Failure of a killed Leishmania amazonensis vaccine against American cutaneous leishmaniasis in Colombia
We report the results of a double-blind, randomized, placebo-controlled clinical trial of a killed whole-cell Leishmania amazonensis candidate vaccine against American cutaneous leishmaniasis (CL) in Colombia. The trial subjects were 2597 healthy volunteers with negative leishmanin skin test (LST) s...
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| Veröffentlicht in: | Transactions of the Royal Society of Tropical Medicine and Hygiene 2005-08, Vol.99 (8), p.593-598 |
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| container_title | Transactions of the Royal Society of Tropical Medicine and Hygiene |
| container_volume | 99 |
| creator | Vélez, Iván D. Gilchrist, Katherine Arbelaez, María P. Rojas, Carlos A. Puerta, Juan A. Antunes, Carlos M.F. Zicker, Fabio Modabber, Farrokh |
| description | We report the results of a double-blind, randomized, placebo-controlled clinical trial of a killed whole-cell
Leishmania amazonensis candidate vaccine against American cutaneous leishmaniasis (CL) in Colombia. The trial subjects were 2597 healthy volunteers with negative leishmanin skin test (LST) selected from rural Colombian soldiers who were going to patrol endemic areas. They were randomized to receive either three doses of vaccine (
n
=
1295) or placebo (
n
=
1302) given at 20-day intervals. An active and passive case detection system was established to follow-up volunteers for 1 year after vaccination. Safety and efficacy of the vaccine were determined by comparing local and systemic adverse reactions after each dose and the incidence of parasitologically confirmed CL. In the vaccine and placebo groups 101 (7.7%) and 88 (6.8%) volunteers developed CL respectively. The vaccine was shown to be safe but offered no protection against CL caused by
L. panamensis in the proposed vaccination schedule. |
| doi_str_mv | 10.1016/j.trstmh.2005.04.002 |
| format | Article |
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Leishmania amazonensis candidate vaccine against American cutaneous leishmaniasis (CL) in Colombia. The trial subjects were 2597 healthy volunteers with negative leishmanin skin test (LST) selected from rural Colombian soldiers who were going to patrol endemic areas. They were randomized to receive either three doses of vaccine (
n
=
1295) or placebo (
n
=
1302) given at 20-day intervals. An active and passive case detection system was established to follow-up volunteers for 1 year after vaccination. Safety and efficacy of the vaccine were determined by comparing local and systemic adverse reactions after each dose and the incidence of parasitologically confirmed CL. In the vaccine and placebo groups 101 (7.7%) and 88 (6.8%) volunteers developed CL respectively. The vaccine was shown to be safe but offered no protection against CL caused by
L. panamensis in the proposed vaccination schedule.</description><identifier>ISSN: 0035-9203</identifier><identifier>EISSN: 1878-3503</identifier><identifier>DOI: 10.1016/j.trstmh.2005.04.002</identifier><identifier>PMID: 15893351</identifier><identifier>CODEN: TRSTAZ</identifier><language>eng</language><publisher>Oxford: Elsevier Ltd</publisher><subject>Adult ; Animals ; Biological and medical sciences ; Colombia ; Colombia - epidemiology ; Cutaneous leishmaniasis ; Double-Blind Method ; General aspects ; Humans ; Incidence ; Leishmania - immunology ; Leishmania amazonensis ; Leishmaniasis, Cutaneous - epidemiology ; Leishmaniasis, Cutaneous - prevention & control ; Leishvacin ; Male ; Medical sciences ; Military Personnel ; Protozoan Vaccines - therapeutic use ; Rural Health ; Survival Analysis ; Treatment Failure ; Vaccines, Inactivated - therapeutic use</subject><ispartof>Transactions of the Royal Society of Tropical Medicine and Hygiene, 2005-08, Vol.99 (8), p.593-598</ispartof><rights>2005 Royal Society of Tropical Medicine and Hygiene</rights><rights>Royal Society of Tropical Medicine and Hygiene 2005</rights><rights>2005 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c468t-707f2c754337726a770eaacbc4f4232928cfb655508bf55d0b1a03a148363fc03</citedby><cites>FETCH-LOGICAL-c468t-707f2c754337726a770eaacbc4f4232928cfb655508bf55d0b1a03a148363fc03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,781,785,27929,27930</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=16908181$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15893351$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vélez, Iván D.