A clinical trial to evaluate the safety and immunogenicity of the LEISH-F1 + MPL-SE vaccine when used in combination with meglumine antimoniate for the treatment of cutaneous leishmaniasis
Abstract Forty-four adult patients with cutaneous leishmaniasis (CL) were enrolled in a randomized, double-blind, controlled, dose-escalating clinical trial and were randomly assigned to receive three injections of either the LEISH-F1 + MPL-SE vaccine (consisting of 5, 10, or 20 μg recombinant Leish...
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| Veröffentlicht in: | Vaccine 2010-09, Vol.28 (40), p.6581-6587 |
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| creator | Nascimento, Evaldo Fernandes, Demetrios F Vieira, Edva P Campos-Neto, Antonio Ashman, Jill A Alves, Fabiana P Coler, Rhea N Bogatzki, Lisa Y Kahn, Stuart J Beckmann, Anna Marie Pine, Samuel O Cowgill, Karen D Reed, Steven G Piazza, Franco M |
| description | Abstract Forty-four adult patients with cutaneous leishmaniasis (CL) were enrolled in a randomized, double-blind, controlled, dose-escalating clinical trial and were randomly assigned to receive three injections of either the LEISH-F1 + MPL-SE vaccine (consisting of 5, 10, or 20 μg recombinant Leishmania polyprotein LEISH-F1 antigen + 25 μg MPL® -SE adjuvant) ( n = 27), adjuvant alone ( n = 8), or saline placebo ( n = 9). The study injections were given subcutaneously on Days 0, 28, and 56, and the patients were followed through Day 336 for safety, immunological, and clinical evolution endpoints. All patients received chemotherapy with meglumine antimoniate starting on Day 0. The vaccine was safe and well tolerated. Nearly all vaccine recipients and no adjuvant-alone or placebo recipients demonstrated an IgG antibody response to LEISH-F1 at Day 84. Also at Day 84, 80% of vaccine recipients were clinically cured, compared to 50% and 38% of adjuvant-alone and placebo recipients. The LEISH-F1 + MPL-SE vaccine was safe and immunogenic in CL patients and appeared to shorten their time to cure when used in combination with meglumine antimoniate chemotherapy. |
| doi_str_mv | 10.1016/j.vaccine.2010.07.063 |
| format | Article |
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The study injections were given subcutaneously on Days 0, 28, and 56, and the patients were followed through Day 336 for safety, immunological, and clinical evolution endpoints. All patients received chemotherapy with meglumine antimoniate starting on Day 0. The vaccine was safe and well tolerated. Nearly all vaccine recipients and no adjuvant-alone or placebo recipients demonstrated an IgG antibody response to LEISH-F1 at Day 84. Also at Day 84, 80% of vaccine recipients were clinically cured, compared to 50% and 38% of adjuvant-alone and placebo recipients. The LEISH-F1 + MPL-SE vaccine was safe and immunogenic in CL patients and appeared to shorten their time to cure when used in combination with meglumine antimoniate chemotherapy.</description><identifier>ISSN: 0264-410X</identifier><identifier>EISSN: 1873-2518</identifier><identifier>DOI: 10.1016/j.vaccine.2010.07.063</identifier><identifier>PMID: 20688040</identifier><identifier>CODEN: VACCDE</identifier><language>eng</language><publisher>Kidlington: Elsevier Ltd</publisher><subject>Adjuvants ; Adjuvants, Immunologic - administration & dosage ; Adolescent ; Adult ; Allergy and Immunology ; Antibodies, Protozoan - blood ; Antibody Formation ; Antigens, Protozoan - immunology ; Applied microbiology ; Biological and medical sciences ; Chemotherapy ; Clinical trials ; Cutaneous ; Double-Blind Method ; Drug Therapy, Combination ; Female ; Fundamental and applied biological sciences. Psychology ; Hepatitis ; Humans ; Immunogenicity ; Immunoglobulin G - blood ; Immunologic ; Injections ; Leishmania ; Leishmaniasis ; Leishmaniasis vaccines ; Leishmaniasis, Cutaneous - immunology ; Leishmaniasis, Cutaneous - therapy ; Male ; Meglumine - administration & dosage ; Meglumine - immunology ; Microbiology ; Middle Aged ; Organometallic Compounds - administration & dosage ; Organometallic Compounds - immunology ; Polyproteins - immunology ; Protozoan Vaccines - adverse effects ; Protozoan Vaccines - immunology ; Recombinant Proteins - immunology ; Tropical diseases ; Vaccines ; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) ; Vector-borne diseases ; Young Adult</subject><ispartof>Vaccine, 2010-09, Vol.28 (40), p.6581-6587</ispartof><rights>Elsevier Ltd</rights><rights>2010 Elsevier Ltd</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2010 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Sep 14, 2010</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c509t-b5f5233c7884d88b78a7bed1c5c231b3063139b2fea6b5c10c7d4c2581e15b073</citedby><cites>FETCH-LOGICAL-c509t-b5f5233c7884d88b78a7bed1c5c231b3063139b2fea6b5c10c7d4c2581e15b073</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1497225409?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,777,781,3537,27905,27906,45976,64364,64366,64368,72218</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23260957$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20688040$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nascimento, Evaldo</creatorcontrib><creatorcontrib>Fernandes, Demetrios F</creatorcontrib><creatorcontrib>Vieira, Edva P</creatorcontrib><creatorcontrib>Campos-Neto, Antonio</creatorcontrib><creatorcontrib>Ashman, Jill A</creatorcontrib><creatorcontrib>Alves, Fabiana P</creatorcontrib><creatorcontrib>Coler, Rhea N</creatorcontrib><creatorcontrib>Bogatzki, Lisa Y</creatorcontrib><creatorcontrib>Kahn, Stuart J</creatorcontrib><creatorcontrib>Beckmann, Anna Marie</creatorcontrib><creatorcontrib>Pine, Samuel O</creatorcontrib><creatorcontrib>Cowgill, Karen D</creatorcontrib><creatorcontrib>Reed, Steven G</creatorcontrib><creatorcontrib>Piazza, Franco M</creatorcontrib><title>A clinical trial to evaluate the safety and immunogenicity of the LEISH-F1 + MPL-SE vaccine when used in combination with meglumine antimoniate for the treatment of cutaneous leishmaniasis</title><title>Vaccine</title><addtitle>Vaccine</addtitle><description>Abstract Forty-four adult patients with cutaneous leishmaniasis (CL) were enrolled in a randomized, double-blind, controlled, dose-escalating clinical trial and were randomly assigned to receive three injections of either the LEISH-F1 + MPL-SE vaccine (consisting of 5, 10, or 20 μg recombinant Leishmania polyprotein LEISH-F1 antigen + 25 μg MPL® -SE adjuvant) ( n = 27), adjuvant alone ( n = 8), or saline placebo ( n = 9). The study injections were given subcutaneously on Days 0, 28, and 56, and the patients were followed through Day 336 for safety, immunological, and clinical evolution endpoints. All patients received chemotherapy with meglumine antimoniate starting on Day 0. The vaccine was safe and well tolerated. Nearly all vaccine recipients and no adjuvant-alone or placebo recipients demonstrated an IgG antibody response to LEISH-F1 at Day 84. Also at Day 84, 80% of vaccine recipients were clinically cured, compared to 50% and 38% of adjuvant-alone and placebo recipients. The LEISH-F1 + MPL-SE vaccine was safe and immunogenic in CL patients and appeared to shorten their time to cure when used in combination with meglumine antimoniate chemotherapy.</description><subject>Adjuvants</subject><subject>Adjuvants, Immunologic - administration & dosage</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Allergy and Immunology</subject><subject>Antibodies, Protozoan - blood</subject><subject>Antibody Formation</subject><subject>Antigens, Protozoan - immunology</subject><subject>Applied microbiology</subject><subject>Biological and medical sciences</subject><subject>Chemotherapy</subject><subject>Clinical trials</subject><subject>Cutaneous</subject><subject>Double-Blind Method</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Fundamental and applied biological sciences. 