HealthyPhase 1NCT00778388
Study Assessing Safety and Immunogenicity of IC43 Vaccination Against Pseudomonas Aeruginosa in Healthy Volunteers
A Phase 1 study testing IC43 in people with Healthy, run by Valneva Austria GmbH at 3 sites in 2 countries.
Trial summary
The objective is to confirm the optimal dose of IC43 in regard to immunogenicity, safety and tolerability. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- IC43
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2008to Sep 2009
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- written informed consent obtained prior to study entry
- healthy adults aged between 18 and 65 years
- no clinically relevant pathological findings in any of the investigations at the Screening visit. Minor deviations of laboratory values from the normal range may be accepted, if judged by the investigator to have no clinical relevance
- In female subjects either childbearing potential terminated by surgery or a negative serum pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception
Who cannot join
- History of autoimmune diseases and malignancies
- Active or passive vaccination 4 weeks before and during the entire study protocol
- Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
- History of severe hypersensitivity reactions and anaphylaxis
- Known hypersensitivity or allergic reactions to one of the components of the vaccine
- Clinically significant diseases as judged by the investigator
- Immunodeficiency due to immunosuppressive therapy
- A family history of congenital or hereditary immunodeficiency
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Dr. Daniel Sehrt
Göttingen, Göttingen
Dr. Jutta Harten
Münster, Münster
About this study
Official title: Against Pseudomonas Aeruginosa in Healthy Volunteers
The objective is to confirm the optimal dose of IC43 in regard to immunogenicity, safety and tolerability.
Read the detailed description
The study will be designed as a multi-center, observer-blinded, randomized, placebocontrolled phase 1 study in healthy adult subjects of 18 to 65 years of age. A total of 160 healthy male and female subjects is planned to be enrolled and randomized in five groups receiving different dosages and formulations of IC43 or placebo.
- Conditions
- Healthy
- Being tested
- IC43, Placebo
- Keywords
- Pseudomonas Aeruginosa
- 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 IC43 Pseudomonas Aeruginosa
The study consists of a screening visit within 14 days before the administration of the investigational medicinal product (IMP), an experimental part of 180 days with seven outpatient visits on days 0, 3, 7, 14, 28, 90 and 180 and with vaccinations on days 0 and 7. IC43 vaccine will be administered intramuscularly during study visit 0 and 7 at three different doses, adjuvanted with Al(OH)3, or in one dose without Al(OH)3. Injection volumes will be 0.5 mL, 1 mL or 2 mL. Placebo will be administered intramuscularly at a dosage of 1 mL.
PlaceboDrug
Also called NaCl
The study consists of a screening visit within 14 days before the administration of the investigational medicinal product (IMP), an experimental part of 180 days with seven outpatient visits on days 0, 3, 7, 14, 28, 90 and 180 and with vaccinations on days 0 and 7. IC43 vaccine will be administered intramuscularly during study visit 0 and 7 at three different doses, adjuvanted with Al(OH)3, or in one dose without Al(OH)3. Injection volumes will be 0.5 mL, 1 mL or 2 mL. Placebo will be administered intramuscularly at a dosage of 1 mL.
| Study group | Role | What they receive |
|---|---|---|
| IC43 50 | Active comparator | IC43 50 mcg with AI(OH)3 Receives: Biological: IC43 |
| IC43 100 with | Active comparator | IC43 100 mcg with AI(OH)3 Receives: Biological: IC43 |
| IC43 100 w/o | Active comparator | IC43 100 mcg w/o AI(OH)3 Receives: Biological: IC43 |
| IC43 200 | Active comparator | IC43 200 mcg with AI(OH)3 Receives: Biological: IC43 |
| Placebo | Placebo comparator | Placebo (0,9% NaCl) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunogenicity at day 14
Measured: see above
rate of serious adverse events during vaccination period until 6 months after first vaccination
Measured: see above
safety laboratory parameters at intervals up to day 180
Measured: see above
systemic and local tolerability at intervals up to day 180
Measured: see above
Secondary outcomes (4)
immunogenicity
Measured: see above
measurement of functional antibody induction
Measured: see above
measurement of antibody avidity on days 7 and 14
Measured: see above
measurement of anti-histidine antibodies on days 7, 14, 90, and 180
Measured: see above
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valneva Austria GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sonja Ernsthofer, Mag., Study director, Valneva Austria GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778388
- Sponsor's protocol ID
- IC43-101
- Status last verified
- Oct 2012
- First submitted
- 22 Oct 2008
- Last updated
- 19 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
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
- Against Pseudomonas Aeruginosa in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00778388
- Acronym / sponsor ID
- IC43-101
- Conditions
- Healthy
- Keywords
- Pseudomonas Aeruginosa
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Valneva Austria GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 23 Oct 2008 (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.
