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Valneva, Pfizer Report Further Positive Data for Investigational Lyme Disease Vaccine

A sub-analysis of phase 2 data compared the immunogenicity of their VLA15 vaccine in adults after administration of 2 or 3 primary series doses with the latter demonstrating a stronger response.

Valneva and Pfizer have developed an investigational Lyme Disease vaccine, VLA15, and today reported that adult participants aged 18-65 years who received 3 doses of the companies’ vaccine demonstrated a stronger immune response compared to those who received 2 doses.

Specifically, the induction of anti-OspA IgG (anti-outer surface protein A immunoglobulin G) antibody titers was higher in participants who received 3 doses. Poised with this data, the companies have decided to utilize a 3-dose priming schedule for adults in the phase 3 studies.

This information comes from a sub-analysis of the phase 2 data. The phase 2 trial, VLA15-221, compared the immunogenicity of the vaccine after administration of 2 (at months 0 and 6) or 3 (at months 0, 2 and 6) primary series doses in groups aged 5-11, 12-17 and 18-65 years.

It is important to note, that adult participants in both the 2 and the 3 dose cohorts showed immunogenicity.

In the 5-17 year old population, the trial is still ongoing. Data for this age group is expected to be reported in the first half of this year.

“I’m very pleased with these results, which are critical for determining the optimal vaccination schedule for our planned phase 3 trial,”Valneva CEO Juan Carlos Jaramillo MD, said. “In partnership with Pfizer, we are excited to further investigate this vaccine candidate, which will hopefully help provide protection against Lyme disease for both adults and children.” 

VLA15 is a multivalent protein subunit vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, which is the bacteria that causes Lyme disease.

The phase 3 trial is expected to start in the third quarter of this year.