Table 2.
VLP vaccines on the market and in the clinical development.
| Vaccine name | Company/institution | Route of administration (adjuvant) | Expression system | VLP platform | VLP type | Vaccine antigen | Clinical development stage | Reference |
|---|---|---|---|---|---|---|---|---|
| Allergic rhinoconjuctivitis and asthma | ||||||||
| CYT003-QβG10 | Cytos Biotechnology | SC (none) | Bacteria (E. coli) | Qβ | Non-enveloped | G10 (CpG DNA) | Phase 2 | [412], [413], [414], [415] |
| Alzheimer's disease | ||||||||
| CAD106 | Cytos Biotechnology/Novartis | SC, IM (unspecified) | Bacteria (E. coli) | Qβ | Non-enveloped | Aβ1-6 | Phase 2 | [117], [416], [417], [418] |
| Breast cancer | ||||||||
| Pevion Biotech | IM (none) | Cell-free | Influenza virosome | Enveloped | Her2/neu | Phase 1 | [399] | |
| C. albicans | ||||||||
| PEV7 | Pevion Biotech | IM (none) | Cell-free | Influenza virosome | Enveloped | C.a. SAP2 | Phase 1 | [398], [419] |
| Type II diabetes mellitus | ||||||||
| CYT013-IL1bQβ | Cytos Biotechnology | SC (none) | Bacteria (E. coli) | Qβ | Non-enveloped | IL-1β | Phase 1/2a | [420], [421] |
| Hepatitis A | ||||||||
| Epaxal® | Crucell | IM (none) | Cell-free | Influenza virosome | Enveloped | Inactivated HAV RG-SB | Licensed | [25] |
| Hepatitis B | ||||||||
| GenHevac B® | Pasteur-Merieux Aventis | IM (aluminum hydroxide) | Mammalian (CHO cells) | HBsAg | Non-envelopeda | HBsAg | Licensed | [21], [407], [422] |
| Bio-Hep-B® (Sci-B-Vac®) | BTG (SciGen, FDS Pharma) | IM (aluminum hydroxide) | Mammalian (CHO cells) | HBsAg | Non-enveloped | HBsAg | Licensed | [423] |
| DTP-Hep B® | P.T. Bio Farma | IM (aluminum hydroxide) | Yeast (P. pastoris) | HBsAg | Non-enveloped | HBsAg | Licensed | [424], [425] |
| Engerix-B® | GSK | IM (aluminum hydroxide) | Yeast (S. cerevisiae) | HBsAg | Non-enveloped | HBsAg | Licensed | [53], [408], [426] |
| Enivac HB® | Panacea Biotec | IM (aluminum hydroxide) | Yeast (P. pastoris) | HBsAg | Non-enveloped | HBsAg | Licensed | [427] |
| Euvax B® | LG Life Sciences | IM (aluminum hydroxide) | Yeast (S. cerevisiae) | HBsAg | Non-enveloped | HBsAg | Licensed | [428] |
| Gene Vac-B® | Serum Inst. of India | IM (aluminum hydroxide) | Yeast (H. polymorpha) | HBsAg | Non-enveloped | HBsAg | Licensed | [429] |
| Heberbiovac HB® | CIGB-Heber Biotec | IM (aluminum hydroxide) | Yeast (P. pastoris) | HBsAg | Non-enveloped | HBsAg | Licensed | [430] |
| Hepavax-Gene® | Crucell | IM (aluminum hydroxide) | Yeast (H. polymorpha) | HBsAg | Non-enveloped | HBsAg | Licensed | [431] |
| Recombivax HB® | Merck | IM (aluminum hydroxide) | Yeast (S. cerevisiae) | HBsAg | Non-enveloped | HBsAg | Licensed | [12], [432], [433] |
| Revac-B® | Bharat Biotech International | IM (aluminum hydroxide) | Yeast (P. pastoris) | HBsAg | Non-enveloped | HBsAg | Licensed | [434] |
| Shanvac-B® | Shantha Biotechnics | IM (aluminum hydroxide) | Yeast (P. pastoris) | HBsAg | Non-enveloped | HBsAg | Licensed | [435] |
| Polish Academy of Sciences/TJU | Oral (none) | Plant (Tg lettuce) | HBsAg | Non-enveloped | HBsAg | Phase 1 | [27] | |
| ASA | Oral (none) | Plant (Tg potato) | HBsAg | Non-enveloped | HBsAg | Phase 1 | [28] | |
| Hepatitis C | ||||||||
| Pevion Biotech | IM (none) | Cell-free | Influenza virosome | Enveloped | HCV peptides | Phase 1 | [391] | |
| HIV | ||||||||
| British Biotech Pharmaceuticals/NIAID | SC/IM, IM (aluminum hydroxide)/oral or rectal (none) | Yeast (S. cerevisiae) | Ty p1 | Non-enveloped | HIV-1 Gag p17/p24 | Phase 2 | [130], [131], [132] | |
| MYM-V101 | Pevion Biotech/Mymetics Corporation | IM, IN (none) | Cell-free | Influenza virosome | Enveloped | HIV-1 gp41 | Phase 1 | [401] |
| HPV | ||||||||
| Gardasil® | Merck | IM (aluminum hydroxyphosphate sulphate) | Yeast (S. cerevisiae) | HPV | Non-enveloped | HPV6/11/16/18 L1 | Licensed | [13] |
| Cervarix® | GSK | IM (aluminum hydroxide & MPL) | Insect (High Five™ cells) | HPV | Non-enveloped | HPV16/18 L1 | Licensed | [11] |
