Immunization, BoosterPhase 1/2NCT02280447
3 Adjuvated Reduced Dose IPV-Al SSI Vaccines and Non-adjuvated Full Dose IPV SSI, as Booster Vaccination to Adolescents
A Phase 1/2 study testing 1/3 IPV-Al SSI, manufactured by SSI, Denmark, 1/5 IPV-Al SSI, manufactured by SSI, Denmark and 1/10 IPV-Al SSI, manufactured by SSI, Denmark in people with Immunization, Booster, run by Statens Serum Institut at 3 sites in Denmark.
Trial summary
The background of the clinical trial is the overall aim of the World Health Organization (WHO) to obtain eradication of polio in the world. As part of this overall plan, inactivated polio vaccine (IPV) against poliovirus types 1, 2 and 3, at an affordable price, needs to become available in low resource third World… Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunization, Booster
- What is being tested?
- 1/3 IPV-Al SSI, manufactured by SSI, Denmark, 1/5 IPV-Al SSI, manufactured by SSI, Denmark and 1/10 IPV-Al SSI, manufactured by SSI, Denmark
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesDenmark
- Study dates
- 13 Nov 2014to 5 Mar 2015
- Phase
- Phase 1/2
- 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 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescents from ≥ 10 to ≤ 15 years of age at inclusion
- Healthy assessed from medical history and oral temperature at inclusion
- Vaccinated in Denmark according to the current vaccination program of 3 IPV doses in infancy and one IPV dose at pre-school age (i.e. born ≥ 1 July 1999)
- Signed informed consent from adolescent's parent(s)/legal guardian(s)
- Grant of authorised person's access to adolescent's medical records from adolescent's parent(s)/legal guardian(s)
- Is willing and likely to comply with trial procedures
Who cannot join
- Vaccinated with IPV ≤ 5 years prior to inclusion
- Vaccinated with OPV any time prior to inclusion
- Travelled in wild polio virus endemic region ≤ 5 years prior to inclusion
- History of serious adverse reaction(s) after any previous vaccination
- Known or suspected allergy to active or inactive vaccine constituents
- Vaccinated with a live vaccine (e.g. measles, mumps, rubella, varicella, yellow fever or typhoid) ≤ 1 month prior to inclusion or during the trial. Subjects vaccinated with inactivated vaccines (e.g. tetanus, diphtheria, human papillomavirus, hepatitis A or B) are eligible for inclusion
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- Known or suspected immunodeficiency (e.g. HIV, leukaemia, lymphoma)
- Severe uncontrolled disease (e.g. diabetes, asthma, epilepsy, heart or Crohn's disease). Patients in controlled medical treatment may be included, as assessed by the investigator
- In treatment with systemic corticosteroids given p.o., i.v., i.m. ≤ 1 month prior to inclusion or during the trial. Subjects administered corticosteroid topically or by asthma inhalators are eligible for inclusion
- In treatment with immune modulating products ≤ 3 months prior to inclusion or during the trial, e.g. blood products, immunoglobulins, cytostatics (e.g. methotrexate), TNF-antagonists (e.g. etanercerpt, infliximab, adalimumab, golimumab, certolizumab), or immunosuppressants (e.g. azathioprine or ciclosporin)
- In treatment with any investigational medicinal product ≤ 3 months prior to inclusion or during the trial
- A positive pregnancy test result at inclusion (for females who have had their first period) and/or objection to use contraception (for females who are sexually active)
- Is unsuitable for participation in the trial or is not likely to comply with instructions as assessed by the investigator
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
CCBR
Aalborg, DK-9000
CCBR
Ballerup Municipality, DK-2750
CCBR
Vejle, DK-7100
About this study
Official title: Safety and Immunogenicity of 3 Adjuvated Reduced Dose IPV-Al SSI Vaccines and Non-adjuvated Full Dose IPV SSI, Given as a Booster Vaccination to Adolescents With a History of IPV Vaccination at 3, 5, 12 Months and 5 Years of Age
The background of the clinical trial is the overall aim of the World Health Organization (WHO) to obtain eradication of polio in the world. As part of this overall plan, inactivated polio vaccine (IPV) against poliovirus types 1, 2 and 3, at an affordable price, needs to become available in low resource third World countries.
