March 8, 2021: “Valneva SE (“Valneva”), a specialty vaccine company focused on prevention of diseases with major unmet needs, and Pfizer Inc. announced initiation of study VLA15-221.
The VLA15-221 study builds on previous positive Phase 2 studies, incorporates new dose regimens and is anticipated to be the final Phase 2 study readout before a decision to progress into pivotal Phase 3 studies.
As announced in December 2020, VLA15-221 is a randomized, observer-blind, placebo-controlled Phase 2 study.
It will be the first VLA15 study to include a pediatric population (aged 5-17 years). Overall, the study will enroll approximately 600 healthy participants (aged 5-65 years) who will receive VLA15 or placebo.
It will compare the three-dose vaccination schedule (Month 0-2-6) with a two-dose schedule (Month 0-6).
“We are excited to be part of the Lyme disease vaccine development program with Valneva.
We hope this Phase 2 trial, with a simplified schedule, will provide evidence that the investigational vaccine can be used in populations that are at risk of contracting Lyme disease, potentially including children age five years and older,” said Kathrin Jansen, Senior Vice President and Head of Pfizer Vaccine Research and Development.
Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva commented, “This trial initiation marks an important step in the development of VLA15 toward a potential licensure.
Including a pediatric population in Phase 2 means we could, if successful, add this population to the Phase 3 research program, to potentially offer a vaccine for Lyme disease that may help prevent disease in both adults and children, if approved.
We are pleased that, together with our partner Pfizer, we have decided to pursue this development while preparing for a potential Phase 3 start.”
Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop VLA15.
Under the terms of the agreement, first subject, first dose in this study will trigger a milestone payment of $10 million from Pfizer to Valneva.
About VLA 15
VLA15 is the only active Lyme disease vaccine candidate in clinical development today, and covers six serotypes that are prevalent in North America and Europe.
This investigational multivalent protein subunit vaccine targets the outer surface protein A (OspA) of Borrelia, an established mechanism of action for a Lyme disease vaccine.
OspA is one of the most dominant surface proteins expressed by the bacteria when present in a tick.
VLA15 has demonstrated strong immunogenicity and safety data in pre-clinical and clinical studies so far.
The program was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in July 2017.
Valneva and Pfizer announced a collaboration for VLA15’s development and commercialization at the end of April 2020.
The two companies are working closely together on the next development steps.
About Clinical Study VLA15-221
VLA15-221 is a randomized, observer-blind, placebo-controlled Phase 2 study. It is the first clinical study with VLA15 that enrolls a pediatric population aged 5 years and older.
A total of approximately 600 participants will receive VLA15 at two different immunization schedules (Month 0-2-6 or Month 0-6, 200 volunteers each) or placebo (Month 0-2-6, 200 volunteers).
Vaccines will receive VLA15 at a dose of 180µg, which was selected based on data generated in the two previous Phase 2 studies.
The main safety and immunogenicity readout (Primary Endpoint analysis) will be at Month 7, where peak antibody titers are expected.
A subset of participants will receive a booster dose of VLA15 or placebo at Month 18 (Booster Phase) and will be followed up for further three years to monitor antibody persistence.
VLA15 will be tested as an alum-adjuvanted formulation and administered intramuscularly.
The study will be conducted at sites which are located in areas where Lyme disease is endemic and will enroll volunteers with a cleared past infection with Borrelia burgdorferi, the bacteria that cause Lyme disease, as well as B. burgdorferi naïve volunteers.
About Lyme Disease
Lyme disease is a systemic infection caused by Borrelia bacteria burgdorferi sensu lato transmitted to humans by infected Ixodes ticks.
It is considered the most common vector borne illness in the Northern Hemisphere. According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 476,000 Americans are diagnosed and treated for Lyme disease each year with at least a further 200,000 cases in Europe.
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.
Left untreated, the disease can disseminate and cause more serious complications affecting the joints (arthritis), the heart (carditis) or the nervous system.
The medical need for vaccination against Lyme disease is steadily increasing as the disease footprint widens.”