Vaccitech has engaged with Primary Care Clinical Trial Unit at Oxford University to run a small pilot study entitled RIVET (Re-inventing Influenza vaccine Efficacy Trials) as a precursor to its large phase IIb (INVICTUS) novel influenza vaccine study scheduled to start in late 2017.
The target number of participants is between 26 and 46 with the study split over 2 stages.
Stage I is designed to look at the acceptability and refinement of the recruitment process with particular focus on the logistics & language of baseline visit. Stage I will enrol 6 participants who will undergo the full baseline visit and will start in late November 2016. Following enrolment, all 6 participants will take part in a focus group to provide feedback to Vaccitech.
Stage II is designed to look at the acceptability and refinement of the follow up processes. 20 – 40 participants still to receive seasonal influenza vaccine will be enrolled with the focus on the capture of data post baseline visit and tools to collect such data. Stage II is ongoing with 22 participants currently enrolled. Analysis of the data collection methods as well as the actual data will be ongoing throughout the 2016/7 influenza season with a final formal analysis due May 2017.
The data analysis derived from stage I and II will drive the final development of the INVICTUS study design. INVICTUS will run over 2017/8 and 2018/9 and is expected to enrol 2,048 healthy participants across the 2 influenza seasons.