PERIOD ONLY)

• Abnormal spirometry assessed to be clinically significant.
• Known close contact with anyone known to have influenza in the past 7 days at the time of quarantine.
• Influenza-like illness (ILI) symptoms as assessed at the admission to clinic on Day -2 prior to challenge.
• Presence of fever, defined as participant presenting with a temperature reading of > 38.0°C on admission to quarantine.
• Qualitative Polymerase chain reaction (PCR) results positive for viral infection. However, participants may be included into later challenge cohort.
• Acute use of any medication or other product, prescription or over-the-counter, for symptoms of rhinitis or nasal congestion within 7 days prior to challenge. This includes any oral corticosteroid or beta agonist containing nasal spray.