universal flu vaccine (M-001) / Scinai Immunotherap - LARVOL DELTA

Safety and immunogenicity of Multimeric-001 (M-001) followed by seasonal quadrivalent inactivated influenza vaccine in young adults - A randomized clinical trial. (PubMed, Vaccine) - P2 | "M-001 administration induced a subset of polyfunctional CD4+ T cells that persisted through 6 months of follow-up, but it did not improve HAI or MN antibody responses to IIV4. (clinicaltrials.gov NCT03058692)."

Clinical • Journal • Infectious Disease • Influenza • Respiratory Diseases • CD4 • IFNG • IL2 • TNFA

A Pivotal Trial to Assess the Safety and Clinical Efficacy of the M-001 as a Standalone Universal Flu Vaccine (clinicaltrials.gov) - P3; N=12463; Completed; Sponsor: BiondVax Pharmaceuticals ltd.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Respiratory Diseases • CD4 • IFNG • PCR

A Pivotal Trial to Assess the Safety and Clinical Efficacy of the M-001 as a Standalone Universal Flu Vaccine (clinicaltrials.gov) - P3; N=12463; Active, not recruiting; Sponsor: BiondVax Pharmaceuticals ltd.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • PCR

Preliminary data from NIH/NIAID-sponsored phase 2 clinical trial of BiondVax's M-001 universal influenza vaccine candidate validates results of previous clinical trials (PRNewswire) - P2, N=120; NCT03058692; "BiondVax Pharmaceuticals...announced today that preliminary data from the Phase 2 clinical trial of BiondVax's M-001 universal influenza vaccine candidate have been published...The primary objectives of the trial were to assess safety and T-cell responses to M‑001. The data, which are consistent with results of previous clinical trials of M-001, indicate that both primary objectives were achieved. Analysis of the data is ongoing, and the clinical study report (CSR) is expected in Q2 2020...In parallel, BiondVax's pivotal, clinical efficacy, Phase 3 trial in Europe, involving 12,463 older adults, is ongoing. Results of that trial are expected by the end of 2020."

P2 data • P3 data

A Pivotal Trial to Assess the Safety and Clinical Efficacy of the M-001 as a Standalone Universal Flu Vaccine (clinicaltrials.gov) - P3; N=9630; Recruiting; Sponsor: BiondVax Pharmaceuticals ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Two Doses of Multimeric-001 (M-001) Followed by Influenza Vaccine (clinicaltrials.gov) - P2; N=120; Completed; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Active, not recruiting ➔ Completed

Clinical • Trial completion