Pseudomonas Aeruginosa InfectionPhase 2/3NCT01563263
Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43
A Phase 2/3 study testing IC43 in people with Pseudomonas Aeruginosa Infection, run by Valneva Austria GmbH at 50 sites in 6 countries.
Trial summary
This is a confirmatory, randomized, placebo-controlled, multi-center, double-blinded phase II/III study. The study population consists of male or female intensive care unit (ICU) patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and 80 years. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pseudomonas Aeruginosa Infection
- What is being tested?
- IC43
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 803 participants
- Where
- 50 sitesin 6 countries
- Study dates
- Mar 2012to Dec 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female patients admitted to an intensive care unit (ICU) with need for mechanical ventilation for at least 48 hours, aged between 18 and 80 years at Visit 0
- written informed consent or waiver according to the national regulations
- no childbearing potential or negative pregnancy test
Who cannot join
- Sequential Organ Failure Assessment (SOFA) < 4 on Day 0
- Patients <6 months post organ transplantation
- readmission to ICU during the current total hospital stay on Day 0
- patients admitted to ICU within 2 days after surgery
- patients admitted to ICU due to trauma
- elective surgery until Day 28 after first vaccination
Trial locations and contacts
50 sites in 6 countries.
50 sites in 6 countries
Germany14 sites
HELIOS Klinikum Aue
Aue, Aue, 08280
HELIOS Klinikum Berlin-Buch
Berlin, State of Berlin, 13125
Charite-Universitätsmedizin Berlin
Berlin, State of Berlin, 13353
Carl-Thiem-Klinikum Cottbus
Cottbus, Cottbus, 03048
Städtisches Klinikum Dessau
Dessau, Dessau-Roßlau, 06847
Klinikum Dortmund
Dortmund, Dortmund, 44145
Neurologische Universitätsklinik
Dresden, Dresden, 01307
HELIOS Klinikum Erfurt
Erfurt, Erfurt, 99089
Helios Kreikrankenhaus Gotha/Ohrdruf
Gotha, Gotha, 99867
Bermannstrost BG Kliniken Halle
Halle, Halle/Saale, 06112
Saarland University Hospital
Homburg/Saar, Homburg/Saar, 66421
Universitätsklinikum Schleswig-Holstein
Kiel, Kiel, 24105
Klinikum rechts der Isar
München, München, 81675
HELIOS Klinikum Wuppertal
Wuppertal, Wuppertal, 42283
Hungary10 sites
St. Imre Hospital
Budapest, Budapest, 1115
Uzsoki Hospital
Budapest, Budapest, 1145
Országos Korányi TBC és Pulmonológiai Intézet
Budapest, 1122
Kenezy Korhaz Debrecen
Debrecen, Debrecen, 4043
Debreceni Egyetem OEC Kazincbarcikai Korhaz
Kazincbarcika, Kazincbarcika, 3700
Flor Ferenc Korhaz Hospital
Kistarcsa, Kistarcsa, 2143
University of Pecs
Pécs, Pecs, 7623
Pécsi Tudományegyetem Neurológiai Klinika
Pécs
University of Szeged
Szeged, Szeged, 6725
Fejer County Hospital
Székesfehérvár, Szekesfehervar, 8000
Czechia7 sites
Faculty Hospital St. Ann
Brno, Brno, 65691
Faculty Hospital
Hradec Krakove, Hradec Krakove, 50005
Fakultní nemocnice Olomouc
Olomouc
Faculty Hospital Kralovske Vinohrady
Prague, Prague, 10034
Faculty Hospital Motol
Prague, Prague, 15006
Central Military Hospital
Prague, Prague, 16902
Krajská nemocnice T. Bati, a.s.
Zlín
Spain7 sites
Hospital Universitario Infanta Cristina
Badajoz
Vall d'Hebron University Hospital
Barcelona, Barcelona, 08035
Hospital Clinico San Carlos
Madrid, Madrid, 28040
Hospital Universitario de Getafe
Madrid, Madrid, 28905
University Hospital Marques de Valdecilla
Santander Cantabria, Santander Cantabria, 39008
Hospital Universitario Dr. Peset
Valencia, Valencia, 46022
Hospital Universitario y Policlínico La Fe
Valencia
Austria6 sites
LKH - University Clinic Graz
Graz, Graz, 8036
LKH Salzburg
Salzburg, State of Salzburg, 5050
Medical University of Vienna
Vienna, State of Vienna, 1090
Otto Wagner Spital
Vienna, State of Vienna, 1140
Wilhelminenspital & Kaiserin-Elisabeth-Spital
Vienna, State of Vienna, 1160
Krankenhaus Hietzing
Vienna, 1130
Belgium6 sites
ULB Hospital Erasme
Brussels, Brussels Capital, 1070
University Hospital Brussels
Brussels, Brussels Capital, 1090
Hospital Saint Luc
Brussels, Brussels Capital, 1200
Ziekenhuis Oost Limburg
Genk, Genk, 3600
University Hospital Ghent
Ghent, Ghent, 9000
Clinique St. Pierre
Ottignies, Ottignies, 1340
About this study
Official title: A Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43 Recombinant Pseudomonas Vaccine Intensive Care Patients
This is a confirmatory, randomized, placebo-controlled, multi-center, double-blinded phase II/III study. The study population consists of male or female intensive care unit (ICU) patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and 80 years.
