This is a first in man dose escalation study, to assess the safety and immunogenicity of the candidate influenza vaccine ChAdOx1-NP+M1. All volunteers recruited will be healthy adults aged 18-50. Volunteers will be enrolled and doses will be escalated according to a "3+3" study plan. Up to 24 volunteers will be vaccinated. Following one dose of the vaccine, volunteers will be followed up to assess the side effect profile of the vaccine and to take blood tests. A series of immunology assays will be performed to determine how potent the vaccine is at inducing an immune response.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
15
Dose escalation in a 3+3 study plan; 5 x10\^8 vp, 5 x10\^9 vp, 2.5 x10\^10 vp, 5 x10\^10 vp
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
Oxford, United Kingdom
Safety
Analysis of data on adverse events.
Time frame: 3 weeks
Reactogenicity
Immunogenicity endpoints will include interferon-gamma ELISpot as a marker of cell-mediated immunity.
Time frame: 3 weeks
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