Valneva SE yesterday announced positive topline results from the phase-III trial Cov-Compare of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.
In a statement, Valneva notified that the phase-III, Cov-Compare trial recruited a total of 4,012 participants aged 18 years and older across 26 trial sites in the United Kingdom. The trial met its co-primary endpoints: VLA2001 demonstrated superiority against AZD1222 (ChAdOx1-S), in terms of geometric mean titer for neutralisation antibodies (GMT ratio=1.39, p<0.0001), (VLA2001 GMT 803.5 (95% CI: 748.48, 862.59)), (AZD1222(ChAdOx1-S) GMT 576.6 (95% CI 543.6, 611.7)), as well as non-inferiority in terms of seroconversion rates (SCR above 95 per cent in both treatment groups) at two weeks after the second vaccination (i.e. day 43) in adults aged 30 years and older.
T-cell responses analysed in a sub-set of participants showed that VLA2001 induced broad antigen-specific IFN-gamma producing T-cells reactive against the S- (74.3 per cent), N- (45.9 per cent) and M- (20.3 per cent) protein, the statement added.
It also informed that the tolerability profile of VLA2001 was significantly more favourable compared to the active comparator vaccine. Participants 30 years and older reported significantly fewer solicited adverse events up to seven days after vaccination, both with regards to injection site reactions (73.2 per cent VLA2001 vs. 91.1% AZD1222 (ChAdOx1-S), p<0.0001) and systemic reactions (70.2% VLA2001 vs. 91.1% AZD1222 (ChAdOx1-S), p<0.0001). No unsolicited treatment-related serious adverse events (SAE) have been reported. Less than one per cent reported an adverse event of special interest in both treatment groups. Participants in the younger age group vaccinated with VLA2001 showed an overall safety profile comparable to the older age group.
Further, according to the statement, the occurrence of COVID-19 cases (exploratory endpoint) was similar between treatment groups. The complete absence of any severe COVID-19 cases may suggest that both vaccines used in the study prevented severe COVID-19 caused by the circulating variant(s) (predominantly Delta).
Adam Finn, Professor, Paediatrics, University of Bristol, Trial Chief Investigator, said, “The low levels of reactogenicity and high functional anti-body responses alongside broad T-cell responses seen with this adjuvanted inactivated whole virus vaccine are both impressive and extremely encouraging. This is a much more traditional approach to vaccine manufacture than the vaccines so far deployed in the UK, Europe and North America and these results suggest this vaccine candidate is on track to play an important role in overcoming the pandemic.”
Adding to it, Thomas Lingelbach, Chief Executive Officer, Valneva, 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. We are keen to propose an alternative vaccine solution for people who have not yet been vaccinated.”
As part of the product development strategy, Valneva has completed recruitment of 306 volunteers aged 56 years and older in New Zealand into its VLA2001-304 trial and expects topline data in early 2022. Valneva has also announced the start of recruitment of adolescents as an expansion of the Cov-Compare trial. The company is preparing for trials in children (five-to-12 years of age) and a Valneva sponsored booster trial to evaluate VLA2001’s booster performance for people in need of a booster, the statement further said.