(CercleFinance.com) – Valneva and Pfizer on Thursday unveiled new data at six months on the persistence of antibodies in children and adults vaccinated with their candidate against Lyme disease.
These results show that antibody levels remained above their initial level six months after the last injection of three doses (at months 0, 2 and 6) or two doses (at months 0 and 6).
It should be noted that higher antibody levels were observed with a three-dose vaccination schedule compared to the two-dose vaccination schedule, thus validating the use of this schedule in the ongoing Phase 3 study.
Data were collected from 96 healthy adults and 81 pediatric participants (aged 5 to 17 years) for the three-dose vaccination schedule.
For the two-dose vaccination schedule, 84 healthy adults and 78 pediatric participants were recruited.
At the same time, no safety problem was observed during this six-month follow-up, specify the two groups.
Earlier this year, Pfizer and Valneva launched a Phase 3 clinical study to assess the efficacy, safety and immunogenicity of VLA152.
About 6,000 participants aged 5 years and older should receive three doses of VLA15 or saline placebo as the primary series, followed by a booster dose of VLA15 or saline placebo.
Recruitment of study participants is ongoing in Europe and the United States and is expected to be complete in the second quarter of 2023
Subject to the success of Phase 3 studies, Pfizer could potentially submit marketing authorization applications to health authorities in the United States and Europe in 2025.
Following these announcements, Valneva shares rose 3.3% on Thursday in the first exchanges on the Paris Stock Exchange.