Safety, tolerability and immunogenicity of the ExPEC4V (JNJ-63871860) vaccine for prevention of invasive extraintestinal pathogenic Escherichia coli disease: A phase 1, randomized, double-blind, placebo-controlled study in healthy Japanese participants

Human Vaccines & Immunotherapeutics
Megumi InouePatricia Ibarra de Palacios

Abstract

This Phase 1, randomized, double-blind, placebo-controlled study was conducted to evaluate the safety, tolerability and immunogenicity of different doses of ExPEC4V conjugate vaccine (4-16µg Polysaccharide [PS]/serotype) in healthy Japanese participants, stratified into younger (≥20 to <50 years) or older age groups (≥50 years). Within each age group, participants were randomized to a single vaccination with 1 of 3 dose levels of ExPEC4V (4, 8 and 16 µg PS/serotype) or placebo. Safety and tolerability were the primary objectives; immunogenicity was secondary. Of the 48 participants, 47 (98%) completed; one (2%) in the placebo group discontinued. A total of 48% participants had ≥1 AE (younger group: n = 13 [54%]; older group: n = 10 [41.7%]). Solicited and unsolicited AEs were reported in 44% and 8% participants, respectively in the combined ExPEC4V groups. Pain/tenderness (n = 11 [31%]) and redness (n = 9 [25%]) were the most frequently reported solicited local AEs, whereas fatigue (n = 4 [11%]), headache (n = 4 [11%]), muscle pain (n = 2 [6%]), and malaise (n = 5 [14%]) were the most common solicited systemic AEs in the combined ExPEC4V group. No serious AEs, deaths, or discontinuation due to AEs were reported. All doses were ...Continue Reading

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Citations

Feb 23, 2018·Infectious Diseases and Therapy·Eric A F SimõesXavier Carbonell-Estrany
Jul 15, 2020·Nature Reviews. Urology·Livia Lacerda Mariano, Molly A Ingersoll
Jul 7, 2020·Expert Review of Vaccines·Jennifer Mhairi DowBrendan William Wren
Mar 18, 2021·Glycoconjugate Journal·Michael KowarikMichael Wacker
Jun 3, 2021·International Journal of Molecular Sciences·Giada AntonelliFrancesca Schiavetti

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Methods Mentioned

BETA
ELISA
pregnancy test
Enzyme-linked immunosorbent assay

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