Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Neglected Disease Pipeline > Targets > Recombinant/purified protein vaccines Background Overview | Existing Products | Get Involved What are Recombinant/Purified Protein Vaccines? Recombinant or purified protein vaccines consist of protein antigens that have either been produced in a heterologous expression system (e.g., bacteria or yeast) or purified from large amounts of the pathogenic organism. The vaccinated person produces antibodies to the protein antigen, thus protecting him/her from disease. Overview Recombinant/purified protein vaccines are based on the concept that humoral immune responses mounted to an infection are often targeted toward specific localized regions on the surface of protein antigens known as epitopes. The recombinant proteins for vaccination are produced by expressing these immunogenic proteins using heterologous expression systems. The immunogenic protein antigens can also be purified from the infectious organism. Once purified, protein antigens, recombinant and endogenous, are administered with an adjuvant to boost the immune response. Administering just the most immunogenic protein or proteins from an infectious organisms as a vaccine produces a more targeted immune response. This strategy also eliminates the risk of active infection that can occur with live attenuated vaccines or even inactivated vaccines where inactivation is incomplete. Existing Products There are a limited number of recombinant/purified protein vaccines currently in use. Examples of successful recombinant/purified protein vaccines are listed here. The majority of on market vaccines using this strategy are related to protecting a person against the damage caused by secreted toxins rather than protecting a person against infection by the bacterium or virus. Vaccine Description Impact Cholera Recombinant cholera toxin B is a component of Dukoral, a cholera vaccine that also contains inactivated whole bacteria. Dukoral has limited efficacy and duration of immune response. Interestingly, Dukoral provides some cross protection against enterotoxigenic E. coli (ETEC) due to similarities between ETEC and cholera toxins. Cholera vaccines are not yet widely available, so the true impact of these vaccines has not been determined. Diphtheria Diphtheria vaccine is based on purified diphtheria toxin that is chemically inactivated. The inactivated toxin is referred to as a toxoid. As it is the toxin rather than the bacterium that causes the majority of diphtheria symptoms, producing antibodies to the toxin protects against symptomatic disease even though it does not prevent infection with the bacteria. Since the introduction of the combined diphtheria, tetanus, pertussis vaccine through the World Health Organization (WHO) Expanded Program on Immunization in 1974, reported diphtheria cases dropped by more than 90%. The number of countries providing Hepatitis B Tetanus A recombinant protein vaccine against hepatitis B infection has been available since 1981. The vaccine uses hepatitis B surface antigen produced in yeast. Similar to the diphtheria vaccine, the tetanus vaccine is based on the use of inactivated tetanus toxin to produce antibodies that neutralize the toxin even though they do not kill the infectious bacteria. hepatitis B vaccinations has increased from 31 in 1992 to 164 in 2006. As the health impact of hepatitis B is associated with chronic infection, the health impact of the vaccination has not been extensively measured. As mentioned above, the combined diphtheria, tetanus, pertussis vaccine has had a significant health impact. The focus of tetanus vaccination is on the prevention of mother to neonatal transmission of the bacteria that cause tetanus. Get Involved To learn how you can get involved in neglected disease drug, vaccine or diagnostic research and development, or to provide updates, changes, or corrections to the Global Health Primer website, please view our FAQs or contact us at [email protected]. Back to Top Pipeline & Analysis Get Involved PIPELINE Product/Research Program Developers AIDSVAX B/E Armed Forces Research Institute of Medical Sciences, Thailand Global Solutions for Infectious Diseases Henry M. Jackson Foundation for the Advancement of Military Medicine Mahidol University Ministry of Public Health, Thailand National Institute of Allergy and Infectious Diseases Royal