Source:http://linkedlifedata.com/resource/pubmed/id/16054272
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
45
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pubmed:dateCreated |
2005-10-17
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pubmed:abstractText |
We report results of a Phase III trial of the multi-subunit recombinant Leishmania polyprotein MML for the protection of dogs against infection by Leishmania infantum. The antigen, also known as Leish-111f, is the first antileishmanial human vaccine entered Phase I clinical testing. The study was performed in a leishmaniasis endemic area of southern Italy. Three groups of 15 Leishmania-free beagle dogs each, received 3 monthly injections with vaccines A (MML+MPL-SE adjuvant), B (sterile saline = control) and C (MML+Adjuprime adjuvant), respectively, before transmission season 2002. The surviving dogs received a second three-dose vaccine course 1 year later. The dogs were naturally exposed to sandfly bites for 2.5 months in 2002, and for 5 months in 2003. Every 2 months post vaccination, dogs were examined by clinical and immunological evaluation, and by specific serology, microscopy, culture and PCR. A weak lymphoproliferative response to MML was seen in A and C groups throughout the study period. One year after the first vaccine course, the cumulative incidence of leishmanial infections was 40% in group A, 43% in group B and 36% in group C. Two-year post-vaccination (1 year after the second vaccine course) the cumulative incidence was 87% in group A (with three symptomatic cases), 100% in group B (with no symptomatic cases) and 100% in group C (with two symptomatic cases). The efficacy of the MML vaccine as an immunotherapeutic agent for the prevention of disease progression (subpatent infection-->asymptomatic patent infection-->symptomatic patent infection) was evaluated through follow-up of dogs found infected prior to the second vaccination. Among 15 infected animals, progression to a subsequent stage of infection was found in 5/6 dogs of group A, 3/6 of group B and 2/3 of group C. We conclude that vaccination with MML is not effective to prevent leishmaniasis infection and disease progression in dogs under field conditions.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical |
http://linkedlifedata.com/resource/pubmed/chemical/Antigens, Protozoan,
http://linkedlifedata.com/resource/pubmed/chemical/DNA, Complementary,
http://linkedlifedata.com/resource/pubmed/chemical/Immunoglobulin G,
http://linkedlifedata.com/resource/pubmed/chemical/Protozoan Vaccines,
http://linkedlifedata.com/resource/pubmed/chemical/Recombinant Proteins
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pubmed:status |
MEDLINE
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pubmed:month |
Nov
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pubmed:issn |
0264-410X
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:day |
1
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pubmed:volume |
23
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
5245-51
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pubmed:dateRevised |
2006-11-15
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pubmed:meshHeading |
pubmed-meshheading:16054272-Animals,
pubmed-meshheading:16054272-Antigens, Protozoan,
pubmed-meshheading:16054272-Cell Proliferation,
pubmed-meshheading:16054272-DNA, Complementary,
pubmed-meshheading:16054272-Disease Progression,
pubmed-meshheading:16054272-Disease Reservoirs,
pubmed-meshheading:16054272-Dog Diseases,
pubmed-meshheading:16054272-Dogs,
pubmed-meshheading:16054272-Enzyme-Linked Immunosorbent Assay,
pubmed-meshheading:16054272-Immunization, Secondary,
pubmed-meshheading:16054272-Immunoglobulin G,
pubmed-meshheading:16054272-Italy,
pubmed-meshheading:16054272-Leishmania infantum,
pubmed-meshheading:16054272-Leishmaniasis, Visceral,
pubmed-meshheading:16054272-Lymphocytes,
pubmed-meshheading:16054272-Protozoan Vaccines,
pubmed-meshheading:16054272-Psychodidae,
pubmed-meshheading:16054272-Recombinant Proteins,
pubmed-meshheading:16054272-Ticks,
pubmed-meshheading:16054272-Vaccination
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pubmed:year |
2005
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pubmed:articleTitle |
Failure of a multi-subunit recombinant leishmanial vaccine (MML) to protect dogs from Leishmania infantum infection and to prevent disease progression in infected animals.
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pubmed:affiliation |
Dipartimento di Malattie Infettive, Parassitarie e Immunomediate, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Roma, Italy. gradoni@iss.it
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pubmed:publicationType |
Journal Article,
Randomized Controlled Trial,
Research Support, Non-U.S. Gov't
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