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October 19, 2021

Valneva’s Covid-19 vaccine meets co-primary goals in Phase III trial

VLA2001 was well tolerated with a tolerability profile that is highly favourable as compared to AstraZeneca’s vaccine. 

Valneva has reported that its inactivated, adjuvanted Covid-19 vaccine candidate, VLA2001, met the co-primary goals of the Phase III Cov-Compare clinical trial in adolescent and adult subjects.

VLA2001 comprises inactivated whole SARS-CoV-2 virus particles with high S-protein density, along with alum adjuvant and Dynavax Technologies’ CpG 1018 adjuvant.

The randomised, controlled, observer-blind, comparative immunogenicity Phase III trial enrolled 4,012 adults and is currently recruiting 660 adolescent subjects aged 12 years and above.

Last month, Valneva commenced recruitment of adolescent subjects in the vaccine trial.

The trial is being carried out at 26 trial centres in the UK. A total of 2,972 subjects aged 30 years and above were categorised in a 2:1 ratio to receive two intramuscular doses of either VLA2001 or AstraZeneca’s Covid-19 vaccine, AZD1222 (ChAdOx1-S), at a gap of 28 days.

The superiority of the geometric mean titre (GMT) ratio of Valneva’s vaccine to AZD1222 is one of the co-primary immunogenicity goals.

Valneva noted that the other co-primary goal is non-inferiority of seroconversion rates (SCR) of neutralising antibodies as assessed at two weeks on receiving the second shot in people aged 30 years and above.

The trial will also assess the safety and tolerability of the VLA2001 vaccine two weeks after the second dose in adult and adolescent subjects.

According to the data from adult subjects aged 18 years and above, the trial met its co-primary endpoints.

VLA2001 was superior to AZD1222 and showed non-inferiority of SCR at two weeks after the second shot in individuals aged 30 years and above.

VLA2001 elicited wide-ranging antigen-specific IFN-gamma inducing T-cells that are reactive against the S, N and M proteins in a subset of subjects.

The vaccine was demonstrated to be well tolerated with its tolerability profile more favourable than AstraZeneca’s shot.

Younger subjects receiving VLA2001 had an overall safety profile in line with the older age group.

The trial’s exploratory endpoint of incidence of Covid-19 cases was comparable across the treatment arms.

Furthermore, the absence of severe cases of Covid-19 could indicate that the vaccines used in the trial averted severe disease caused by the SARS-CoV-2 variants, especially the Delta variant.

Valneva CEO Thomas Lingelbach said: “These results confirm the advantages often associated with inactivated whole virus vaccines.

“We are committed to bringing our differentiated vaccine candidate to licensure as quickly as possible and continue to believe that we will be able to make an important contribution to the global fight against the Covid-19 pandemic.”

Valneva initiated the Phase III VLA2001-304 trial of its VLA2001 in New Zealand this August.

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