Trial reportHuman vaccines & immunotherapeutics2018
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.
Trial report in Human vaccines & immunotherapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
20 citing papers in PubMed, 23 citations in OpenAlex.
- Loss of O-antigen due toScience advances · 2026Article
- A 25-year landscape of Escherichia coli vaccine development: systematic review of human clinical studies.NPJ vaccines · 2026Article
- Immunogenicity and Safety of the ExPEC9VVaccines · 2026Article
- Research Progress on perinatalFrontiers in microbiology · 2026Review
- Harnessing pro-inflammatory and immunopathologic immune responses in urinary tract infections for vaccine development: it's all about a balance.Frontiers in immunology · 2026Review
- The Bacterial Swiss Army Knife: ExPEC Utilizes Multiple Resistance Mechanisms to Counteract Host Immune Responses.Vaccines · 2025Review
- Current Scientific Advances in Vaccines Against UTIs: Challenges and Prospects.Microorganisms · 2025Review
- A qualitative burden of disease study in patients with invasive Escherichia coli disease aged ≥ 60 years in the United States.BMC infectious diseases · 2025Article
- Antimicrobial resistance and vaccines in Enterobacteriaceae including extraintestinal pathogenic Escherichia coli and Klebsiella pneumoniae.npj antimicrobials and resistance · 2025Review
- Recent approaches in computational modelling for controlling pathogen threats.Life science alliance · 2024Review
- A randomized phase 1/2a trial of ExPEC10V vaccine in adults with a history of UTI.NPJ vaccines · 2024Article
- Progress toward a vaccine for extraintestinal pathogenicInfection and immunity · 2024Article
- Safety, Reactogenicity, Immunogenicity, and Dose Selection of 10-Valent Extraintestinal PathogenicOpen forum infectious diseases · 2023Article
- Evolution of Vaccines Formulation to Tackle the Challenge of Anti-Microbial Resistant Pathogens.International journal of molecular sciences · 2023Review
- Preclinical Immunogenicity and Efficacy of Optimized O25b O-Antigen Glycoconjugates To Prevent MDR ST131 E. coli Infections.Infection and immunity · 2022Article
- The development and characterization of an E. coli O25B bioconjugate vaccine.Glycoconjugate journal · 2021Article
- Strategies to Tackle Antimicrobial Resistance: The Example ofInternational journal of molecular sciences · 2021Review
- A One Health Perspective for Defining and DecipheringComparative medicine · 2021Review
- The immune response to infection in the bladder.Nature reviews. Urology · 2020Review
- Vaccines against extraintestinal pathogenicGut microbesReview
Corrections and comments
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Authors and funding
11 authors at 4 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
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 immunogenic with an increase in IgG (ELISA) geometric mean titers of at least 5-fold from baseline to Days 15 and 30 for all serotypes. Of participants vaccinated with ExPEC4V, 75% - 100% demonstrated an ELISA titer increase of ≥2-fold. Strong correlation observed between ELISA and OPK. ExPEC4V was well tolerated and elicited an immunogenic response at all dose levels (up to 16 µg PS/serotype) in healthy Japanese participants.
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