Valneva has started the Phase III VLA2001-304 clinical trial of its adjuvanted Covid-19 vaccine candidate, VLA2001, in New Zealand.
VLA2001 has inactivated whole virus particles of the SARS-CoV-2 virus with high S-protein density and two adjuvants, alum and Dynavax’s CpG 1018.
Meant for active immunisation of at-risk individuals, the vaccine can also potentially be used as a booster.
The Phase III VLA2001-304 trial will involve two cohorts.
The open-label Cohort 1 will enrol nearly 150 subjects aged 56 years or above to assess the safety and immunogenicity of two doses of VLA2001 administered with a gap of 28 days.
Cohort 2 will analyse the immunogenicity data of VLA2001 against another Covid-19 vaccine candidate, VLA2101, targeting variant strain in nearly 600 subjects aged 12 years or above.
Valneva noted that the trial will be carried out at approximately ten centres in the country.
The trial’s objective is to gather data in the elderly population and facilitate variant-bridging via immune-comparability.
Data from VLA2001-304 is anticipated to complement trials that are underway and back further regulatory filings, Valneva added.
Valneva chief medical officer Juan Carlos Jaramillo said: “The fight against Covid-19 continues and it’s extremely important that we continue to gather as much data as possible in all age groups across the population.
“We have also been working on variants of concern as part of our continued efforts to stay ahead of the virus causing Covid-19 especially since we believe that our inactivated, whole-virus platform will be adaptable across variants.”
In April this year, the company reported that initial results from Part A of the Phase I/II trial demonstrated VLA2001 to be highly immunogenic in 153 healthy adults aged 18 to 55 years.
Later in June, Valneva concluded subject enrolment in pivotal Phase III Cov-Compare (VLA2001-301) trial of the vaccine, recruiting more than 4,000 subjects.
On obtaining favourable data from the Cov-Compare trial, the company intends to seek regulatory approval in the fourth quarter of this year.