Results

August 29, 2022, Valneva SE reported further positive Phase 3 results for its inactivated, adjuvanted COVID-19 vaccine VLA2001. Additional readouts from the Company’s pivotal VLA2001-301 “Cov-Compare” trial showed persistent immunogenicity and first positive heterologous booster results following primary vaccination with ChAdOx1-S (AstraZeneca).

On October 18, 2021, Valneva announced VLA2001 had successfully met both co-primary endpoints.  

VLA2001 induced broad T-cell responses with antigen-specific IFN-gamma-producing T-cells against the S, M, and N proteins.

VLA2001 was well tolerated, demonstrating a statistically significant better tolerability profile compared to active comparator vaccine

This is a multicentre, randomized, observer-blind, active-controlled, superiority, Phase 3 study to compare the immunogenicity of VLA2001 to AZD1222 in terms of GMT.

Approximately 4000 participants will be recruited for the study. About 3000 participants aged 30 years and above will be randomized in a 2:1 ratio to receive 2 intramuscular recommended doses of either VLA2001 (n=3000) or AZD1222 (n=1000). In addition, approximately 1000 subjects aged 18-29 years will participate in this study in a non-randomized, open-label fashion to receive VLA2001. The 2 doses of vaccination for both vaccines will be administered 28 days apart, on Days 1 and 29. All visits will be conducted at the clinical site on an outpatient basis.

Immunogenicity (neutralizing antibody titers) and safety will be assessed up to months 12 after the first vaccination.

Participants will be provided with an electronic Diary (e-Diary) and will be trained to record specifically solicited systemic and local symptoms daily as well as any additional AEs during the follow-up period after each of both vaccinations up to the next visit to the site until Day 43 visit has been completed.