A phase I trial of WRSS1, a Shigella sonnei live oral vaccine in Bangladeshi adults and children

Human Vaccines & Immunotherapeutics
Rubhana RaqibMalabi M Venkatesan

Abstract

Shigella sonnei live vaccine candidate, WRSS1, which was previously evaluated in US, Israeli and Thai volunteers, was administered orally to Bangladeshi adults and children to assess its safety, clinical tolerability and immunogenicity. In a randomized, placebo-controlled, dose-escalation, age-descending study, 39 adults (18-39 years) and 64 children (5-9 years) were enrolled. Each adult cohort (n = 13) received one dose of 3x104, or three doses of 3 × 105 or 3 × 106 colony forming unit (CFU) of WRSS1 (n = 10) or placebo (n = 3). Each child cohort (n = 16) received one dose of 3x103, or three doses of 3x104, 3x105, or 3 × 106 CFU WRSS1 (n = 12) or placebo (n = 4). WRSS1 elicited mostly mild and transient reactogenicity events in adults and children. In the 3 × 106 dose group, 50% of the adults shed the vaccine; no shedding was seen in children. At the highest dose, 100% of adults and 40% of children responded with a ≥ 4-fold increase of S. sonnei LPS-specific IgA antibody in lymphocyte supernatant (ALS). At the same dose, 63% of adults and 70% of children seroconverted with IgA to LPS, while in placebo, 33% of adults and 18% of children seroconverted. Both the vaccinees and placebos responded with fecal IgA to LPS, indicating p...Continue Reading

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Citations

Jul 11, 2019·Human Vaccines & Immunotherapeutics·Dani Cohen, Khitam Muhsen
Jun 20, 2020·Gut Microbes·Hyesuk SeoWeiping Zhang
Aug 20, 2021·Advanced Drug Delivery Reviews·Yuandong ZhangXun Sun

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Methods Mentioned

BETA
PCR
pregnancy test
enzyme-linked immunosorbent assay
ELISA

Clinical Trials Mentioned

NCT01813071

Software Mentioned

SPSS
GraphPad Prism
Stata
Statistical package for the Social Science ( SPSS )
SAS®

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