Pneumococcal InfectionsPhase 1NCT00873431
Open-Label Study Assessing The Safety, Immunogenicity and Dose Response of IC47
A Phase 1 study testing IC47 in people with Pneumococcal Infections, run by Valneva Austria GmbH at 1 site in Germany.
Trial summary
The main aim of this clinical study is to investigate the safety and tolerability of different dose strengths of IC47 up to 6 months after the first vaccination. A total of 32 healthy subjects (male or female) will participate in this clinical study. The subjects will be divided into 4 groups of 8 subjects each. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- IC47
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2009to Feb 2010
- 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
- Healthy adults ≥ 18 to </= 65
- female subjects: post-menopausal or practicing reliable methods of contraception during the study
Who cannot join
- History of autoimmune diseases and malignancies.
- History of severe hypersensitivity reactions and anaphylaxis.
- Immunodeficiency due to immunosuppressive therapy.
- Infection with HIV, Hepatitis B or Hepatitis C.
- Pregnancy, lactation
- Vulnerable subjects
Trial locations and contacts
1 site in 1 country.
Germany1 site
Parexel International GmbH, Institute for Clinical Pharmacology
Berlin, State of Berlin, 14050
About this study
Official title: An Open-Label Phase 1 Study Assessing the Safety, Immunogenicity and Dose Response of IC47, a New Vaccine Against Streptococcus Pneumoniae, in Healthy Subjects.
The main aim of this clinical study is to investigate the safety and tolerability of different dose strengths of IC47 up to 6 months after the first vaccination.
A total of 32 healthy subjects (male or female) will participate in this clinical study. The subjects will be divided into 4 groups of 8 subjects each. Thirty (30) μg or 150 μg of IC47 will be administered three times in intervals of 42 days each.
Read the detailed description
This Phase 1 study will be conducted in four groups of 8 healthy subjects at a single study center. 32 subjects will be enrolled. The following table shows the design of the different study groups. The amount of protein shown in the table refers to the total protein content and is comprised of an equal amount of the three individual components.
- Conditions
- Pneumococcal Infections
- Being tested
- IC47
- Keywords
- Prevention of pneumococcal infections
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IC47Biological
solution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84
| Study group | Role | What they receive |
|---|---|---|
| IC47 30 mcg | Experimental | 30 mcg with Alum Receives: Biological: IC47 |
| IC47 30 mcg w/o | Experimental | 30 mcg without Alum Receives: Biological: IC47 |
| IC47 150 mcg | Experimental | 150 mcg with Alum Receives: Biological: IC47 |
| IC47 150 mcg w/o | Experimental | 150 mcg without Alum Receives: Biological: IC47 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of any SAEs (possibly)related to the study vaccine
Measured: Day 0 - Day 264
Occurrence of any Grade 3 or higher adverse reactions (possibly)related to the study vaccine
Measured: Day 0 - Day 264
Occurrence of solicited local and systemic AEs within 1 week after vaccination
Measured: Day 0 - Day 264
Secondary outcomes (1)
Determination of vaccine-specific IgG levels
Measured: Day 0 - Day 264
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal InfectionsStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valneva Austria GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PATH
- Responsible party
- Sponsor
- Investigators
- Evelyn Hatzenbichler, PhD, Study director, Valneva Austria GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873431
- Sponsor's protocol ID
- IC47-101
- Status last verified
- Oct 2012
- First submitted
- 31 Mar 2009
- 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
- An Open-Label Phase 1 Study Assessing the Safety, Immunogenicity and Dose Response of IC47, a New Vaccine Against Streptococcus Pneumoniae, in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT00873431
- Acronym / sponsor ID
- IC47-101
- Conditions
- Pneumococcal Infections
- Keywords
- Prevention of pneumococcal infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Valneva Austria GmbHIndustry (pharma, biotech, devices)
- Collaborators
- PATH
- Study start
- Mar 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 1 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.
The main aim of this clinical study is to investigate the safety and tolerability of different dose strengths of IC47 up to 6 months after the first vaccination.
A total of 32 healthy subjects (male or female) will participate in this clinical study. The subjects will be divided into 4 groups of 8 subjects each. Thirty (30) μg or 150 μg of IC47 will be administered three times in intervals of 42 days each.
Detailed description
This Phase 1 study will be conducted in four groups of 8 healthy subjects at a single study center. 32 subjects will be enrolled. The following table shows the design of the different study groups. The amount of protein shown in the table refers to the total protein content and is comprised of an equal amount of the three individual components.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IC47 30 mcg | Experimental | Biological: IC4730 mcg with Alum |
| IC47 30 mcg w/o | Experimental | Biological: IC4730 mcg without Alum |
| IC47 150 mcg | Experimental | Biological: IC47150 mcg with Alum |
| IC47 150 mcg w/o | Experimental | Biological: IC47150 mcg without Alum |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Healthy adults ≥ 18 to </= 65
- female subjects: post-menopausal or practicing reliable methods of contraception during the study
Key exclusion criteria (6 listed)
- History of autoimmune diseases and malignancies.
- History of severe hypersensitivity reactions and anaphylaxis.
- Immunodeficiency due to immunosuppressive therapy.
- Infection with HIV, Hepatitis B or Hepatitis C.
- 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 |
|---|---|---|
| IC47solution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84 | Biological | IC47 150 mcg, IC47 150 mcg w/o, IC47 30 mcg, IC47 30 mcg w/o |
Primary outcome
Occurrence of any SAEs (possibly)related to the study vaccine
Time frame: Day 0 - Day 264
Occurrence of any Grade 3 or higher adverse reactions (possibly)related to the study vaccine
Time frame: Day 0 - Day 264
Occurrence of solicited local and systemic AEs within 1 week after vaccination
Time frame: Day 0 - Day 264
1 secondary outcome
Determination of vaccine-specific IgG levels
Time frame: Day 0 - Day 264
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.
Related trials for Pneumococcal Infections
RecruitingObservational study
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Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years
Pneumonia, Bacterial
Active, not recruitingObservational study
A Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia
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Pneumonia and Pleuropneumonia in Hospitalized Children
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Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents
Pneumococcal Disease
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.
Evelyn Hatzenbichler, PhD 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 1 study testing IC47 in people with Pneumococcal Infections, run by Valneva Austria GmbH at 1 site in Germany.
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 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 Germany. 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. 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?
Occurrence of any SAEs (possibly)related to the study vaccine (time frame: Day 0 - Day 264). The study lists 3 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.