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New vaccine trial targets Covid variants

Vaccine maker Valneva SE announced the initiation of a further Phase III trial for its COVID-19 vaccine candidate VLA2001.

VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants. It is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe. It is intended for active immunisation of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination including addressing new variants.

 The French specialty vaccine company will conduct the trial named VLA2001-304  at approximately 10 trial sites in New Zealand. The aim of VLA2001-304 is to generate data in the elderly and is also designed to potentially enable variant-bridging through immune-comparability. The trial will enroll two cohorts. Cohort 1 will include approximately 150 volunteers aged 56 years and older in an open-label manner in order to generate safety and immunogenicity data for this age group. Cohort 2 will include approximately 600 volunteers aged 12 years and older in order to compare immunogenicity data of Valneva’s original COVID-19 vaccine candidate, VLA2001, to an additional COVID-19 vaccine candidate, VLA2101, to be based on a variant strain to be confirmed. In both cohorts, vaccinations will be administered in a 2-dose immunisation schedule 28 days apart.

“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,” commented Juan Carlos Jaramillo, Valneva’s CMO. “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.”