Safety and immunogenicity of an intranasal Shigella flexneri 2a Invaplex 50 vaccine
| Autor: | M.R. Nelson, Jackie Saunders, K. Ross Turbyfill, Melissa L. Coughlin, Alexis A. Kordis, Ryan T. Ranallo, Theron C. Gilliland, Paul B. Keiser, Chad K. Porter, Robert Gormley, Mark S. Riddle, Chris Soltis, Carlos Williams, David R. Tribble, Joyce Lapa, Edwin V. Oaks, Erica Jones, Robert W. Kaminski, Shahida Baqar |
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| Rok vydání: | 2011 |
| Předmět: |
Adult
Lipopolysaccharides Male Adolescent Lipopolysaccharide Guinea Pigs Shigella flexneri Mice Young Adult chemistry.chemical_compound Immune system Double-Blind Method Shigella Vaccines Antigen Animals Humans Medicine Antibody-Producing Cells Adverse effect Immunity Mucosal Administration Intranasal Antigens Bacterial General Veterinary General Immunology and Microbiology biology business.industry Drug Administration Routes Immunogenicity Vaccination Public Health Environmental and Occupational Health Nasal Sprays Middle Aged biology.organism_classification Antibodies Bacterial Immunity Humoral Immunoglobulin A Infectious Diseases chemistry Immunoglobulin G Immunology Molecular Medicine Female Nasal administration business |
| Zdroj: | Vaccine. 29:7009-7019 |
| ISSN: | 0264-410X |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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