Table 2.
Nanovaccines approved or in clinical trialsa
| Organization | Name of vaccine | Type of antigen | Nanomaterial used | Clinical trial (registration number) | Refs |
|---|---|---|---|---|---|
| Moderna and NIAID | mRNA-1273 LNP | mRNA-1273 mRNA | LNP with mRNA encapsulated | Phase I (NCT04283461) Phase II (NCT04405076) Phase III (NCT04470427) |
[139,140] |
| BioNTech and Pfizer | mRNA BNT162b2 | mRNA encoding the trimerized RBD of SARS-CoV-2 | LNP with mRNA encapsulated | Phase I/II (UTRN U1111-1249-4220) Phase I/II (Germany) NCT04537949 EudraCT Number (Germany) (2020–001038-36) Phase II/III (USA) (NCT04368728) Phase I/II (ChiCTR2000034825) Phase I (Japan) NCT04588480 |
[141,142] |
| Novavax | NVX-CoV2373 | Full-length SARS-CoV-2 S glycoprotein | Recombinant glycoprotein NP saponin-based Matrix-M1 adjuvant | Phase I (NCT04368988) Phase II (NCT04533399) Phase III (UK) (2020–004123-16) Phase III (USA/Mexico) NCT04611802 |
[143] |
| Imperial College, London Acuitas Therapeutics, Vancouver |
LNP-nCoV saRNA ARCT-021 |
saRNA and pre-fusion stabilized SARS-CoV-2 S protein | LNP with saRNA encapsulated | ISRCTN1707269, NCT04480957 | |
| Suzhou Abogen Biosciences Walvax Biotechnology and People's Liberation Army |
ARCoV | mRNA encoding RBD of SARS-CoV-2 S glycoprotein | LNP with mRNA encapsulated | Phase I (ChiCTR2000034112) | |
| Novavax | SARS-CoV S protein and influenza M1 protein | SARS-CoV VLP nanovaccine | Preclinical | ||
| Imophoron and Bristol University | Multiepitope display | VLP ADDomer™ | Preclinical | http://www.bristol.ac.uk/news/2020/april/covid-19-vaccine-platform.html | |
| Fundan University, Shanghai JiaoTong University, and RNACure Biopharma | mRNA cocktail | LNP with VLP encapsulated | Preclinical | [144] | |
| Crucell | Inflexal®V | Influenza | Virosome with influenza virus surface antigens (hemagglutinin and neuraminidase) | Phase III completed NCT01631110 |
EMA |
| Crucell | Epaxal® | Hepatitis A | Virosome with inactivated virus particles | Phase III completed NCT01307436 |
EMA |
| Merck | Gardasil®9 | HPV | Capsomere (major capsid protein L1) | Completed NCT00090220 |
FDA EMA |
| GSK | Cervarix® | HPV | Capsomere (major capsid protein L1) | Phase II NCT00316693 Phase III NCT03728881 |
FDA EMA |
| Dendreon Pharmaceuticals | Provenge (Sipuleucel-T) | Prostate cancer | Each dose of contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF | Phase III completed NCT00065442 |
FDA |
| Novavax | NanoFluTM | Influenza | Recombinant HA protein on Tween 80 NP with Matrix-M adjuvant | Phase III NCT04120194 |
Active |
| Novavax | ResVaxTM | RSV (protection of infants via maternal immunization) | Recombinant near full-length RSV F protein on Tween 80 NP with/without alum adjuvant | Phase III NCT02624947 2016-002302-39 |
Completed (2020) |
| Novavax | ResVaxTM (coadministration with influenza vaccine) | RSV and influenza (≥60 years of age) | Recombinant near full-length RSV F protein on Tween 80 NP with/without alum adjuvant coadministered with licensed influenza vaccine | Phase I NCT01709019 |
Completed (2014) |
| Novavax | EBOV GP Vaccine | Ebola | 2014 Guinea Ebola virus recombinant glycoprotein on Tween 80 NP with/without Matrix-M adjuvant | Phase I NCT02370589 |
Completed (2016) |
| Sensei Biotherapeutics | PAN-301-1 | Prostate cancer | Modified bacteriophage (viral NP) expressing 200–300 copies of part of the human aspartyl (asparaginyl) β-hydroxylase molecule on the viral head | Phase I NCT03120832 |
Completed (2019) |
| DAIDS/NIAID/NIH | MPER-656 | HIV | HIV-1 gp41 membrane proximal external region (MPER) with liposomes | Phase I NCT03934541 |
Active |
| BioNTech | W_ova1 | Ovarian cancer | Liposome-formulated mRNAs. Three ovarian cancer tumor-associated antigens in combination with (neo-)adjuvant chemotherapy | Phase I NCT04163094 |
Active |
| ImmunoVaccine Technologies | DPX-0907 | Ovarian, breast, and prostate cancer | Liposomes with seven tumor-specific HLA-A2-restricted peptides, a universal T helper peptide, and a polynucleotide adjuvant in Montanide ISA51 VG | Phase I NCT01095848 |
Completed (2015) |
| Merck | Tecemotide | Multiple myeloma | Liposomes with tecemotide lipopeptide and 3-O-deacyl-4′-monophosphoryl lipid adjuvant | Phase II NCT01094548 |
Completed (2016) |
| NSCLC (discontinued) | Phase I/II NCT00960115 Phase III NCT01015443 NCT02049151 NCT00409188 |
Completed (2015) Terminated for NSCLC indication |
|||
| NSCLC (bevacizumab) |
Phase II NCT00828009 |
Active | |||
| Breast cancer | Phase III NCT00925548 |
Terminated (clinical hold) | |||
| Colon/rectum carcinoma | Phase II NCT01462513 |
Completed (2018) | |||
| Prostate cancer | Phase II NCT01496131 |
Completed (2018) | |||
| Rectal cancer | Phase II NCT01507103 |
Completed (2017) | |||
| Cascadian Therapeutics | ONT-10 | Solid tumor | Liposomal MUC1 cancer vaccine | Phase I NCT01556789 NCT01978964 |
Completed (2018) (2018) |
| XEME Biopharma | OncoquestTM | Follicular lymphoma Chronic lymphocytic leukemia |
Liposomes containing autologous tumor-derived antigen and IL-2 | Phase I NCT01976520 Phase II NCT02194751 |
Active Active |
| Lipotek Pty | Lipovaxin-MM | Metastatic melanoma | Multicomponent liposomes containing tumor antigens (gp100, tyrosinase, and melanA/MART-1) with DC-targeting moiety DMS-5000 | Phase I NCT01052142 |
Completed (2012) |
| NasVax | VaxiSomeTM-Influenza | Influenza | VaxiSomeTM (ceramide carbamoyl-spermine/cholesterol) liposomal adjuvant/delivery system combined with commercial influenza vaccine | Phase II NCT00915187 |
Completed (2011) |
a
Abbreviations: ARE, Asparagus racemosus extract; CsAuNPs, chitosan-functionalized AuNPs; F, RSV fusion protein; HA, influenza virus hemagglutinin; HPV, human papillomavirus; LNP, lipid nanoparticle; melanA/MART-1, melanoma antigen recognized by T cells; MUC1, mucin 1; NSCLC, non-small cell lung cancer; PAP-GM-CSF, pulmonary alveolar proteinosis granulocyte macrophage colony-stimulating factor; RBD, receptor-binding domain; RSV, respiratory syncytial virus; S, SARS-CoV-19 spike protein; saRNA, self-amplifying mRNA; VLP, vaccine-like particle.