Thai Army Medical Department The EMMES Corporation Tripler Army Medical Center Walter Reed Army Institute of Research RTS,S/AS01 GlaxoSmithKline Malaria Vaccine Initiative Bilhvax Eurogentec French National Institute of Health and Medical Research Institut Pasteur HIV p17/p24:Ty-VLP (Preventative) GlaxoSmithKline HIV p17/p24:Ty-VLP (Theraputic) GlaxoSmithKline PvCSP/AS01 GlaxoSmithKline Malaria Vaccine Initiative Walter Reed Army Institute of Research AMA1-C1/Alhydrogel National Institute of Allergy and Infectious Diseases University of Oxford GMZ2 African Malaria Network Trust Statens Serum Institut Discovery Pre-clinical Phase I Phase II Phase III Vakzine Projekt Management GmbH M72 Aeras Global TB Vaccine Foundation GlaxoSmithKline South African Tuberculosis Vaccine Initiative DEN1-80E Merck & Co., Inc. dmLT National Institute of Allergy and Infectious Diseases PATH Tulane University DCVax-001 Celldex Therapeutics Inc. Rockefeller University EnvPro National Institute of Allergy and Infectious Diseases St. Jude Children's Research Hospital PEV301 & 302 Mymetics S.A. Pevion Biotech Ltd. Swiss Tropical and Public Health Institute BSAM-2/Alhydrogel National Institute of Allergy and Infectious Diseases EBA-175 RII-NG Baylor College of Medicine National Institute of Allergy and Infectious Diseases JAIVAC-1 Bharat Biotech European Vaccine Initiative International Centre for Genetic Engineering and Biotechnology Pneumo meningitis & pneumonia in infants (monovalent) Sanofi Pasteur IC47 Intercell AG PATH Sm14 (Schisto) Brazillian Innovation Agency Oswaldo Cruz Foundation Aeras Global TB Vaccine SSI/SP H4-IC31® Foundation Intercell AG Sanofi Pasteur South African Tuberculosis Vaccine Initiative Statens Serum Institut H1-CAF01 Statens Serum Institut H1-IC31 Statens Serum Institut SSI H56-IC31® Aeras Global TB Vaccine Foundation Statens Serum Institut Sm14 (Fascioliasis) Brazilian Ministry of Health Oswaldo Cruz Foundation TAT vaccine Instituto Superiore di Sanita South African AIDS Vaccine Initiative Subunit recombinant antigen (domain III) vaccine Cuban Center for Genetic Engineering and Biotechnology Pedro Kouri Tropical Medicine Institute LEISH-F3 Infectious Disease Research Institute PneuGEM Mucosis B.V. PATH Radboud University Nijmegen Medical Centre FTL-LTB chimera protein Naval Medical Research Center Sanofi Pasteur University of Colorado LT/ST fusion proteins International Enteric Vaccine Consortium PATH Research Council of Norway EtpA glycoprotein University of Tennesee Multivalent protein vaccine candidate (PATH/St. Jude) PATH St. Jude Children's Research Hospital University of Adelaide University of Alabama at Birmingham Human Hookworm NaGST-1 Vaccine Initiative Oswaldo Cruz Foundation Sabin Vaccine Institute NaAPR-1 Human Hookworm Vaccine Initiative Oswaldo Cruz Foundation Sabin Vaccine Institute PvRII International Centre for Genetic Engineering and Biotechnology Malaria Vaccine Initiative AnAPN-1 Johns Hopkins University Medical School Malaria Vaccine Initiative Sabin Vaccine Institute TSP2 Instituto Butantan James Cook University Oswaldo Cruz Foundation Sabin Vaccine Institute Leprosy vaccine program Infectious Disease Research Institute CelTOS + GLA-SE Bill & Melinda Gates Foundation Infectious Disease Research Institute US Agency for International Development Walter Reed Army Institute of Research AMA1-DiCo Biomedical Primate Research Centre European Vaccine Initiative IMX-MSP4 Imaxio University of Oxford trypanosome vaccine antibodies iBIO FB-1811 Folia Biotech rSm-p80 Texas Tech University Group-common pneumococcal vaccine GlaxoSmithKline NasVax rMOMP vaccine National Institute of Allergy and Infectious Diseases University of California, Irvine Novel T-cell antigen vaccine Children's Hospital Boston Genocea Biosciences PATH Pneumoccocal vaccine adjuvant development program PATH University of Glasgow rWbGST University of Illinois Chicago Pfs48 Gennova Biopharmaceuticals Malaria Vaccine Initiative Tulane University Anti-L3 vaccine (NYBC) New York Blood Center Anti-L3 vaccine (LSTM) Liverpool School of Tropical Medicine Mimopath-based Shigellosis vaccine Mucosis B.V. PATH Mimopath-based ETEC vaccine Mucosis B.V. PATH Chimigen malaria vaccine Paladin Biosciences division of Paladin Labs Inc. Chimigen HIV vaccine Paladin Biosciences division of Paladin Labs Inc. AMA1 Malaria Vaccine Initiative Walter and Elizabeth Hall Institute of