Policy & Regulation
Dynavax's CpG 1018 adjuvant meets both co-primary endpoints in Phase 3 COV-COMPARE trial
19 October 2021 -

Biopharmaceutical company Dynavax Technologies Corporation (Nasdaq:DVAX) said on Monday that Valneva SE reported positive topline results from the Phase 3 COV-COMPARE trial of its inactivated COVID-19 vaccine candidate VLA2001 using Dynavax's CpG 1018 adjuvant.

Dynavax developed CpG 1018 adjuvant to provide an enhanced vaccine immune response. The CpG 1018 adjuvant provides a well- developed technology and a significant safety database, supporting development and large-scale manufacturing of a COVID-19 vaccine.

According to the companies, Cov-Compare is a randomized, observer-blind, controlled, comparative immunogenicity trial in 4,012 adults and 660 adolescents. Co-Primary immunogenicity endpoints are superiority of GMT ratio of VLA2001 compared to AZD1222 as well as non-inferiority of seroconversion rates of neutralizing antibodies administered in a two-dose immunization schedule four weeks apart.

This trial is being conducted at 26 sites across the UK . About 2,972 participants 30 years of age and older were randomized in a 2:1 ratio to receive two intramuscular doses of either VLA2001 or AZD1222 at the recommended dose level, 28 days apart, on Days one and 29.

The company said VLA2001 demonstrated superiority against AZD1222 in geometric mean titer for neutralization antibodies as well as non-inferiority in seroconversion rates at two weeks after the second vaccination to meet both co-primary endpoints.

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