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D</au><au>Reed, Steven G</au><au>Piazza, Franco M</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A clinical trial to evaluate the safety and immunogenicity of the LEISH-F1 + MPL-SE vaccine when used in combination with meglumine antimoniate for the treatment of cutaneous leishmaniasis</atitle><jtitle>Vaccine</jtitle><addtitle>Vaccine</addtitle><date>2010-09-14</date><risdate>2010</risdate><volume>28</volume><issue>40</issue><spage>6581</spage><epage>6587</epage><pages>6581-6587</pages><issn>0264-410X</issn><eissn>1873-2518</eissn><coden>VACCDE</coden><abstract>Abstract Forty-four adult patients with cutaneous leishmaniasis (CL) were enrolled in a randomized, double-blind, controlled, dose-escalating clinical trial and were randomly assigned to receive three injections of either the LEISH-F1 + MPL-SE vaccine (consisting of 5, 10, or 20 μg recombinant Leishmania polyprotein LEISH-F1 antigen + 25 μg MPL® -SE adjuvant) ( n = 27), adjuvant alone ( n = 8), or saline placebo ( n = 9). The study injections were given subcutaneously on Days 0, 28, and 56, and the patients were followed through Day 336 for safety, immunological, and clinical evolution endpoints. All patients received chemotherapy with meglumine antimoniate starting on Day 0. The vaccine was safe and well tolerated. Nearly all vaccine recipients and no adjuvant-alone or placebo recipients demonstrated an IgG antibody response to LEISH-F1 at Day 84. Also at Day 84, 80% of vaccine recipients were clinically cured, compared to 50% and 38% of adjuvant-alone and placebo recipients. The LEISH-F1 + MPL-SE vaccine was safe and immunogenic in CL patients and appeared to shorten their time to cure when used in combination with meglumine antimoniate chemotherapy.</abstract><cop>Kidlington</cop><pub>Elsevier Ltd</pub><pmid>20688040</pmid><doi>10.1016/j.vaccine.2010.07.063</doi><tpages>7</tpages></addata></record> |
| fulltext | fulltext |
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| ispartof | Vaccine, 2010-09, Vol.28 (40), p.6581-6587 |
| issn | 0264-410X 1873-2518 |
| language | eng |
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| source | MEDLINE; Elsevier ScienceDirect Journals; ProQuest Central UK/Ireland |
| subjects | Adjuvants Adjuvants, Immunologic - administration & dosage Adolescent Adult Allergy and Immunology Antibodies, Protozoan - blood Antibody Formation Antigens, Protozoan - immunology Applied microbiology Biological and medical sciences Chemotherapy Clinical trials Cutaneous Double-Blind Method Drug Therapy, Combination Female Fundamental and applied biological sciences. Psychology Hepatitis Humans Immunogenicity Immunoglobulin G - blood Immunologic Injections Leishmania Leishmaniasis Leishmaniasis vaccines Leishmaniasis, Cutaneous - immunology Leishmaniasis, Cutaneous - therapy Male Meglumine - administration & dosage Meglumine - immunology Microbiology Middle Aged Organometallic Compounds - administration & dosage Organometallic Compounds - immunology Polyproteins - immunology Protozoan Vaccines - adverse effects Protozoan Vaccines - immunology Recombinant Proteins - immunology Tropical diseases Vaccines Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Vector-borne diseases Young Adult |
| title | A clinical trial to evaluate the safety and immunogenicity of the LEISH-F1 + MPL-SE vaccine when used in combination with meglumine antimoniate for the treatment of cutaneous leishmaniasis |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-19T09%3A37%3A00IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=A%20clinical%20trial%20to%20evaluate%20the%20safety%20and%20immunogenicity%20of%20the%20LEISH-F1%20+%20MPL-SE%20vaccine%20when%20used%20in%20combination%20with%20meglumine%20antimoniate%20for%20the%20treatment%20of%20cutaneous%20leishmaniasis&rft.jtitle=Vaccine&rft.au=Nascimento,%20Evaldo&rft.date=2010-09-14&rft.volume=28&rft.issue=40&rft.spage=6581&rft.epage=6587&rft.pages=6581-6587&rft.issn=0264-410X&rft.eissn=1873-2518&rft.coden=VACCDE&rft_id=info:doi/10.1016/j.vaccine.2010.07.063&rft_dat=%3Cproquest_cross%3E872133976%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1497225409&rft_id=info:pmid/20688040&rft_els_id=1_s2_0_S0264410X10010741&rfr_iscdi=true |