By NewsDesk @bactiman63
Specialty vaccine company, Valneva SE, announced yesterday its plans to accelerate pediatric development of its Lyme vaccine candidate, VLA15, in collaboration with Pfizer Inc., with the planned initiation of study VLA15-221 in the first quarter of 2021, subject to regulatory approval.
VLA15-221 is planned as a randomized, observer-blind, placebo-controlled Phase 2 study. Currently, the study will include approximately 600 healthy participants (5-65 years of age) who will receive VLA15 at the dose of 180µg, which was selected based on recent data generated in the two ongoing Phase 2 studies.
If approved, it will be the first clinical study of VLA15 to enroll a pediatric population aged 5-17 years and will compare the three-dose vaccination schedule Month 0-2-6 with a reduced two-dose schedule of Month 0-6.
“This will be an important study that we anticipate will provide evidence that the vaccine can be used in the populations that are at risk of the devastating consequences of Lyme disease, using a simplified schedule,” said Kathrin Jansen, Senior Vice President and Head of Pfizer Vaccine Research and Development.
- Michael Osterholm, PhD on lockdowns, masks and COVID-19 testing
- Canada: Salmonella outbreak linked to hedgehogs rises
- Hepatitis E outbreak in Burkina Faso: 15 deaths in pregnant/postpartum women
- Monkeypox deaths top 200 in DR Congo
- UK authorizes Pfizer COVID-19 vaccine, 1st EUA following Phase 3 trial
- COVID-19 vaccines update: Outbreak News This Week, Episode 3