Medical Research Walter Reed Army Institute of Research PvDBII International Centre for Genetic Engineering and Biotechnology Malaria Vaccine Initiative Traveler's diarrhea vaccine Intercell AG On Hold LEISH-F1 + MPL-SE Infectious Disease Research Institute On Hold LEISH-F2 + MPL-SE Infectious Disease Research Institute On Hold EP1043 National Institute of Allergy and Infectious Diseases VaxOnco On Hold NaASP-2 Human Hookworm Vaccine Initiative Oswaldo Cruz Foundation Sabin Vaccine Institute On Hold FMP010 GlaxoSmithKline US Agency for International Development US Army Medical Research and Materiel Command On Hold rBCG30 University of California, Los Angeles On Hold Back to Top ANALYSIS Although there are a limited number of recombinant or purified protein vaccines currently in use, recombinant protein vaccines make up the majority of products in development for neglected tropical diseases. The relative strengths, weaknesses, opportunities, and risks for recombinant/purified protein vaccines for viral, bacterial, and parasitic diseases are summarized here. Strengths Weaknesses Opportunities AIDSVAX failed to show efficacy in a clinical trial among intravenous drug users when used alone Combination with other vaccination technologies, especially as part of prime-boost regimens Risks Recombinant/purified protein: Viral diseases Relevant neglected tropical diseases: HIV (AIDSVAX B/E, phase III; multiple additional products in discovery through phase II) Dengue (DEN1-80E, phase I) Established method for prevention of viral infections based on success of hepatitis B vaccine Other dengue vaccines are in more advanced stages of development Mechanism of protection from the phase III study of AIDSVAX is unclear; more information is needed to determine if recombinant protein technology should be pursued as part of future HIV vaccine programs AIDSVAX demonstrated clinical efficacy (~30% protection) in phase III in combination with another product Recombinant/purified protein: Bacterial diseases Relevant neglected tropical diseases: Cholera (component of Dukoral, on market) Partial efficacy has been observed for the recombinant cholera toxin B component of Dukoral Tuberculosis (M72, phase II; multiple additional products in pre-clinical and phase I) Human clinical trial data does not yet exist for the effects of recombinant protein vaccines for the prevention of tuberculosis Combination with other vaccination technologies, especially as part of prime-boost regimens Current vaccines for enteric bacterial infections, such as cholera and ETEC, and tuberculosis are only partially effective, so it is unlikely a recombinant protein vaccine will be effective on its own Combination with other vaccination technologies There are currently no vaccines available for ETEC (dmLT, phase I) Recombinant/purified protein: Parasitic protozoan diseases Relevant neglected tropical diseases: RTS,S vaccine demonstrated clinical RTS,S did not demonstrate sterilizing Malaria (RTS,S, phase III; multiple products in discovery through phase II development) efficacy for malaria prevention (~30-50%) and reduced disease severity Leishmaniasis (LEISH-F3, pre-clinical; variation on LEISH-F1 and -F2 vaccines previously in phase II development) immunity Previous clinical trials of leishmaniasis vaccines focused on cutaneous leishmaniasis, so efficacy for prevention of the more severe visceral disease remains to be determined especially as part of prime-boost regimens There are currently no vaccines for this group of organisms, so successful development may be translatable to other diseases caused by parasitic protozoa the prevention of infection with parasitic protozoa, so it is unclear if vaccination will be successful for prevention More extensive studies needed to understand if partial protection reduces severity of disease if complete sterilizing immunity is not possible Recombinant/purified protein: Parasitic helminth diseases Relevant neglected tropical diseases: Schistosomiasis (Bilvax, phase III; Sm14 phase I; TSP 2, pre-clinical) Hookworm (NaGST-1 and NaAPR-1, pre-clinical) Lymphatic filariasis (rWbGST, discovery) Because multicellular helminthes are difficult to culture, live attenuated and inactivated vaccines are impractical; recombinant proteins represent the most advanced stage alternative technology for these organisms Previous attempts at vaccine development for hookworm