Pfizer (NYSE:PFE) and vaccine firm Valneva (Nasdaq:VALN; Euronext Paris:VLA) have released six-month antibody persistence data for children and adults receiving their Lyme disease vaccine candidate.
In the Phase 2 VLA15-221 study, individuals received either three doses of the vaccine (at months 0, 2 and 6) or two doses (at months 0 and 6).
The study involved both children and adults. The companies collected data from 96 healthy adults and 81 pediatric participants aged 5 to 17 for the three-dose schedule. In addition, they collected data from 84 healthy adults and 78 participants aged 5 to 17 for the two-dose schedule.
The three-dose vaccination schedule bested the two-dose schedule overall. Relative to baseline, geometric mean fold rises (GMFR) were 1.9-fold for Serotype 1 (ST1) to 3.2-fold for Serotype 2 (ST2) across all participants receiving three vaccine doses. The levels were highest in the 5- to 11-year-old arm of the three-dose portion of the trial, with GMFR levels ranging from 2.8-fold (ST1) to 6.6-fold (ST2).
According to Pfizer and Valneva, the experimental vaccine was well tolerated. No vaccine-related serious adverse events (SAEs) and no safety concerns were identified in a six-month observational follow-up.
“We are pleased with these antibody persistence data that further validate the use of the three-dose vaccination schedule in our ongoing Phase 3 study and the acceptable safety and tolerability profiles of our vaccine candidate,” said Dr. Juan Carlos Jaramillo, chief medical officer of Valneva, in a news release. “Lyme disease continues to spread, representing a high unmet medical need that impacts the lives of many in the Northern Hemisphere, and each new report of positive data takes us a step closer to potentially bringing this vaccine to both adults and children who could benefit from it.”
The companies will continue to test the three-dose schedule in the aforementioned Phase 3 study. In the Vaccine Against Lyme for Outdoor Recreationists (VALOR) study (NCT05477524), roughly 6,000 participants 5 years of age and older will get three doses of the VLA15 vaccine candidate or a saline placebo. Participants will also receive a booster dose of VLA15 or saline.
Valneva’s shares were up 8.08%, hitting €6.77 in early afternoon trading. Pfizer shares increased 1.58% to $50.92.
In June, Pfizer announced it would invest $95 million in Valneva.
Filed Under: Infectious Disease