Participants will be randomized to receive either VLA2001 (the vaccine being tested) or a placebo (an inactive substance that looks like the vaccine). They will not initially know which treatment they have received. However, all participants will be told at day 71 of the trial which treatment they have received.
Once accepted onto the trial, participants in the VLA2001 group will receive two doses of VLA2001, 28 days apart, and a third dose (booster vaccination) of VLA2001 seven months after enrolling into the study – for a total of three injections. Participants in the placebo group will receive two doses of a placebo, 28 days apart. Two months after enrolling into the study, they will receive two doses of the VLA2001 vaccine, 28 days apart – for a total of four injections.
In total, participants will have up to eight (VLA2001 group) or nine (placebo group) visits. The study will last approximately 12 months.
Dr Will Carroll, Principal Investigator for the study at MPFT said “We hope that this study will give us important insights into how the Valneva vaccine works in young people. The battle against COVID-19 is far from over. Valneva’s vaccine is based on traditional vaccine technology, as it is an inactivated, whole-virus vaccine. This type of vaccine has been used for decades to protect young people from diseases like polio. The new study will offer young people aged 12-17 years the chance to be part of important medical research.”
Everyone who takes part will get two doses of the vaccine. It will help us to fully understand how well it protects younger people and for how long. We need young people who have not already had a COVID-19 vaccine to take part. The team is made up of experienced researchers who are very used to working with younger people. We know that a lot of young people are really motivated by the idea that they are helping others. This is certainly the case with this study, as it will expand the number of vaccine types available.”
Ruth Lambley-Burke, Head of Research and Innovation at the Trust added; “Clinical research is extremely important in the fight against COVID-19 and we are pleased to play our role in the Valneva clinical study in the West Midlands.”
For more information about the study or to register your interest, please contact the MPFT Research team on:
Phone: 0808 196 3890
Email: Valneva@mpft.nhs.uk