Valneva, hit by COVID contract chaos, sees Lyme disease vaccine drop-off in phase 2, but boosters helping

Valneva and partner Pfizer say their experimental Lyme disease vaccine has seen a drop-off in protection after 18 months and will need a booster, though early data suggest that later shot can help.

The French biotech and the Big Pharma released new data early Tuesday morning for their Lyme disease vaccine candidate VLA15, a multivalent protein subunit shot that targets the outer surface protein A (OspA) of the Borrelia bacteria. OspA is one of the most dominant surface proteins expressed by the bacteria when present in a tick.

The updated package from the phase 2 test, which is looking at the immunogenicity and safety of the shot in a month 0-2-6 vaccination schedule, builds on the top-line data published a year ago, which showed the treatment met its primary endpoint of predicting a strong response after one month.

Now, new data show that after 18 months antibody titers, which can demonstrate how one part of your immune system is remembering the shot, “declined thereafter across all groups, remaining above baseline but confirming the need for a booster strategy.”

Here, giving the booster dose “elicited a strong anamnestic response” according to the biotech, yielding a 2.9-fold to 4.2-fold increase in anti-OspA IgG antibody titers, when compared with titers seen when the shot was first given.

The study “is continuing to monitor persistence of antibody responses” Valneva said, and comes as Pfizer has been making the case that its COVID vaccine, made with Germany’s BioNTech, also needed a booster shot to help battle new variants of SARS-CoV-02.

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Pfizer penned the $308 million Lyme disease vaccine R&D pact with Valneva last May right at the start of its COVID vaccine journey. VLA15, which was then the only active Lyme disease vaccine program in clinical development, covers six serotypes that are prevalent in North America and Europe.

Collectively, around half a million people across the two regions are infected with the bacteria Borrelia, causing in many long-term debilitating disorders if not treated quickly. It’s predominately spread to humans by infected Ixodes ticks. A phase 3 is slated for next year.

“We are excited by these additional Phase 2 results, which we believe take us a step closer to making a major contribution against this severe disease, subject to regulatory approval,” said Juan Carlos Jaramillo, M.D., chief medical officer of Valneva.

The big market focus remains, however, on Valneva’s COVID vaccine work. This was dealt a setback in commercial terms this month after the biotech, which recently pulled off a Nasdaq IPO, saw those shares plunge 42% after Britain said it has canceled a contract for about 100 million doses of its COVID vaccine, mainly over concerns about when it would win approval for use given it lags behind its rivals.

Its COVID shot, which uses the more traditional vaccine tech of an inactivated virus like the flu jabs, is pushing on in the clinic, however, with the biotech saying last week it has started a booster test and trials in teenagers for VLA2001.

Valneva already has a licensed vaccine portfolio that includes Ixiaro, marketed as Jespect in Australia and New Zealand, for the prevention of Japanese encephalitis, as well as Dukoral to prevent cholera.