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Recombinant Antigens/Proteins Vaccine Candidate Clinical Trial Information Results Reporting Information Developer Name (Specify) Candidate Name (Specify) Target Antigen(s) Vaccine Platform Proposed Immune Delivery Method Adjuvant R&D Status Registry ID number(s) Trial Status Sponsor Name Sponsor Type Phase Study Start Date Primary Study Sample Size, Location Results Reporting Status Mechanism of Action (Type: Specify name) Completion Date Completion Date Enrollment and Age Recombinant Antigens/Proteins Altimmune (UK) FP-01.1 Nucleoprotein (NP), Matrix Synthetic peptide-based T cell response (e.g., cytotoxic Intramuscular None Inactive, no longer in NCT01265914 Completed Immune Targeting Systems Ltd Industry Phase 1 8/1/10 3/1/11 8/1/11 49 Adults (18 to 55 London, United Kingdom Results reported in peer- (Immune Targeting Systems Ltd) protein (M1), RNA T-lymphocytes) development years) reviewed journal polymerase PB1, RNA polymerase PB2, HA head domain, conserved epitopes Altimmune (UK) FP-01.1 Nucleoprotein (NP), Matrix Synthetic peptide-based T cell response (e.g., cytotoxic Intramuscular None Inactive, no longer in NCT02071329 Completed Immune Targeting Systems Ltd Industry Phase 1 1/1/14 12/1/14 12/1/14 111 Adults (18 to 45 London, United Kingdom Results not yet reported (Immune Targeting Systems Ltd) protein (M1), RNA T-lymphocytes) development years) polymerase PB1, RNA polymerase PB2, HA head domain, conserved epitopes Altimmune (UK) FP-01.1 Nucleoprotein (NP), Matrix Synthetic peptide-based T cell response (e.g., cytotoxic Intramuscular Other: Unspecified Inactive, no longer in NCT01677676 Completed Immune Targeting Systems Ltd Industry Phase 1 1/1/12 5/1/12 9/1/12 48 Adults (18 to 55 Brisbane, Queensland, Results not yet reported (Immune Targeting Systems Ltd) protein (M1), RNA T-lymphocytes) development years) Australia polymerase PB1, RNA polymerase PB2, HA head domain, conserved epitopes Altimmune (UK) FP-01.1 Nucleoprotein (NP), Matrix Synthetic peptide-based T cell response (e.g., cytotoxic Intramuscular Other: Unspecified Inactive, no longer in NCT01701752 Completed Immune Targeting Systems Ltd Industry Phase 1 9/1/12 4/1/13 4/1/13 120 Older Adults (65 to Unspecified Results not yet reported (Immune Targeting Systems Ltd) protein (M1), RNA T-lymphocytes) development 74 years) polymerase PB1, RNA polymerase PB2, HA head domain, conserved epitopes Altimmune (UK) FP-01.1 Nucleoprotein (NP), Matrix Synthetic peptide-based T cell response (e.g., cytotoxic Intramuscular Inactive, no longer in See preclinical information Immune Targeting Systems Ltd Industry (Immune Targeting Systems Ltd) protein (M1), RNA T-lymphocytes) development polymerase PB1, RNA polymerase PB2, HA head domain, conserved epitopes Altimmune (UK) FP-01.1 Nucleoprotein (NP), Matrix Synthetic peptide-based T cell response (e.g., cytotoxic Intramuscular Inactive, no longer in Immune Targeting Systems Ltd Industry (Immune Targeting Systems Ltd) protein (M1), RNA T-lymphocytes) development polymerase PB1, RNA polymerase PB2, HA head domain, conserved epitopes BiondVax Pharmaceuticals Ltd Multimeric-001 (M-001) HA head domain, Peptide-based, T cell response (e.g., cytotoxic Intramuscular None Active, currently in NCT03450915 Open, not recruiting BiondVax Pharmaceuticals Ltd. Industry Phase 3 8/1/19 Estimated May Estimated 12,463 Adults and Older 83 clinical trial sites in 7 Results not yet reported (Israel) conserved epitopes, Recombinant protein T-lymphocytes), B cell development 2020 December 2020 Adults (50 years and countries in Eastern Europe Nucleoprotein (NP), Matrix response (e.g., neutralizing older); half over 65 years protein (M1) antibodies) BiondVax Pharmaceuticals Ltd Multimeric-001 (M-001) HA head domain, Peptide-based, T cell response (e.g., cytotoxic Intramuscular None Active, currently in NCT03058692 Completed National Institute of Allergy and Government Phase 2 4/9/18 1/14/19 1/14/19 120 Adults (18 to 49 United States: Iowa, Ohio, Results reported in registry (Israel) conserved epitopes, Recombinant protein T-lymphocytes), B cell development Infectious Disease (NIAID) years) Texas Nucleoprotein (NP), Matrix response (e.g., neutralizing protein (M1) antibodies) 1 Results Reporting Information Preclinical Studies Key Partners Other Data Sources Interim Publication Type, Date, and Link Full Publication Type, Date, and Link Clinical Trials Registry, Publication Study Intent Publication Link Name(s) Contact Notes References Date and Link Information Recombinant Antigens/Proteins Peer-reviewed publication or journal [1] Francis 2015 (PMID: 24928790) 6/10/2014 [2] Gottlieb 2014 (PMID: 25172355) Francis 2015 PMID: 24928790 [3] https://clinicaltrials.gov/ct2/show/NCT01265914 [1] Francis 2015 (PMID: 24928790) [2] Gottlieb 2014 (PMID: 25172355) [3] https://clinicaltrials.gov/ct2/show/NCT02071329 [1] Francis 2015 (PMID: 24928790) [2] Gottlieb 2014 (PMID: 25172355) [3] https://clinicaltrials.gov/ct2/show/NCT01677676 [1] Francis 2015 (PMID: 24928790) [2] Gottlieb 2014 (PMID: 25172355) [3] https://clinicaltrials.gov/ct2/show/NCT01701752 Unknown Unknown [1] Francis 2015 (PMID: 24928790) [2] Gottlieb 2014 (PMID: 25172355) [1] Francis 2015 (PMID: 24928790) [2] Gottlieb 2014 (PMID: 25172355) [1] Rudolph 2014 (PMID: 21285533) [2] Gottlieb 2014 (PMID: 25172355) [3] Astmon 2012 (PMID: 22318394) [4] Astmon 2014 (PMID: 25173483) [5] Van Doorn 2017 (PMID: 28296763) [6] Press Release 2019 [7] https://clinicaltrials.gov/ct2/show/NCT03450915 clinicaltrials.gov [1] Rudolph 2014 (PMID: 21285533) 2/5/2020 [2] Gottlieb 2014 (PMID: 25172355) https://clinicaltrials.gov/ct2/show/results/N CT03058692 [3] Astmon 2012 (PMID: 22318394) [4] Astmon 2014 (PMID: 25173483) [5] Van Doorn 2017 (PMID: 28296763) [6] Press release 2019 [7] Press release 2020 [8] https://clinicaltrials.gov/ct2/show/NCT03058692 2 Vaccine Candidate Clinical Trial Information Results Reporting Information Developer Name (Specify) Candidate Name (Specify) Target Antigen(s) Vaccine Platform Proposed Immune Delivery Method Adjuvant R&D Status Registry ID number(s) Trial Status Sponsor Name Sponsor Type Phase Study Start Date Primary Study Sample Size, Location Results Reporting Status Mechanism of Action (Type: Specify name) Completion Date Completion Date Enrollment and Age Recombinant Antigens/Proteins BiondVax Pharmaceuticals Ltd Multimeric-001 (M-001) HA head domain, Peptide-based, T cell response (e.g., cytotoxic Intramuscular None NCT02691130 Completed (a) BiondVax Pharmaceuticals Industry, Government Phase 2 11/1/15 10/1/16 1/1/17 224 Adults (18 to 60 Budapest, Hungary Interim results reported (Israel) conserved epitopes, Recombinant protein T-lymphocytes), B cell Ltd. years) Nucleoprotein (NP), Matrix response (e.g., neutralizing (b) Seventh Framework protein (M1) antibodies) Program BiondVax Pharmaceuticals Ltd Multimeric-001 (M-001) HA head domain, Peptide-based, T cell response (e.g., cytotoxic Intramuscular None NCT02293317 Completed BiondVax Pharmaceuticals Ltd. Industry Phase 2 11/1/14 3/1/15 6/1/15 37 Adults and Older Tel Aviv, Israel Interim results reported (Israel) conserved epitopes, Recombinant protein T-lymphocytes), B cell Adults (50 to 65 years) Nucleoprotein (NP), Matrix response (e.g., neutralizing protein (M1) antibodies) BiondVax Pharmaceuticals Ltd Multimeric-001 (M-001) HA head domain, Peptide-based, T cell response (e.g., cytotoxic Intramuscular Aluminum salts: Alum NCT01419925 Completed BiondVax Pharmaceuticals Ltd. Industry Phase 2 8/1/11 1/1/12 1/1/12 120 Older Adults (65 Jerusalem, Isreal Interim results reported, (Israel) conserved epitopes, Recombinant protein T-lymphocytes), B cell years and older) Results reported in peer- Nucleoprotein (NP), Matrix response (e.g., neutralizing reviewed journal protein (M1) antibodies) BiondVax Pharmaceuticals Ltd Multimeric-001 (M-001) HA head domain, Peptide-based, T cell response (e.g., cytotoxic Intramuscular Other: unspecified NCT01146119 Completed BiondVax Pharmaceuticals Ltd. Industry Phase 2 7/1/10 5/1/11 6/1/11 200 Adults (18 to 49 Israel: Jerusalem, Tel Aviv Interim results reported (Israel) conserved epitopes, Recombinant protein T-lymphocytes), B cell years) Nucleoprotein (NP), Matrix response (e.g., neutralizing protein (M1) antibodies) BiondVax Pharmaceuticals Ltd Multimeric-001 (M-001) HA head domain, Peptide-based, T cell response (e.g., cytotoxic Intramuscular Oil-in-water: Montanide NCT01010737 Completed BiondVax Pharmaceuticals Ltd. Industry Phase 1 9/1/09 3/1/10 3/1/10 60 Adults and Older Tel Aviv, Israel Interim results reported (Israel) conserved epitopes, Recombinant protein T-lymphocytes), B cell ISA VG51 Adults (55 to 75 years) Nucleoprotein (NP), Matrix response (e.g., neutralizing protein (M1) antibodies) 3 Results Reporting Information Preclinical Studies Key Partners Other Data Sources Interim Publication Type, Date, and Link Full Publication Type, Date, and Link Clinical Trials Registry, Publication Study Intent Publication Link Name(s) Contact Notes References Date and Link Information Recombinant Antigens/Proteins Sponsor press release [1] Rudolph 2014 (PMID: 21285533) 07/20/17 [2] Gottlieb 2014 (PMID: 25172355) http://www.biondvax.com/2017/07/biondvax- reports-positive-phase-2b-clinical-trial-results-for- its-universal-flu-vaccine/ [3] Astmon 2012 (PMID: 22318394) [4] Astmon 2014 (PMID: 25173483) [5] Van Doorn 2017 (PMID: 28296763) [6] https://clinicaltrials.gov/ct2/show/NCT02691130 Sponsor website [1] Rudolph 2014 (PMID: 21285533) http://www.biondvax.com/clinical-trials/ [2] Gottlieb 2014 (PMID: 25172355) [3] Astmon 2012 (PMID:
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