Ignite Creation Date:
2024-05-06 @ 1:26 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01818362
Status:
COMPLETED
Last Update Posted:
2015-12-15
First Post:
2013-03-18
Brief Title:
A Phase I Study of Candidate Influenza Vaccines MVA-NPM1 and ChAdOx1 NPM1
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
A Phase I Study to Determine the Safety and Immunogenicity of Vaccination Regimens Employing the Candidate Influenza Vaccines MVA-NPM1 and ChAdOx1 NPM1
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 NPM1 and MVA NPM1 in heterologous prime-boost regimens A crossover design will allow comparison of the two vaccines Volunteers will be divided into 4 groups n12 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 NPM1 on day 0 and group 6 will receive this with an additional boost of MVA-NPM1 8 weeks later
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 NPM1 on day 0 and group 6 will receive this with an additional boost of MVA-NPM1 8 weeks later
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None