Clinical Trials

To date, BiondVax has completed 6 clinical trials (two Phase 1/2 and four Phase 2) covering 698 patients and in each trial, BiondVax’s vaccine was shown to be safe, well-tolerated, and immunogenic. BiondVax’s M-001 is embarking on a phase II trial in the United States funded by the US National Institute of Health (NIH), and is preparing to launch a Phase 3 trial later.

TitleNameLocationPhaseYearDesignEnrollmentStatus
Pivotal clinical efficacy Phase 3 trialBVX-010Europe3Q4 2018A multi-center, randomized, double-blind, placebo-controlled pivotal Phase 3 trial to assess the safety and clinical efficacy of a M-001 influenza vaccine administered intramuscularly twice in older adults and elderly (>50 years)~7700Planning underway 2017. Details indicated here reflect current plan, subject to change.
Assess the Safety, Reactogenicity, and Immunogenicity of Two Doses of Multimeric-001 (M-001) Followed by Seasonal Trivalent Influenza Vaccine.BVX-008United States2Q2 2018double-blind, multicenter, randomized and placebo-controlled to assess safety, reactogenicity and immunogenicity 120CTA signed November 2017. (Details here). Trial expected to begin after 2017/18 flu season.
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
219Statistically significant positive results. Both primary endpoints achieved: Safety and influenza-specific cellular immune responses. (Details here)
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