Valneva has reported phase 2 data on the third booster dose of its Pfizer-partnered Lyme disease vaccine candidate, ticking off another task for a prospect that could reach regulatory review next year.
Investigators randomized 560 healthy participants to receive vaccine candidate VLA15, given in one of two immunization schedules, or placebo. Valneva’s primary endpoint assessed participants one month after the completion of the primary series vaccination schedule. But the biotech continued to track the subjects across three booster shots, culminating in a dose given at Month 42.
Valneva’s latest data drop features results from people tested one month after the Month 42 dose. The analysis showed that, after the third booster shot, participants mounted an antibody response against the six serotypes covered by the vaccine candidate.
Kids, adolescents and adults all responded. Seroconversion rates hit 100% for all outer surface protein A serotypes in all age groups. Valneva said the seroconversion rates and antibody titers were in line with the responses seen after the first and second booster shots. Safety and tolerability were also similar, the biotech said, with no concerns identified in any treatment or age group.
The results form part of Valneva’s case for people receiving a yearly booster dose before the start of the annual Lyme season, which typically runs from late spring to early fall in the U.S. No vaccines are currently approved in the U.S. to protect against Lyme. GSK withdrew a product in 2002 because of poor sales. The geographic range of the disease has expanded since then.
Valneva and Pfizer’s attempt to address the unmet need centers on two phase 3 trials that are nearing completion. If successful, the studies could support filings for approval in the U.S. and European Union next year. Valneva CEO Thomas Lingelbach set out the importance of the readout to the company on an earnings call last month.
“The Lyme disease program with Pfizer is not only the single largest catalyst for the company and its future development and strategic optionality, but it’s also the vaccine that could make the single largest impact to people’s lives,” Lingelbach said. “We have really a great opportunity to become, on the back of a positive Lyme outcome, the leading vaccine biotech in the world.”