Valneva: positive results for homologous booster of its inactivated vaccine candidate and …

Published on Thursday, December 16, 2021

Valneva, a vaccine company, has announced first positive data in its phase 1/2 study, VLA2001-201, regarding the use of its inactivated and adjuvanted COVID-19 vaccine candidate, VLA2001, as a booster dose. These initial data confirm that VLA2001 significantly increased the immunity of participants who received the same vaccine as their primary immunization.

77 of 153 phase 1/2 study participants, ages 18 to 55, received a booster dose of VLA2001 seven to eight months after completing their primary vaccination cycle with a low, medium, or high dose of VLA2001 . All participants received a single VLA2001 booster vaccine at the same dose (high) used in the pivotal phase 3 “Cov-Compare” 1 trial. IgG antibody titers (based on peak protein) were measured at the time of the booster dose and also two weeks after the booster dose. 45 of 77 participants who received a booster dose were included in the final analysis2.

The third dose of VLA2001 generated an excellent anamnestic response, with similar antibody levels seen whether participants were initially vaccinated with a low, medium, or high dose (GMT 9699.3 (95% CI: 8497.76, 11070.71)). This demonstrates a strong booster effect, with an increase in antibody levels against Wuhan virus 42 to 106 times compared to the antibody levels seen before the booster dose.

Antibody titers measured two weeks after the booster dose were approximately four times higher than those seen two weeks after the primary series³.

Juan Carlos Jaramillo, MD, Valneva Medical Director, said: “We are very pleased to report these first positive results for a booster vaccine confirming that VLA2001 significantly increased the immunity of participants who had received VLA2001 during their primary vaccination, regardless of the initial level of neutralizing antibodies at the time of boost. Boosting several months (typically six months or more) after primary immunization is generally effective for inactivated and adjuvanted vaccines. Our teams are working diligently on our current registration requests so that we can quickly implement our vaccine and make sure it reaches the people who need it. I want to thank once again those responsible for this trial, as well as all the participants and collaborators of the trial, in particular the National Institute for Health Research and the clinical teams of the NHS research centers ”.

In addition to this initial data, Valneva plans to announce more data on peer withdrawals from the Cov-Compare study. At the same time, Valneva is preparing to launch a study dedicated to heterologous boosters, which will evaluate a booster dose of VLA2001 injected at least six months after a primary vaccination with other vaccines or after a natural Covid-19 infection. This study should start in early 2022.

Valneva will also evaluate the ability of VLA2001 to generate neutralizing antibodies against variants of interest, including Omicron, using booster participant serum.

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1 Valneva announces positive Phase 3 results for its inactivated and adjuvanted COVID-19 vaccine candidate, VLA2001
2 27 of the remaining participants who were not included in the final analysis had also received another COVID-19 vaccine, and five developed SARS-CoV-2 infection during the study.
3 Average of neutralizing antibody titers (GMT ratio = 1.39, p <0.0001), (VLA2001 GMT 803.5 (95% CI: 748.48, 862.59).

Source and visual: Valneva