Lyme Disease Vaccine Booster Protects Children Too

While there are no approved human vaccines for Lyme disease, results from a new study show a booster dose can produce a strong immune response in children, adolescents, and adults.

France-based Valneva SE and Pfizer Inc. today announced positive pediatric and adolescent immunogenicity and safety data for their Lyme disease vaccine candidate, VLA15, when given as a booster.

The VLA15-221 Phase 2 clinical trial showed a strong anamnestic antibody response for all serotypes in pediatric (5 to 11 years of age) and adolescent participants (12 to 17 years of age), as well as in adults (18 to 65 years of age), one month after administration of a booster dose (month 19).

Depending on the primary vaccination schedule (month 0-2-6 or month 0-6), participants seroconverted after the booster dose, yielding seroconversion rates of 95.3% and 94.6% for all outer surface protein A (OspA) serotypes in all age groups, respectively.

Additionally, OspA antibody titers were significantly higher one month after the booster dose compared to one month after the primary schedule, with 3.3- to 3.7-fold increases (Geometric Mean Fold Rises) in adults, 2.0- to 2.7-fold increases in adolescents and 2.3- to 2.5-fold increases in children for all serotypes.

“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,” commented Annaliesa Anderson, Ph.D., Senior Vice President and Head of Vaccine Research and Development at Pfizer, in a press release on September 7, 2023.

These results follow six-month antibody persistence data in children and adults reported for the VLA15-221 study in December 20222 and positive immunogenicity and safety data reported in April 20223.

Pfizer aims to submit a Biologics License Application to the U.S. Food and Drug Administration and a Marketing Authorisation Application to the European Medicines Agency in 2026, subject to positive Phase 3 data.