</creatorcontrib><creatorcontrib>Gilchrist, Katherine</creatorcontrib><creatorcontrib>Arbelaez, María P.</creatorcontrib><creatorcontrib>Rojas, Carlos A.</creatorcontrib><creatorcontrib>Puerta, Juan A.</creatorcontrib><creatorcontrib>Antunes, Carlos M.F.</creatorcontrib><creatorcontrib>Zicker, Fabio</creatorcontrib><creatorcontrib>Modabber, Farrokh</creatorcontrib><title>Failure of a killed Leishmania amazonensis vaccine against American cutaneous leishmaniasis in Colombia</title><title>Transactions of the Royal Society of Tropical Medicine and Hygiene</title><addtitle>Trans R Soc Trop Med Hyg</addtitle><addtitle>Trans R Soc Trop Med Hyg</addtitle><description>We report the results of a double-blind, randomized, placebo-controlled clinical trial of a killed whole-cell
Leishmania amazonensis candidate vaccine against American cutaneous leishmaniasis (CL) in Colombia. The trial subjects were 2597 healthy volunteers with negative leishmanin skin test (LST) selected from rural Colombian soldiers who were going to patrol endemic areas. They were randomized to receive either three doses of vaccine (
n
=
1295) or placebo (
n
=
1302) given at 20-day intervals. An active and passive case detection system was established to follow-up volunteers for 1 year after vaccination. Safety and efficacy of the vaccine were determined by comparing local and systemic adverse reactions after each dose and the incidence of parasitologically confirmed CL. In the vaccine and placebo groups 101 (7.7%) and 88 (6.8%) volunteers developed CL respectively. The vaccine was shown to be safe but offered no protection against CL caused by
L. panamensis in the proposed vaccination schedule.</description><subject>Adult</subject><subject>Animals</subject><subject>Biological and medical sciences</subject><subject>Colombia</subject><subject>Colombia - epidemiology</subject><subject>Cutaneous leishmaniasis</subject><subject>Double-Blind Method</subject><subject>General aspects</subject><subject>Humans</subject><subject>Incidence</subject><subject>Leishmania - immunology</subject><subject>Leishmania amazonensis</subject><subject>Leishmaniasis, Cutaneous - epidemiology</subject><subject>Leishmaniasis, Cutaneous - prevention & control</subject><subject>Leishvacin</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Military Personnel</subject><subject>Protozoan Vaccines - therapeutic use</subject><subject>Rural Health</subject><subject>Survival Analysis</subject><subject>Treatment Failure</subject><subject>Vaccines, Inactivated - therapeutic use</subject><issn>0035-9203</issn><issn>1878-3503</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkE1v1DAQQC0EokvhHyDkC70lHcdxnFyQqqUfSCuKEEiIizVxJq23ibPYSQX8erLKqr2hnnx5b2b8GHsrIBUgitNtOoY49rdpBqBSyFOA7BlbiVKXiVQgn7MVgFRJlYE8Yq9i3M6AEqp6yY6EKisplVixmwt03RSIDy1Hfue6jhq-IRdve_QOOfb4d_Dko4v8Hq11njjeoPNx5Gc9BWfRczuN6GmYIu8ezL3gPF8P3dDXDl-zFy12kd4c3mP2_eL82_oq2VxfflqfbRKbF-WYaNBtZrXKpdQ6K1BrIERb27zNM5lVWWnbulBKQVm3SjVQCwSJIi9lIVsL8pidLHN3Yfg1URxN76KlrlsONIWuVCa0msF8AW0YYgzUml1wPYY_RoDZBzZbswQ2-8AGcjP3m7V3h_lT3VPzKB2KzsD7A4DRYtcG9NbFR66ooBTlnjtduGHaPXV1shgujvT7wcFwN_9KamWufvw0Wm8uP6svX83Hmf-w8DT3vncUTLSOvKXGBbKjaQb3_4X_ADo-unM</recordid><startdate>20050801</startdate><enddate>20050801</enddate><creator>Vélez, Iván D.</creator><creator>Gilchrist, Katherine</creator><creator>Arbelaez, María P.</creator><creator>Rojas, Carlos A.</creator><creator>Puerta, Juan A.</creator><creator>Antunes, Carlos M.F.