using larval stage recombinant proteins caused unexpected allergic reactions in patients with previous exposure to hookworm which may limit protein antigen choices to those of adult stage worms Combinations of recombinant proteins for a single organism or across multiple organisms to improve immune response Combination with mass drug administration to prevent reinfection Studies are needed that examine effects on severity or decreases in worm burden beyond prevention of infection Many helminthes can be treated with inexpensive drugs through mass drug administration programs, so it is unclear what role vaccination will play in control programs There are currently no vaccines for the prevention of helminth infections so it is unclear if vaccination will be successful for prevention Get Involved To learn how you can get involved in neglected disease drug, vaccine or diagnostic research and development, or to provide updates, changes, or corrections to the Global Health Primer website, please view our FAQs or contact us at [email protected]. Back to Top Tools Get Involved Recombinant and purified protein vaccines benefit from extensive resources from the biochemistry community for the production and purification of proteins including: • Multiple heterologous recombinant protein expression systems (e.g., bacteria, yeast, mammalian cells, cell free extracts) • Multiple protein tagging and purification methods (e.g., epitope tags, affinity tags, cleavable tags) • Automated protein purification systems (e.g., variety of fast protein liquid chromatography systems using gel filtration, anion/cation exchange, or hydrophobic properties There are numerous publications and manuals with detailed protocols for protein expression and purification especially from vendors who sell protein purification equipment and accessories.1-3 More information on the availability of tools for protein antigen identification and expression for specific neglected diseases is available in each of the specific disease profiles. References 1. Walker JM (ed.) The Protein Protocols Handbook, 3rd edition, 2009. 2. Promega Protocols & Applications Guide: Protein purification and analysis, available here. 3. Elsevier scientific journal: Protein Expression and Purification, available here. Get Involved To learn how you can get involved in neglected disease drug, vaccine or diagnostic research and development, or to provide updates, changes, or corrections to the Global Health Primer website, please view our FAQs or contact us at [email protected]. Product Details AIDSVAX B/E Synonyms: AIDSVAX B/E Disease: Human Immunodeficiency Virus (HIV) Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive, boost, clades B and E Mechanism of Action: MN gp120, A244 gp120 Product Type: Vaccine Molecule Class: Administration Route: IM PRV Elegible? No Notes: Clinical Trials: Publications: Currently in Phase III with ALVAC-HIV (vCP1521) but originally entered Phase III alone in 1999. NCT00006327 NCT00001096 NCT00002402 NCT00337181 NCT00223080 NCT00000879 NCT00000871 NCT00011037 19843557 AMA1 Synonyms: AMA1 Disease: Malaria Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? Yes Notes: Clinical Trials: Publications: AMA1-C1/Alhydrogel Synonyms: AMA1-C1/Alhydrogel Disease: Malaria Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive, P. falciparum erythrocytic stage Mechanism of Action: Mixture of two recombinant synthetic AMA1 proteins from two Plasmodium falciparum strains Notes: Product Type: Vaccine Molecule Class: PRV Elegible? Yes Administration Route: IM Clinical Trials: Publications: NCT00984763 NCT00427167 NCT00344539 NCT00414336 NCT00740090 AMA1-DiCo Synonyms: AMA1-DiCo Disease: Malaria Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? Yes Clinical Trials: Notes: Publications: A diversity covering approach to increase immunogenicity to multiple AMA-1 alleles. For more information on this product, see European Vaccine Initiative. AnAPN-1 Synonyms: AnAPN-1 Disease: Malaria Target/Technology: Recombinant/purified protein vaccines Specific Indication: Transmission blocking Mechanism of Action: AnAPN-1 Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? Yes Notes: Clinical Trials: Publications: Anti-L3 vaccine (LSTM) Synonyms: Anti-L3 vaccine (LSTM) Disease: Onchocerciasis (River Blindness) Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? Yes Notes: Clinical Trials: Publications: 