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Safety and immunogenicity of an intranasal Shigella flexneri 2a Invaplex 50 vaccine.
Riddle, Mark S; Kaminski, Robert W; Williams, Carlos; Porter, Chad; Baqar, Shahida; Kordis, Alexis; Gilliland, Theron; Lapa, Joyce; Coughlin, Melissa; Soltis, Chris; Jones, Erica; Saunders, Jackie; Keiser, Paul B; Ranallo, Ryan T; Gormley, Robert; Nelson, Michael; Turbyfill, K Ross; Tribble, David; Oaks, Edwin V.
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  • Riddle MS; Naval Medical Research Center, Silver Spring, MD, USA.
Vaccine ; 29(40): 7009-19, 2011 Sep 16.
Article en En | MEDLINE | ID: mdl-21787825
BACKGROUND: Shigella flexneri 2a lipopolysaccharide 50 is a nasally delivered subunit vaccine consisting of a macromolecular complex composed of LPS, IpaB, IpaC and IpaD. The current study examined vaccine safety and immunogenicity across a dose range and the clinical performance of a new intranasal delivery device. METHODS: Volunteers (N=36) were randomized to receive vaccine via the Dolphin™ (Valois of America, Congers, New York) intranasal spray device at one of three doses (240, 480, and 690 µg) on days 0, 14, and 28. Another group (N=8) received the 240 µg dose via pipette. Vaccine safety was actively monitored and antigen-specific humoral and mucosal immune responses were determined. RESULTS: There were no serious adverse events and the majority of adverse events (98%) were mild. Antibody secreting cells (ASC), plasma, and mucosal immune responses to Shigella antigens were detected at all three dose levels with the 690 µg dose inducing the highest magnitude and frequency of responses. Vaccination with comparable doses of Invaplex 50 via the Dolphin™ resulted in higher plasma and ASC immune responses as compared to pipette delivery. CONCLUSION: In this trial the S. flexneri 2a Invaplex 50 vaccine was safe, well-tolerated and induced robust levels of antigen-specific intestinal IgA and ASC responses. The spray device performed well and offered an advantage over pipette intranasal delivery.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Shigella flexneri / Lipopolisacáridos / Inmunidad Mucosa / Vacunas contra la Shigella / Anticuerpos Antibacterianos / Antígenos Bacterianos Tipo de estudio: Clinical_trials Límite: Adolescent / Adult / Animals / Female / Humans / Male / Middle aged Idioma: En Revista: Vaccine Año: 2011 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Países Bajos
Texto completo
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XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Shigella flexneri / Lipopolisacáridos / Inmunidad Mucosa / Vacunas contra la Shigella / Anticuerpos Antibacterianos / Antígenos Bacterianos Tipo de estudio: Clinical_trials Límite: Adolescent / Adult / Animals / Female / Humans / Male / Middle aged Idioma: En Revista: Vaccine Año: 2011 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Países Bajos