Pfizer and Valneva have announced positive phase 2 paediatric results for their Lyme disease vaccine candidate, VLA15.
The companies plan to include paediatric participants in their future phase 3 trial, which will assess VLA15 in adults and paediatric patients aged 5 years and older. The phase 3 trial is anticipated to start in the third quarter of 2022, subject to regulatory approval.
VLA15 is currently the only Lyme disease vaccine candidate in clinical development. The vaccine uses a mechanism that targets the outer surface protein A of Borrelia burgdorferi, the bacteria transmitted from Ixodes ticks.
Lyme disease is a systemic infection transmitted to people by infected Ixodes ticks carrying Borreliaburgdorferi bacteria. It is estimated to affect around 476,000 people in the US and 130,000 people in Europe each year.
Early symptoms of Lyme disease are often overlooked or misinterpreted and can include a gradually expanding, bull’s-eye shaped rash called Erythema migrans, fatigue, fever, headache, mild stiff neck, arthralgia or myalgia.
When left untreated, the disease can cause more serious complications like arthritis, carditis or affect the nervous system. Cases are rising as it continues to spread, underscoring the medical need for vaccination against the disease.
The phase 2 randomised study is the first clinical study using VLA15 with an enrolled paediatric group – those aged five to 17 years. It compared the immunogenicity and safety of the vaccine after administration of two or three primary doses in groups aged 5 to 11, 12 to 17 and 18 to 65 years.
Paediatric patients who received VLA15 – either as two or three doses – showed that VLA15 offered more immunity than in adults. The data builds on the strong immunogenicity profile already reported for adults (aged 18 to 65 years) in February 2022.
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.