Trial reportCritical care (London, England)2020
Efficacy, immunogenicity, and safety of IC43 recombinant Pseudomonas aeruginosa vaccine in mechanically ventilated intensive care patients-a randomized clinical trial.
Trial report in Critical care (London, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01563263 (A Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43 Recombinant Pseudomonas Vaccine Intensive Care Patients), which is not on this map. Cited by 51 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
A Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43 Recombinant Pseudomonas Vaccine Intensive Care Patients
Who cites it
51 citing papers in PubMed, 77 citations in OpenAlex.
- Targeting Outer Membrane Vesicles ofJournal of microbiology and biotechnology · 2026Review
- Development of an mRNA vaccine against the OprF ofMicrobiology spectrum · 2026Article
- Systematic Review of Antimicrobial Therapies and Clinical Outcomes inLife (Basel, Switzerland) · 2026Review
- Review
- Immunoinformatic design of a multi-epitope vaccine candidate targeting multidrug-resistant Pseudomonas aeruginosa.BMC immunology · 2026Article
- Design of a novel proteome-derived scaffold presenting epitopes of Pseudomonas aeruginosa in native conformation.Scientific reports · 2026Article
- A mutation-aware proteomics approach for designing a multi-epitope vaccine against multidrug-resistantMicrobiology spectrum · 2026Article
- Bibliometric analysis of Pseudomonas aeruginosa vaccine development highlighting research status, evolution, and future opportunities.Naunyn-Schmiedeberg's archives of pharmacology · 2026Review
- Increased total plasma TGF-β1 levels and deregulated IgA-IgM axis in chronic obstructive pulmonary disease.Journal of medical biochemistry · 2026Article
- Prevalence and genotyping of Pseudomonas aeruginosa from food and human sources.Scientific reports · 2026Article
- Next-generation anti-infective drugs in the post-antibiotic era: focusing on anti-virulence agents targeting the bacterial quorum sensing system.Frontiers in cellular and infection microbiology · 2026Review
- Taming Superbugs: Current Progress and Challenges in Combating ESKAPE Pathogens.Pathogens (Basel, Switzerland) · 2025Review
- High-Yield Outer Membrane Vesicles Derived From Probiotics as a Nanoplatform for Precise Treatment and Prophylaxis of Pseudomonas aeruginosa Infection.Journal of extracellular vesicles · 2025Article
- The Central Importance of Vaccines to Mitigate the Threat of Antibiotic-Resistant Bacterial Pathogens.Vaccines · 2025Review
- Article
- Healthcare-Associated Infections: The Role of Microbial and Environmental Factors in Infection Control-A Narrative Review.Infectious diseases and therapy · 2025Review
- Monosaccharide-Based Synthetic TLR4 Agonist Enhances Vaccine Efficacy againstACS infectious diseases · 2025Article
- Review
- Peptide vaccines: an innovative therapeutic approach against antibiotic-resistant bacterial infections.Frontiers in immunology · 2025Review
- Fc-modification of anti-PcrV gene-encoded antibodies modulates complement-mediated killing of Pseudomonas aeruginosa.Frontiers in immunology · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
23 authors at 19 institutions in 7 countries.
Funding
Abstract
backgroundPseudomonas aeruginosa infections are a serious threat in intensive care units (ICUs). The aim of this confirmatory, randomized, multicenter, placebo-controlled, double-blind, phase 2/3 study was to assess the efficacy, immunogenicity, and safety of IC43 recombinant Pseudomonas aeruginosa vaccine in non-surgical ICU patients.
methodsEight hundred patients aged 18 to 80 years admitted to the ICU with expected need for mechanical ventilation for ≥ 48 h were randomized 1:1 to either IC43 100 μg or saline placebo, given in two vaccinations 7 days apart. The primary efficacy endpoint was all-cause mortality in patients 28 days after the first vaccination. Immunogenicity and safety were also evaluated.
findingsAll-cause mortality rates at day 28 were 29.2% vs 27.7% in the IC43 and placebo groups, respectively (P = .67). Overall survival (Kaplan-Meier survival estimates, P = .46) and proportion of patients with ≥ one confirmed P. aeruginosa invasive infection or respiratory tract infection also did not differ significantly between both groups. The geometric mean fold increase in OprF/I titers was 1.5 after the first vaccination, 20 at day 28, after the second vaccination, and 2.9 at day 180. Significantly more patients in the placebo group (96.5%) had ≥ one adverse event (AE) versus the IC43 100 μg group (93.1%) (P = .04). The most frequently reported severe AEs in the IC43 and placebo groups were respiratory failure (6.9% vs 5.7%, respectively), septic shock (4.1% vs 6.5%), cardiac arrest (4.3% vs 5.7%), multiorgan failure (4.6% vs 5.5%), and sepsis (4.6% vs 4.2%). No related serious AEs were reported in the IC43 group.
interpretationThe IC43 100 μg vaccine was well tolerated in this large population of medically ill, mechanically ventilated patients. The vaccine achieved high immunogenicity but provided no clinical benefit over placebo in terms of overall mortality.
trial registrationhttps://clinicaltrials.gov (NCT01563263). Registration was sent to ClinicalTrials.gov on March 14, 2012, but posted by ClinicalTrials.gov on March 26, 2012. The first subject was included in the trial on March 22, 2012.
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Registered trials
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.