Safety and immunogenicity of an intranasal Shigella flexneri 2a Invaplex 50 vaccine

Mark S. Riddle, Robert W. Kaminski, Carlos Williams, Chad Porter, Shahida Baqar, Alexis Kordis, Theron Gilliland, Joyce Lapa, Melissa Coughlin, Chris Soltis, Erica Jones, Jackie Saunders, Paul B. Keiser, Ryan T. Ranallo, Robert Gormley, Michael Nelson, K. Ross Turbyfill, David Tribble, Edwin V. Oaks*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

66 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)7009-7019
Number of pages11
JournalVaccine
Volume29
Issue number40
DOIs
StatePublished - 16 Sep 2011
Externally publishedYes

Keywords

  • Immunogenicity
  • Invaplex
  • Nasal vaccine
  • Shigella flexneri

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