Biotech company, Valneva SE, announced today positive initial booster data and final Phase 1 data for its leading, unique Lyme disease vaccine candidate VLA15.
To investigate whether a VLA15 booster will elicit an anamnestic response , Valneva amended its Phase 1 study protocol during 2018, adding a booster dose in a sub-cohort of the Phase 1 study population. At the same time the full Phase 1 study population has been followed-up across all doses for up to one year, providing the final Phase 1 data.
The final Phase 1 data confirmed the safety and tolerability profile observed at all time-points, as reported in the interim analysis. VLA15 demonstrated a favorable safety profile and had no associated safety concerns. In addition, the final Phase 1 immunogenicity results indicated that the alum-adjuvanted formulations elicit higher immune-responses at all time-points, confirming the interim data findings. As expected, based on the interim Phase 1 data, antibody titres declined post Day 84 across all groups, trending towards baseline at approximately one year post initial vaccination.
To evaluate the benefit of a booster dose, 64 subjects across the two higher dose groups (48µg and 90µg, both with and without alum) from Phase 1 received a booster in the period 12 to 15 months after their initial dose in the primary immunization. These single re-vaccinations resulted in a significant immune-response, yielding OspA antibody titres at levels 2.7-fold (ST32 ) – 5.8- fold (ST1) over the initial titres observed at Day 84 (geometric mean fold rise (GMFR)). These results are in line with published data from other OspA-based Lyme vaccines that had previously been in development.
Wolfgang Bender, M.D., Ph.D., Chief Medical Officer of Valneva, commented, “These encouraging results support our current development plans and hypothesis for our leading vaccine candidate, VLA15. As a result of these findings, we have included a VLA15 booster in the Phase 2 program that is now underway. Addressing the significant, and growing, unmet medical need caused by Lyme disease is our top priority, VLA15 remains the only Lyme vaccine candidate in clinical development worldwide.”
Valneva announced primary endpoint (interim) data from its Phase 1 trial of VLA15 (VLA15- 101) in March 2018.
Given the range of immune response and the variability across the different serotypes (seroconversion rates at Day 84 were between 71.4% (ST1) and 96.4%(ST2)), the ongoing Phase 2 study (VLA15-201) includes two higher doses (135 µg and 180µg, both adjuvanted with alum) and a study evaluating an alternative vaccination schedule (VLA15-202) is scheduled to commence mid-2019.
The complete Phase 2 study is expected to be approximately two years in duration with interim data (primary endpoint) expected mid-2020.
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