By NewsDesk  @bactiman63

Specialty vaccine company, Valneva, today announced positive initial results for its second Phase 2 study (VLA15-202) of Lyme disease vaccine candidate VLA15.

Borrelia burgdorferi spirochetes/CDC

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.


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