About: Efficacy, immunogenicity, and safety of IC43 recombinant Pseudomonas aeruginosa vaccine in mechanically ventilated intensive care patients

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About: Efficacy, immunogenicity, and safety of IC43 recombinant Pseudomonas aeruginosa vaccine in mechanically ventilated intensive care patients—a randomized clinical trial Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : covidontheweb.inria.fr associated with source document(s)

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Efficacy, immunogenicity, and safety of IC43 recombinant Pseudomonas aeruginosa vaccine in mechanically ventilated intensive care patients—a randomized clinical trial
Creator	Rello, Jordi Schaaf, Bernhard Creteur, Jacques Depuydt, Pieter Eller, Philipp Meier-Hellmann, Andreas Molnár, Zsolt Staudinger, Thomas Várkonyi, István Adlbrecht, Christopher Dubischar, Katrin Eder-Lingelbach, Susanne Héjja, Mária Klingler, Anton Laenen, Margot Lorente, Jose Schneider, Hauke Spapen, Herbert Wressnigg, Nina Wurm, Raphael Zauner, Christian Kanesa-Thasan 17, Niranjan
Source	PMC
abstract	BACKGROUND: Pseudomonas 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. METHODS: Eight 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. FINDINGS: All-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. INTERPRETATION: The 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 REGISTRATION: https://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.
has issue date	2020-03-04(xsd:dateTime)
bibo:doi	10.1186/s13054-020-2792-z
bibo:pmid	32131866
has license	cc-by
sha1sum (hex)	e75af04e81a9fe76f1bf0eeea81ba2ef8e12fd7c
schema:url	https://doi.org/10.1186/s13054-020-2792-z
resource representing a document's title	Efficacy, immunogenicity, and safety of IC43 recombinant Pseudomonas aeruginosa vaccine in mechanically ventilated intensive care patients—a randomized clinical trial
has PubMed Central identifier	PMC7057595
has PubMed identifier	32131866
schema:publication	Crit Care
resource representing a document's body	covid:e75af04e81a9fe76f1bf0eeea81ba2ef8e12fd7c#body_text
is schema:about of	named entity 'vaccine' named entity 'aim' named entity 'vaccine' covid:arg/e75af04e81a9fe76f1bf0eeea81ba2ef8e12fd7c named entity 'ICU' named entity 'Hungary' named entity 'phase 2 trial' named entity 'placebo group' named entity 'antibiotic' named entity 'cefepime' named entity 'immunogenicity' named entity 'antibiotic treatment' named entity 'clinical trials' named entity 'safety' named entity 'placebo-controlled' named entity 'vaccine' named entity 'Pseudomonas aeruginosa infections' named entity 'Pseudomonas aeruginosa' named entity '8.1' named entity 'informed consent' named entity 'P. aeruginosa' named entity 'all-cause mortality' named entity 'antibody' named entity '17.1' named entity 'vaccination' named entity 'deltoid muscle' named entity 'antiinfective' named entity 'mortality rates' named entity 'epitopes' named entity 'placebo' named entity 'ICU' named entity 'intensive care' named entity 'phase 2 study' named entity 'study population' named entity 'benefits and risks' named entity 'elective surgery' named entity 'plasmapheresis' named entity 'treatment groups' named entity 'placebo group' named entity 'immunocompromised' named entity 'ICU' named entity 'HIV infection' named entity 'ITT' named entity 'enzyme-linked immunosorbent assay' named entity 'high-risk' named entity 'carbapenems' named entity 'phase 3' named entity 'treatment groups' named entity 'all-cause mortality' named entity 'antibiotic' named entity 'mortality rate' named entity 'Germany' named entity 'antibiotic' named entity 'C-reactive protein' named entity 'elective surgery' named entity 'organ transplant' named entity 'phase 2 study' named entity 'ICU' named entity 'treatment group' named entity 'statistically significantly'

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