drugset / Trial / NCT01623518

A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine ChAdOx1-NP+M1

NCT01623518 ↗

Phase 1 Completed 15 enrolled University of Oxford
NaSingle-groupOpen-label

Summary

This is a first in man dose escalation study, to assess the safety and immunogenicity of the candidate influenza vaccine ChAdOx1-NP+M1. All volunteers recruited will be healthy adults aged 18-50. Volunteers will be enrolled and doses will be escalated according to a "3+3" study plan. Up to 24 volunteers will be vaccinated. Following one dose of the vaccine, volunteers will be followed up to assess the side effect profile of the vaccine and to take blood tests. A series of immunology assays will be performed to determine how potent the vaccine is at inducing an immune response.

Timeline

Start
2012-06
Primary completion
2013-03
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Subject ChAdOx1-NP+M1 Vaccine 5e+08 unknown —
Subject ChAdOx1-NP+M1 Vaccine 5e+09 unknown —
Subject ChAdOx1-NP+M1 Vaccine 2.5e+10 unknown —
Subject ChAdOx1-NP+M1 Vaccine 5e+10 unknown —

Indications