Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Oxford | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single intramuscular injection of MVA-NP+M1 vaccine | Experimental | MVA-NP+M1, a novel vaccine will be administered intramuscular. The total volume given is 0.5ml and the dose given is 1.5E8 pfu. Each volunteer will receive one single injection only over a few seconds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MVA-NP+M1 | Biological | Intramuscular injection of novel vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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 | 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 | 28 days post vaccination |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adrian Hill, MD | Director, The Jenner Institute, Oxford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Clinical Vaccinology and Tropical Medicine (CCVTM) | Oxford | Oxfordshire | OX3 7LJ | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided