Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
45
pubmed:dateCreated
2005-10-17
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.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Nov
pubmed:issn
0264-410X
pubmed:author
pubmed:issnType
Print
pubmed:day
1
pubmed:volume
23
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
5245-51
pubmed:dateRevised
2006-11-15
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
pubmed:year
2005
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.
pubmed:affiliation
Dipartimento di Malattie Infettive, Parassitarie e Immunomediate, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Roma, Italy. gradoni@iss.it
pubmed:publicationType
Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't