19901988 Anti-L3 vaccine (NYBC) Synonyms: Anti-L3 vaccine (NYBC) Disease: Onchocerciasis (River Blindness) Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? Yes Notes: Clinical Trials: Publications: Bilhvax Synonyms: Bilhvax Sh28GST Disease: Schistosomiasis Target/Technology: Recombinant/purified protein vaccines Specific Indication: Prevention of reinfection after concurrent treatment, S. haematobium Mechanism of Action: Product Type: Vaccine Administration Route: SC Molecule Class: PRV Elegible? Yes Notes: Clinical Trials: Publications: NCT00870649 12753436 BSAM-2/Alhydrogel Synonyms: BSAM-2/Alhydrogel Disease: Malaria Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: Preventive, P. falciparum erythrocytic stage Product Type: Vaccine MSP-1 and AMA-1 Molecule Class: Administration Route: PRV Elegible? Yes Notes: Clinical Trials: Publications: NCT00889616 CelTOS + GLA-SE Synonyms: Disease: Malaria Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: antigen + adjuvant Product Type: Vaccine Molecule Class: PRV Elegible? Yes Notes: Administration Route: Clinical Trials: Publications: Chimigen HIV vaccine Synonyms: Chimigen HIV vaccine Disease: Human Immunodeficiency Virus (HIV) Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? No Notes: Clinical Trials: Publications: Dendritic cell-receptor targeted approach. Chimigen malaria vaccine Synonyms: Chimigen malaria vaccine Disease: Malaria Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive Mechanism of Action: CSP, AMA, LSA, and MSP Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? Yes Notes: Clinical Trials: Publications: Combines four malaria antigens and targets dendritic cells. DCVax-001 Synonyms: DCVax-001 Disease: Human Immunodeficiency Virus (HIV) Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? No Notes: Clinical Trials: Publications: NCT01127464 DEN1-80E Synonyms: DEN1-80E HBV-001 D1 Recombinant E subunit vaccine Disease: Dengue fever Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive, serotype 1 Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? Yes Notes: Clinical Trials: Publications: NCT00936429 20097152 dmLT Synonyms: dmLT Disease: Enterotoxigenic E. coli (ETEC) Target/Technology: Recombinant/purified protein vaccines Specific Indication: Anti-toxin, LT Mechanism of Action: Molecule Class: Product Type: Vaccine Administration Route: Oral PRV Elegible? No Notes: Clinical Trials: Publications: NCT01147445 EBA-175 RII-NG Synonyms: EBA-175 RII-NG Disease: Malaria Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive, P. falciparum erythrocytic stage Mechanism of Action: EBA Product Type: Vaccine Molecule Class: Administration Route: IM PRV Elegible? Yes Notes: Clinical Trials: Publications: NCT00347555 NCT01026246 16735084 20702657 EnvPro Synonyms: EnvPro Disease: Human Immunodeficiency Virus (HIV) Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: IM PRV Elegible? No Notes: Clinical Trials: Publications: NCT00076947 EP1043 Synonyms: EP1043 Disease: Human Immunodeficiency Virus (HIV) Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: Preventive pol, vpu, gag Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? No Notes: Clinical Trials: Safety and tolerability demonstrated in Phase I trial in combination with EP1090 but only weak immunogenicity observed. NCT00141024 Publications: EtpA glycoprotein Synonyms: EtpA glycoprotein Disease: Enterotoxigenic E. coli (ETEC) Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? No Notes: Clinical Trials: Publications: FB-1811 Synonyms: FB-1811 Disease: Typhoid fever Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? No Notes: Clinical Trials: Publications: FMP010 Synonyms: FMP010 Plasmodium falciparum Malaria protein 010 Disease: Malaria Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: Product Type: Vaccine Molecule Class: MSP-1 PRV Elegible? Yes Notes: Clinical Trials: Administration Route: Publications: NCT00666380 NCT00317473 FTL-LTB chimera protein Synonyms: FTL-LTB chimera protein Disease: Enterotoxigenic E. coli (ETEC) Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? No Notes: Clinical Trials: Publications: GMZ2 Synonyms: GMZ2 Disease: Malaria Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive, P. falciparum erythrocytic stage Mechanism of Action: GLURP and MSP3 Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? Yes Notes: Clinical Trials: Publications: NCT00397449 NCT00424944 