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Vaccines

Valneva and Pfizer Advance Lyme Disease Vaccine with Positive Paediatric Phase 2 Data

Strategic Insights

— 1 min read

Valneva SE and Pfizer Inc announced positive Phase 2 paediatric results for their Lyme disease vaccine candidate, VLA15, on April 26, 2022. The new data plan to include paediatric participants in their upcoming Phase 3 trial, evaluating VLA15 in adults and children aged 5 years and above. The Phase 2 trial, VLA15-221, enrolled a paediatric population aged 5-17 years and compared the immunogenicity and safety of VLA15 after two or three primary series doses in different age groups. The results show that VLA15 was more immunogenic in paediatric participants than in adults with both vaccination schedules tested. The safety profile in children was similar to that in adults, with no vaccine-related serious adverse events observed.

Key Takeaways:

  • Valneva and Pfizer's Lyme disease vaccine candidate, VLA15, demonstrated positive Phase 2 paediatric results, leading to the inclusion of paediatric participants in their planned Phase 3 trial.
  • The Phase 2 trial, VLA15-221, enrolled 190 paediatric participants aged 5-17 years and compared the immunogenicity and safety of VLA15 after two or three primary series doses in different age groups.
  • VLA15 was found to be more immunogenic in paediatric participants than in adults with both vaccination schedules tested.
  • The safety profile in children was similar to that in adults, with no vaccine-related serious adverse events observed.
  • The companies plan to submit the paediatric data for publication and presentation at a future scientific congress.
  • VLA15 will be evaluated in adults and paediatric subjects 5 years of age and above in the planned Phase 3 trial.

Statistics:

  • 190 paediatric participants aged 5-17 years were enrolled in the Phase 2 trial, VLA15-221.
  • 93 paediatric participants received VLA15 in the two-dose schedule, and 97 received it in the three-dose schedule.
  • No vaccine-related serious adverse events (SAEs) were observed in paediatric participants.
  • The planned Phase 3 trial is expected to be initiated in 3Q 2022, subject to regulatory approval.

Sources:

  • Pfizer, website: http://www.pfizer.com/ (Copyright Pfizer Inc 2022)

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