A Phase I Study of Candidate Influenza Vaccines MVA-NP+M1 and ChAdOx1 NP+M1
- Conditions
- Seasonal Influenza
- Interventions
- Biological: MVA NP+M1Biological: ChAdOx1 NP+M1
- Registration Number
- NCT01818362
- Lead Sponsor
- University of Oxford
- Brief Summary
This will be a randomised observational phase 1 study in 48 healthy volunteers aged 18-50. The study is assessing safety and immunogenicity of viral vectored vaccines ChAdOx1 NP+M1 and MVA NP+M1 in heterologous prime-boost regimens. A crossover design will allow comparison of the two vaccines. Volunteers will be divided into 4 groups (n=12 in each group). Groups will be recruited simultaneously to control for seasonal changes in influenza. This is because at certain times of year there is likely to be a higher naturally acquired T cell response to influenza than at other times due to circulating influenza virus in the community.
The study has been extended to include 2 additional groups (group 5 \& 6), each containing 12 healthy adults aged 50 years or above. Group 5 will receive ChAdOx 1 NP+M1 on day 0, and group 6 will receive this with an additional boost of MVA-NP+M1 8 weeks later.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 4 MVA NP+M1 MVA NP+M1 1.5 x 10⁸pfu followed by ChAdOx1 NP+M1 2.5 x 10¹⁰vp 52 weeks later. Group 6 ChAdOx1 NP+M1 ChAdOx1 NP+M1 2.5 x 10¹⁰vp followed by MVA NP+M1 1.5 x 10⁸pfu 8 weeks later. Group 3 MVA NP+M1 MVA NP+M1 1.5 x 10⁸pfu followed by ChAdOx1 NP+M1 2.5 x 10¹⁰vp 8 weeks later. Group 4 ChAdOx1 NP+M1 MVA NP+M1 1.5 x 10⁸pfu followed by ChAdOx1 NP+M1 2.5 x 10¹⁰vp 52 weeks later. Group 6 MVA NP+M1 ChAdOx1 NP+M1 2.5 x 10¹⁰vp followed by MVA NP+M1 1.5 x 10⁸pfu 8 weeks later. Group 2 ChAdOx1 NP+M1 ChAdOx1 NP+M1 2.5 x 10¹⁰vp followed by MVA NP+M1 1.5 x 10⁸pfu 52 weeks later. Group 1 MVA NP+M1 ChAdOx1 NP+M1 2.5 x 10¹⁰vp followed by MVA NP+M1 1.5 x 10⁸pfu 8 weeks later. Group 1 ChAdOx1 NP+M1 ChAdOx1 NP+M1 2.5 x 10¹⁰vp followed by MVA NP+M1 1.5 x 10⁸pfu 8 weeks later. Group 2 MVA NP+M1 ChAdOx1 NP+M1 2.5 x 10¹⁰vp followed by MVA NP+M1 1.5 x 10⁸pfu 52 weeks later. Group 3 ChAdOx1 NP+M1 MVA NP+M1 1.5 x 10⁸pfu followed by ChAdOx1 NP+M1 2.5 x 10¹⁰vp 8 weeks later. Group 5 MVA NP+M1 ChAdOx1 NP+M1 2.5 x 10¹⁰vp
- Primary Outcome Measures
Name Time Method To assess the safety of prime/boost vaccination regimens employing MVA-NP+M1 and ChAdOx1 NP+M1. Up to 78 weeks post first vaccination. Safety will be assessed by the nature, frequency, severity, seriousness and duration of adverse events arising during the study combined with analysis of hematology and biochemistry lab tests for abnormalities.
- Secondary Outcome Measures
Name Time Method To assess the cellular immune response generated by prime/boost vaccination regimens employing MVA-NP+M1 and ChAdOx1 NP+M1. 78 weeks after first vaccination The secondary outcomes of peak immune response after first vaccination and peak immune response after second vaccination will be analysed by calculating the area under the curve of the immune response (IFN-γ SFC/ million PBMCs) for each volunteer from baseline to week 78. The mean area under the curve in the 4 groups will then be compared using an analysis of variance, or in the case of skewed data a Kruskal Wallis test. Further pairwise comparisons will be made if a significant difference is found between groups.
Trial Locations
- Locations (3)
Surrey Clinical Research Centre, University of Surrey
🇬🇧Guildford, United Kingdom
NIHR Wellcome Trust Clinical Research Facility Southampton
🇬🇧Southampton, United Kingdom
Centre for Clinical Vaccinology and Tropical Medicine
🇬🇧Oxford, Oxfordshire, United Kingdom