Table 1.
Examples of liposome adjuvant vaccines against infectious diseases tested in clinical trials. This compilation of completed or ongoing studies involving liposomes for vaccination of humans was generated with data from ClinicalTrials.gov. Here we have indicated the target disease, the vaccine composition, the route of administration, the clinical testing stage, and the reference number.
| Name | Disease | Description | Route of administration | Sponsor | Status | ClinicalTrials.gov Identifier |
|---|---|---|---|---|---|---|
| FMP012 with AS01B | Malaria | Falciparum malaria protein (FMP012) in a formulation based on liposomes mixed with the immunostimulants monophosphoryl lipid (MPL) and Quillaja saponaria Molina, fraction 21 | Intramuscular injection | US Army Medical Research and GlaxoSmithKline | Phase 1 | NCT02174978 |
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| TVDV with Vaxfectin [21] | Dengue fever | Tetravalent dengue vaccine (TVDV) with Vaxfectin® cationic lipid-based adjuvant | Intramuscular injection | US Army Medical Research and Materiel Command | Phase 1 | NCT01502358 |
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| Ag85B-ESAT-6 with CAF01 [22] | Tuberculosis | Subunit protein antigen Ag85B-ESAT-6 with two-component liposomal adjuvant system composed of a cationic liposome vehicle (dimethyldioctadecylammonium (DDA) stabilized with a glycolipid immunomodulator (trehalose 6,6-dibehenate (TDB)) | Intramuscular injection | Statens Serum Institut | Phase 1 | NCT00922363 |
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| Biocine with lipid A [23] | HIV | Recombinant envelope protein rgp120/HIV-1SF2 combined with lipid A | Intradermal | National Institute of Allergy and Infectious Diseases | Phase 1 | NCT00001042 |
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| PAMVAC with GLA-SE or GLA-LSQ |
Malaria | Placental malaria vaccine candidate adjuvant with alhydrogel, glucopyranosyl lipid adjuvant-stable emulsion (GLA-SE), or glucopyranosyl lipid adjuvant-liposome-QS-21 formulation (GLA-LSQ) | Intramuscular injection | Tuebingen University Hospital | Phase 1 | NCT02647489 |
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| ID93 with GLA-SE [24] |
Tuberculosis | Recombinant fusion protein incorporating four M. tuberculosis antigens (ID93) formulated with glucopyranosyl lipid adjuvant- (GLA-) stable emulsion (SE) | Intramuscular injection | National Institute of Allergy and Infectious Diseases | Phase 1 | NCT02508376 |
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| Novel liposomal based intranasal influenza vaccine | Influenza | Liposomal-based influenza vaccine | Intranasal | Hadassah Medical Organization | Phase 2 | NCT00197301 |
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| VaxiSome with CCS/C [25] | Influenza | Commercial split influenza virus and polycationic liposome as adjuvant (CCS/C) | Intramuscular injection | NasVax Ltd. | Phase 2 | NCT00915187 |
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| Fluzone with JVRS-100 [26] | Influenza | Inactivated trivalent influenza virus vaccine administered with cationic lipid-DNA complex adjuvant JVRS-100 | Intradermal | Colby Pharmaceutical Company and Juvaris BioTherapeutics |
Phase 2 | NCT00936468 |
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| RTS/S with AS01 [27] | Malaria | Repeat sequences of the Plasmodium falciparum circumsporozoite protein (RTS/S) fused to the hepatitis B surface antigen with a liposome-based adjuvant system that also contains monophosphoryl lipid A (MPL) and Quillaja saponaria Molina, fraction 21 | Intramuscular injection | KEMRI-Wellcome Trust Collaborative Research Program and GlaxoSmithKline | Phase 3 | NCT00872963 |
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| Amphomul [28] | Visceral leishmaniasis | Amphotericin B lipid emulsion | Intramuscular injection | Bharat Serums and Vaccines Limited | Phase 3 | NCT00876824 |