Read the detailed description
This is a confirmatory, randomized, placebo-controlled, multi-center, double-blinded phase II/III study. The study population consists of male or female intensive care unit (ICU) patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and 80 years.
Eight-hundred patients will be enrolled at approximately 50 study centers. Informed consent (i.e., from the patient or from the patient's legally authorized representative) or waiver will be obtained according to regional requirements prior to any study related procedures. Patients will be randomized to receive either IC43 100 mcg or placebo and will receive the first vaccination on Day 0. The second vaccination will be applied on Day 7. In case ICU discharge occurs before Day 7, immunization will be done at the hospital ward.
- Conditions
- Pseudomonas Aeruginosa Infection
- Being tested
- IC43, Placebo
- Keywords
- IC43, Pseudomonas Aeruginosa, mechanically ventilated ICU patients, ICU patients
- Medical subject headings
- Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IC43Biological
Also called Pseudomonas Aeruginosa
100 mcg
PlaceboDrug
Also called phosphate buffered saline (PBS)
phosphate buffered saline (PBS) solution containing 0,9 % NaCl
| Study group | Role | What they receive |
|---|---|---|
| IC43 100 mcg | Active comparator | IC43 100 mcg intramuscular injection, IC43 is a recombinant Pseudomonas aeruginosa fusion protein Receives: Biological: IC43 |
| Placebo | Placebo comparator | phosphate buffered saline solution containing 0,9 % NaCL Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of deaths until Day 28
Measured: until Day 28
Secondary outcomes (18)
number of deaths in comparison on Day 14, 56 and 90
Measured: until Day 90
number of deaths onDay 28, 56 and 90 in patients surviving Day 14 and receiving IC43 or placebo
Measured: until Day 90
number of deaths on Day 14, 28, 56 and 90 in patients surviving Day 3 and receiving IC43 or placebo
Measured: until Day 90
number of overall survival in all patients and in patients surviving Day 14
Measured: until Day 180
number of deaths related to sepsis at Day 14, 28, 56 and 90 in patients receiving IC43 or placebo
Measured: until Day 90
number of surviving subjects after Sepsis receiving IC43 or placebo
Measured: until Day 180
number of deaths in patients in-ICU and in-hospital receiving IC43 or placebo until Day 14, 28, 56,90, 180
Measured: until Day 180
percentage of patients with invasive infection with P. aeruginosa, such as bacteremia or P. aeruginosa urinary tract infection in patients receiving IC43 or placebo up to Day 56 after first vaccination
Measured: until Day 56
percentage of patients with P. aeruginosa respiratory tract infection or P. aeruginosa respiratory tract colonization in patients receiving IC43 or placebo up to Day 56 after first vaccination
Measured: until Day 56
Organ function in patients receiving IC43 or placebo during ICU stay
Measured: during ICU stay
Days of ICU stay in patients receiving IC43 or placebo
Measured: Until Day 180
Immunogenicity at Day 7, 14, 28, 56 and 180 as determined by OprF/I specific IgG antibody titer measured by ELISA in patients receiving IC43 or placebo
Measured: until Day 180
Number of SAEs and AEs during the vaccination period up to 180 days after the first vaccination
Measured: until Day 180
systemic tolerability
blood pressure
Measured: until Day 7
number of local reactions at the injection site
Measured: until Day 180
Composite measure of laboratory parameters
Measured: until Day 56
systemic tolerability
pulse
Measured: until Day 7
systemic tolerability
body temperature
Measured: until Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pseudomonas Aeruginosa InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 803 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valneva Austria GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susanne Eder, Mag, Study chair, Valneva Austria GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563263
- Sponsor's protocol ID
- IC43-202
- Status last verified
- Mar 2016
- First submitted
- 14 Mar 2012
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Adlbrecht C, Wurm R, Depuydt P, Spapen H, Lorente JA, Staudinger T, Creteur J, Zauner C, Meier-Hellmann A, Eller P, Laenen MV, Molnar Z, Varkonyi I, Schaaf B, Hejja M, Sramek V, Schneider H, Kanesa-Thasan N, Eder-Lingelbach S, Klingler A, Dubischar K, Wressnigg N, Rello J. Efficacy, immunogenicity, and safety of IC43 recombinant Pseudomonas aeruginosa vaccine in mechanically ventilated intensive care patients-a randomized clinical trial. Crit Care. 2020 Mar 4;24(1):74. doi: 10.1186/s13054-020-2792-z.
PubMed 32131866
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43 Recombinant Pseudomonas Vaccine Intensive Care Patients
- ClinicalTrials.gov ID
- NCT01563263
- Acronym / sponsor ID
- IC43-202
- Conditions
- Pseudomonas Aeruginosa Infection
- Keywords
- IC43, Pseudomonas Aeruginosa, mechanically ventilated ICU patients, ICU patients
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 803 participants (actual)
- Lead sponsor
- Valneva Austria GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a confirmatory, randomized, placebo-controlled, multi-center, double-blinded phase II/III study. The study population consists of male or female intensive care unit (ICU) patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and 80 years.