The primary objective of the phase I/II clinical trial is to provide proof of concept (POC) that up to 10 times dose reduction of IPV SSI does not decrease the immunogenicity clinically significantly compared to full dose IPV SSI, by demonstrating the non-inferiority of the booster effects of each of 3 Al(OH)3 adjuvated reduced dose IPV formulations (1/3 IPV-Al SSI, 1/5 IPV-Al SSI and 1/10 IPV-Al SSI) compared to non-adjuvated full dose IPV SSI.
A total of 240 healthy adolescents with a history of IPV SSI vaccination at 3, 5, 12 months and 5 years of age according to the Danish vaccination program will be included in the trial.
Read the detailed description
The trial is a phase I/II, parallel- and multi-group, randomised, controlled, multi-centre, non-inferiority trial investigating the safety and immunogenicity of 4 IPV vaccines, given as a booster vaccination to adolescents who have completed primary infant vaccination and pre-school booster vaccination with IPV in Denmark.
At Visit 1 (Screening and vaccination visit), written informed consent is obtained and the subject's eligibility is assessed according to the pre-specified in-/exclusion criteria, including measurement of oral temperature. If the subject is included, a pre-vaccination blood sample is taken for polio antibody determinations, and the subject is randomly allocated into one of the 4 groups to be vaccinated.
The subjects are observed for ½ an hour after the IMP injection and any immediate adverse events observed are to be recorded. A diary, thermometer and ruler are handed out to the subjects so that they can measure daily the injection site reactions and temperature the first 3 days (72 hours) and record any adverse event until the follow-up visit.
At Visit 2 (Follow-up visit), 28-35 days later, a post-vaccination blood sample is taken, the diary is collected, and adverse events and concomitant medications are recorded in the eCRF.
The trial is conducted in two parts. In the first part, 50 % of the subjects are randomised with allocation weights 4:4:1:1 to IPV SSI, 1/3 IPV-Al SSI, 1/5 IPV-Al SSI or 1/10 IPV-Al SSI, respectively. In the second part, the corresponding allocation weights are 1:1:4:4 for the remaining 50 % of the subjects.
After inclusion of 50 % of the subjects, an interim immunogenicity analysis is planned. While the interim analysis on 50% of the completed subjects is performed, the trial continues to recruit and randomise the remaining 50% of the subjects.
- Conditions
- Immunization, Booster
- Being tested
- 1/3 IPV-Al SSI, manufactured by SSI, Denmark, 1/5 IPV-Al SSI, manufactured by SSI, Denmark, 1/10 IPV-Al SSI, manufactured by SSI, Denmark, IPV SSI, manufactured by SSI, Denmark
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1/3 IPV-Al SSI, manufactured by SSI, DenmarkBiological
Also called Reduced dose (1/3) IPV adjuvated to Al(OH)3
Intramuscular injection of 0.5 mL vaccine into deltoid muscle
1/5 IPV-Al SSI, manufactured by SSI, DenmarkBiological
Also called Reduced dose (1/5) IPV adjuvated to Al(OH)3
Intramuscular injection of 0.5 mL vaccine into deltoid muscle
1/10 IPV-Al SSI, manufactured by SSI, DenmarkBiological
Also called Reduced dose (1/10) IPV adjuvated to Al(OH)3
Intramuscular injection of 0.5 mL vaccine into deltoid muscle
IPV SSI, manufactured by SSI, DenmarkBiological
Also called Full dose inactivated polio vaccine, non-adjuvated
Intramuscular injection of 0.5 mL vaccine into deltoid muscle
| Study group | Role | What they receive |
|---|---|---|
| 1/3 IPV-Al SSI | Experimental | Reduced dose Al(OH)3 adjuvated IPV SSI with 1/3 of dose in full dose non-adjuvated IPV SSI (i.e.: Type 1:40 DU; Type 2:8 DU; Type 3:32 DU)
1 X 0.5 mL suspension for injection for intramuscular use Receives: Biological: 1/3 IPV-Al SSI, manufactured by SSI, Denmark |
