PoliomyelitisPhase 1IPV-004NCT01997632
Phase 1 Study on the Safety and Reactogenicity of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) Given Intramuscularly Compared to Standard Trivalent Inactivated Poliovirus Vaccine (IPV) in Healthy Adults
A Phase 1 study testing a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-IPV2 HD) and a single dose of the standard trivalent inactivated poliovirus vaccine (IPV)(Imovax Polio®). in people with Poliomyelitis, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The purpose of this study is to investigate if the study vaccine, m-IPV2 HD (vaccine that only contains polio serotype 2 in high dose), is as safe as the standard IPV Imovax (that contains the 3 serotypes of polio). This safety evaluation will be done in young adults. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-IPV2 HD) and a single dose of the standard trivalent inactivated poliovirus vaccine (IPV)(Imovax Polio®).
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2013to May 2014
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults 18-45 years of age
- Subjects born in Belgium or any other country where mandatory polio vaccination is performed.
- Written informed consent obtained from the subject.
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception for 2 months after vaccination.
Who cannot join
- Participation in another clinical trial.
- Any polio vaccine within 6 months before study inclusion.
- Any other vaccination in the period starting 14 days before administration of study vaccine and ending 28 days after administration of the study vaccine.
- Previous severe reaction after vaccination with polio vaccine.
- Known hypersensitivity to one or more components of the vaccine.
- Uncontrolled, clinically significant neuro-psychiatric, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic or endocrine disease.
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- Subjects with an history of malignant disease (cancer)
- Known human immunodeficiency virus (HIV) positivity or other immune deficiency or immune suppressive treatment or auto-immune disease. For corticosteroids, a prednisone dose of <20 mg/day, or equivalent, is allowed. Inhaled and topical corticosteroids are allowed.
- Acute disease and/or fever (higher or equal to 37.5°C, measured orally) at the time of enrolment. Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory tract infection) without fever may be enrolled at the discretion of the investigator.
- Pregnant or lactating female. Subject who, in the opinion of the investigator, is unlikely to comply with the protocol or is inappropriate for any other reason.
- Known hypersensitivity to one or more components of the vaccine.
- Uncontrolled, clinically significant neuro-psychiatric, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic or endocrine disease.
- Subjects with an history of malignant disease (cancer)
- Known human immunodeficiency virus (HIV) positivity or other immune deficiency or immune suppressive treatment or auto-immune disease. For corticosteroids, a prednisone dose of <20 mg/day, or equivalent, is allowed. Inhaled and topical corticosteroids are allowed.
- Acute disease and/or fever (higher or equal to 37.5°C, measured orally) at the time of enrolment. Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory tract infection) without fever may be enrolled at the discretion of the investigator.
- Pregnant or lactating female.
- Subject who, in the opinion of the investigator, is unlikely to comply with the protocol or is inappropriate for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate if the study vaccine, m-IPV2 HD (vaccine that only contains polio serotype 2 in high dose), is as safe as the standard IPV Imovax (that contains the 3 serotypes of polio). This safety evaluation will be done in young adults.
If the study vaccine appears to be safe, it will be tested at a later stage in the target group (infants and children) to evaluate the immunogenicity of the vaccine. After all, the purpose is to use the study vaccine in the future to protect young children against Polio serotype 2. Disease with Polio type 2 indeed recently re-appeared, so vaccination of young children to come to a complete eradication of Polio is needed. The standard use of Imovax to protect against Polio serotype 2 would be too expensive. Therefore, a monovalent Polio vaccine containing only serotype 2 (= the vaccine that will be evaluated in this study), has been developed.
Read more
The duration of the study will be approximately 6 months. 120 subjects between 18 and 45 years of age will participate in Belgium.
During the study there will be 2 groups of subjects. Subjects will be assigned by chance to one of these groups. One group will receive one single injection of the study vaccine m-IPV2 HD (which contains only serotype 2), the other group will receive one single injection of the standard polio vaccine IPV, Imovax (which contains the 3 serotypes).
After this vaccination, there will be a follow-up period of 6 months. Subjects will be asked to come to the study centre one more time for the second visit (on Day 8, which is 7 days after the first visit). They will also receive 2 follow-up phone calls for approximately one month and 6 months after vaccination.
- Conditions
- Poliomyelitis
- Being tested
- a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-IPV2 HD), a single dose of the standard trivalent inactivated poliovirus vaccine (IPV)(Imovax Polio®).
- Keywords
- Poliomyelitis, Vaccine
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-IPV2 HD)Biological
a single dose m-IPV2 HD (study vaccine), 0,5ml
a single dose of the standard trivalent inactivated poliovirus vaccine (IPV)(Imovax Polio®).Biological
a single 0.5 ml dose Imovax Polio (control vaccine)
| Study group | Role | What they receive |
|---|---|---|
| control vaccine: Imovax Polio® | Active comparator | Not described Receives: Biological: a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-IPV2 HD) |
| investigational vaccine | Experimental | Not described Receives: Biological: a single dose of the standard trivalent inactivated poliovirus vaccine (IPV)(Imovax Polio®). |
What is being measured
The primary outcome is the main question the study is designed to answer.
the safety of a single dose of m-IPV2 HD and licensed trivalent IPV
To assess the safety of a single dose of m-IPV2 HD and licensed trivalent IPV in healthy adults based on the incidence of serious and severe adverse events (AEs) within 4 weeks of vaccine administration.
