Phase I evaluation of delta virG Shigella sonnei live, attenuated, oral vaccine strain WRSS1 in healthy adults.

Infection and Immunity
Karen KotloffThomas L Hale

Abstract

We conducted a phase I trial with healthy adults to evaluate WRSS1, a live, oral Delta virG Shigella sonnei vaccine candidate. In a double-blind, randomized, dose-escalating fashion, inpatient volunteers received a single dose of either placebo (n = 7) or vaccine (n = 27) at 3 x 10(3) CFU (group 1), 3 x 10(4) CFU (group 2), 3 x 10(5) CFU (group 3), or 3 x 10(6) CFU (group 4). The vaccine was generally well tolerated, although a low-grade fever or mild diarrhea occurred in six (22%) of the vaccine recipients. WRSS1 was recovered from the stools of 50 to 100% of the vaccinees in each group. The geometric mean peak anti-lipopolysaccharide responses in groups 1 to 4, respectively, were 99, 39, 278, and 233 for immunoglobulin (IgA) antibody-secreting cell counts; 401, 201, 533, and 284 for serum reciprocal IgG titers; and 25, 3, 489, and 1,092 for fecal IgA reciprocal titers. Postvaccination increases in gamma interferon production in response to Shigella antigens occurred in some volunteers. We conclude that WRSS1 vaccine is remarkably immunogenic in doses ranging from 10(3) to 10(6) CFU but elicits clinical reactions that must be assessed in further volunteer trials.

References

Nov 14, 1991·The New England Journal of Medicine·K C HyamsK Y Green
Jun 1, 1990·Microbial Pathogenesis·A A LindbergB A Stocker
Jan 1, 1990·Reviews of Infectious Diseases·R E Black
Jun 1, 1987·The Journal of Infectious Diseases·R E BlackS B Formal
May 1, 1989·Proceedings of the National Academy of Sciences of the United States of America·M L BernardiniP J Sansonetti
Jun 1, 1986·Infection and Immunity·D W NieselG R Klimpel
Dec 1, 1985·International Journal of Epidemiology·M U KhanB Stoll
Jan 1, 1972·The Journal of Infectious Diseases·H L DuPontE J Gangarosa
Jun 1, 1967·Proceedings of the Society for Experimental Biology and Medicine·S B FormalE H LaBrec
Sep 25, 1995·Biochemical and Biophysical Research Communications·M E MarquartW D Picking
Apr 1, 1995·Antimicrobial Agents and Chemotherapy·S AshkenaziZ Samra
Dec 12, 1994·Archives of Internal Medicine·J R MillerR L Guerrant
Apr 28, 1994·The New England Journal of Medicine·B E Murray
Jan 1, 1997·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·R B SackE H Khan
Jun 22, 1999·Infection and Immunity·T S CosterT L Hale
Feb 5, 2000·The Journal of Immunology : Official Journal of the American Association of Immunologists·T SamandariM B Sztein

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Citations

Jul 16, 2003·International Immunopharmacology·Ruth Arnon, Tamar Ben-Yedidia
Feb 20, 2013·Nature Reviews. Gastroenterology & Hepatology·Eileen M BarryMyron M Levine
Jun 15, 2007·Nature Reviews. Microbiology·Myron M LevineMarcelo B Sztein
Feb 9, 2005·Current Opinion in Gastroenterology·Stavros Sougioultzis, Charalabos Pothoulakis
May 2, 2008·Current Opinion in Infectious Diseases·Mi-Na Kweon
Oct 16, 2007·Clinical Microbiology Reviews·Bryan CoburnB Brett Finlay
Jul 19, 2006·Clinical Microbiology Reviews·David J Diemert
Nov 4, 2009·Infection and Immunity·Ryan T RanalloMalabi M Venkatesan
May 16, 2002·Infection and Immunity·Malabi M VenkatesanJoan Butterton
Jun 27, 2006·Microbial Cell Factories·Ann Detmer, Jacob Glenting
Oct 3, 2012·PloS One·Balamurugan PeriaswamyWolf-Dietrich Hardt
Oct 30, 2010·Emerging Infectious Diseases·Pradip BardhanDavid A Sack
May 25, 2004·Expert Opinion on Biological Therapy·Carol O Tacket
Apr 21, 2012·Microbiology·Kerrie L MayRenato Morona
Dec 2, 2004·Expert Opinion on Biological Therapy·C J AcostaJ D Clemens
Oct 6, 2004·Expert Opinion on Biological Therapy·Lina WangRoss L Coppel
May 28, 2014·Human Vaccines & Immunotherapeutics·Nathalie BöhlesMichael Hensel
Jul 29, 2006·FEMS Immunology and Medical Microbiology·Ryan T RanalloMalabi M Venkatesan
Mar 21, 2015·PLoS Pathogens·Mariaelena CaboniChristiane Gerke
Oct 17, 2012·Vaccine·Ladaporn BodhidattaCarl J Mason
Apr 12, 2014·Cell Host & Microbe·Anna Brotcke ZumstegArturo Zychlinsky
Apr 24, 2014·Therapeutic Advances in Vaccines·Shai Ashkenazi, Dani Cohen
Nov 1, 2016·Clinical and Vaccine Immunology : CVI·Wilbur H Chen, Karen L Kotloff
May 6, 2016·Clinical and Vaccine Immunology : CVI·Punnee PitisuttithumLadaporn Bodhidatta
Feb 23, 2019·Human Vaccines & Immunotherapeutics·Rubhana RaqibMalabi M Venkatesan
Dec 22, 2006·Expert Review of Vaccines·Malabi M Venkatesan, Ryan T Ranallo

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