Organ TransplantationNCT01254955
Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients
An observational study of Organ Transplantation, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Organ transplant patients and staff members at the Transplant Institute have received pandemic H1N1 influenza vaccine (Pandemrix) and specific antibody production was measured by haemagglutination inhibition according to the clinical guidelines and policy, respectively. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Organ Transplantation
- What is being tested?
- H1N1 vaccine Pandemrix
- Type of treatment
- Vaccines
- How many people
- Not given
- Where
- 1 siteSweden
- Study dates
- Oct 2009to Aug 2011
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Tranplant patients at the out-patient clinical ward and staff members at the Transplant Institute, Sahlgrenska University Hospital.
Who may be able to join
- Cohort number 1:Organ transplant patients who were vaccinated and serum sample drawn at baseline.
- Cohort number 2: Staff members who were vaccinated and serum sample drawn at baseline.
Who cannot join
- Cohort number 1: Organ transplant patients who were vaccinated and no serum sample drawn at baseline.
- Cohort number 2: Staff members who were vaccinated and no serum sample drawn at baseline.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Transplant Institute, Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, 413 45
About this study
Organ transplant patients and staff members at the Transplant Institute have received pandemic H1N1 influenza vaccine (Pandemrix) and specific antibody production was measured by haemagglutination inhibition according to the clinical guidelines and policy, respectively. This study retrospectively assessed the immune response after vaccination.
Read the detailed description
A total of 100 organ transplant patients and 36 healthy controls were included in the study. All individuals were vaccinated between October and November 2009 and received 2 doses of Pandemrix. Serum samples were collected at baseline before vaccination and 1 month after the first and second vaccination. Individual hemagglutination-inhibiting serum antibody titers were measured.Frequency of > 4 -fold increase in antibody titers and seroconversion from non-protective prevaccination titers to protective postvaccination titers were recorded. Adverse events were reported.
- Conditions
- Organ Transplantation
- Being tested
- H1N1 vaccine Pandemrix
- Keywords
- 2009 H1N1 influenza vaccine, organ transplant patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H1N1 vaccine PandemrixBiological
| Study group | Role | What they receive |
|---|---|---|
| organ transplant patients | Not described Receives: Biological: H1N1 vaccine Pandemrix | |
| healthy controls | Not described Receives: Biological: H1N1 vaccine Pandemrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of responders in organ transplant patients and controls
Secondary outcomes (1)
Frequency of >4-fold titre rise in organ transplant patients and controls
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startOct 2009
- Primary completionJan 2011
- Study completionAug 2011
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 Organ TransplantationStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanda Friman, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254955
- Sponsor's protocol ID
- ALFGBG-141031
- Status last verified
- Jan 2012
- First submitted
- 6 Dec 2010
- Last updated
- 16 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Felldin M, Studahl M, Svennerholm B, Friman V. The antibody response to pandemic H1N1 2009 influenza vaccine in adult organ transplant patients. Transpl Int. 2012 Feb;25(2):166-71. doi: 10.1111/j.1432-2277.2011.01391.x. Epub 2011 Nov 26.
PubMed 22117586
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients
- ClinicalTrials.gov ID
- NCT01254955
- Acronym / sponsor ID
- ALFGBG-141031
- Conditions
- Organ Transplantation
- Keywords
- 2009 H1N1 influenza vaccine, organ transplant patients
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 7 Dec 2010 (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.
Organ transplant patients and staff members at the Transplant Institute have received pandemic H1N1 influenza vaccine (Pandemrix) and specific antibody production was measured by haemagglutination inhibition according to the clinical guidelines and policy, respectively. This study retrospectively assessed the immune response after vaccination.
Detailed description
A total of 100 organ transplant patients and 36 healthy controls were included in the study. All individuals were vaccinated between October and November 2009 and received 2 doses of Pandemrix. Serum samples were collected at baseline before vaccination and 1 month after the first and second vaccination. Individual hemagglutination-inhibiting serum antibody titers were measured.Frequency of > 4 -fold increase in antibody titers and seroconversion from non-protective prevaccination titers to protective postvaccination titers were recorded. Adverse events were reported.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| organ transplant patients | – | Biological: H1N1 vaccine Pandemrix |
| healthy controls | – | Biological: H1N1 vaccine Pandemrix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Tranplant patients at the out-patient clinical ward and staff members at the Transplant Institute, Sahlgrenska University Hospital.
Key inclusion criteria (2 listed)
- Cohort number 1:Organ transplant patients who were vaccinated and serum sample drawn at baseline.
- Cohort number 2: Staff members who were vaccinated and serum sample drawn at baseline.
Key exclusion criteria (2 listed)
- Cohort number 1: Organ transplant patients who were vaccinated and no serum sample drawn at baseline.
- Cohort number 2: Staff members who were vaccinated and no serum sample drawn at baseline.
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 |
|---|---|---|
| H1N1 vaccine Pandemrix | Biological | healthy controls, organ transplant patients |
Primary outcome
Frequency of responders in organ transplant patients and controls
1 secondary outcome
Frequency of >4-fold titre rise in organ transplant patients and controls
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 16 Jan 2012.
- Results publication: PubMed 22117586Felldin M, Studahl M, Svennerholm B, Friman V. The antibody response to pandemic H1N1 2009 influenza vaccine in adult organ transplant patients. Transpl Int. 2012 Feb;25(2):166-71. doi: 10.1111/j.1432-2277.2011.01391.x. Epub 2011 Nov 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Organ Transplantation, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 2 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 16 Jan 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 Sweden. 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.
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?
Frequency of responders in organ transplant patients and controls. 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 NCT01254955, 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 16 Jan 2012.