VLA2001 has inactivated whole virus particles of SARS-CoV-2 with high S-protein density along with two adjuvants, alum and Dynavax’s CpG 1018.
As per the initial data, the vaccine demonstrated to be generally safe and well-tolerated in all dose groups and was also highly immunogenic with a 100% seroconversion rate for S-protein binding IgG antibodies in high dose group.
Two weeks after a two-dose regimen in the high dose group, the geometric mean titer of neutralising antibodies was similar or above the levels for a panel of convalescent sera.
“This includes potential modifications to the vaccine to address variants, using our existing manufacturing process.”
On obtaining regulatory approval, Valneva anticipates initiating a pivotal, comparative immunogenicity Phase III trial with the high dose formulation by this month-end.
In a separate development, Ampio Pharmaceuticals has reported results from a pre-clinical study showing that its lead drug candidate, Ampion, hinders a vital pro-inflammatory pathway in the types of immune cells implicated in Covid-19 and lupus nephritis.