Pfizer and Valneva have reported antibody persistence data six months after the completion of a three or two-dose vaccination schedule with their Lyme disease vaccine candidate, VLA15, in both children and adults.
This is the first time that antibody persistence data has been reported in paediatric populations for VLA15, which is also the only Lyme disease vaccine candidate currently in clinical development.
Following positive immunogenicity and safety data for phase 2 study VLA15-221 in April this year, the companies evaluated the persistence of antibodies six months after the month zero-two-six and zero-six vaccination schedule with VLA15 in healthy participants.
Consistent with results seen in previous clinical studies, antibody levels declined over time in all study groups but remained above baseline, confirming their persistence six months after completion of both vaccination schedules.
Overall, antibody levels remained higher with the three-dose vaccination schedule compared to the two-dose schedule, the companies said.
In August, Pfizer and Valneva announced they had initiated the phase 3 VALOR study to investigate the efficacy, safety and immunogenicity of VLA15 in approximately 6,000 participants aged five years and older.
Enrolment is ongoing in Europe and the US, and is expected to be completed in the second quarter of 2023.
Upon successful completion of the studies, Pfizer could submit a Biologics Licence Application to the US Food and Drug Administration and Marketing Authorisation Application to the European Medicines Agency in 2025.
Lyme disease is a systemic infection transmitted to people by infected Ixodes ticks carrying Borrelia Burgdorferi bacteria. It is estimated to affect around 476,000 people in the US and 130,000 people in Europe each year.
Early symptoms, such as a gradually expanding erythematous rash called erythema migrans or more unspecific symptoms like fatigue, fever, headache or mild stiff neck are often overlooked or misinterpreted. If left untreated, the disease can cause more serious complications including arthritis, carditis or affect the nervous system.
“Rates of Lyme disease continue to increase globally, underscoring the importance of a vaccine that may help protect both adults and children,” said Annaliesa Anderson, senior vice president and chief scientific officer of vaccine research and development at Pfizer.
She continued: “This six-month antibody persistence data is encouraging, and we hope that the data generated from the phase 3 studies will further support the positive evidence for VLA15 to date.”