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 the Viroflu® seasonal influenza vaccine. All volunteers recruited will be healthy adults aged 18 and over.
This study is designed to test the safety and effectiveness of a combination of two vaccines for influenza. One of these vaccines will be the seasonal influenza vaccine 'Viroflu' ('Inflexal V'). The second will be an investigational viral vectored vaccine called MVA NP+M1. The rationale for combining these two vaccines is that they work differently and that by combining the two vaccines, stronger and broader immune responses may be produced. The MVA NP+M1 vaccine has been evaluated in five previous clinical trials. In total, over 80 volunteers have received this vaccine. There have been no vaccine related serious adverse events. Higher doses of MVA NP+M1 are more reactogenic, however at the dose to be used in this study the majority of adverse events are mild. 20 volunteers will be recruited in this study. They will all be adults over the age of 18. Volunteers will be assigned to one of two groups. Volunteers in group 1 will receive Viroflu, followed by a dose of MVA NP+M1. Volunteers in group 2 will receive Viroflu followed by a placebo injection (saline). Volunteers will be blinded so that they do not know which group they have been allocated to and will be asked to complete diary cards listing any adverse events after vaccination. Vaccinations will be administered into the thigh as the deltoid muscle is not normally large enough to accept two intramuscular injections. Volunteers will followed up for 6 months in total. Two days after vaccination they will receive a telephone call from one of the clinical team. They will then attend three follow up visits (at weeks 1, 3 and 26). At each visit, volunteers will have blood tests taken and will be questioned about any adverse events they may have experienced.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
3
2013-2014 season Viroflu, manufactured by Crucell. Contains 15 microgrammes of haemagglutinin (HA) from an H1N1 subtype influenza A virus, an H3N2 subtype influenza A virus and an influenza B virus per 0.5 ml dose. MVA-NP+M1 manufactured by by IDT Biologika GmbH, Germany. Each vial of MVA-NP+M1 contains 700 microlitres volume at a concentration of 1.3 x108 pfu/ml in 10mM Tris buffer. The dose of MVA-NP+M1 to be used in this study will be 1.5 x108 pfu.
2013-2014 season Viroflu, manufactured by Crucell. Contains 15 microgrammes of haemagglutinin (HA) from an H1N1 subtype influenza A virus, an H3N2 subtype influenza A virus and an influenza B virus per 0.5 ml dose. 0.9% saline placebo.
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
Oxford, Oxfordshire, United Kingdom
Cellular immune response generated by co-administration of MVA-NP+M1 and the Viroflu® seasonal influenza vaccine
Interferon-gamma ELISpot will be used as a marker of cell-mediated immunity.
Time frame: 26 weeks
Humoral immune response generated by co-administration of MVA-NP+M1 and the Viroflu® seasonal influenza vaccine
Humoral response will be measured by HI titre, ELISA, or neutralising antibody assay.
Time frame: 26 weeks
Safety of co-administration of MVA-NP+M1 and the Viroflu® seasonal influenza vaccine
Data pertaining to adverse events will be actively and passively collected; the data will be presented according to frequency, severity and duration of adverse events.
Time frame: Participants will be followed for the duration of the study, an expected average of 6 months
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