Influenza Clinical Trial
Official title:
A Phase I Study to Determine the Safety and Immunogenicity of Co-administration of the Candidate Influenza Vaccine MVA-NP+M1 and the Viroflu® Seasonal Influenza Vaccine
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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