AspleniaPhase 4NCT01846923
B Memory Cell Response to Vaccination With the 13-valent Pneumococcal Conjugate Vaccine in Asplenic Individuals
A Phase 4 study testing PCV13 in people with Asplenia and β-thalassemia Major, run by Aghia Sophia Children's Hospital of Athens at 1 site in Greece.
Trial summary
The purpose of this study is to determine whether one dose of the 13-valent pneumococcal conjugate vaccine (PCV13) induces immunological memory in asplenic adults and whether previously administered immunizations with the 23-valent polysaccharide pneumococcal vaccine influence the cellular immune response to PCV13 in… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asplenia, β-thalassemia Major
- What is being tested?
- PCV13
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2010to Feb 2012
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Asplenia
- β-thalassemia major
- older than 18 years
Who cannot join
- no previously recorded allergy to PCV
- no intravenous immunoglobulin (IVIG) given within the previous 6 months
- no other vaccine given within the previous 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the B Memory Cell Response to Vaccination With the 13-valent Pneumococcal Conjugate Vaccine in Asplenic Individuals With Beta-thalassemia Major
The purpose of this study is to determine whether one dose of the 13-valent pneumococcal conjugate vaccine (PCV13) induces immunological memory in asplenic adults and whether previously administered immunizations with the 23-valent polysaccharide pneumococcal vaccine influence the cellular immune response to PCV13 in this group.
- Conditions
- Asplenia, β-thalassemia Major
- Being tested
- PCV13
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCV13Biological
| Study group | Role | What they receive |
|---|---|---|
| PCV13 | Experimental | Not described Receives: Biological: PCV13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by ELISpot)
Measured: One month post-PCV13
immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by ELISpot)
Measured: one month post PCV13
Secondary outcomes (1)
Maintenance of B memory cells three years after PCV13 vaccination
Measured: three years after study vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2013 (estimated)
- Study startOct 2010
- Primary completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AspleniaStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aghia Sophia Children's Hospital of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vana Spoulou, Aghia Sophia Children's Hospital of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846923
- Sponsor's protocol ID
- 51657MoH
- Status last verified
- May 2013
- First submitted
- 29 Apr 2013
- Last updated
- 6 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Papadatou I, Lagousi T, Kattamis A, Spoulou V. Antibody persistence 5 years after a 13-valent pneumococcal conjugate vaccine in asplenic patients with beta-thalassemia: assessing the need for booster. Ann Hematol. 2019 Mar;98(3):775-779. doi: 10.1007/s00277-019-03615-z. Epub 2019 Jan 25.
PubMed 30683996Papadatou I, Piperi C, Alexandraki K, Kattamis A, Theodoridou M, Spoulou V. Antigen-specific B-cell response to 13-valent pneumococcal conjugate vaccine in asplenic individuals with beta-thalassemia previously immunized with 23-valent pneumococcal polysaccharide vaccine. Clin Infect Dis. 2014 Sep 15;59(6):862-5. doi: 10.1093/cid/ciu409. Epub 2014 May 30.
PubMed 24879786
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the B Memory Cell Response to Vaccination With the 13-valent Pneumococcal Conjugate Vaccine in Asplenic Individuals With Beta-thalassemia Major
- ClinicalTrials.gov ID
- NCT01846923
- Acronym / sponsor ID
- 51657MoH
- Conditions
- Asplenia, β-thalassemia Major
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Aghia Sophia Children's Hospital of AthensUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Feb 2012 (actual)
- First posted
- 6 May 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 determine whether one dose of the 13-valent pneumococcal conjugate vaccine (PCV13) induces immunological memory in asplenic adults and whether previously administered immunizations with the 23-valent polysaccharide pneumococcal vaccine influence the cellular immune response to PCV13 in this group.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCV13 | Experimental | Biological: PCV13 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Asplenia
- β-thalassemia major
- older than 18 years
Key exclusion criteria (3 listed)
- no previously recorded allergy to PCV
- no intravenous immunoglobulin (IVIG) given within the previous 6 months
- no other vaccine given within the previous 6 months
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 |
|---|---|---|
| PCV13 | Biological | PCV13 |
Primary outcome
immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by ELISpot)
Time frame: One month post-PCV13
immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by ELISpot)
Time frame: one month post PCV13
1 secondary outcome
Maintenance of B memory cells three years after PCV13 vaccination
Time frame: three years after study vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2013.
- Derived from this study: PubMed 30683996Papadatou I, Lagousi T, Kattamis A, Spoulou V. Antibody persistence 5 years after a 13-valent pneumococcal conjugate vaccine in asplenic patients with beta-thalassemia: assessing the need for booster. Ann Hematol. 2019 Mar;98(3):775-779. doi: 10.1007/s00277-019-03615-z. Epub 2019 Jan 25.
- Derived from this study: PubMed 24879786Papadatou I, Piperi C, Alexandraki K, Kattamis A, Theodoridou M, Spoulou V. Antigen-specific B-cell response to 13-valent pneumococcal conjugate vaccine in asplenic individuals with beta-thalassemia previously immunized with 23-valent pneumococcal polysaccharide vaccine. Clin Infect Dis. 2014 Sep 15;59(6):862-5. doi: 10.1093/cid/ciu409. Epub 2014 May 30.
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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?
A Phase 4 study testing PCV13 in people with Asplenia and β-thalassemia Major, run by Aghia Sophia Children's Hospital of Athens at 1 site in Greece.
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 3 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: status not confirmed, as of the sponsor's last update on 6 May 2013. 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 Greece. 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?
Results are not available in the source record.
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?
immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by ELISpot) (time frame: One month post-PCV13). 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?
On the ClinicalTrials.gov record for NCT01846923, which also lists 2 linked publications.
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 6 May 2013.