Valneva is planning to initiate a further Phase III trial (VLA2001-304) for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.
The new VLA2001-304 study will aim to generate data in the elderly and is also designed to potentially enable variant-bridging through immune-comparability.
The study, which will be conducted in New Zealand, is set to recruit approximately 150 participants aged 56 years and older with the aim of generating additional safety and immunogenicity data in this age group following vaccination with VLA2001 (two doses 28 days apart).
Juan Carlos Jaramillo chief medical officer of Valneva, said: “The fight against COVID-19 continues and it’s extremely important that we continue to gather as much data as possible in all age groups across the population.
"Everyone should have access to technology best suited to protect them against this virus. We have also been working on Variants of Concern as part of our continued efforts to stay ahead of the virus causing COVID-19 especially since we believe that our inactivated, whole-virus platform will be adaptable across variants. Hence we are extremely pleased to be able to invest in this very important additional clinical trial," he added.
In June 2021, Valneva announced that it had completed recruitment for VLA2001’s pivotal Phase III trial Cov-Compare (VLA2001-301) with over 4,000 randomised participants.