Kidney TransplantationPhase 4SOT13NCT01781871
Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Compared to the Pneumococcal Polysaccharide Vaccine in Adult Kidney and Liver Transplant Patients
A Phase 4 study testing Prevenar13 and Pneumovax in people with Kidney Transplantation and Liver Transplantation, run by Helsinki University Central Hospital at 2 sites in Finland.
Trial summary
Severe Pneumococcal disease, such as bacteremia, meningitis and pneumonia, cause significant morbidity and mortality in both otherwise healthy adult population and in the immunocompromised patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Transplantation, Liver Transplantation
- What is being tested?
- Prevenar13 and Pneumovax
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 2 sitesFinland
- Study dates
- Jan 2013to 4 Oct 2017
- Phase
- Phase 4
- 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
- consecutive new kidney or liver transplantation in our center
- kidney or liver retransplantation in our center
Who cannot join
- Age < 18 years
- Previous Pneumococcal vaccination < 3 years ago
- Febrile illness at the time of vaccination
- Any sign of graft failure or rejection at the time of vaccination
- Splenectomy
- Pregnancy
- Critically ill patient due to any cause, including terminal uncompensated liver disease
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Helsinki University Central Hospital
Helsinki, HUS, 00029
Heikki Saha
Tampere, 33521
About this study
Official title: Immunogenicity of Repeated Dose 13-valent Pneumococcal Conjugate Vaccine Compared to the Existing Recommended Protocol of Pneumococcal Polysaccharide Vaccine in Adult Kidney and Liver Transplant Patients
Severe Pneumococcal disease, such as bacteremia, meningitis and pneumonia, cause significant morbidity and mortality in both otherwise healthy adult population and in the immunocompromised patients. The incidence rate of invasive pneumococcal disease is considerably higher among organ transplant patients than in healthy individuals. Routine immunization with Pneumococcal vaccine is recommended pretransplant and once 3-5 years after the transplantation. The efficacy and immunogenicity of Pneumococcal polysaccharide vaccine(Pneumovax®) is suboptimal in this patient group. The conjugate Pneumococcal vaccine has been shown to be more immunogenic and safe in some other subgroups of immunocompromised patients. We intend to compare the immunogenicity of repeated dose 13-valent Pneumococcal conjugate vaccine (Prevenar13®)to the existing recommended protocol of Pneumococcal polysaccharide vaccine (Pneumovax®) in adult kidney and liver transplant patients.
- Conditions
- Kidney Transplantation, Liver Transplantation
- Being tested
- Prevenar13, Pneumovax
- Keywords
- Pneumococcal vaccination, immunogenicity, solid organ transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevenar13Biological
Prevenar13 0.5ml injected intramuscularly (im.) at day 1 and at 6 months after the transplantation.
PneumovaxBiological
0.5ml Pneumovax injected intramuscularly at day 1.
| Study group | Role | What they receive |
|---|---|---|
| Prevenar13 | Experimental | 68 kidney transplant patients vaccinated with Prevenar13 as they enter the transplant waiting list. Pre- and postvaccination serotype specific ELISA and OPA measured. Revaccination at 6 months after the transplantation with Prevenar13, again pre- and postvaccination serotype specific ELISA and OPA measured Receives: Biological: Prevenar13 |
| Pneumovax | Active comparator | 68 kidney transplant patients vaccinated with Pneumovax as they enter the transplant waiting list, serotype specific ELISA and OPA measured before and after the vaccination. At six and seven months after transplantation ELISA and OPA measured parallel to the experimental group Receives: Biological: Pneumovax |
| liver Prevenar13 | Experimental | 30 liver transplant patients vaccinated with Prevenar13 once they enter the transplant waiting list. Serotype specific ELISA and OPA measured before and after the vaccination. Revaccinated with Prevenar13 at 6 months after the transplantation. ELISa and OPA measured pre- and postvaccination. Receives: Biological: Prevenar13 |
| liver Pneumovax | Active comparator | 30 liver transplant patients vaccinated with Pneumovax once they enter the transplant waiting list. Serotype specific ELISA and OPA measured pre- and postvaccination. At 6 and 7 months posttransplant ELISA and OPA measured parallel to the experimental group. Receives: Biological: Pneumovax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline serum serotype specific immunoglobulin G (IgG) antibodies to 13 polysaccharides and their opsonophagocytic activity (OPA) after the first vaccination
Measured: baseline and 4 weeks after the first vaccination
Change from baseline serum serotype specific IgG antibodies to 13 polysaccharides and their opsonophagocytic activity (OPA) after the second Prevenar vaccination
Measured: baseline and 4 weeks after the second vaccination
Secondary outcomes (2)
vaccination reactions
Questionaire and phone interview assessment of vaccination reactions and adverse effects.
Measured: from vaccination upto 1 week
rejection
Urine analyses and creatinine measurement with kidney transplant patients. Alanine aminotransferase measurement with liver transplant patients.
