Clinical Trials

Valneva and Pfizer have announced positive paediatric and adolescent immunogenicity and safety data for their Lyme disease vaccine candidate, VLA15, when given as a booster. Results from the VLA15-221 phase 2 trial demonstrated a strong anamnestic antibody response in paediatric, adolescent and adult patients one month after booster administration.

Results from the trial emphasise the vaccine candidate’s potential to provide immunity against Lyme disease in both paediatric and adolescent populations, with the safety and tolerability of the vaccine remaining consistent with previous trials. No vaccine-related serious adverse events or safety concerns were observed.

Annaliesa Anderson PhD, senior vice president and head of Vaccine Research and Development at Pfizer, added: “Protection against Lyme disease is important for anyone who lives or spends time outdoors in areas where Lyme disease is endemic. This data from the VLA15-221 study is vital to improve our understanding of how vaccination may help to protect both adults and children from this potentially devastating disease. We are encouraged by the positive phase 2 results for VLA15, and, in partnership with Valneva, look forward to continuing to study the vaccine candidate in ongoing phase 3 clinical trials.”

“We are pleased with this data, which validates the use of a booster dose in all age groups,” Juan Carlos Jaramillo MD, chief medical officer of Valneva, commented. “Lyme disease continues to spread, representing an important unmet medical need that impacts the lives of many people in the Northern Hemisphere. With each new set of positive data, we come one step closer to potentially bringing this vaccine to both adults and children living in areas where Lyme disease is endemic.”