Table 1 FDA approved or clinical trial stage VLP-based vaccines against infectious diseases
Trade name | Infectious agent | Target disease | Status | Company | Antigen(s) | Expression System |
|---|---|---|---|---|---|---|
Gardasil® | Human Papilloma Virus (HPV) | Human papillomavirus, Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Approved | Merck | Major capsid protein L1 epitope of HPV types 6, 11, 16, and 18 | Yeast |
Gardasil9® | Human Papilloma Virus (HPV) | Human papillomavirus Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Approved | Merck | Major capsid protein L1 epitope of HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Yeast |
Cervarix® | Human Papilloma Virus (HPV) | Human papillomavirus (Types 16 and 18) | Approved | Glaxo-SmithKline Inc | Major capsid protein L1 epitope of HPV types 16 and 18 | Insect cells |
Sci-B-Vacâ„¢ | Hepatitis B Virus | Hepatitis B | Approved | VBI Vaccines | The three epitopes of hepatitis B surface antigen: S, Pre-S1, and Pre-S2 | Eukaryotic cells (Chinese hamster ovary (CHO) cells) |
Mosquirixâ„¢ | Plasmodium falciparum | Malaria | Approved | Glaxo-SmithKline Inc | Plasmodium falciparum circumsporozoite protein fused to the Hepatitis B surface antigen, combined with Hepatitis B surface antigen (S) | Yeast |
Still no trade name | Influenza Virus | Seasonal Flu | Clinical trial Phase 3 (Clinical trial No.: NCT03301051) | Medicago | A mix of recombinant H1, H3, and two B hemagglutinin proteins | Plant (Nicotiana benthamiana) |
Still no trade name | Influenza Virus | Pandemic Flu | Clinical trial Phase 2 [24] | Medicago | Hemagglutinin protein | Plant |
Still no trade name | SARS-CoV-2 Virus | COVID-19 | Clinical trial Phase 1 (Clinical trial No.: NCT04450004) [25] | Medicago | SARS-CoV-2 spike protein | Plant (Nicotiana benthamiana) |
NanoFluâ„¢ | Influenza Virus | Seasonal Influenza | Clinical trial Phase 3 (Clinical trial No.: NCT04120194) [26] | Novavax | Recombinant hemagglutinin (HA) protein | Insect cells |
ResVaxâ„¢ | Respiratory Syncytial Virus (RSV) | RSV | Clinical trial Phase 3 [27] | Novavax | RSV fusion (F) protein | Insect cells |
NVX-CoV2373 | SARS-CoV-2 Virus | COVID-19 | Clinical trial Phase 1 [28] | Novavax | Trimeric full-length SARS-CoV-2 spike glycoproteins | Insect cells |
Ebola GP Vaccine | Ebola Virus | Ebola | Clinical trial Phase 1 [29] | Novavax | Ebola glycoprotein | Insect cells |
Hecolin® | Hepatitis E Virus | Hepatitis E | Approved [30] | Xiamen Innovax Biotec | A segment (amino acids 368–606) of the HEV open reading frame 2 (ORF2) capsid protein from HEV genotype 1 | Escherichia coli |
Still no trade name | HIV (human immunodeficiency virus) | Acquired immunodeficiency syndrome (AIDS) | Clinical trial Phase 1 (Clinical trial No.: NCT00001053) [31] | Univ. of Rochester AVEG, Rochester, New York, United States | HIV p17/p24:Ty-VLP | Yeast |
Still no trade name | Norwalk Virus | Acute Gastroenteritis | Clinical trial Phase 1 (Clinical trial No.: NCT00973284) [32] | Takeda | Derived from norovirus GI.1 genotype | Insect cells |