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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIV and MVA-NP+M1 | Experimental | Co-administration group 1 dose of seasonal influenza vaccine (TIV) and 1 dose of 1.5 x108pfu MVA-NP+M1 |
|
| Saline placebo and seasonal influenza vaccine TIV | Placebo Comparator | Control group 1 dose of seasonal influenza vaccine (TIV) and 1 dose of a saline placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIV and MVA-NP+M1 | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants will be followed for the duration of the study, an expected average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants will be followed for the duration of the study, an expected average of 6 months |
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Inclusion Criteria:
Men and women aged 50 or over with no upper age limit
Exclusion Criteria:
Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
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| Name | Affiliation | Role |
|---|---|---|
| Adrian VS Hill, DPhil FRCP | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital | Oxford | OX3 7LJ | United Kingdom |
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| Saline placebo and seasonal influenza vaccine TIV | Biological | Saline placebo, intramuscular injection into the thigh. Inactivated Influenza Vaccine (Split Virion) 0.5ml (containing 15 micrograms of haemagglutinin, intramuscular injection into the thigh |
|
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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