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Valneva and Pfizer initiate phase 3 Lyme disease vaccine study

VLA15 is the only Lyme disease vaccine candidate currently in clinical development

Valneva

Valneva and Pfizer have announced the initiation of a phase 3 study to investigate the efficacy, safety and immunogenicity of their Lyme disease candidate VLA15.

VLA15 is the only Lyme disease vaccine candidate currently in clinical development. The vaccine uses a mechanism that targets the outer surface protein A of Borrelia burgdorferi and it has demonstrated a strong immunogenicity and safety profile in pre-clinical and clinical studies so far.

The randomised, placebo-controlled, phase 3 VALOR study plans to enrol approximately 6,000 participants aged five years and older and will be conducted at up to 50 sites located in areas where Lyme disease is highly endemic, including the US, Germany, Poland, Finland, Sweden and the Netherlands.

Three doses of VLA15 180µg or saline placebo will be administered to participants as a primary vaccination series followed by one booster dose of VLA15 or saline placebo.

Upon successful completion, Pfizer could submit a Biologics Licence Application (BLA) to the US Food and Drug Administration (FDA) and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2025.

The announcement follows the two companies entering into an Equity Subscription Agreement and updating the terms of their Collaboration and Licence Agreement for VLA15 in June.

As per the terms of the  agreement, Valneva will receive a $25m milestone payment from Pfizer upon initiation of the phase 3 study.

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 of Lyme disease, such as a gradually expanding erythematous rash called erythema migrans or more unspecific symptoms like fatigue, fever, headache, mild stiff neck, arthralgia or myalgia, are often overlooked or misinterpreted.

If left untreated, the disease can cause more serious complications including arthritis, carditis or affect the nervous system. Cases are rising as it continues to spread, underscoring the medical need for vaccination against the disease.

Annaliesa Anderson, senior vice president and head of vaccine research and development at Pfizer, said: "With increasing global rates of Lyme disease, providing a new option for people to help protect themselves from the disease is more important than ever.

“We hope that the data generated from the phase 3 study will further support the positive evidence for VLA15 to date, and we are looking forward to collaborating with the research sites across the US and Europe on this important trial."

Article by
Emily Kimber

9th August 2022

From: Research

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