Mucosal Vaccine Development Based on Liposome Technology

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
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
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
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
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
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
Novel liposomal based intranasal influenza vaccine	Influenza	Liposomal-based influenza vaccine	Intranasal	Hadassah Medical Organization	Phase 2	NCT00197301
VaxiSome with CCS/C [25]	Influenza	Commercial split influenza virus and polycationic liposome as adjuvant (CCS/C)	Intramuscular injection	NasVax Ltd.	Phase 2	NCT00915187
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
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
Amphomul [28]	Visceral leishmaniasis	Amphotericin B lipid emulsion	Intramuscular injection	Bharat Serums and Vaccines Limited	Phase 3	NCT00876824