Linked Life Data

8578831

Source:http://linkedlifedata.com/resource/pubmed/id/8578831

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
16
pubmed:dateCreated
1996-3-12
pubmed:abstractText
In the absence of a definitive immunologic correlate of protection against shigellosis, promising Shigella vaccine candidates have been selected based on their ability to confer resistance against experimental challenge with wild-type Shigella in healthy adult volunteers. A limitation of this model has been the low and often variable attack rate of illness among controls, necessitating repeated inpatient studies to demonstrate statistically significant results. In this study, the Shigella challenge model was modified by using bicarbonate buffer instead of skimmed milk as the delivery vehicle to enhance survival of the ingested challenge inoculum. To determine the ability of the modified model to detect protective efficacy, 11 veteran volunteers (previously challenged with S. flexneri 2a in bicarbonate buffer) and 12 immunologically naive control subjects were challenged with 1.4 x 10(3) c.f.u. S. flexneri 2a. Shigellosis occurred in 3 veterans and 11 control subjects (27 vs 92%, p = 0.003), yielding a protective efficacy of 70%. Dose response was evaluated in an additional seven naive subjects who were inoculated with a log lower (1.4 x 10(2) c.f.u.) S. flexneri 2a and had a significantly diminished attack rate of shigellosis (317 (43%) vs 11/12 (92%), p = 0.04). These findings indicate that the modified bicarbonate challenge model using an inoculum of 10(3) c.f.u. is a safe, repeatable, and valid method of selecting Shigella vaccines and other immunoprophylactic agents that are likely to confer protection against natural shigellosis.
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:volume
13
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
1488-94
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed:year
1995
pubmed:articleTitle
A modified Shigella volunteer challenge model in which the inoculum is administered with bicarbonate buffer: clinical experience and implications for Shigella infectivity.
pubmed:affiliation
Department of Medicine, University of Maryland School of Medicine, Baltimore 21201, USA.
pubmed:publicationType
Journal Article, Clinical Trial, Research Support, U.S. Gov't, Non-P.H.S., Randomized Controlled Trial