Table I.
IFV and RSV vaccines and mAbs currently in clinical trials
| Phase | Type | Registration no. | Study sponsor | References | Comments | |
|---|---|---|---|---|---|---|
| Influenza | ||||||
| Standard vaccines | ||||||
| Topical imiquimod in immunocompromised patients | Phase 2, pilot | ID and IM vaccination (Intanza/Mutagrip) | NCT02960815 | University of Lausanne Hospitals | TLR7 adjuvant | |
| H7N9 with AS03 adjuvant | Phase 1 | NCT02957656 | NIAID | |||
| H7N9 with MF59 | Phase 1 | NCT02251288 | NIAID | |||
| H5N8 with AS03 or M59 | Phase 1 | Inactivated vaccine | NCT03014310 | NIAID | ||
| IVACFLU-A/H5N1 | Phase 2/3 | Inactivated vaccine | NCT02612909 | Institute of Vaccines and Medical Biologicals, Vietnam | ||
| GC3110B | Phase 3 | Multidose quadrivalent | NCT02915809 | Green Cross Corporation | ||
| V118_18 | Phase 3 | Quadrivalent MF59 adjuvanted | EudraCT: 2015-000728-27 | Sequiris | ||
| Heterotypic vaccines | ||||||
| FLU-v004 | Phase 2b | Broad-spectrum synthetic epitope mixture: M1, NP, and M2 | NCT02962908 EudraCT: 2016-002134-74 | PepTcell | 131, 132, 133 | H1N1 challenge model |
| MVA-NP+M1 | Phase 2a | MVA viral vector vaccine | EudraCT: 2009-010334-21 NCT00942071 (Phase I study) |
University of Oxford/Wellcome Trust | 134, 135 | Completed 2010, reported 2017 |
| M-001 | Phase 2b | Recombinant multimeric protein – 9 conserved epitopes from HA stem, M1, NP | EudraCT: 2015-001979-46 | BiondVax Pharmaceuticals | 127, 136, 137, 138 | |
| Multimeric M-001 followed by H7N9 with M59 | Phase 2 | NCT03058692 | NIAID | |||
| Passive immunization | ||||||
| MEDI8852 | Phase 2a | NCT03028909 | MedImmune | Monoclonal IgG1κ against type A influenza—targets conserved HA stalk group 1 and 2 | ||
| VIS410 | Phase 2a | NCT03040141 | Visterra | 126 | Anti-HA monocolonal for type A influenza group 1 and 2 | |
| CR6261 | Phase 2 | NCT02371668 | NIAID | 98 | Anti-HA monocolonal for type A influenza; targets helical region in the stem; group 1 only | |
| MHAA4549A | Phase 2 |
NCT02623322 NCT02293863 EudraCT: 2016-000425-40 |
Genentech | 124 | Monoclonal IgG1 against type A influenza—targets conserved HA stalk group 1 and 2 | |
| CTP27 | Phase 2 |
NCT02071914 EudraCT: 2013-004544-32 KCT0002211 |
Celltrion | Mixed antibodies to group 1 and 2 | ||
| TCN-032 | Phase 2a (completed 2012) | NCT01719874 | Theraclone Sciences | 125 | M2e monoclonal type A influenza | |
| RSV | ||||||
| Vaccines | ||||||
| RSV vaccine GSK3389245A | Phase 2 | RSV viral proteins in chimpanzee-derived adenovector |
NCT02927873 EudraCT: 2016-000117-76 |
GlaxoSmithKline | Phase 2 started recruiting in January 2017 IM in infants 12-17 mo |
|
| GSK3003891A | Phase 2 | Viral fusion protein |
NCT02956837 EudraCT: 2015-005742-58 |
Vaccination of pregnant women started recruitment in January 2017 | ||
| RSV cps2 vaccine | Phase 1 | Live attenuated vaccine | NCT01968083 | NIAID | ||
| RSV Vaccines (multiple formulations) | Phase 1 | Recombinant live attenuated vaccine |
NCT02237209 NCT02601612 |
NIAID | Nasal delivery to infants; expected results this year | |
| DPX-RSV(A) | Phase 1 | RSV SH antigen with DepoVax adjuvant | NCT02472548 | Dalhousie University with ImmunoVaccine Technologies | Liposome in oil delivery | |
| MEDI7510 | Phase 2b | RSV sF antigen with GLA adjuvant | NCT02508194 | MedImmune | Study terminated early | |
| MEDI-534 | Phase 2a | RSV/PIV3 live attenuated vaccine | NCT00686075 | MedImmune | 139, 140 | |
| RSV-F Particle Vaccine | Phase 3 | RSV F protein nanoparticle vaccine with aluminum hydroxide adjuvant | NCT02624947 | Novavax | 129, 130, 141 | Maternal vaccination strategy |
| RSV001 | Phase 1 | NCT01805921 | ReiThera | |||
| VXA-RSV-f | Phase 1 | Adenoviral vector–based RSV F Protein Vaccine | NCT02830932 | Vaxart | Oral formulation | |
| MVA-BN RSV | Phase 2b | Recombinant vaccine expressing 5 epitopes from F & G proteins | NCT02873286 | Bavarian Nordic | ||
| SynGem | Phase 1 | F protein VLP–Lactococcus | NCT02958540 | Mucosis | ||
| Passive immunization | ||||||
| MEDI8897 | Phase 2b | NCT02878330 | MedImmune | 128 | RSV monoclonal | |
| MEDI-524 (Motavizumab) | Phase 3 | NCT00121108 | MedImmune | 142, 143 | RSV monoclonal, positive results | |
| ALX-0171 | Phase 2b | Trivalent RSV F-protein binder | NCT02979431 | Ablynx | 144 | Inhaled anti-RSV nanobody |
| REGN-2222 (Suptavumab) | Phase 3 | NCT02325791 | Regeneron Pharmaceuticals | Human anti-RSV F protein mAb | ||
| RSV-IVIG RI-001 & RI-002 |
Phase 3, primary end point met | NCT01814800 | ADMA biologics | 145, 146 | Pooled donor plasma with high neutralizing RSV immunoglobulin; primary immunodeficiency disease |
GLA, Glucopyranosyl lipid adjuvant; ID, intradermal; IM, intramuscular; NIAID, National Institute of Allergy and Infectious Diseases.