ArticleOpen forum infectious diseases2023
Safety, Reactogenicity, Immunogenicity, and Dose Selection of 10-Valent Extraintestinal Pathogenic
Article in Open forum infectious diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.
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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
28 citing papers in PubMed, 27 citations in OpenAlex.
- Safety and Immunogenicity of a Klebsiella pneumoniae Tetravalent Bioconjugate Vaccine (Kleb4V) Administered to Healthy Adults: A First-in-Human Phase I/II Randomized and Controlled Study.The Journal of infectious diseases · 2026Trial
- Development and validation of a high-throughput agglutination assay for O-serogrouping clinicalMicrobiology spectrum · 2026Article
- Validation of electrochemiluminescent (ECL)-based immunoassay to determine the levels of antibodies againstMicrobiology spectrum · 2026Article
- UropathogenicAntibiotics (Basel, Switzerland) · 2026Review
- Comprehensive genomic characterization of extraintestinal pathogenic Escherichia coli isolated from neonates: multiple center insights into virulence, resistance, and transmission dynamics.Genome medicine · 2026Article
- A 25-year landscape of Escherichia coli vaccine development: systematic review of human clinical studies.NPJ vaccines · 2026Article
- Molecular epidemiology and structural diversity of O101/O162 O-antigen variants among Escherichia coli bacteremia isolates.Scientific reports · 2026Article
- Immunogenicity and Safety of the ExPEC9VVaccines · 2026Article
- Population Structure of Escherichia coli Isolated From the Human Bloodstream, Human and Animal Feces, and the Environment in Northern Tanzania.The Journal of infectious diseases · 2026Article
- 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
- A qualitative burden of disease study in patients with invasive Escherichia coli disease aged ≥ 60 years in the United States.BMC infectious diseases · 2025Article
- The Central Importance of Vaccines to Mitigate the Threat of Antibiotic-Resistant Bacterial Pathogens.Vaccines · 2025Review
- High diversity of Escherichia coli causing invasive disease in neonates in Malawi poses challenges for O-antigen based vaccine approach.Communications medicine · 2025Article
- Recent Advances in Bioconjugate Vaccine Development.Vaccines · 2025Review
- Antimicrobial resistance and vaccines in Enterobacteriaceae including extraintestinal pathogenic Escherichia coli and Klebsiella pneumoniae.npj antimicrobials and resistance · 2025Review
- Economic and Disease Burden Associated with Invasive Escherichia coli Disease in the United States.Infectious diseases and therapy · 2025Article
- Urinary tract infections: pathogenesis, host susceptibility and emerging therapeutics.Nature reviews. Microbiology · 2025Review
- A cynomolgus monkeyInfection and immunity · 2024Article
- Vaccines and monoclonal antibodies to prevent healthcare-associated bacterial infections.Clinical microbiology reviews · 2024Review
Corrections and comments
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Authors and funding
10 authors at 5 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: ExPEC10V is a bioconjugate vaccine containing O-antigen polysaccharides of 10 extraintestinal pathogenic Methods: The observer-blind, active-controlled design included a 28-day screening, vaccination, 181-day follow-up, and 1-year follow-up. Participants (60-85 years of age) were randomized to ExPEC10V low dose (antigen dose range, 4-8 µg), ExPEC10V medium dose (4-16 µg), or ExPEC10V high dose (8-16 µg); 4-valent ExPEC vaccine (ExPEC4V); or 13-valent pneumococcal conjugate vaccine (PCV13). The incidence of adverse events (AEs; solicited, day 15; unsolicited, day 30; serious AEs, day 181) and immunogenicity (electrochemiluminescent-based assay [ECL] and multiplex opsonophagocytic assay [MOPA]) were assessed. Optimal ExPEC10V dose was determined from safety data through day 30 and an immunogenicity dose selection algorithm based on day 15 ECL and MOPA results. Results: A total of 416 participants were included (median age, 64.0 years; 54.8% female). The incidences of solicited local and systemic AEs were, respectively, 44.2% and 39.4% for low-dose, 52.9% and 46.1% for medium-dose, 57.7% and 45.2% for high-dose ExPEC10V, and 74.1% and 48.1% for PCV13. Five serious AEs, not vaccine related, were reported. The ECL revealed a robust antibody response to ExPEC10V through year 1. Opsonophagocytic killing activity was detected against all but serotype O8; this lack of response against serotype O8 was linked to low assay sensitivity. Based on the totality of data, high-dose ExPEC10V was considered optimal. Conclusions: ExPEC10V was well tolerated and immunogenic in elderly adults against all but serotype O8.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.