| 1/5 IPV-Al SSI | Experimental | Reduced dose Al(OH)3 adjuvated IPV SSI with 1/5 of dose in full dose non-adjuvated IPV SSI (i.e.: Type 1:40 DU; Type 2:8 DU; Type 3:32 DU)
1 X 0.5 mL suspension for injection for intramuscular use Receives: Biological: 1/5 IPV-Al SSI, manufactured by SSI, Denmark |
| 1/10 IPV-Al SSI | Experimental | Reduced dose Al(OH)3 adjuvated IPV SSI with 1/10 of dose in full dose non-adjuvated IPV SSI (i.e.: Type 1:40 DU; Type 2:8 DU; Type 3:32 DU)
1 X 0.5 mL suspension for injection for intramuscular use Receives: Biological: 1/10 IPV-Al SSI, manufactured by SSI, Denmark |
| IPV SSI | Active comparator | Non-adjuvated full dose IPV SSI (i.e.: Type 1:40 DU; Type 2:8 DU; Type 3:32 DU)
1 X 0.5 mL solution for injection for intramuscular use Receives: Biological: IPV SSI, manufactured by SSI, Denmark |
What is being measured
The primary outcome is the main question the study is designed to answer.
Booster effect (day 28 / day 0 titres), from individual serum titre values for antibodies against poliovirus types 1, 2 and 3 measured in pre-vaccination and post-vaccination serum samples by a Vero Cell neutralising assay
Measured: On the day of and 28 days after the vaccination
Secondary outcomes (2)
Seroconversion (≥ 4-fold day 28 / day 0 titre rise) rates, from individual serum titre values for antibodies against poliovirus types 1, 2 and 3 measured in pre-vaccination and post-vaccination serum samples by a Vero Cell neutralising assay
Measured: On the day of and 28 days after the vaccination
Frequencies of adverse events following the vaccination
Measured: On the day of and 28 days after the vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study start13 Nov 2014
- Primary completionMar 2015
- Study completion5 Mar 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 Immunization, BoosterStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Statens Serum Institut
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, CCBR Clinical Research, Larix A/S
- Responsible party
- Sponsor
- Investigators
- Line Markdanner Lindgren, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280447
- Sponsor's protocol ID
- VIPV-04
- Other IDs
- 2014-000052-29, 2014
- Status last verified
- Nov 2018
- First submitted
- 29 Oct 2014
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lindgren LM, Tingskov PN, Justesen AH, Nedergaard BS, Olsen KJ, Andreasen LV, Kromann I, Sorensen C, Dietrich J, Thierry-Carstensen B. First-in-human safety and immunogenicity investigations of three adjuvanted reduced dose inactivated poliovirus vaccines (IPV-Al SSI) compared to full dose IPV Vaccine SSI when given as a booster vaccination to adolescents with a history of IPV vaccination at 3, 5, 12months and 5years of age. Vaccine. 2017 Jan 23;35(4):596-604. doi: 10.1016/j.vaccine.2016.12.027. Epub 2016 Dec 24.
PubMed 28027810
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of 3 Adjuvated Reduced Dose IPV-Al SSI Vaccines and Non-adjuvated Full Dose IPV SSI, Given as a Booster Vaccination to Adolescents With a History of IPV Vaccination at 3, 5, 12 Months and 5 Years of Age
- ClinicalTrials.gov ID
- NCT02280447
- Acronym / sponsor ID
- VIPV-04
- Conditions
- Immunization, Booster
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Statens Serum InstitutUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, CCBR Clinical Research, Larix A/S
- Study start
- 13 Nov 2014 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- 5 Mar 2015 (actual)
- First posted
- 31 Oct 2014 (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 background of the clinical trial is the overall aim of the World Health Organization (WHO) to obtain eradication of polio in the world. As part of this overall plan, inactivated polio vaccine (IPV) against poliovirus types 1, 2 and 3, at an affordable price, needs to become available in low resource third World countries.