Measured: at 1 and 2 months 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 posted1 Feb 2013 (estimated)
- Study startJan 2013
- Primary completion4 Oct 2017
- Study completion4 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University Hospital
- Responsible party
- Principal investigator, Mari Eriksson, Helsinki University Central Hospital
- Investigators
- Veli-Jukka Anttila, MD,PhD,Docent, Principal investigator, HUCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781871
- Sponsor's protocol ID
- HUCH
- Acronym
- SOT13
- Status last verified
- Oct 2017
- First submitted
- 22 Nov 2012
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of Repeated Dose 13-valent Pneumococcal Conjugate Vaccine Compared to the Existing Recommended Protocol of Pneumococcal Polysaccharide Vaccine in Adult Kidney and Liver Transplant Patients
- ClinicalTrials.gov ID
- NCT01781871
- Acronym / sponsor ID
- SOT13 / HUCH
- Conditions
- Kidney Transplantation, Liver Transplantation
- Keywords
- Pneumococcal vaccination, immunogenicity, solid organ transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Tampere University Hospital
- Study start
- Jan 2013
- Primary completion
- 4 Oct 2017 (actual)
- Study completion
- 4 Oct 2017 (actual)
- First posted
- 1 Feb 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.
Severe Pneumococcal disease, such as bacteremia, meningitis and pneumonia, cause significant morbidity and mortality in both otherwise healthy adult population and in the immunocompromised patients. The incidence rate of invasive pneumococcal disease is considerably higher among organ transplant patients than in healthy individuals. Routine immunization with Pneumococcal vaccine is recommended pretransplant and once 3-5 years after the transplantation. The efficacy and immunogenicity of Pneumococcal polysaccharide vaccine(Pneumovax®) is suboptimal in this patient group. The conjugate Pneumococcal vaccine has been shown to be more immunogenic and safe in some other subgroups of immunocompromised patients. We intend to compare the immunogenicity of repeated dose 13-valent Pneumococcal conjugate vaccine (Prevenar13®)to the existing recommended protocol of Pneumococcal polysaccharide vaccine (Pneumovax®) in adult kidney and liver transplant patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prevenar13 | Experimental | Biological: Prevenar1368 kidney transplant patients vaccinated with Prevenar13 as they enter the transplant waiting list. Pre- and postvaccination serotype specific ELISA and OPA measured. Revaccination at 6 months after the transplantation with Prevenar13, again pre- and postvaccination serotype specific ELISA and OPA measured |
| Pneumovax | Active comparator | Biological: Pneumovax68 kidney transplant patients vaccinated with Pneumovax as they enter the transplant waiting list, serotype specific ELISA and OPA measured before and after the vaccination. At six and seven months after transplantation ELISA and OPA measured parallel to the experimental group |
| liver Prevenar13 | Experimental | Biological: Prevenar1330 liver transplant patients vaccinated with Prevenar13 once they enter the transplant waiting list. Serotype specific ELISA and OPA measured before and after the vaccination. Revaccinated with Prevenar13 at 6 months after the transplantation. ELISa and OPA measured pre- and postvaccination. |
| liver Pneumovax | Active comparator | Biological: Pneumovax30 liver transplant patients vaccinated with Pneumovax once they enter the transplant waiting list. Serotype specific ELISA and OPA measured pre- and postvaccination. At 6 and 7 months posttransplant ELISA and OPA measured parallel to the experimental group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- consecutive new kidney or liver transplantation in our center
- kidney or liver retransplantation in our center
Key exclusion criteria (7 listed)
- Age < 18 years
- Previous Pneumococcal vaccination < 3 years ago
- Febrile illness at the time of vaccination
- Any sign of graft failure or rejection at the time of vaccination
- Splenectomy
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 |
|---|---|---|
| Prevenar13Prevenar13 0.5ml injected intramuscularly (im.) at day 1 and at 6 months after the transplantation. | Biological | Prevenar13, liver Prevenar13 |
| Pneumovax0.5ml Pneumovax injected intramuscularly at day 1. | Biological | Pneumovax, liver Pneumovax |
Primary outcome
Change from baseline serum serotype specific immunoglobulin G (IgG) antibodies to 13 polysaccharides and their opsonophagocytic activity (OPA) after the first vaccination
Time frame: baseline and 4 weeks after the first vaccination
Change from baseline serum serotype specific IgG antibodies to 13 polysaccharides and their opsonophagocytic activity (OPA) after the second Prevenar vaccination
Time frame: baseline and 4 weeks after the second vaccination
2 secondary outcomes
vaccination reactions
Time frame: from vaccination upto 1 week
rejection
Time frame: at 1 and 2 months 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 5 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
Veli-Jukka Anttila, MD,PhD,Docent principal investigator
HUCH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prevenar13 and Pneumovax in people with Kidney Transplantation and Liver Transplantation, run by Helsinki University Central Hospital at 2 sites in Finland.
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 2 inclusion and 7 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 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change from baseline serum serotype specific immunoglobulin G (IgG) antibodies to 13 polysaccharides and their opsonophagocytic activity (OPA) after the first vaccination (time frame: baseline and 4 weeks after the first vaccination). 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 5 Oct 2017.