French biotech company Valneva has launched a Phase III Cov-Compare (VLA2001-301) clinical trial of its inactivated Covid-19 virus vaccine candidate, VLA2001.
VLA2001 constitutes inactivated whole virus particles of SARS-CoV-2 with high S-protein density and two adjuvants, alum and Dynavax’s proprietary toll-like receptor 9 (TLR9) agonist adjuvant CpG 1018.
The company had observed positive initial data from its Phase I/II clinical trial that showed the vaccine’s safety profile and immunogenicity. The Cov-Compare trial will analyse VLA2001 as compared with AstraZeneca’s vaccine now known as Vaxzevria.
This randomised, observer-blind, controlled, comparative immunogenicity trial will enrol around 4,000 adult participants. Supported by the UK National Institute for Health Research, the trial will be carried out at approximately 25 sites in the UK.
The participants will receive two intramuscular doses of the vaccine administered four weeks apart. The primary objective of the study is to establish the superiority of VLA2001 over Vaxzevria in terms of the geometric mean titer ratio of SARS-CoV-2-specific neutralising antibodies in adult subjects aged 30 years and above, at two weeks on administering the second dose. In addition, the trial will assess the safety and tolerability of the vaccine two weeks after administering the second dose in adult subjects aged 18 and above.
Valneva commenced the Phase I/II VLA2001-201 clinical study of VLA2001 in December last year.