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Re-inventing influenza vaccine efficacy trials

The purpose of this pilot study is to test the processes for a new trials that will be running during winter 2017-18 looking at a combination of a new vaccine against flu together with the current seasonal flu vaccine in adults aged 65 years and over.

BACKGROUND

There are two parts of the immune system that can protect us against flu infections. The standard vaccine only stimulates one part of the immune system to produce antibodies. Next year we will start testing a new flu vaccine that stimulates both parts of the immune system (T cells as well as antibodies) to see if this means that people get a flu-like illness less often. We will test this in a trial called INVICTUS.

This year we are running RIVET, a pilot study of the follow up processes for the INVICTUS Trial.

ELIGIBILITY


To be eligible you must usually receive the usual seasonal flu vaccine but not have had it yet.

What the study will involve

To ensure we test our process fully we will be in regular contact with people taking part for the whole of the winter period and we will ask you to share your experience with us in the end.
We will be asking volunteers to help develop the processes for the main trial by:

  1. Letting us know you are interested in taking part by calling or returning a reply slip to the research team.
  2. We will then book you an appointment at your home with a study team member at a time that works for you.

Your first appointment should take no longer than 45 min and we will:

  • Answer any questions you may have about taking part
  • Sign a consent form with you to say you are happy taking part and you understand what is involved
  • Take your pulse and temperature
  • Ask you some questions about yourself and your medical history
  • Provide you with a thermometer and tape measure
  • Ask you to let us know when you receive your flu jab

Once you have received your routine flu jab from your GP practice you will complete a diary for 1 week following your routine flu vaccination appointment telling us about any flu-like symptoms.

We will contact you at regular intervals throughout the winter season (Aprox. Oct - Apr) via your preferred contact method.

If you have any flu-like symptoms at any point throughout the winter season you will need to let us know and complete a diary card telling us how you feel until you feel completely better.

We will ask you to take part in an interview to tell us your thoughts on the follow up process.

This should take no longer than 45 mins and will take place at your home or over the telephone.

Study design: Observational pilot study
Sponsor: Vaccitech
Ethical approval: 16/SS/0135
Chief Investigator: Professor Chris Butler

RIVET

Vaccitech