Pfizer and Valneva’s phase 3 Lyme disease vaccine clinical trial has gone badly wrong.
After discovering good clinical practice (GCP) violations at some trial sites, the partners have removed around half of the enrolled participants from the study.
The clinical trial got underway in August with the goal of enrolling around 18,000 healthy people who live in areas with endemic Lyme disease and lead lifestyles that put them at increased risk of being bitten by ticks.
Participants are receiving either VLA15 or placebo to assess the ability of the multivalent protein subunit vaccine to reduce the risk of catching Lyme disease.
As of last month, Valneva aimed to complete enrollment for the 6,000-subject primary efficacy readout in the second quarter, putting it and Pfizer on track to file for approval in 2025. Now, the pivotal trial has suffered a serious setback, as Valneva explained in a statement.
“Pfizer, as the study sponsor, has decided to discontinue a significant percentage of participants in the U.S.
These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of GCP at certain clinical trial sites run by a third-party clinical trial site operator,” the French vaccine developer said.
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