NCT00703066 20009515 Group-common pneumococcal vaccine Synonyms: Group-common pneumococcal vaccine Disease: Pneumococcal disease Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive Mechanism of Action: Product Type: Molecule Class: Administration Route: Vaccine PRV Elegible? No Notes: Clinical Trials: Publications: H1-CAF01 Synonyms: H1-CAF01 Ag85B-ESAT-6/CAF01 Disease: Tuberculosis (TB) Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive, boost Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? Yes Notes: Clinical Trials: Publications: NCT00922363 H1-IC31 Synonyms: H1-IC31 Ag85B-ESAT-6/IC31 Disease: Tuberculosis (TB) Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive, boost Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? Yes Notes: Clinical Trials: Publications: NCT01049282 20488515 20226890 HIV p17/p24:Ty-VLP (Preventative) Synonyms: HIV p17/p24:Ty-VLP (Preventative) HIV vaccine 732461 Disease: Human Immunodeficiency Virus (HIV) Specific Indication: Preventive Target/Technology: Recombinant/purified protein vaccines Mechanism of Action: Molecule Class: Administration Route: IM Product Type: Vaccine PRV Elegible? No Notes: Clinical Trials: Publications: NCT00001053 NCT00434512 NCT00972725 HIV p17/p24:Ty-VLP (Theraputic) Synonyms: HIV p17/p24:Ty-VLP (Theraputic) HIV vaccine 732462 Disease: Human Immunodeficiency Virus (HIV) Target/Technology: Recombinant/purified protein vaccines Mechanism of Action: Specific Indication: Therapeutic Molecule Class: Product Type: Administration Route: IM Vaccine PRV Elegible? No Notes: Clinical Trials: Publications: NCT00814762 NCT01092611 NCT01218113 IC47 Synonyms: IC47 Disease: Pneumococcal disease Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: IM PRV Elegible? No Notes: Clinical Trials: NCT00873431 IMX-MSP4 Publications: Synonyms: IMX-MSP4 Disease: Malaria Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? Yes Notes: Clinical Trials: Publications: JAIVAC-1 Synonyms: JAIVAC-1 Disease: Malaria Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive, P. falciparum erythrocytic stage Mechanism of Action: rPfMSP-119 and rPfEBA175 Molecule Class: Product Type: Vaccine Administration Route: PRV Elegible? Yes Notes: Clinical Trials: Publications: 20009515 LEISH-F1 + MPL-SE Synonyms: LEISH-F1 + MPL-SE LEISH-111f + MPL-SE Disease: Leishmaniasis Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive and therapeutic, Visceral leishmaniasis (VL) Mechanism of Action: Product Type: Vaccine Administration Route: Molecule Class: PRV Elegible? Yes Notes: Clinical Trials: Replaced by improved product LEISH-F2. NCT00486382 NCT00121849 NCT00111553 NCT00111514 NCT00121862 Publications: LEISH-F2 + MPL-SE Synonyms: LEISH-F2 + MPL-SE Disease: Leishmaniasis Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive and therapeutic, Visceral leishmaniasis (VL) Mechanism of Action: Product Type: Vaccine Administration Route: Molecule Class: PRV Elegible? Yes Notes: Clinical Trials: Replaced by improved product, LEISH-F3. NCT01011309 NCT00982774 Publications: LEISH-F3 Synonyms: LEISH-F3 Disease: Leishmaniasis Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive, Visceral leishmaniasis (VL) Mechanism of Action: Product Type: Vaccine Administration Route: Molecule Class: PRV Elegible? Yes Notes: Clinical Trials: Publications: Leprosy vaccine program Synonyms: Leprosy vaccine program Disease: Leprosy Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? Yes Notes: Clinical Trials: Publications: LT/ST fusion proteins Synonyms: LT/ST fusion proteins Disease: Enterotoxigenic E. coli (ETEC) Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? No Notes: Clinical Trials: Publications: M72 Synonyms: M72 Disease: Tuberculosis (TB) Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive, boost Mechanism of Action: Molecule Class: Product Type: Vaccine Administration Route: IM PRV Elegible? Yes Notes: Clinical Trials: Publications: More information on this product is available from AERAS. NCT00600782 NCT00621322 19188599 Mimopath-based ETEC vaccine Synonyms: Mimopath-based ETEC vaccine Disease: Enterotoxigenic E. coli (ETEC) Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: Product Type: Vaccine Molecule Class: PRV Elegible? No Notes: Recombinant protein carried by bacterium-like particles (BLPs). Mimopath-based Shigellosis vaccine Administration Route: Oral Clinical Trials: Publications: Synonyms: