On 1st December 2022 Pfizer and Valneva reported antibody persistence data 6 months after the completion of a vaccination schedule with their Lyme disease vaccine candidate, VLA15. This was reported in both children and adults, the first time that antibody resistance data are reported in paediatric populations for this vaccine candidate.
Moving through the Phases
As we reported earlier this year, Phase II in April 2022 produced “positive immunogenicity and safety data”. As a result, the investigations continued, to evaluate the persistence of antibodies 6 months after the study of a Month 0-2-6 and Month 0-6 vaccination schedule. This was done in healthy adults and paediatric participants.
Data were collected in 96 health adults and 81 paediatric participants (5-17 years of age) for the schedule involving vaccination at months 0-2-6, and 84 healthy adults and 78 paediatric patients for the month 0-6 schedule.
Although antibodies did decline over time, they remained “above baseline”, confirming persistence 6 months after the completion of both schedules. Antibody levels generally remained higher after the 3-dose schedule, compared to the 2-dose schedule. The statement also indicated that “no vaccine-related serious adverse events (SAEs) and no safety concerns” were observed in the follow up.
Several months ago, Pfizer and Valneva initiated a Phase III study, VALOR. Enrolment is taking place across Europe and the US, with up to 6,000 participants over the age of 5 expected to receive 3 doses of VLA15 or a saline placebo, followed by a booster dose.
Validation of the vaccine
Dr Juan Carlos Jaramillo, CMO at Valneva, is “pleased with these antibody persistence data”. They “further validate” the 3-dose vaccination strategy for the Phase III study and the “acceptable safety and tolerability profiles of our vaccine candidate”.
“Lyme disease continues to spread, representing a high unmet medical need that impacts the lives of many in the Northern Hemisphere, and each new report of positive data takes us a step closer to potentially bringing this vaccine to both adults and children who could benefit from it.”
Dr Annaliesa Anderson, SVP and CSO of Vaccine Research and Development at Pfizer agreed, suggesting that “rates of Lyme disease continue to increase globally”.
“These six-month antibody persistence data are encouraging, and we hope that the data generated from the Phase III studies will further support the positive evidence for VLA15 to date.”
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