VALNEVA AND PFIZER REPORT FURTHER POSITIVE PHASE 2 RESULTS, INCLUDING BOOSTER RESPONSE, FOR LYME DISEASE VACCINE CANDIDATEhttps://www.pfizer.com/news/press-release/press-release-detail/valneva-and-pfizer-report-further-positive-phase-2-resultsSaint-Herblain (France) and New York (United States), September 28, 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. (NYSE: PFE), today announced further positive Phase 2 results, including booster response, for Lyme disease vaccine candidate VLA15.
The Phase 2 study, VLA15-202, is evaluating the immunogenicity and safety of VLA15 in a Month 0-2-6 vaccination schedule. The study enrolled 246 healthy adults 18 to 65 years of age in the U.S. As announced in October 20201, the study met its primary endpoint of demonstrating that VLA15 was immunogenic across all dose groups tested and elicited high antibody responses across all serotypes (ST1 - ST6) at one month after completion of the primary vaccination series. Continued evaluation at Month 18 showed that antibody titers declined thereafter across all groups, remaining above baseline but confirming the need for a booster strategy.
VLA15 was safe and well-tolerated across all doses and age groups tested. No related Serious Adverse Events (SAEs) were observed in any treatment group.
Participants who received a complete primary vaccination series with 180 µg doses of VLA15, were invited to continue the study in a booster extension phase and were randomized to receive an additional 180 µg dose of VLA15 (N=39) or placebo (N=19) at Month 18.
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VLA15 is the only active Lyme disease vaccine candidate in clinical development. This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease, and covers the six OspA serotypes that are prevalent in North America and Europe. OspA is one of the most dominant surface proteins expressed by the bacteria when present in a tick. VLA15 has demonstrated strong immunogenicity and safety data in pre- clinical and clinical studies so far. The program was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in July 2017.
Interesting, on several levels. First, Lyme disease is caused by a bacterium, so this would be yet another vaccine than does not use traditional dead/inactivated virus technology. Second, it is a
three-dose regime, yet another vaccine that is not single dose, and the first I've heard of (not that my knowledge is anywhere near exhaustive) that uses three doses. Third, it would be yet another vaccine with scheduled boosters.
The big news, of course, is that it would be the first vaccine against Lyme disease, a pretty big deal.