Detailed description
This is a confirmatory, randomized, placebo-controlled, multi-center, double-blinded phase II/III study. The study population consists of male or female intensive care unit (ICU) patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and 80 years.
Eight-hundred patients will be enrolled at approximately 50 study centers. Informed consent (i.e., from the patient or from the patient's legally authorized representative) or waiver will be obtained according to regional requirements prior to any study related procedures. Patients will be randomized to receive either IC43 100 mcg or placebo and will receive the first vaccination on Day 0. The second vaccination will be applied on Day 7. In case ICU discharge occurs before Day 7, immunization will be done at the hospital ward.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IC43 100 mcg | Active comparator | Biological: IC43IC43 100 mcg intramuscular injection, IC43 is a recombinant Pseudomonas aeruginosa fusion protein |
| Placebo | Placebo comparator | Drug: Placebophosphate buffered saline solution containing 0,9 % NaCL |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male or female patients admitted to an intensive care unit (ICU) with need for mechanical ventilation for at least 48 hours, aged between 18 and 80 years at Visit 0
- written informed consent or waiver according to the national regulations
- no childbearing potential or negative pregnancy test
Key exclusion criteria (6 listed)
- Sequential Organ Failure Assessment (SOFA) < 4 on Day 0
- Patients <6 months post organ transplantation
- readmission to ICU during the current total hospital stay on Day 0
- patients admitted to ICU within 2 days after surgery
- patients admitted to ICU due to trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IC43Also: Pseudomonas Aeruginosa100 mcg | Biological | IC43 100 mcg |
| PlaceboAlso: phosphate buffered saline (PBS)phosphate buffered saline (PBS) solution containing 0,9 % NaCl | Drug | Placebo |
Primary outcome
number of deaths until Day 28
Time frame: until Day 28
18 secondary outcomes
number of deaths in comparison on Day 14, 56 and 90
Time frame: until Day 90
number of deaths onDay 28, 56 and 90 in patients surviving Day 14 and receiving IC43 or placebo
Time frame: until Day 90
number of deaths on Day 14, 28, 56 and 90 in patients surviving Day 3 and receiving IC43 or placebo
Time frame: until Day 90
number of overall survival in all patients and in patients surviving Day 14
Time frame: until Day 180
number of deaths related to sepsis at Day 14, 28, 56 and 90 in patients receiving IC43 or placebo
Time frame: until Day 90
number of surviving subjects after Sepsis receiving IC43 or placebo
Time frame: until Day 180
number of deaths in patients in-ICU and in-hospital receiving IC43 or placebo until Day 14, 28, 56,90, 180
Time frame: until Day 180
percentage of patients with invasive infection with P. aeruginosa, such as bacteremia or P. aeruginosa urinary tract infection in patients receiving IC43 or placebo up to Day 56 after first vaccination
Time frame: until Day 56
percentage of patients with P. aeruginosa respiratory tract infection or P. aeruginosa respiratory tract colonization in patients receiving IC43 or placebo up to Day 56 after first vaccination
Time frame: until Day 56
Organ function in patients receiving IC43 or placebo during ICU stay
Time frame: during ICU stay
Days of ICU stay in patients receiving IC43 or placebo
Time frame: Until Day 180
Immunogenicity at Day 7, 14, 28, 56 and 180 as determined by OprF/I specific IgG antibody titer measured by ELISA in patients receiving IC43 or placebo
Time frame: until Day 180
Number of SAEs and AEs during the vaccination period up to 180 days after the first vaccination
Time frame: until Day 180
systemic tolerability
Time frame: until Day 7
number of local reactions at the injection site
Time frame: until Day 180
Composite measure of laboratory parameters
Time frame: until Day 56
systemic tolerability
Time frame: until Day 7
systemic tolerability
Time frame: until Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
- Derived from this study: PubMed 32131866Adlbrecht C, Wurm R, Depuydt P, Spapen H, Lorente JA, Staudinger T, Creteur J, Zauner C, Meier-Hellmann A, Eller P, Laenen MV, Molnar Z, Varkonyi I, Schaaf B, Hejja M, Sramek V, Schneider H, Kanesa-Thasan N, Eder-Lingelbach S, Klingler A, Dubischar K, Wressnigg N, Rello J. Efficacy, immunogenicity, and safety of IC43 recombinant Pseudomonas aeruginosa vaccine in mechanically ventilated intensive care patients-a randomized clinical trial. Crit Care. 2020 Mar 4;24(1):74. doi: 10.1186/s13054-020-2792-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne Eder, Mag study chair
Valneva Austria GmbH
50 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing IC43 in people with Pseudomonas Aeruginosa Infection, run by Valneva Austria GmbH at 50 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Germany, Hungary, Czechia, Spain, Austria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of deaths until Day 28 (time frame: until Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01563263, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2016; AzTrials last refreshed its copy on 26 Oct 2026.