Investigators observe strong immunogenicity profile in study participants aged 5 to 17 years 1 month after the primary vaccination series.
Pfizer and Valneva announced positive phase 2 pediatric data for their vaccine candidate for Lyme disease, VLA15.
Based on the results, the companies are planning an inclusion of children for the phase 3 trial. The trial will evaluate VLA15 in individuals aged 5 years and older and is expected to begin in the third quarter of 2022.
“Lyme disease affects all age groups, but with their affinity for being active outdoors, the pediatric population is at the greatest risk of Lyme disease. These first pediatric results are therefore extremely important and support the inclusion of pediatric participants in our planned phase 3 trial,” Juan Carlos Jaramillo, MD, chief medical officer of Valneva, said in a statement.
The phase 2 trial, VLA15-221, is the first clinical study of VLA15 that included a pediatric population. It compared the immunogenicity and safety of the vaccine candidate after administration of 2 or 3 primary series doses in age groups of 5 to 7 years, 12 to 17 years, and 18 to 65 years.
The 2-dose series was administered at 0 and 6 months, and the 3-dose series was administered at 0, 2, and 6 months.
In children who received either dosing series, investigators found that the vaccine candidate was more immunogenic than in adults with both vaccination schedules tested.
The data builds on the immunogenicity profile that was already reported for adult individuals aged 18 to 65 years. Similarly, to adults, the immunogenicity and safety data support a 3-dose primary vaccination series in children during the phase 3 study.
“The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens. These positive pediatric data mark 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,” Kathrin Jansen, PhD, senior vice president and head of vaccine research and development at Pfizer, said in the statement.
The safety and tolerability profile observed in the pediatric age group was similar to adult individuals. There were no vaccine-related serious adverse events observed.
The study included 585 individuals who received VLA15 at a dose of 180 µg, which was determined based on data from 2 previous phase 2 studies. The main immunogenicity and safety reading was performed 1 month after the primary vaccination series.
Additionally, 190 individuals received the vaccine candidate in a 3-dose series, and 187 received the 2-month series. An additional 208 individuals received a 3-dose series of the placebo.
A subset of individuals will receive a booster does of the vaccine candidate or the placebo at month 18 in a booster phase. These individuals will be monitored for an additional 3 years for antibody persistence.
The companies plan to submit these data for publication and presentation at a future scientific congress.
Valneva and Pfizer report positive phase 2 pediatric data for Lyme disease vaccine candidate. Pfizer. News release. April 26, 2022. Accessed April 26, 2022. https://www.pfizer.com/news/press-release/press-release-detail/valneva-and-pfizer-report-positive-phase-2-pediatric-data