</creator><creator>Zicker, Fabio</creator><creator>Modabber, Farrokh</creator><general>Elsevier Ltd</general><general>Royal Society of Tropical Medicine and Hygiene</general><general>Elsevier</general><scope>BSCLL</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20050801</creationdate><title>Failure of a killed Leishmania amazonensis vaccine against American cutaneous leishmaniasis in Colombia</title><author>Vélez, Iván D. ; Gilchrist, Katherine ; Arbelaez, María P. ; Rojas, Carlos A. ; Puerta, Juan A. ; Antunes, Carlos M.F. ; Zicker, Fabio ; Modabber, Farrokh</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c468t-707f2c754337726a770eaacbc4f4232928cfb655508bf55d0b1a03a148363fc03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Adult</topic><topic>Animals</topic><topic>Biological and medical sciences</topic><topic>Colombia</topic><topic>Colombia - epidemiology</topic><topic>Cutaneous leishmaniasis</topic><topic>Double-Blind Method</topic><topic>General aspects</topic><topic>Humans</topic><topic>Incidence</topic><topic>Leishmania - immunology</topic><topic>Leishmania amazonensis</topic><topic>Leishmaniasis, Cutaneous - epidemiology</topic><topic>Leishmaniasis, Cutaneous - prevention & control</topic><topic>Leishvacin</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Military Personnel</topic><topic>Protozoan Vaccines - therapeutic use</topic><topic>Rural Health</topic><topic>Survival Analysis</topic><topic>Treatment Failure</topic><topic>Vaccines, Inactivated - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Vélez, Iván D.</creatorcontrib><creatorcontrib>Gilchrist, Katherine</creatorcontrib><creatorcontrib>Arbelaez, María P.</creatorcontrib><creatorcontrib>Rojas, Carlos A.</creatorcontrib><creatorcontrib>Puerta, Juan A.</creatorcontrib><creatorcontrib>Antunes, Carlos M.F.</creatorcontrib><creatorcontrib>Zicker, Fabio</creatorcontrib><creatorcontrib>Modabber, Farrokh</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Transactions of the Royal Society of Tropical Medicine and Hygiene</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Vélez, Iván D.</au><au>Gilchrist, Katherine</au><au>Arbelaez, María P.</au><au>Rojas, Carlos A.</au><au>Puerta, Juan A.</au><au>Antunes, Carlos M.F.</au><au>Zicker, Fabio</au><au>Modabber, Farrokh</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Failure of a killed Leishmania amazonensis vaccine against American cutaneous leishmaniasis in Colombia</atitle><jtitle>Transactions of the Royal Society of Tropical Medicine and Hygiene</jtitle><stitle>Trans R Soc Trop Med Hyg</stitle><addtitle>Trans R Soc Trop Med Hyg</addtitle><date>2005-08-01</date><risdate>2005</risdate><volume>99</volume><issue>8</issue><spage>593</spage><epage>598</epage><pages>593-598</pages><issn>0035-9203</issn><eissn>1878-3503</eissn><coden>TRSTAZ</coden><abstract>We report the results of a double-blind, randomized, placebo-controlled clinical trial of a killed whole-cell
Leishmania amazonensis candidate vaccine against American cutaneous leishmaniasis (CL) in Colombia. The trial subjects were 2597 healthy volunteers with negative leishmanin skin test (LST) selected from rural Colombian soldiers who were going to patrol endemic areas. They were randomized to receive either three doses of vaccine (
n
=
1295) or placebo (
n
=
1302) given at 20-day intervals. An active and passive case detection system was established to follow-up volunteers for 1 year after vaccination. Safety and efficacy of the vaccine were determined by comparing local and systemic adverse reactions after each dose and the incidence of parasitologically confirmed CL. In the vaccine and placebo groups 101 (7.7%) and 88 (6.8%) volunteers developed CL respectively. The vaccine was shown to be safe but offered no protection against CL caused by
L. panamensis in the proposed vaccination schedule.</abstract><cop>Oxford</cop><pub>Elsevier Ltd</pub><pmid>15893351</pmid><doi>10.1016/j.trstmh.2005.04.002</doi><tpages>6</tpages></addata></record> |
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| ispartof | Transactions of the Royal Society of Tropical Medicine and Hygiene, 2005-08, Vol.99 (8), p.593-598 |
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| source | MEDLINE; Oxford University Press Journals All Titles (1996-Current) |
| subjects | Adult Animals Biological and medical sciences Colombia Colombia - epidemiology Cutaneous leishmaniasis Double-Blind Method General aspects Humans Incidence Leishmania - immunology Leishmania amazonensis Leishmaniasis, Cutaneous - epidemiology Leishmaniasis, Cutaneous - prevention & control Leishvacin Male Medical sciences Military Personnel Protozoan Vaccines - therapeutic use Rural Health Survival Analysis Treatment Failure Vaccines, Inactivated - therapeutic use |
| title | Failure of a killed Leishmania amazonensis vaccine against American cutaneous leishmaniasis in Colombia |
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