| V503 | Merck | IM (none) | Yeast (S. cerevisiae) | HPV | Non-enveloped | HPV6/11/16/18/31/33/45/52/58 L1 | Phase 3 | [436] |
| Human parvovirus B19 | ||||||||
| VAI-VP705 | NIH/Meridian Life Science | IM (MF59) | Insect (Sf-9 cells) | B19 | Non-enveloped | B19 VP1, VP2 | Phase 1/2 | [247], [248], [249], [250], [437] |
| Hypertension | ||||||||
| CYT006-AngQβ | Cytos Biotechnology | SC (none) | Bacteria (E. coli) | Qβ | Non-enveloped | Ang II | Phase 2 | [118], [119], [120], [438], [439], [440] |
| Influenza | ||||||||
| Novavax | IM (none) | Insect (Sf-9 cells) | Influenza virus | Enveloped | A/California/04/09 (H1N1) HA, NA | Phase 2 | [23] | |
| Medicago | IM (none) | Plant (transient N. benthamiana) | Influenza virus | Enveloped | A/California/04/09 (H1N1) HA | Phase 1 | [378] | |
| Novavax | IM (none) | Insect (Sf-9 cells) | Influenza virus | Enveloped | A/Indonesia/05/05 (H5N1) HA, NA | Phase 1/2a | [228] | |
| Medicago | IM (aluminum hydroxide) | Plant (transient N. benthamiana) | Influenza virus | Enveloped | A/Indonesia/05/05 (H5N1) HA | Phase 2 | [22], [377], [441] | |
| Novavax | IM (none) | Insect (Sf-9 cells) | Influenza virus | Enveloped | A/Brisbane/59/07 (H1N1), A/Brisbane/10/07, B/Florida/04/06 (H3N2) HA, NA | Phase 2a | [442] | |
| Inflexal® V | Crucell | IM (none) | Cell-free | Influenza virosome | Enveloped | A (H1N1), A (H3N2), B, HA, NA | Licensed | [26] |
| ACAM-FLU-A | Sanofi Pasteur | IM (Stimulon QS21) | Bacteria (E. coli) | HBcAg | Non-enveloped | Influenza A M2e | Phase 1 | [33], [115] |
| Malaria (P. falciparum) | ||||||||
| MalariVax (ICC-1132) | Apovia | IM (aluminum hydroxide, Montanide) | Bacteria (E. coli) | HBcAg | Non-enveloped | P.f. CSP | Phase 1 | [24], [114] |
| RTS,S | GSK/PATH Malaria Vaccine Initiative & Gates Found | IM (AS01, AS02) | Yeast (S. cerevisiae) | HBsAg | Non-enveloped | P.f. CSP | Phase 3 | [14], [443] |
| PEV3 | Pevion Biotech | IM (none) | Cell-free | Influenza virosome | Enveloped | P.f. CSP, AMA-1 | Phase 1/2 | [29], [30], [31], [32] |
| Malignant melanoma | ||||||||
| CYT004-MelQβG10 | Cytos Biotechnology | IM (±Montanide, Imiquimod) | Bacteria (E. coli) | Qβ | Non-enveloped | Melan-4, G10 DNA (CpG) | Phase 2 | [444], [445] |
| Nicotine addiction | ||||||||
| NIC002 | Cytos Biotechnology/Novartis/Duke University | SC (±aluminum hydroxide) | Bacteria (E. coli) | Qβ | Non-enveloped | Nicotine | Phase 2 | [446], [447], [448], [449], [450] |
| NV | ||||||||
| Baylor College of Medicine | Oral (none) | Insect (Sf-9 cells) | NV | Non-enveloped | NV CP | Phase 1 | [189], [190] | |
| LigoCyte Pharmaceuticals | IM (MPL, alum) | Insect (Sf-9 cells) | NV | Non-enveloped | NV CP | Phase 1 | [193] | |
| LigoCyte Pharmaceuticals | IN (±MPL, chitosan, mannitol, sucrose) | Insect (Sf-9 cells) | NV | Non-enveloped | NV CP | Phase 1; Phase 1/2 | [191], [192] | |
| Center for Vaccine Development (University of Maryland) | Oral (none) | Plant (Tg potato) | NV | Non-enveloped | NV CP | Phase 1 | [362], [363] | |
| Rabies | ||||||||
| TJU | Oral (none) | Plant (Tg spinach) | AlMV | Non-enveloped | Rabies GP/NP | Phase 1 | [66] | |
| RSV | ||||||||
| Novavax | IM (aluminum phosphate) | Insect (Sf-9 cells) | RSV | Non-enveloped | RSV-F | Phase 1 | [236], [237] | |
Abbreviations: AlMV, alfalfa mosaic virus; AMA-1, apical membrane antigen-1; Ang II, angiotensin II; CHO, Chinese hamster ovary cells; CP, coat protein; CSP, circumsporozoite protein; GP, glycoprotein; HA, hemagglutinin; HAV, hepatitis A vaccine; HBcAg, hepatitis B core antigen; HBsAg, hepatitis B surface antigen; HCV, hepatitis C virus; HIV, human immunodeficiency virus; HPV, human papillomavirus; IM, intramuscular; IN, intranasal; MPL, monophosphoryl lipid A; NA, neuraminidase; N/A, not applicable; NDV, Newcastle disease virus; NP, nucleocapsid protein; NV, Norwalk virus; RSV, respiratory syncytial virus; RSV-F, RSV F protein; SC, subcutaneous; Tg, transgenic; TJU, Thomas Jefferson University.
a
HBsAg VLPs contain host cell lipids.