This is a first in human, phase I, open label study of the MVA viral vector (produced in the novel immortalised duck retinal cell line AGE1.CR.pIX) expressing the influenza antigens NP and M1 as a fusion protein, in healthy adult volunteers. MVA-NP+M1 will be given alone intramuscularly as a single dose. There will be 1 study group and a total of 6 volunteers will be enrolled. Staggered enrollment will apply for the first three volunteers within the group.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
6
Intramuscular injection of novel vaccine
Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)
Oxford, Oxfordshire, United Kingdom
Measure of local reactogenicity following intramuscular injection of MVA-NP+M1
Occurrence and severity of solicited local reactogenicity signs and symptoms for 7 days following vaccination using a diary card.
Time frame: 7 days post vaccination
Measure of systemic reactogenicity following intramuscular injection of MVA-NP+M1
Occurrence and severity rating of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination using a diary card.
Time frame: 7 days post vaccination
Measure the occurrence of adverse events following intramuscular injection of MVA-NP+M1
Occurrence and severity of unsolicited adverse events for 28 days following the vaccination using a diary card.
Time frame: 28 days post vaccination
Assessment of safety laboratory assessments following intramuscular injection of MVA-NP+M1
Review of changes in safety laboratory measures from baseline visit to Day 2, Day 7, Day 21 and Day 28 visits
Time frame: 28 days post vaccination
Serious Adverse Events that occur during the study
Review of causality and relationship to MVA-NP+M1 for any serious adverse events during the whole study duration
Time frame: 28 days post vaccination
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