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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
24
1.5 x 108 pfu MVA-NP+M1, intramuscular injection into the thigh. Inactivated Influenza Vaccine (Split Virion) 0.5ml (containing 15 micrograms of haemagglutinin, intramuscular injection into the thigh
Saline placebo, intramuscular injection into the thigh. Inactivated Influenza Vaccine (Split Virion) 0.5ml (containing 15 micrograms of haemagglutinin, intramuscular injection into the thigh
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
Oxford, United Kingdom
Safety of co-administration of MVA-NP+M1 and seasonal influenza vaccine.
The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events.
Time frame: Participants will be followed for the duration of the study, an expected average of 6 months
Immune response generated by co-administration of MVA-NP+M1 and seasonal influenza vaccine
To assess immune response generated by co-administration of MVA-NP+M1 by interferon-gamma ELISpot and ELISA.
Time frame: Participants will be followed for the duration of the study, an expected average of 6 months
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