Measured: 4 weeks
the reactogenicity of a single dose of m-IPV2 HD and licensed trivalent IPV
To assess the reactogenicity of a single dose of m-IPV2 HD and licensed trivalent IPV in healthy adults based on the incidence of solicited local and general AEs within 7 days of vaccine administration.
Measured: 7 days
Secondary outcomes (1)
the safety of a single dose of m-IPV2 HD and licensed trivalent IPV
To assess the safety of a single dose of m-IPV2 HD and licensed trivalent IPV in healthy adults based on the incidence of serious AEs within 6 months of vaccine administration.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PoliomyelitisStudies 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, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geert Leroux-Roels, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997632
- Sponsor's protocol ID
- 2013/914
- Other IDs
- 2013-004598-29
- Acronym
- IPV-004
- Status last verified
- Nov 2015
- First submitted
- 22 Nov 2013
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study on the Safety and Reactogenicity of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) Given Intramuscularly Compared to Standard Trivalent Inactivated Poliovirus Vaccine (IPV) in Healthy Adults
- ClinicalTrials.gov ID
- NCT01997632
- Acronym / sponsor ID
- IPV-004 / 2013/914
- Conditions
- Poliomyelitis
- Keywords
- Poliomyelitis, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 28 Nov 2013 (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 purpose of this study is to investigate if the study vaccine, m-IPV2 HD (vaccine that only contains polio serotype 2 in high dose), is as safe as the standard IPV Imovax (that contains the 3 serotypes of polio). This safety evaluation will be done in young adults.
If the study vaccine appears to be safe, it will be tested at a later stage in the target group (infants and children) to evaluate the immunogenicity of the vaccine. After all, the purpose is to use the study vaccine in the future to protect young children against Polio serotype 2. Disease with Polio type 2 indeed recently re-appeared, so vaccination of young children to come to a complete eradication of Polio is needed. The standard use of Imovax to protect against Polio serotype 2 would be too expensive. Therefore, a monovalent Polio vaccine containing only serotype 2 (= the vaccine that will be evaluated in this study), has been developed.
The duration of the study will be approximately 6 months. 120 subjects between 18 and 45 years of age will participate in Belgium.
During the study there will be 2 groups of subjects. Subjects will be assigned by chance to one of these groups. One group will receive one single injection of the study vaccine m-IPV2 HD (which contains only serotype 2), the other group will receive one single injection of the standard polio vaccine IPV, Imovax (which contains the 3 serotypes).
After this vaccination, there will be a follow-up period of 6 months. Subjects will be asked to come to the study centre one more time for the second visit (on Day 8, which is 7 days after the first visit). They will also receive 2 follow-up phone calls for approximately one month and 6 months after vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control vaccine: Imovax Polio® | Active comparator | Biological: a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-IPV2 HD) |
| investigational vaccine | Experimental | Biological: a single dose of the standard trivalent inactivated poliovirus vaccine (IPV)(Imovax Polio®). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adults 18-45 years of age
- Subjects born in Belgium or any other country where mandatory polio vaccination is performed.
- Written informed consent obtained from the subject.
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
Key exclusion criteria (17 listed)
- Participation in another clinical trial.
- Any polio vaccine within 6 months before study inclusion.
- Any other vaccination in the period starting 14 days before administration of study vaccine and ending 28 days after administration of the study vaccine.
- Previous severe reaction after vaccination with polio vaccine.
- Known hypersensitivity to one or more 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 |
|---|---|---|
| a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-IPV2 HD)a single dose m-IPV2 HD (study vaccine), 0,5ml | Biological | control vaccine: Imovax Polio® |
| a single dose of the standard trivalent inactivated poliovirus vaccine (IPV)(Imovax Polio®).a single 0.5 ml dose Imovax Polio (control vaccine) | Biological | investigational vaccine |
Primary outcome
the safety of a single dose of m-IPV2 HD and licensed trivalent IPV
Time frame: 4 weeks
To assess the safety of a single dose of m-IPV2 HD and licensed trivalent IPV in healthy adults based on the incidence of serious and severe adverse events (AEs) within 4 weeks of vaccine administration.
the reactogenicity of a single dose of m-IPV2 HD and licensed trivalent IPV
Time frame: 7 days
To assess the reactogenicity of a single dose of m-IPV2 HD and licensed trivalent IPV in healthy adults based on the incidence of solicited local and general AEs within 7 days of vaccine administration.
1 secondary outcome
the safety of a single dose of m-IPV2 HD and licensed trivalent IPV
Time frame: 6 months
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 10 Nov 2015.
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Poliomyelitis
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.
Geert Leroux-Roels, MD, PhD principal investigator
University Hospital, Ghent
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 a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-IPV2 HD) and a single dose of the standard trivalent inactivated poliovirus vaccine (IPV)(Imovax Polio®). in people with Poliomyelitis, run by University Hospital, Ghent at 1 site in Belgium.
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 7 inclusion and 17 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 10 Nov 2015. 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 Belgium. 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?
the safety of a single dose of m-IPV2 HD and licensed trivalent IPV (time frame: 4 weeks). The study lists 2 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 10 Nov 2015.