– Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, and Pfizer Inc. (NYSE: PFE), today announced that they have completed recruitment for the Phase 2 trial, VLA15-221, of Lyme disease vaccine candidate, VLA15. The trial builds on previous positive Phase 2 trials and includes both adult and pediatric participants with the aim to support acceleration of the vaccine candidate’s pediatric program.
A total of 625 participants, 5 to 65 years of age, have been randomized in the Phase 2 trial to receive VLA15 at Month 0-2-6 or Month 0-6 (200 volunteers each) or placebo at Month 0-2-6 (200 volunteers). The main safety and immunogenicity readout will be performed approximately one month after completion of the primary vaccination schedule (i.e. at Month 7). The objective of the trial is to show safety and immunogenicity down to 5 years of age and to evaluate the optimal vaccination schedule for use in Phase 3.
Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “This recruitment completion represents another important milestone in the development of VLA15. If successful, this trial could enable the inclusion of a pediatric population in the Phase 3 trial. Lyme disease continues to be a major concern and is prevalent in children1, it is therefore extremely important for us to potentially offer a vaccine that could protect both adults and children as rapidly as we can. We’d like to thank everyone involved in the trials for their contributions to keep the development moving forward and on track.”
“Given the medical importance of Lyme disease, its possible long term impact, and the known mechanism of vaccine protection, the development of a multivalent vaccine for prevention of 6 serotypes of Borrelia has the potential to address a great unmet need,” said Kathrin Jansen, PhD, Senior Vice President and Head of Pfizer Vaccine Research and Development. “We are pleased that the Phase 2 trial has reached full recruitment and look forward to what we hope will be a successful conclusion of the study.”
Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop VLA152. Positive top-line results have already been reported for two Phase 2 clinical trials of VLA15 in over 800 healthy adults. Topline results for VLA15-221 are expected in the first half of 2022.
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 uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease. 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 20173.
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 625 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). Vaccinees 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 performed at Month 7, when peak antibody titers are anticipated. A subset of participants will receive a booster dose of VLA15 or placebo at Month 18 (Booster Phase) and will be followed for three additional years to monitor antibody persistence.
VLA15 is tested as an alum-adjuvanted formulation and administered intramuscularly. The study is conducted at sites which are located in areas where Lyme disease is endemic and has enrolled volunteers with a cleared past infection with Borrelia burgdorferias well as Borrelia burgdorferi naïve volunteers.
About Lyme Disease
Lyme disease is a systemic infection caused by Borrelia burgdorferi bacteria transmitted to humans by infected Ixodes ticks4. 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 year5, and there are at least a further 200,000 cases in Europe annually6. 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 widens7.
About Valneva SE
Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. We take a highly specialized and targeted approach to vaccine development, beginning with the identification of deadly and debilitating infectious diseases that lack a prophylactic vaccine solution and for which there are limited therapeutic treatment options. We then apply our deep understanding of vaccine science, including our expertise across multiple vaccine modalities, as well as our established vaccine development capabilities, to develop prophylactic vaccines to address these diseases. We have leveraged our expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID- 19.