Valneva SE (“Valneva”), a specialty vaccine company focused on prevention of diseases with major unmet needs, today announced positive initial results for its second Phase 2 study (VLA15-202) of Lyme disease vaccine candidate VLA15.
Compared to study VLA15-201, study VLA15-202 investigated a vaccination schedule of Month 0-2-6 based on matching doses.
VLA15 was generally safe across all doses and age groups tested. The tolerability profile including fever rates was comparable to other lipidated recombinant vaccines or lipid containing formulations. As in VLA15-201, no related Serious Adverse Events (SAEs) were observed in any treatment group. Reactogenicity decreased following the first vaccination.
Compared to study VLA15-201, immunogenicity was further enhanced using a Month 0-2-6 schedule. SCRs (Seroconversion Rates), after completion of the primary vaccination series, showed similar responses and ranged from 93.8% [ST1] to 98.8% [ST2, ST4]. Antibody responses were comparable in the two dose groups tested.
The immunological response in older adults, one of the main target groups for a Lyme vaccine, is particularly encouraging, as already observed in VLA15-201.
Furthermore, results did not indicate that prior exposure to Borrelia spirochetes (sero-positivity) has an impact on immunogenicity or safety, also as observed in VLA15-201.
A Serum Bactericidal Assay (SBA), assessing the functional immune response against Lyme disease after vaccination with VLA15, was conducted for the first time and demonstrated functionality of antibodies against all OspA serotypes. Assays, such as SBAs, are commonly used to enable a potential prediction of vaccine efficacy via the measurement of vaccine-induced functional immune responses.
Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “We are extremely pleased with these results which showed an excellent immunological profile, further supported by additional positive data through the Serum Bactericidal Assay (SBA). With these encouraging data we are now well positioned to continue development. Lyme disease continues to be a high unmet medical need and our objective remains to work closely with Pfizer to offer a preventative solution as soon as possible.”
VLA15-202 Day 208 safety and immunogenicity data support advancing the program with the Month 0-2-6 schedule. Valneva and Pfizer will finalize dosage analysis and prepare for the next development steps in the coming months.
About Phase 2 Clinical Study VLA15-202
VLA15-202, the second Phase 2 study, is a randomized, observer-blind, placebo controlled trial conducted in the US.
A total of 246 volunteers received 135 µg or 180 µg of VLA15 (approximately 100 subjects each) or placebo (approximately 50 subjects).
VLA15 was tested as alum adjuvanted formulation and was administered intramuscularly in three injections, given at Month 0, 2 and 6 (compared to Month 0, 1 and 2 in study VLA15-201).
Subjects are followed for 18 months, with the main immunogenicity readout at one month after completion of the primary vaccination series (primary endpoint). The study enrolled healthy adults 18 to 65 years of age.
Study centers are located in areas where Lyme disease is endemic; volunteers with a cleared past infection with Borrelia burgdorferi, the bacteria that cause Lyme disease, were also enrolled.
VLA15 is the only active Lyme disease vaccine 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, Phase 1 and Phase 2studies. 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 Lyme Disease
Lyme disease is a systemic infection caused by Borrelia bacteria 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 300,000 Americans are diagnosed with 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.
About Valneva SE
Valneva is a specialty vaccine company focused on prevention of diseases with major unmet needs. Valneva’s portfolio includes two commercial vaccines for travelers: IXIARO®/JESPECT® indicated for the prevention of Japanese encephalitis and DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. Valneva has various vaccines in development including unique vaccines against Lyme disease, COVID-19 and chikungunya. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the US with over 500 employees. For more information, visit www.valneva.com and follow the Company on LinkedIn.
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 Valneva Receives FDA Fast Track Designation for its Lyme Disease Vaccine Candidate VLA15
 Valneva and Pfizer Announce Collaboration to Co-Develop and Commercialize Lyme Disease Vaccine, VLA15
 Stanek et al. 2012, The Lancet 379:461–473
 As estimated by the CDC, https://www.cdc.gov/lyme/stats/humancases.html.
 Estimated from available national data. Number largely underestimated based on WHO Europe Lyme Report as case reporting is highly inconsistent in Europe and many LB infections go undiagnosed; ECDC tick-borne-diseases-meeting-report
 New Scientist, Lyme disease is set to explode and we still don’t have a vaccine; March 29, 2017 https://www.newscientist.com/article/mg23431195-800-lyme-disease-is-set-to-explode-and-you-cant-protect-yourself/