Clinical Trials

To date, BiondVax has completed 7 clinical trials (two Phase 1/2 and five Phase 2) with a total of 818 participants and in each trial BiondVax’s vaccine was shown to be safe, well-tolerated, and immunogenic. A phase 2 trial in the United States funded by the US National Institute of Health (NIH) reported results in 2020, and a pivotal, clinical efficacy, Phase 3 trial in over 12,000 participants is ongoing across seven European countries.

TitleNameLocationPhaseYearDesignEnrollmentStatus
A Pivotal Trial to Assess the Safety and Clinical Efficacy of the M-001 as a Standalone Universal Flu VaccineBVX-010Europe3Q3 2018A Pivotal Multi-center, Randomized, Modified Double-blind, Placebo-controlled Phase 3 Trial to Assess the Safety and Clinical Efficacy of M-001 Influenza Vaccine Administered Intra-muscularly Twice in Older Adults and Elderly (≥50 Years)12,463Ongoing. Results expected by end of October 2020. Details.
Assess the Safety, Reactogenicity, and Immunogenicity of Two Doses of Multimeric-001 (M-001) Followed by Seasonal Quadrivalent Influenza VaccineBVX-008United States2Q2 2018Double-blind, multicenter, randomized and placebo-controlled to assess safety, reactogenicity and immunogenicity 120Both primary endpoints achieved.
Details.
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