Journal
VACCINE
Volume 28, Issue 37, Pages 6076-6085Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.vaccine.2010.06.086
Keywords
Shigella flexneri; Invaplex; Nasal vaccine
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Funding
- Work Unit [643807A.849.D.A0002.]
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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 mu g). 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 >= 50 mu g with the highest IgG ASC, Invaplex 50 (100%) and S. flexneri 2a LPS (71%), as well as, serologic responses (43%) occurring with the 240 mu g dose. Fecal IgA responses, Invaplex 50(38.5%) and LPS (30.8%), were observed at doses >= 240 mu g. 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. Published by Elsevier Ltd.
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