Valneva has started a pivotal Phase III Cov-Compare (VLA2001-301) clinical trial of its inactivated, Covid-19 vaccine candidate, VLA2001.
VLA2001 has inactivated whole virus particles of SARS-CoV-2 with high S-protein density and two adjuvants, alum and Dynavax’s CpG 1018.
The latest development follows positive initial data from Valneva’s Phase I/II clinical trial that showed the vaccine’s safety profile and immunogenicity.
Cov-Compare will analyse VLA2001 as compared with AstraZeneca’s conditionally approved vaccine 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.
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Its primary objective is to establish the superiority of VLA2001 over Vaxzevria in terms of 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 at two weeks after administering the second dose in adult subjects aged 18 and above.
On obtaining promising data from this trial, Valneva plans to submit an application to obtain initial regulatory approval for the vaccine in September this year.
Dynavax CEO Ryan Spencer said: “We are excited to see the rapid initiation of the comparative Phase III clinical trial, providing an opportunity for Valneva’s inactivated whole virus vaccine candidate adjuvanted with CpG 1018 to demonstrate superior immunogenicity with respect to the comparator.”
Valneva commenced the Phase I/II VLA2001-201 clinical study of VLA2001 in December last year.
In another development, Claritas Pharmaceuticals and CMAX Clinical Research have entered into an agreement to carry out a Phase I clinical study of the former’s novel, liquid, nitric oxide-releasing drug R-107 for Covid-19 treatment.
The randomised, placebo-controlled, single-blind, single ascending dose trial will analyse the pharmacokinetics and safety profile of R-107.