Safety of MVA-NP+M1,manufactured on the AGE1.CR.pIX cell line - FLU008
Research type
Research Study
Full title
A phase I study to determine the safety and immunogenicity of the candidate influenza vaccine MVA-NP+M1 manufactured on the AGE1.CR.pIX novel avian cell line, in healthy adult volunteers
IRAS ID
225916
Contact name
Adrian Hill
Contact email
Sponsor organisation
Vaccitech Limited
Eudract number
2017-001104-30
Duration of Study in the UK
0 years, 5 months, 1 days
Research summary
This will be a phase 1 study in healthy volunteers aged 18-50. The study is assessing safety and immunogenicity of the candidate viral vectored vaccine MVA NP+M1, manufactured using a new technology. The MVA NP+M1 was previously manufactured using chicken embryo fibroblasts (CEF) cells. There are a number of disadvantages to using CEF cells for the production of the MVA vectored vaccines including limited scalability of the process and possible shortage of material in case of an avian pandemic. Therefore, the MVA NP+M1 for use in this study is being produced in the novel immortalised duck retinal cell line AGE1.CR.pIX. This cell line was designed according to the current regulatory requirements and was optimized to address the scalability limitations imposed by the CEF manufacturing process.
This study will enable us to assess the safety of the vaccine and the extent of the immune response in healthy volunteers. We will do this by giving participants one dose of the vaccine and then we will take blood samples for safety monitoring and to collect information about the immune system. We will also record any symptoms that occur after vaccination.
The MVA NP+M1 manufactured on CEF cells have been safely used in 145 individuals up to the age of 85 years old. Previous studies in Oxford have demonstrated that the optimal dose of MVA NP+M1 is 1.5 x 10⁸pfu, balancing immunogenicity and reactogenicity. This will be the first use of the MVA NP+M1 manufactured using the new cell line but this new technology has been safely used in a previous Ebola vaccine trial (MVA-EBOZ). Six volunteers will receive a single dose of the new vaccine into their arms and will be followed up for 1 month.
Vaccines will be administered at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM) in Oxford.REC name
South Central - Berkshire Research Ethics Committee
REC reference
17/SC/0288
Date of REC Opinion
26 Jun 2017
REC opinion
Favourable Opinion