Table 2 |.
VP1-based norovirus vaccine candidates in clinical development
| Company | Vaccine platform (expression system) | Adjuvant | Administration route | Genotypes | Development stage | Refs. |
|---|---|---|---|---|---|---|
| Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd | Protein (Pichia pastoris) | Aluminium hydroxide | Intramuscular | GI.1, GII.3, GII.4, GII.17 | Phase I/II | NCT04563533 (ref. 193) and NCT06524947 (ref. 194) |
| Chengdu Kanghua Biological products Co., Ltd | Protein (Pichia pastoris) | Aluminium hydroxide | Intramuscular | GI.1, GII.2, GII.3, GII.4, GII.6, GII.17 | Phase I planned | NCT05805618 (ref. 195) |
| Hillevax, Inc. (nee Takeda Vaccines, Inc., Ligocyte Pharmaceuticals, Inc.) | Protein (Baculovirus) | Aluminium hydroxide | Intramuscular | GI.1, GII.4 | Phase II | NCT01168401 (refs. 148,196–198), NCT01609257 (refs. 150,199–201), NCT02038907 (refs. 202,203), NCT02142504 (refs. 147.204,205), NCT02153112 (refs. 153,154,206), NCT02475278 (refs. 149,207,208), NCT02661490 (ref. 209), NCT02669121 (refs. 151,210,211), NCT03039790 (ref. 212), NCT05281094 (ref. 206), NCT05972733 (ref. 213) and NCT06007781 (ref. 214) |
| Icon Genetics GmbH | Protein (Nicotiana benthamiana) | None | Intramuscular | GI.4, GII.4 | Phase I | NCT05508178 (refs. 160,161,215) |
| Moderna | mRNA lipid nanoparticle | None | Intramuscular | GI.3, GII.3, GII.4 | Phase I | NCT05992935 (ref. 216) and NCT06592794 (ref. 217) |
| National Vaccine and Serum Institute, China | Protein (Hansenula polymorpha) | Aluminium hydroxide | Intramuscular | GI.1, GII.4 | Phase III. | NCT04188691 (ref. 218), NCT04941261 (ref. 219) and NCT05916326 (ref. 220) |
| Vaxart, Inc. | Recombinant virus vector (replication-deficient, adenovirus type 5) | Double-stranded RNA hairpin | Oral | GI.1, GII.4 | Phase II | NCT02868073 (refs. 221,222), NCT03125473 (ref. 223), NCT03897309 (ref. 224), NCT04854746 (ref. 225), NCT04875676 (ref. 226), NCT05212168 (refs. 158,227), NCT05213728 (ref. 228) and NCT05626803 (ref. 229) |