Source:http://linkedlifedata.com/resource/pubmed/id/20619378
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| Predicate | Object |
|---|---|
| rdf:type | |
| lifeskim:mentions | |
| pubmed:issue |
37
|
| pubmed:dateCreated |
2010-8-13
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| pubmed:databankReference | |
| pubmed:abstractText |
Shigellosis is a leading cause of diarrhea worldwide prompting vaccine development. The Shigella flexneri Invaplex 50 is a macromolecular complex containing IpaB, IpaC, and LPS, formulated from an aqueous extract of virulent Shigella delivered via nasal administration. Preclinical vaccine testing demonstrated safety, immunogenicity and efficacy. An open-label dose-escalating phase 1 study evaluated a 3-dose (2-week intervals) regimen via nasal pipette delivery. Thirty-two subjects were enrolled into one of four vaccine dose groups (10, 50, 240, or 480 microg). The vaccine was well tolerated with minor short-lived nasal symptoms without evidence of dose effect. Antibody-secreting cell (ASC) responses were elicited at doses > or =50 microg with the highest IgG ASC, Invaplex 50 (100%) and S. flexneri 2a LPS (71%), as well as, serologic responses (43%) occurring with the 240 microg dose. Fecal IgA responses, Invaplex 50 (38.5%) and LPS (30.8%), were observed at doses > or =240 microg. The Invaplex 50 nasal vaccine was safe with encouraging mucosal immune responses. Follow-on studies will optimize dose, delivery mechanism and assess efficacy in a S. flexneri 2a challenge study.
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| pubmed:language |
eng
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| pubmed:journal | |
| pubmed:citationSubset |
IM
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| pubmed:chemical | |
| pubmed:status |
MEDLINE
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| pubmed:month |
Aug
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| pubmed:issn |
1873-2518
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| pubmed:author |
pubmed-author:AnanthakrishnanMM,
pubmed-author:AroraRR,
pubmed-author:BaqarSS,
pubmed-author:CantrellJJ,
pubmed-author:KaminskaJJ,
pubmed-author:NelsonMM,
pubmed-author:OaksEE,
pubmed-author:PorterCC,
pubmed-author:SandersJJ,
pubmed-author:SaundersJJ,
pubmed-author:TribbleDD,
pubmed-author:TurbyfillRR,
pubmed-author:WilliamsCC,
pubmed-author:ZauchaGG
|
| pubmed:copyrightInfo |
Published by Elsevier Ltd.
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| pubmed:issnType |
Electronic
|
| pubmed:day |
23
|
| pubmed:volume |
28
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| pubmed:owner |
NLM
|
| pubmed:authorsComplete |
Y
|
| pubmed:pagination |
6076-85
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| pubmed:meshHeading |
pubmed-meshheading:20619378-Administration, Intranasal,
pubmed-meshheading:20619378-Adult,
pubmed-meshheading:20619378-Animals,
pubmed-meshheading:20619378-Antibody Formation,
pubmed-meshheading:20619378-Antibody-Producing Cells,
pubmed-meshheading:20619378-Dysentery, Bacillary,
pubmed-meshheading:20619378-Female,
pubmed-meshheading:20619378-Guinea Pigs,
pubmed-meshheading:20619378-Humans,
pubmed-meshheading:20619378-Immunity, Mucosal,
pubmed-meshheading:20619378-Immunization Schedule,
pubmed-meshheading:20619378-Immunoglobulin A,
pubmed-meshheading:20619378-Immunoglobulin G,
pubmed-meshheading:20619378-Male,
pubmed-meshheading:20619378-Mice,
pubmed-meshheading:20619378-Mice, Inbred BALB C,
pubmed-meshheading:20619378-Shigella Vaccines,
pubmed-meshheading:20619378-Shigella flexneri,
pubmed-meshheading:20619378-Young Adult
|
| pubmed:year |
2010
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| pubmed:articleTitle |
Safety and immunogenicity of a Shigella flexneri 2a Invaplex 50 intranasal vaccine in adult volunteers.
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| pubmed:affiliation |
Naval Medical Research Center, Silver Spring, MD, USA. dtribble@usuhs.mil
|
| pubmed:publicationType |
Journal Article,
Research Support, U.S. Gov't, Non-P.H.S.,
Clinical Trial, Phase I
|