Valneva has initiated recruitment of adolescent subjects in the pivotal Phase III Cov-Compare (VLA2001-301) clinical trial of its inactivated Covid-19 vaccine candidate, VLA2001, in the UK.
VLA2001 has inactivated whole virus particles of SARS-CoV-2 with increased S-protein density, along with two adjuvants, alum and Dynavax Technologies’ CpG 1018.
The trial intends to enrol nearly 660 adolescent subjects aged 12 to 17 years.
An initial group of subjects will be enrolled in an open-label, non-randomised format, the company noted.
Based on safety review, the remaining subjects will be randomised to receive two doses of either the vaccine or placebo administered at a gap of 28 days.
This regimen will be followed by a booster shot after seven months of enrolment.
Valneva plans to expand the trial to enrol subjects aged below 12 years based on results from the adolescent cohort.
Topline data from the trial, anticipated earlier in the fourth quarter of this year, is estimated to set a base for potential regulatory approval in adults.
The company has also started to provide boosters to volunteers in its Phase I/II VLA2001-201 trial.
This planned expansion of VLA2001 clinical trials will support future approval in further age groups, in addition to adults.
In April 2021, Valneva started the Cov-Compare trial of VLA2001 in the UK.
The company also initiated booster vaccinations as a continuation of the Phase I/II VLA2001-201 trial, with positive topline results reported in the same month.
Valneva CEO Thomas Lingelbach said: “Our teams at Valneva remain fully committed to carry out VLA2001’s development plan and bring our inactivated vaccine to all patient groups who could benefit.
“We’re confident that many countries, and regulators, will want to have the opportunity to consider our inactivated Covid-19 vaccine.”
The company is currently holding talks with the European Commission on a potential supply deal for the VLA2001 vaccine.
Earlier this month, the UK Government terminated a supply agreement with Valneva for VLA2001.