Table 1.
Universal influenza vaccines in clinical trials
ClinicalTrials.gov Identifier (Status) | Study Title | Start-Completion Dates; Phase; Sponsor | Types of vaccines under investigation |
---|---|---|---|
NCT03275389 (Completed) | A Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals’ Investigational Supra-seasonal Universal Influenza Vaccine | September 8, 2017 – March 26, 2020; Phase 1; GlaxoSmithKline | Supra-seasonal Universal Influenza Vaccines (SUIVs) containing cHA |
NCT03789539 (Active) | Reactogenicity, Safety, and I)mmunogenicity of a Universal Influenza Vaccine Uniflu | Not recruiting; Phase 1; VA Pharma Limited Liability Company | Non adjuvanted Uniflu (four copies of human M2e fused within the immunodominant loop of the HBc antigen) |
NCT00921973 (Active) | Safety of VAX102 Vaccine Given With Seasonal Flu Vaccine in Healthy Adults | June 2009-September 2009; Phase 1 VaxInnate Corporation | Simultaneous administration of VAX102 (four copies of the ectodomain of influenza virus matrix protein 2, M2e, antigen fused to Salmonella typhimurium flagellin, a TLR5 ligand) plus TIV |
NCT03300050 (Completed) | Safety and Immunogenicity of a Live-attenuated Universal Flu Vaccine Followed by an Inactivated Universal Flu Vaccine | October 10, 2017 – August 9, 2019; Phase 1; PATH | Chimeric H8/1N1 live-attenuated universal flu vaccine followed by a chimeric H5/1N1 or chimeric H8/1N1 inactivated universal flu vaccine; adjuvanted with AS03A or unadjuvanted |
NCT00921947 (Completed) | Comparative Safety and Immunogenicity of 1.0 μg Intramuscular (i.m.) and 2.0 μg Subcutaneous (s.c.) Dosing With VAX102 (M2e-flagellin) Universal Influenza Vaccine in Healthy Adults | June 2009 – August 2009; Phase 1/Phase 2; VaxInnate Corporation | VAX102 (four copies of the ectodomain of influenza virus matrix protein 2, M2e, antigen fused to Salmonella typhimurium flagellin, a TLR5 ligand) |
NCT03450915 (Active) | A Pivotal Trial to Assess the Safety and Clinical Efficacy of the M-001 as a Standalone Universal Flu Vaccine | August 1, 2008–December 2020 (estimated); Phase 3; BiondVax Pharmaceuticals Ltd. | M-001 (recombinant protein containing nine conserved epitopes of HA, NP and M1 from different strains of A and B subtypes) administered without adjuvant |
NCT01265914 (Completed) | A Study to Evaluate the Safety, Tolerability and Immunogenicity of a Universal Influenza A Vaccine | August 2010 – August 2011; Phase 1; Immune Targeting Systems Ltd | A mixture of synthetic peptides, modified with a fluorocarbon vector administered without adjuvant |
NCT00877448 (Completed) | A Double-Dose Safety Study of An Influenza Vaccine (Multimeric-001) | June 2009 – November 2009; Phase 1/Phase 2; BiondVax Pharmaceuticals ltd. | M-001 (recombinant protein containing nine conserved epitopes of HA, NP and M1 from different strains of A and B subtypes) administered with (Montanide ISA 51VG) or without adjuvant |
NCT00921206 (Completed) | Study to Investigate the Immune Response to Two Doses of VAX102 Healthy Adults | June 2009 – December 2009; Phase 1; VaxInnate Corporation | VAX102 (four copies of the ectodomain of influenza virus matrix protein 2, M2e, antigen fused to Salmonella typhimurium flagellin, a TLR5 ligand) |
NCT03816878 (Active) | Immunogenicity and Safety Study of Inactivated Subunit H5N1 Influenza Vaccine in Prior Recipients of Live Attenuated H2N2, H6N1, and H9N2 Influenza Vaccines and in H5N1 and Live Attenuated Vaccine Naïve Individuals | Not recruiting; National Institute of Allergy and Infectious Diseases (NIAID); Phase 1; | Inactivated subunit H5N1 |
NCT02293317 (Completed) | Phase II Study to Assess Safety & Immunogenicity of Multimeric-001 Influenza Vaccine, Followed by TIV (BVX006) | November 2014 – June 2015; Phase 2; BiondVax Pharmaceuticals Ltd. | Non-adjuvanted BVX006 (recombinant protein containing conserved linear epitopes from the HA, NP, and M1 proteins of influenza type A and type B strain) followed by a HA based seasonal trivalent influenza vaccine |
NCT01419925 (Completed) | A Study to Assess the Safety and Immunogenicity of M-001 Influenza Vaccine as a Primer to TIV in Elderly Volunteers | August 2011 – January 2012; Phase 2; BiondVax Pharmaceuticals Ltd. | Aluminum phosphate adjuvanted and non-adjuvanted M-001 (recombinant protein containing conserved linear epitopes from the HA, NP, and M1 proteins of influenza type A and type B strain) followed by a HA based seasonal trivalent influenza vaccine |
NCT02691130; (Completed) | Assess the Safety and Immunogenicity of M-001 as A Standalone Influenza Vaccine and as A H5N1 Vaccine Primer in Adults | November 2015 – January 2017; Phase 2; BiondVax Pharmaceuticals ltd; | Non adjuvanted M-001 (recombinant protein containing conserved linear epitopes from the HA, NP, and M1 proteins of influenza type A and type B strain) followed by alum adjuvanted whole virion inactivated H5N1 vaccine |
NCT01405885 (Completed) | A Study of DNA Vaccine With Electroporation for the Prevention of Disease Caused by H1 and H5 Influenza Virus | May 2011 – August 2013; Phase 1; Inovio Pharmaceuticals | DNA based vaccine that contained multiple combinations of H1 and H5 influenza hemagglutinin plasmids followed by in vivo electroporation |
NCT03180801; (Completed) | Efficacy of FLU-v in an H1N1 Influenza Human Challenge Model | August 18, 2016 – May 25, 2017; Phase 2; PepTcell Limited | Montanide ISA-51 adjuvanted FLU-v (peptide vaccine derived from conserved regions of internal viral proteins) administration |
NCT01146119 (Completed) | Further Investigation of an Intramuscular Influenza Vaccine (Multimeric-001) | July 2010 – June 2011; Phase 2; BiondVax Pharmaceuticals Ltd. | Adjuvanted M-001 (recombinant protein containing conserved linear epitopes from the HA, NP, and M1 proteins of influenza type A and type B strain) followed by commercial seasonal trivalent vaccine (season 2011) |
NCT02962908 (Completed) | A Randomised, Double-blind, Placebo-controlled Phase IIb Trial to Test FLU-v Vaccine | August 2016 – July 18, 2017; Phase 2; PepTcell Limited | Montanide ISA-51 adjuvanted and non-adjuvanted FLU-v (peptide vaccine derived from conserved regions of internal viral proteins) administration |