Mimopath-based Shigellosis vaccine Disease: Shigellosis Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: Product Type: Vaccine Molecule Class: PRV Elegible? No Notes: Administration Route: Oral Clinical Trials: Publications: Recombinant protein carried by bacterium-like particles (BLPs). Multivalent protein vaccine candidate (PATH/St. Jude) Synonyms: Multivalent protein vaccine candidate (PATH/St. Jude) Disease: Pneumococcal disease Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? No Notes: Clinical Trials: Publications: NaAPR-1 Synonyms: NaAPR-1 Disease: Soil-Transmitted Helminths: Hookworm Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive, N. americanus Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? Yes Notes: Clinical Trials: Publications: 20948553 NaASP-2 Synonyms: NaASP-2 Disease: Soil-Transmitted Helminths: Hookworm Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive, N. americanus Product Type: Vaccine Mechanism of Action: Molecule Class: Administration Route: PRV Elegible? Yes Notes: Clinical Trials: Publications: Discontinued during Phase I trial in Brazil (2007-2008) due to allergic reaction in patients from endemic areas. NCT00120081 NCT00473967 20948553 NaGST-1 Synonyms: NaGST-1 Disease: Soil-Transmitted Helminths: Hookworm Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive, N. americanus Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? Yes Notes: Clinical Trials: Publications: 20948553 Novel T-cell antigen vaccine Synonyms: Novel T-cell antigen vaccine Disease: Pneumococcal disease Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? No Notes: Clinical Trials: Publications: PEV301 & 302 Synonyms: PEV301 & 302 Disease: Malaria Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: Preventive, P. falciparum pre-erythrocytic and erythrocytic stages AMA-1 and CSP delivered in virosomes Product Type: Vaccine Administration Route: Molecule Class: PRV Elegible? Yes Notes: Clinical Trials: Publications: Previously evaluated as PEV3A. NCT00513669 NCT00408668 18231580 Pfs48 Synonyms: Pfs48 Disease: Malaria Target/Technology: Recombinant/purified protein vaccines Specific Indication: Transmission blocking Mechanism of Action: CH-rPfs48/45 Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? Yes Notes: Clinical Trials: Publications: 19623257 PneuGEM Synonyms: PneuGEM Multivalent protein vaccine candidate (PATH/Mucosis) Disease: Pneumococcal disease Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: Intranasal PRV Elegible? No Notes: Clinical Trials: Publications: Recombinant protein carried by bacterium-like particles (BLPs). Pneumo meningitis & pneumonia in infants (monovalent) Synonyms: Pneumo meningitis & Disease: Pneumococcal disease Target/Technology: Recombinant/purified protein vaccines pneumonia in infants (monovalent) Specific Indication: Preventive Mechanism of Action: Molecule Class: Product Type: Vaccine Administration Route: PRV Elegible? No Notes: Clinical Trials: Publications: Pneumoccocal vaccine adjuvant development program Synonyms: Pneumoccocal vaccine adjuvant development program Disease: Pneumococcal disease Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? No Notes: Clinical Trials: Publications: PvCSP/AS01 Synonyms: PvCSP/AS01 VMP001/AS01B Disease: Malaria Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive, P. vivax pre-erythrocytic stage Mechanism of Action: Product Type: Vaccine Administration Route: IM Molecule Class: PRV Elegible? Yes Notes: Clinical Trials: Publications: NCT01157897 PvDBII Synonyms: PvDBII P. vivax duffy binding protein II Disease: Malaria Target/Technology: Recombinant/purified protein vaccines Specific Indication: P.vivax Mechanism of Action: Molecule Class: Product Type: Vaccine Administration Route: PRV Elegible? Yes Notes: Clinical Trials: Publications: PvRII Synonyms: PvRII Disease: Malaria Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive, P. vivax erythrocytic stage Mechanism of Action: DBP Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? Yes Notes: Clinical Trials: Publications: rBCG30 Synonyms: rBCG30 Disease: Tuberculosis (TB) Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? Yes Notes: Clinical Trials: Publications: rMOMP vaccine Synonyms: rMOMP vaccine Disease: Trachoma Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: recombinant prime + protein subunit boost Product Type: Vaccine PRV Elegible? Molecule Class: