Lyme Vaccine Clinical Trials Reported as Positive for Pediatrics

Positive Phase 2 clinical trial results for the Lyme disease vaccine candidate (VLA15) in the pediatric population have just been announced by Pfizer and Valneva. VLA15 is currently the only Lyme disease vaccine candidate in clinical development, and is the first clinical study to enroll children aged 5 to 17 years old. This phase 2 clinical study compared the “immunogenicity and safety” of the vaccine after patients received either two or three primary doses in various age groups. 

Results of the study showed that pediatric patients who received VLA15 as part of either a two or three dose regime developed more immunity than in adult patients. Researchers contend that this new data supports the “strong immunogenicity profile” already reported for adults aged 18 to 65 years.

Pfizer and Valneva plan to release the clinical trial data in both publication and presentation in the future. They also plan to continue to enroll pediatric patients in their proposed phase 3 trial, expected to commence in fall or 2022, which will further evaluate VLA15  efficacy and safety in patients 5 years old to adults. 

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The safety and tolerability of the vaccine given to the 5-17-year age group was similar to the earlier reported profile in adults, while no vaccine-related serious adverse events were recorded.

Kathrin Jansen, senior vice president and head of vaccine R&D at Pfizer, said: “The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens. The positive paediatric data marks an important step forward in the ongoing development of VLA15, and we are excited to continue working with Valneva to potentially help protect both adults and children from Lyme disease.”

The two companies plan to present the data for publication and presentation at a future scientific congress.