This is a single blinded placebo controlled phase I study, to assess the safety and
immunogenicity of co-administration of the candidate influenza vaccine MVA-NP+M1 with
seasonal influenza vaccine. All volunteers recruited will be adults aged 50 and over.
The rationale behind co-administration of MVA-NP+M1 with a seasonal influenza vaccine (TIV)
is that the immune system will be stimulated to produce both influenza specific T cells and
influenza specific antibodies.
Inclusion Criteria:
Men and women aged 50 or over with no upper age limit
- Resident in or near Oxford for the duration of the vaccination study
- Able and willing (in the Investigators' opinions) to comply with all study
requirements
- Willing to allow the investigators to discuss the volunteer's medical history with
their General Practitioner
- For females who are not post-menopausal, a negative pregnancy test on the day of
vaccination and agreement to practice effective contraception for the duration of the
study
- Agreement to refrain from blood donation during the course of the study
- Written informed consent
Exclusion Criteria:
Participation in another research study involving an investigational product in the 30
days preceding enrolment, or planned use during the study period
- Receipt of MVA or smallpox vaccines in the last 5 years, or receipt of the 2011/12
seasonal influenza vaccine prior to entering the study.
- Administration of immunoglobulins and/or any blood products within the three months
preceding the planned administration of the vaccine candidate
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV
infection; asplenia; recurrent, severe infections and chronic (more than 14 days)
immunosuppressant medication within the past 6 months (inhaled/topical steroids are
allowed)
- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine, e. g. egg products
- Any history of anaphylaxis in reaction to vaccination
- Recent treatment for cancer (except basal cell carcinoma and cervical carcinoma in
situ)
- History of serious psychiatric condition
- Suspected or known current injecting drug or alcohol abuse (as defined by an alcohol
intake of greater than 42 units every week)
- Seropositive for hepatitis B surface (HBsAg) or hepatitis C virus (antibodies to HCV)
- For pre-menopausal females, pregnancy, lactation or willingness/intention to become
pregnant during the study
- 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.
- No response / confirmation from GP regarding previous medical history