The primary objective of the phase I/II clinical trial is to provide proof of concept (POC) that up to 10 times dose reduction of IPV SSI does not decrease the immunogenicity clinically significantly compared to full dose IPV SSI, by demonstrating the non-inferiority of the booster effects of each of 3 Al(OH)3 adjuvated reduced dose IPV formulations (1/3 IPV-Al SSI, 1/5 IPV-Al SSI and 1/10 IPV-Al SSI) compared to non-adjuvated full dose IPV SSI.
A total of 240 healthy adolescents with a history of IPV SSI vaccination at 3, 5, 12 months and 5 years of age according to the Danish vaccination program will be included in the trial.
Detailed description
The trial is a phase I/II, parallel- and multi-group, randomised, controlled, multi-centre, non-inferiority trial investigating the safety and immunogenicity of 4 IPV vaccines, given as a booster vaccination to adolescents who have completed primary infant vaccination and pre-school booster vaccination with IPV in Denmark.
At Visit 1 (Screening and vaccination visit), written informed consent is obtained and the subject's eligibility is assessed according to the pre-specified in-/exclusion criteria, including measurement of oral temperature. If the subject is included, a pre-vaccination blood sample is taken for polio antibody determinations, and the subject is randomly allocated into one of the 4 groups to be vaccinated.
The subjects are observed for ½ an hour after the IMP injection and any immediate adverse events observed are to be recorded. A diary, thermometer and ruler are handed out to the subjects so that they can measure daily the injection site reactions and temperature the first 3 days (72 hours) and record any adverse event until the follow-up visit.
At Visit 2 (Follow-up visit), 28-35 days later, a post-vaccination blood sample is taken, the diary is collected, and adverse events and concomitant medications are recorded in the eCRF.
The trial is conducted in two parts. In the first part, 50 % of the subjects are randomised with allocation weights 4:4:1:1 to IPV SSI, 1/3 IPV-Al SSI, 1/5 IPV-Al SSI or 1/10 IPV-Al SSI, respectively. In the second part, the corresponding allocation weights are 1:1:4:4 for the remaining 50 % of the subjects.
After inclusion of 50 % of the subjects, an interim immunogenicity analysis is planned. While the interim analysis on 50% of the completed subjects is performed, the trial continues to recruit and randomise the remaining 50% of the subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1/3 IPV-Al SSI | Experimental | Biological: 1/3 IPV-Al SSI, manufactured by SSI, DenmarkReduced dose Al(OH)3 adjuvated IPV SSI with 1/3 of dose in full dose non-adjuvated IPV SSI (i.e.: Type 1:40 DU; Type 2:8 DU; Type 3:32 DU) 1 X 0.5 mL suspension for injection for intramuscular use |
| 1/5 IPV-Al SSI | Experimental | Biological: 1/5 IPV-Al SSI, manufactured by SSI, DenmarkReduced dose Al(OH)3 adjuvated IPV SSI with 1/5 of dose in full dose non-adjuvated IPV SSI (i.e.: Type 1:40 DU; Type 2:8 DU; Type 3:32 DU) 1 X 0.5 mL suspension for injection for intramuscular use |
| 1/10 IPV-Al SSI | Experimental | Biological: 1/10 IPV-Al SSI, manufactured by SSI, DenmarkReduced dose Al(OH)3 adjuvated IPV SSI with 1/10 of dose in full dose non-adjuvated IPV SSI (i.e.: Type 1:40 DU; Type 2:8 DU; Type 3:32 DU) 1 X 0.5 mL suspension for injection for intramuscular use |
| IPV SSI | Active comparator | Biological: IPV SSI, manufactured by SSI, DenmarkNon-adjuvated full dose IPV SSI (i.e.: Type 1:40 DU; Type 2:8 DU; Type 3:32 DU) 1 X 0.5 mL solution for injection for intramuscular use |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Adolescents from ≥ 10 to ≤ 15 years of age at inclusion
- Healthy assessed from medical history and oral temperature at inclusion
- Vaccinated in Denmark according to the current vaccination program of 3 IPV doses in infancy and one IPV dose at pre-school age (i.e. born ≥ 1 July 1999)
- Signed informed consent from adolescent's parent(s)/legal guardian(s)