Administration Route: Yes Notes: Clinical Trials: Publications: rSm-p80 Synonyms: rSm-p80 Disease: Schistosomiasis Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive, S. mansoni Mechanism of Action: Product Type: Vaccine PRV Elegible? Yes Notes: Clinical Trials: Molecule Class: In prime-boost combination with Sm-p80 DNA vaccines. Administration Route: Publications: 19809833 21277404 RTS,S/AS01 Synonyms: RTS,S/AS01 Mosquirix GSK malaria vaccine 257049 Disease: Malaria Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive, P. falciparum pre-erythrocytic stage Mechanism of Action: PfCSP protein fused to HBsAG (S) antigen that can self assemble into viral particles Product Type: Vaccine Molecule Class: PRV Elegible? Yes Administration Route: IM Notes: Clinical Trials: Publications: In phase III alone and phase II in prime-boost combination with Ad35.CS.01. NCT00866619 NCT00436007 NCT01148459 NCT00197028 NCT01366534 NCT01231503 NCT01345240 NCT00323622 NCT00443131 NCT01323972 NCT00289185 NCT00307021 NCT00360230 20553771 21443960 NCT00380393 rWbGST Synonyms: rWbGST Disease: Lymphatic filariasis (LF) Target/Technology: Recombinant/purified protein vaccines Specific Indication: Wuchereria bancrofti Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? Yes Notes: Clinical Trials: Publications: 19513102 Sm14 (Fascioliasis) Synonyms: Sm14 (Fascioliasis) Disease: Fascioliasis Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? Yes Notes: Clinical Trials: Publications: 18834847 Sm14 (Schisto) Synonyms: Sm14 (Schisto) Disease: Schistosomiasis Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive, S. mansoni with some Fasciola hepatica cross protection Mechanism of Action: Product Type: Vaccine Administration Route: Molecule Class: PRV Elegible? Yes Notes: Clinical Trials: Publications: NCT01154049 20948553 18834847 SSI H56-IC31® Synonyms: SSI H56-IC31® Ag85B-ESAT-6-Rv2660 Disease: Tuberculosis (TB) Target/Technology: Recombinant/purified protein vaccines Specific Indication: Therapeutic, boost Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? Yes Notes: Clinical Trials: More information on this product is available from AERAS. Publications: 21258338 SSI/SP H4-IC31® Synonyms: SSI/SP H4-IC31® SSI HyVac4/AERAS-404 Disease: Tuberculosis (TB) Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive, boost Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? Yes Notes: Clinical Trials: More information on this product is available from AERAS. Publications: 19896449 16714570 Subunit recombinant antigen (domain III) vaccine Synonyms: Subunit recombinant antigen (domain III) vaccine Disease: Dengue fever Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive Mechanism of Action: Chimeric domain III protein fused to p64k of Neisseria meningitidis Product Type: Vaccine PRV Elegible? No Molecule Class: Administration Route: Notes: Clinical Trials: Publications: 21079655 TAT vaccine Synonyms: TAT vaccine Italian AIDS vaccine Disease: Human Immunodeficiency Virus (HIV) Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: inhibits HIV's TAT expression to repress viral production Product Type: Vaccine Molecule Class: PRV Elegible? No Administration Route: Notes: Clinical Trials: An ongoing trial in Italy is testing the efficacy of a prime boost TAT and Env vaccine. See The Instituto Superiore di Sanita's page about their HIV vaccine. NCT00529698 NCT00751595 Publications: Traveler's diarrhea vaccine Synonyms: Traveler's diarrhea vaccine Disease: Enterotoxigenic E. coli (ETEC) Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive, developed for use in travelers Mechanism of Action: Product Type: Vaccine Administration Route: Transcutaneous Molecule Class: PRV Elegible? No Notes: Clinical Trials: Publications: NCT00993681 NCT01040325 NCT00516659 trypanosome vaccine antibodies Synonyms: trypanosome vaccine antibodies Disease: Human African Trypanosomiasis (HAT) Target/Technology: Recombinant/purified protein vaccines Specific Indication: Mechanism of Action: Product Type: Vaccine Molecule Class: PRV Elegible? Yes Administration Route: Notes: Clinical Trials: Publications: TSP2 Synonyms: TSP2 Disease: Schistosomiasis Target/Technology: Recombinant/purified protein vaccines Specific Indication: Preventive, S. mansoni Mechanism of Action: Product Type: Vaccine Molecule Class: Administration Route: PRV Elegible? Yes Notes: Clinical Trials: Publications: 20948553