Trial reportCritical care (London, England)2017
A randomized placebo-controlled phase II study of a Pseudomonas vaccine in ventilated ICU patients.
Trial report in Critical care (London, England), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00876252 (A Phase 2 Pilot Study Assessing Immunogenicity and Safety of IC43 in Intensive Care Patients), which is not on this map. Cited by 49 papers, 1 of them a synthesis that pooled it.
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 Phase 2 Pilot Study Assessing Immunogenicity and Safety of IC43 in Intensive Care Patients
Who cites it
49 citing papers in PubMed, 1 synthesis or guideline pooled it, 75 citations in OpenAlex.
- Pooled it
- Efficacy, immunogenicity, and safety of IC43 recombinant Pseudomonas aeruginosa vaccine in mechanically ventilated intensive care patients-a randomized clinical trial.Critical care (London, England) · 2020Trial
- Role of cell-associated and secretion-independent virulence factors of Pseudomonas aeruginosa in microbial keratitis and anti-virulence therapeutic strategies.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2026Review
- Immunoinformatic design of a multi-epitope vaccine candidate targeting multidrug-resistant Pseudomonas aeruginosa.BMC immunology · 2026Article
- Increased total plasma TGF-β1 levels and deregulated IgA-IgM axis in chronic obstructive pulmonary disease.Journal of medical biochemistry · 2026Article
- 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
- NovelmBio · 2025Article
- Bitter Taste Receptors in Bacterial Infections and Innate Immunity.Immunity, inflammation and disease · 2025Review
- Healthcare-Associated Infections: The Role of Microbial and Environmental Factors in Infection Control-A Narrative Review.Infectious diseases and therapy · 2025Review
- Review
- Peptide vaccines: an innovative therapeutic approach against antibiotic-resistant bacterial infections.Frontiers in immunology · 2025Review
- Mucosal immunization with the lung Lactobacillus-derived amphiphilic exopolysaccharide adjuvanted recombinant vaccine improved protection against P. aeruginosa infection.PLoS pathogens · 2024Article
- Proteomic approach to identify host cell attachment proteins provides protective Pseudomonas aeruginosa vaccine antigen FtsZ.NPJ vaccines · 2024Article
- Advances in Development of Novel Therapeutic Strategies against Multi-Drug ResistantAntibiotics (Basel, Switzerland) · 2024Review
- Immunization with lytic polysaccharide monooxygenase CbpD induces protective immunity againstProceedings of the National Academy of Sciences of the United States of America · 2023Article
- Article
- Anti-Microorganisms · 2023Review
- A protein subunit vaccine elicits a balanced immune response that protects against Pseudomonas pulmonary infection.NPJ vaccines · 2023Article
- Review
- Immunotherapies against human bacterial and fungal infectious diseases: A review.Frontiers in medicine · 2023Review
Corrections and comments
- Commented on by
Authors and funding
34 authors at 20 institutions in 10 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCurrently, no vaccine against Pseudomonas is available. IC43 is a new, recombinant, protein (OprF/I)-based vaccine against the opportunistic pathogen, Pseudomonas aeruginosa, a major cause of serious hospital-acquired infections. IC43 has proven immunogenicity and tolerability in healthy volunteers, patients with burns, and patients with chronic lung diseases. In order to assess the immunogenicity and safety of IC43 in patients who are most at risk of acquiring Pseudomonas infections, it was evaluated in mechanically ventilated ICU patients.
methodsWe conducted a randomized, placebo-controlled, partially blinded study in mechanically ventilated ICU patients. The immunogenicity of IC43 at day 14 was determined as the primary endpoint, and safety, efficacy against P. aeruginosa infections, and all-cause mortality were evaluated as secondary endpoints. Vaccinations (100 μg or 200 μg IC43 with adjuvant, or 100 μg IC43 without adjuvant, or placebo) were given twice in a 7-day interval and patients were followed up for 90 days.
resultsHigher OprF/I IgG antibody titers were seen at day 14 for all IC43 groups versus placebo (P < 0.0001). Seroconversion (≥4-fold increase in OprF/I IgG titer from days 0 to 14) was highest with 100 μg IC43 without adjuvant (80.6%). There were no significant differences in P. aeruginosa infection rates, with a low rate of invasive infections (pneumonia or bacteremia) in the IC43 groups (11.2-14.0%). Serious adverse events (SAEs) considered possibly related to therapy were reported by 2 patients (1.9%) in the group of 100 µg IC43 with adjuvant. Both SAEs resolved and no deaths were related to study treatment. Local tolerability symptoms were mild and rare (<5% of patients), a low rate of treatment-related treatment-emergent adverse events (3.1-10.6%) was observed in the IC43 groups.
conclusionThis phase II study has shown that IC43 vaccination of ventilated ICU patients produced a significant immunogenic effect. P. aeruginosa infection rates did not differ significantly between groups. In the absence of any difference in immune response following administration of 100 μg IC43 without adjuvant compared with 200 μg IC43 with adjuvant, the 100 μg dose without adjuvant was considered for further testing of its possible benefit of improved outcomes. There were no safety or mortality concerns.
trial registrationClinicalTrials.gov, NCT00876252 . Registered on 3 April 2009.
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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.