World-first clinical trial of Valneva’s inactivated Covid-19 vaccine begins in Rochdale

The first patient to be given Valneva's Covid-19 vaccine in a clinical trial run in Rochdale by Panthera Biopartners

Clinical trial operator Panthera has begun vaccinating volunteers in a world-first trial of Valneva’s inactivated Covid-19 vaccine at its site in Rochdale.

The study, which will include 4,000 participants across 24 sites in the UK, is being overseen by the global contract research organisation, Pharm-Olam.

Panthera’s clinical trial sites in Rochdale, Preston and London will be vaccinating healthy volunteers over the age of 18 who have not had a Covid-19 vaccination.

The double-blind phase three trial will compare Valneva’s inactivated vaccine, VLA2001, with AstraZeneca’s conditionally approved vaccine Vaxzeria. Unlike earlier Covid-19 vaccine trials, which involved a placebo dose, everyone involved in this study will receive two active vaccine doses.

Those enrolled in the study over the age of 30 will be randomised to receive two doses of either the Valneva vaccine, or the approved Oxford/AstraZeneca vaccine. Participants aged 18-29 can be enrolled into the study to receive the Valneva vaccine and will not be offered the approved Oxford/AstraZeneca vaccine.

Valneva’s VLA2001 vaccine is the only inactivated, adjuvanted Covid vaccine in clinical development in Europe. Adjuvants are ingredients used in vaccines to create a stronger immune response.

Earlier this month, the specialty vaccine company reported positive Phase 1/2 trial data, which found that its inactivated vaccine was well tolerated with no safety concerns identified, and highly immunogenic.

Valneva plans to make a regulatory license submission to the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom in Autumn 2021, subject to successful Phase 3 data.

Last year Valneva entered a major partnership with the UK government. The UK has the option to purchase up to 190 million doses through to 2025 and has ordered 100 million doses to date, to be delivered in 2021 and 2022.

Stuart Young, CEO of Panthera, commented: “Every new vaccine is another weapon with which we can fight this pandemic and we are very pleased that we have been able to assist in these trials.

“We have put in place strict procedures, SOPs, and PPE at all our sites across the UK to make sure that patients, volunteers, and staff are as safe as possible. It is vital that clinical trials continue to ensure that there are new medications available to prevent and treat, not only Covid-19, but the many other conditions which afflict so many people.”

The Chief Medical Officer at Valneva, Juan Carlos Jaramillo, addeed: “We’re delighted that the trial is underway and would like to applaud the efforts of everyone involved in making this happen. We hope that people across the UK continue to volunteer for studies so that we can continue to make progress against the pandemic.”

This is the third Covid study being undertaken by Panthera, which includes one study where patients with Covid received an antibody to treat symptoms. Panthera also runs trials in chronic disease and cancer.