The objective is to confirm the optimal dose of IC43 in regard to immunogenicity, safety and tolerability.
Detailed description
The study will be designed as a multi-center, observer-blinded, randomized, placebocontrolled phase 1 study in healthy adult subjects of 18 to 65 years of age. A total of 160 healthy male and female subjects is planned to be enrolled and randomized in five groups receiving different dosages and formulations of IC43 or placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| IC43 50 | Active comparator | Biological: IC43IC43 50 mcg with AI(OH)3 |
| IC43 100 with | Active comparator | Biological: IC43IC43 100 mcg with AI(OH)3 |
| IC43 100 w/o | Active comparator | Biological: IC43IC43 100 mcg w/o AI(OH)3 |
| IC43 200 | Active comparator | Biological: IC43IC43 200 mcg with AI(OH)3 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (0,9% NaCl) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- written informed consent obtained prior to study entry
- healthy adults aged between 18 and 65 years
- no clinically relevant pathological findings in any of the investigations at the Screening visit. Minor deviations of laboratory values from the normal range may be accepted, if judged by the investigator to have no clinical relevance
- In female subjects either childbearing potential terminated by surgery or a negative serum pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception
Key exclusion criteria (8 listed)
- History of autoimmune diseases and malignancies
- Active or passive vaccination 4 weeks before and during the entire study protocol
- Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
- History of severe hypersensitivity reactions and anaphylaxis
- Known hypersensitivity or allergic reactions to one of the components of the vaccine
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 AeruginosaThe study consists of a screening visit within 14 days before the administration of the investigational medicinal product (IMP), an experimental part of 180 days with seven outpatient visits on days 0, 3, 7, 14, 28, 90 and 180 and with vaccinations on days 0 and 7. IC43 vaccine will be administered intramuscularly during study visit 0 and 7 at three different doses, adjuvanted with Al(OH)3, or in one dose without Al(OH)3. Injection volumes will be 0.5 mL, 1 mL or 2 mL. Placebo will be administered intramuscularly at a dosage of 1 mL. | Biological | IC43 100 w/o, IC43 100 with, IC43 200, IC43 50 |
| PlaceboAlso: NaClThe study consists of a screening visit within 14 days before the administration of the investigational medicinal product (IMP), an experimental part of 180 days with seven outpatient visits on days 0, 3, 7, 14, 28, 90 and 180 and with vaccinations on days 0 and 7. IC43 vaccine will be administered intramuscularly during study visit 0 and 7 at three different doses, adjuvanted with Al(OH)3, or in one dose without Al(OH)3. Injection volumes will be 0.5 mL, 1 mL or 2 mL. Placebo will be administered intramuscularly at a dosage of 1 mL. | Drug | Placebo |
Primary outcome
immunogenicity at day 14
Time frame: see above
rate of serious adverse events during vaccination period until 6 months after first vaccination
Time frame: see above
safety laboratory parameters at intervals up to day 180
Time frame: see above
systemic and local tolerability at intervals up to day 180
Time frame: see above
4 secondary outcomes
immunogenicity
Time frame: see above
measurement of functional antibody induction
Time frame: see above
measurement of antibody avidity on days 7 and 14
Time frame: see above
measurement of anti-histidine antibodies on days 7, 14, 90, and 180
Time frame: see above
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.
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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.
Sonja Ernsthofer, Mag. study director
Valneva Austria GmbH
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IC43 in people with Healthy, run by Valneva Austria GmbH at 3 sites in 2 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 4 inclusion and 8 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 3 sites in Germany, 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 (time frame: see above). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.