Clinical Trials

To date, BiondVax has completed trials in Israel covering 479 patients and in each trial, BiondVax’s vaccine was shown to be safe and immuogenic. BiondVax is currently embarking on two final phase II trials covering 372 patients, one in the United States funded by the US National Institute of Health and one in Europe funded by the European UNISEC Consortium.

TitleNameLocationPhaseYearDesignEnrollmentStatus
M-001 as primer to
pandemic influenza A/H7N9 in collaboration with DMID/NIH
BVX-008United States22016double-blind, multicenter, randomized and placebo-controlled to assess assess safety, reactogenicity and immunogenicity 180Expected to start soon
M-001 as primer to
pandemic influenza H5N1 in adults (18-60).
Details in EU Clinical Trials Register
BVX-007Europe22016multicenter, randomized, double-blind, active-controlled study to assess immunogenicity and safety
224Sept. 2016 reported Last Patient Out. Results expected 2017
M-001 as primer to
Seasonal influenza in older adults (50-65)
BVX-006Israel22015randomized, placebo-controlled, double-blind study to assess safety and immunogenicity
36M-001 was safe and immunogenic, inducing immunity to multiple influenza strains
M-001 as primer to
Seasonal influenza in the elderly (65+)
BVX-005Israel22012multicenter, randomized, placebo -controlled study to assess safety immunogenicity
120Positive safety profile and induced both humoral and cellular immune responses
Adjuvanted M-001 as primer to Seasonal influenza
in younger adults (18-49)
BVX-004Israel22011randomized, two stage, double-blind, placebo-controlled two-dose, safety and immunogenicity study
200Positive safety profile and induced both humoral and cellular immune responses
M-001 as primer to
Seasonal influenza in the elderly (55-75)
BVX-003Israel1/22010randomized, single-blind, placebo-controlled escalating double-dose, safety and priming potential study
60Positive safety profile and induced both humoral and cellular immune responses
M-001 as primer to
Seasonal influenza
in younger adults (18-49)
BVX-002Israel1/22009randomized, single-blind, placebo-controlled escalating double-dose safety trial
63Well tolerated safe and induced priming