- Grant of authorised person's access to adolescent's medical records from adolescent's parent(s)/legal guardian(s)
Key exclusion criteria (13 listed)
- Vaccinated with IPV ≤ 5 years prior to inclusion
- Vaccinated with OPV any time prior to inclusion
- Travelled in wild polio virus endemic region ≤ 5 years prior to inclusion
- History of serious adverse reaction(s) after any previous vaccination
- Known or suspected allergy to active or inactive vaccine constituents
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 |
|---|---|---|
| 1/3 IPV-Al SSI, manufactured by SSI, DenmarkAlso: Reduced dose (1/3) IPV adjuvated to Al(OH)3Intramuscular injection of 0.5 mL vaccine into deltoid muscle | Biological | 1/3 IPV-Al SSI |
| 1/5 IPV-Al SSI, manufactured by SSI, DenmarkAlso: Reduced dose (1/5) IPV adjuvated to Al(OH)3Intramuscular injection of 0.5 mL vaccine into deltoid muscle | Biological | 1/5 IPV-Al SSI |
| 1/10 IPV-Al SSI, manufactured by SSI, DenmarkAlso: Reduced dose (1/10) IPV adjuvated to Al(OH)3Intramuscular injection of 0.5 mL vaccine into deltoid muscle | Biological | 1/10 IPV-Al SSI |
| IPV SSI, manufactured by SSI, DenmarkAlso: Full dose inactivated polio vaccine, non-adjuvatedIntramuscular injection of 0.5 mL vaccine into deltoid muscle | Biological | IPV SSI |
Primary outcome
Booster effect (day 28 / day 0 titres), from individual serum titre values for antibodies against poliovirus types 1, 2 and 3 measured in pre-vaccination and post-vaccination serum samples by a Vero Cell neutralising assay
Time frame: On the day of and 28 days after the vaccination
2 secondary outcomes
Seroconversion (≥ 4-fold day 28 / day 0 titre rise) rates, from individual serum titre values for antibodies against poliovirus types 1, 2 and 3 measured in pre-vaccination and post-vaccination serum samples by a Vero Cell neutralising assay
Time frame: On the day of and 28 days after the vaccination
Frequencies of adverse events following the vaccination
Time frame: On the day of and 28 days after the vaccination
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 14 Nov 2018.
- Derived from this study: PubMed 28027810Lindgren LM, Tingskov PN, Justesen AH, Nedergaard BS, Olsen KJ, Andreasen LV, Kromann I, Sorensen C, Dietrich J, Thierry-Carstensen B. First-in-human safety and immunogenicity investigations of three adjuvanted reduced dose inactivated poliovirus vaccines (IPV-Al SSI) compared to full dose IPV Vaccine SSI when given as a booster vaccination to adolescents with a history of IPV vaccination at 3, 5, 12months and 5years of age. Vaccine. 2017 Jan 23;35(4):596-604. doi: 10.1016/j.vaccine.2016.12.027. Epub 2016 Dec 24.
- Individual participant dataSharing planned: No
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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.
Line Markdanner Lindgren principal investigator
Principal Investigator
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 1/3 IPV-Al SSI, manufactured by SSI, Denmark, 1/5 IPV-Al SSI, manufactured by SSI, Denmark and 1/10 IPV-Al SSI, manufactured by SSI, Denmark in people with Immunization, Booster, run by Statens Serum Institut at 3 sites in Denmark.
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 13 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 14 Nov 2018. 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 Denmark. 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 combined 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.
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?
Booster effect (day 28 / day 0 titres), from individual serum titre values for antibodies against poliovirus types 1, 2 and 3 measured in pre-vaccination and post-vaccination serum samples by a Vero Cell neutralising assay (time frame: On the day of and 28 days after the vaccination). 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 NCT02280447, 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 14 Nov 2018.