- Valneva SE VALN and Pfizer Inc PFE have announced more positive Phase 2 results, including the booster response, for their Lyme disease vaccine candidate VLA15.
- The 246-subject study is evaluating the immunogenicity and safety of VLA15 in a Month 0-2-6 vaccination schedule.
- The study met its primary endpoint of demonstrating that VLA15 was immunogenic across all dose groups tested.
- Continued evaluation at Month 18 showed that antibody titers declined, remaining above baseline but confirming the need for a booster strategy.
- VLA15 was safe and well-tolerated. No related Serious Adverse Events were observed in any treatment group.
- Participants who received a complete primary vaccination series with 180 µg doses of VLA15 had an option to continue the study in a booster extension phase to receive an additional 180 µg dose of VLA15 (N=39) or placebo (N=19).
- Booster dose elicited a strong anamnestic response yielding a 2.9-fold (ST3) to 4.2-fold (ST1, ST4) increase in anti-OspA IgG antibody titers compared with titers observed after primary immunization.
- All participants seroconverted to anti-OspA IgG after the booster dose, meaning Seroconversion Rates were 100% for all OspA serotypes.
- The companies are planning for a Phase 3 trial in 2022.
- Price Action: PFE stock is down 0.69% at $43.27, and VALN stock is down 2.17% at $29.76 during the premarket session on the last check Tuesday.
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