Pneumonia, Ventilator-AssociatedPhase 2NCT00876252
Study Assessing Immunogenicity and Safety of IC43 In Intensive Care Patients
A Phase 2 study testing IC43 in people with Pneumonia, Ventilator-Associated, run by Valneva Austria GmbH at 1 site in Austria.
Trial summary
Randomized, placebo-controlled, partially blinded phase 2 pilot study. Multicenter study (approximately 50 centers) in approximately 9 countries. Proposed start date is December 2008. The study duration per patient is estimated to be 90 days. Overall study duration is estimated to be 12-18 months. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pneumonia, Ventilator-Associated
- What is being tested?
- IC43
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2008to Feb 2010
- Phase
- Phase 2
- 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 aged between 18 and 80 years
- Patients admitted to an ICU with a need for mechanical ventilation for more than 48 hours at visit 0
- At high risk for acquiring infection against P. aeruginosa at visit 0.
- Patients who, as determined by the investigator, have a high probability of survival for at least 48 hours.
- In females, either childbearing potential terminated by surgery or 1 year post menopausal, or a negative pregnancy test and the willingness of practicing a reliable methods of contraception
- Written informed consent or waiver according to the national regulations
Who cannot join
- Known use of any other investigational or non-registered drug within 30 days prior to IC43 vaccination at Visit 0
- Low severity of illness defined by an acute physiology score < 8 at visit 0
- Patients < 6 months post organ transplantation
- Severe thrombocytopenia or other coagulopathy which in the opinion of the investigator makes the patient unsuitable for intramuscular injection
- Pregnancy, lactation
- Persons who have been committed involuntarily to an institution, e.g. mental health facility or prison, will not participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Pilot Study Assessing Immunogenicity and Safety of IC43 in Intensive Care Patients
Randomized, placebo-controlled, partially blinded phase 2 pilot study. Multicenter study (approximately 50 centers) in approximately 9 countries. Proposed start date is December 2008. The study duration per patient is estimated to be 90 days. Overall study duration is estimated to be 12-18 months.
Read the detailed description
This is a randomized, placebo-controlled, multi-center, partially blinded [i.e., 100 mcg and 200 mcg IC43 with Al(OH)3,, respectively] and placebo, but unblinded for non-adjuvanted IC43 [i.e., 100 mcg w/o Al(OH)3] phase 2 pilot study. The study population consists of male or female ICU patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and 80 years.
- Conditions
- Pneumonia, Ventilator-Associated
- Being tested
- IC43, Placebo
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IC43Biological
Also called IC43 Pseudomonas Aeruginosa
PlaceboDrug
Also called phosphate buffered saline (PBS)
NaCl
| Study group | Role | What they receive |
|---|---|---|
| IC43 100 mcg | Active comparator | IC43 100 mcg with Aluminum hydroxide Receives: Biological: IC43 |
| IC43 200 mcg | Active comparator | IC43 200 mcg with Aluminum hydroxide Receives: Biological: IC43 |
| IC43 100 mcg w/o | Active comparator | IC43 100 mcg without Aluminum hydroxide Receives: Biological: IC43 |
| Placebo | Placebo comparator | phosphate-buffered saline solution containing 0,9 % NaCl and 400 mcg Aluminum hydroxide as an adjuvant Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity at day 14 as determined by OprF/I specific IgG antibody titer measured by ELISA in patients receiving IC43 or placebo
Measured: Day 14
Secondary outcomes (5)
Immunogenicity at day 7
Measured: Day 7
Rate of serious adverse events
Measured: Day 7
Safety laboratory parameters
Measured: Day 7
Systemic tolerability
Measured: Day 7
Local tolerability
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2009 (estimated)
- Study startDec 2008
- Primary completionFeb 2010
- Study completionFeb 2010
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 Pneumonia, Ventilator-AssociatedStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valneva Austria GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicole Haas, Study director, Valneva Austria GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876252
- Sponsor's protocol ID
- IC43-201
- Status last verified
- Oct 2012
- First submitted
- 3 Apr 2009
- Last updated
- 19 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rello J, Krenn CG, Locker G, Pilger E, Madl C, Balica L, Dugernier T, Laterre PF, Spapen H, Depuydt P, Vincent JL, Bogar L, Szabo Z, Volgyes B, Manez R, Cakar N, Ramazanoglu A, Topeli A, Mastruzzo MA, Jasovich A, Remolif CG, Del Carmen Soria L, Andresen Hernandez MA, Ruiz Balart C, Kremer I, Molnar Z, von Sonnenburg F, Lyons A, Joannidis M, Burgmann H, Welte T, Klingler A, Hochreiter R, Westritschnig K. A randomized placebo-controlled phase II study of a Pseudomonas vaccine in ventilated ICU patients. Crit Care. 2017 Feb 4;21(1):22. doi: 10.1186/s13054-017-1601-9.
PubMed 28159015
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Pilot Study Assessing Immunogenicity and Safety of IC43 in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT00876252
- Acronym / sponsor ID
- IC43-201
- Conditions
- Pneumonia, Ventilator-Associated
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Valneva Austria GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 6 Apr 2009 (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.
Randomized, placebo-controlled, partially blinded phase 2 pilot study. Multicenter study (approximately 50 centers) in approximately 9 countries. Proposed start date is December 2008. The study duration per patient is estimated to be 90 days. Overall study duration is estimated to be 12-18 months.
Detailed description
This is a randomized, placebo-controlled, multi-center, partially blinded [i.e., 100 mcg and 200 mcg IC43 with Al(OH)3,, respectively] and placebo, but unblinded for non-adjuvanted IC43 [i.e., 100 mcg w/o Al(OH)3] phase 2 pilot study. The study population consists of male or female ICU patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and 80 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IC43 100 mcg | Active comparator | Biological: IC43IC43 100 mcg with Aluminum hydroxide |
| IC43 200 mcg | Active comparator | Biological: IC43IC43 200 mcg with Aluminum hydroxide |
| IC43 100 mcg w/o | Active comparator | Biological: IC43IC43 100 mcg without Aluminum hydroxide |
| Placebo | Placebo comparator | Drug: Placebophosphate-buffered saline solution containing 0,9 % NaCl and 400 mcg Aluminum hydroxide as an adjuvant |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients aged between 18 and 80 years
- Patients admitted to an ICU with a need for mechanical ventilation for more than 48 hours at visit 0
- At high risk for acquiring infection against P. aeruginosa at visit 0.
- Patients who, as determined by the investigator, have a high probability of survival for at least 48 hours.
- In females, either childbearing potential terminated by surgery or 1 year post menopausal, or a negative pregnancy test and the willingness of practicing a reliable methods of contraception
Key exclusion criteria (6 listed)
- Known use of any other investigational or non-registered drug within 30 days prior to IC43 vaccination at Visit 0
- Low severity of illness defined by an acute physiology score < 8 at visit 0
- Patients < 6 months post organ transplantation
- Severe thrombocytopenia or other coagulopathy which in the opinion of the investigator makes the patient unsuitable for intramuscular injection
- Pregnancy, lactation
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: IC43 Pseudomonas Aeruginosa | Biological | IC43 100 mcg, IC43 100 mcg w/o, IC43 200 mcg |
| PlaceboAlso: phosphate buffered saline (PBS)NaCl | Drug | Placebo |
Primary outcome
Immunogenicity at day 14 as determined by OprF/I specific IgG antibody titer measured by ELISA in patients receiving IC43 or placebo
Time frame: Day 14
5 secondary outcomes
Immunogenicity at day 7
Time frame: Day 7
Rate of serious adverse events
Time frame: Day 7
Safety laboratory parameters
Time frame: Day 7
Systemic tolerability
Time frame: Day 7
Local tolerability
Time frame: 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 19 Oct 2012.
- Derived from this study: PubMed 28159015Rello J, Krenn CG, Locker G, Pilger E, Madl C, Balica L, Dugernier T, Laterre PF, Spapen H, Depuydt P, Vincent JL, Bogar L, Szabo Z, Volgyes B, Manez R, Cakar N, Ramazanoglu A, Topeli A, Mastruzzo MA, Jasovich A, Remolif CG, Del Carmen Soria L, Andresen Hernandez MA, Ruiz Balart C, Kremer I, Molnar Z, von Sonnenburg F, Lyons A, Joannidis M, Burgmann H, Welte T, Klingler A, Hochreiter R, Westritschnig K. A randomized placebo-controlled phase II study of a Pseudomonas vaccine in ventilated ICU patients. Crit Care. 2017 Feb 4;21(1):22. doi: 10.1186/s13054-017-1601-9.
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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.
Nicole Haas study director
Valneva Austria GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IC43 in people with Pneumonia, Ventilator-Associated, run by Valneva Austria GmbH at 1 site in Austria.
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 6 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 19 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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 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.
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?
Immunogenicity at day 14 as determined by OprF/I specific IgG antibody titer measured by ELISA in patients receiving IC43 or placebo (time frame: Day 14). 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 NCT00876252, 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 19 Oct 2012.