NCT01818362

A Phase I Study of Candidate Influenza Vaccines MVA-NP+M1 and ChAdOx1 NP+M1

A Phase I Study to Determine the Safety and Immunogenicity of Vaccination Regimens Employing the Candidate Influenza Vaccines MVA-NP+M1 and ChAdOx1 NP+M1

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Seasonal Influenza

Interventions

Type	Name	Description
BIOLOGICAL	MVA NP+M1	MVA NP+M1 1.5 x 10⁸pfu intramuscularly.
BIOLOGICAL	ChAdOx1 NP+M1	ChAdOx1 NP+M1 2.5 x 10¹⁰vp intramuscularly.

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2013-03-26
• Last updated: 2015-12-15

Locations

3 sites across 1 country: United Kingdom