World News: 16:50 GMT Wednesday 12th June 2019. [VALNEVA via Globe Newswire via SPi World News]
Valneva has previously reported initial booster data and final Phase 1 follow-up data for VLA15, confirming that the vaccine candidate has a favorable safety profile and was immunogenic in all doses and formulations tested. VLA15 elicited an excellent anamnestic response following a booster vaccination in a time window of 12 to 15 months after initial primary immunization.
As part of the VLA15-201 run-in Phase, 120 subjects received one of three alum adjuvanted dose levels of VLA15 (90µg, the high dose from Phase 1, 135µg or 180µg) or placebo. The DSMB has reviewed safety data from those subjects and has cleared the 135µg and 180µg dosage levels for further investigation in the main study phase.
Valneva has commenced preparations to initiate a further Phase 2 study (VLA15-202) to evaluate an alternative immunization schedule. The Company expects this study to commence in the third quarter of this year.
Preliminary Phase 2 results (primary endpoint) are anticipated – as previously announced – mid-2020.
VLA15-201 is the first of two planned, parallel Phase 2 studies. It is a randomized, observer-blind, placebo controlled trial conducted at trial sites in the US and Europe. In the run-in Phase, 120 subjects received one of three dosage levels of VLA15, or placebo. Following review of safety data by an independent Data Safety Monitoring Board, 450 subjects in the main study phase will receive one of two selected dose levels of VLA15 (180 subjects each), or placebo (90 subjects). VLA15 will be tested as alum adjuvanted formulation and will be administered intramuscularly in three injections, given one month apart at Days 1, 29 and 57. Subjects will be followed for one year, with the main immunogenicity readout one month after the third immunization on Day 85 (Primary Endpoint). The study is enrolling healthy adults 18 to 65 years of age. Study centers will be located in areas where Lyme disease is endemic; subjects with a cleared past infection with , the bacteria that cause Lyme disease, will also be enrolled.
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Globe Newswire: 16:50 GMT Wednesday 12th June 2019
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