Immunogenicity, VaccineNCT03405805
Immunological Memory Against Pneumococcus Induced by 3 Infant PCV 13 Vaccination Schedules
An observational study of Immunogenicity, Vaccine and Immunologic Memory, run by Aghia Sophia Children's Hospital of Athens at 1 site in Greece.
Trial summary
The purpose of this study is to evaluate the establishment of immunological memory between the 3 different infant vaccination schedules with the 13-valent pneumococcal conjugate vaccine (PCV13) currently in use. Read more about this study
- Who is it for?
- Ages 2 to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Immunogenicity, Vaccine, Immunologic Memory
- What is being tested?
- 13-valent pneumococcal conjugate vaccine (PCV13)
- Type of treatment
- Vaccines
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 12 Dec 2016to Dec 2019
- 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 2 to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy infants 2-15 months of age living in Athens, Greece
Who may be able to join
- 2-15 months of age
Who cannot join
- previously recorded allergy to PCV
- intravenous immunoglobulin (IVIG) given within the previous 6 months
- primary or secondary immunodeficiency
- any chronic medical condition
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
'Aghia Sophia' Children's Hospital
Athens, Attica, 11527
Vana Spoulou, 00302107467620
Irene Tzovara, MD
About this study
Official title: The Establishment of Serotype-specific Immunological Memory Against Pneumococcus by a 3+1 Versus a 2+1 or 3+0 Infant PCV13 Vaccination Schedule
The purpose of this study is to evaluate the establishment of immunological memory between the 3 different infant vaccination schedules with the 13-valent pneumococcal conjugate vaccine (PCV13) currently in use. We aim to determine the optimal schedule for the establishment of antigen-specific memory B-cell pool, which may serve as a correlate for longevity of immunological memory against vaccine serotypes. Moreover, we will study the transcriptome profiles expressed by peripheral lymphocytes during each immune response in an attempt to reveal immunological mechanisms beyond the antibody and circulating B cells level.
- Conditions
- Immunogenicity, Vaccine, Immunologic Memory
- Being tested
- 13-valent pneumococcal conjugate vaccine (PCV13)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13-valent pneumococcal conjugate vaccine (PCV13)Biological
Also called Prevenar13
Vaccination with PCV13
| Study group | Role | What they receive |
|---|---|---|
| 3+1 | Healthy infants will receive 4 doses of the 13-valent pneumococcal conjugate vaccine (PCV13) at 2,4,6 and 12 months of age and blood and serum collection pre- dose, 7 days post- (only blood) and 28 days post- last dose. Receives: Biological: 13-valent pneumococcal conjugate vaccine (PCV13) | |
| 3+0 | Healthy infants will receive 3 doses of the 13-valent pneumococcal conjugate vaccine (PCV13) at 2,4 and 6 months of age and blood and serum collection pre- dose, 7 days post- (only blood) and 28 days post- last dose. Receives: Biological: 13-valent pneumococcal conjugate vaccine (PCV13) | |
| 2+1 | Healthy infants will receive 3 doses of the 13-valent pneumococcal conjugate vaccine (PCV13) at 2,4 and 12 months of age and blood and serum collection pre- dose, 7 days post- (only blood) and 28 days post- last dose. Receives: Biological: 13-valent pneumococcal conjugate vaccine (PCV13) |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunoglobulin G (IgG) antibody serum titers (measured by ELISA)
measurement of IgG antibody titers in serum pre- and post- last dose of PCV13
Measured: 28 days post last vaccine dose
switched immunoglobulin G (swIgG) B memory cell response (measured by flow cytometry)
phenotype characterisation of swIgG memory B cells pre- and post- last dose of PCV13
Measured: 28 days post last vaccine dose
immunoglobulin M (IgM) B memory cell response (measured by flow cytometry)
phenotype characterisation of IgM memory B cells pre- and post- last dose of PCV13
Measured: 28 days post last vaccine dose
Secondary outcomes (1)
Transcriptional profile of Peripheral Blood Mononuclear Cells (PBMC) in response to PCV13 (measured by RNA-Sequencing)
transcriptome analysis of PBMCs pre- and post last dose of PCV13 on a cohort of patients
Measured: 7 days post last vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start12 Dec 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunogenicity, VaccineStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
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
- Investigators
- Vana Spoulou, MD, PhD, Study chair, "Aghia Sophia" Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405805
- Sponsor's protocol ID
- isppd2018
- Status last verified
- Jan 2018
- First submitted
- 15 Jan 2018
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Establishment of Serotype-specific Immunological Memory Against Pneumococcus by a 3+1 Versus a 2+1 or 3+0 Infant PCV13 Vaccination Schedule
- ClinicalTrials.gov ID
- NCT03405805
- Acronym / sponsor ID
- isppd2018
- Conditions
- Immunogenicity, Vaccine, Immunologic Memory
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aghia Sophia Children's Hospital of AthensUniversity, hospital or other
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 23 Jan 2018 (actual)
- 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 evaluate the establishment of immunological memory between the 3 different infant vaccination schedules with the 13-valent pneumococcal conjugate vaccine (PCV13) currently in use. We aim to determine the optimal schedule for the establishment of antigen-specific memory B-cell pool, which may serve as a correlate for longevity of immunological memory against vaccine serotypes. Moreover, we will study the transcriptome profiles expressed by peripheral lymphocytes during each immune response in an attempt to reveal immunological mechanisms beyond the antibody and circulating B cells level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3+1 | – | Biological: 13-valent pneumococcal conjugate vaccine (PCV13)Healthy infants will receive 4 doses of the 13-valent pneumococcal conjugate vaccine (PCV13) at 2,4,6 and 12 months of age and blood and serum collection pre- dose, 7 days post- (only blood) and 28 days post- last dose. |
| 3+0 | – | Biological: 13-valent pneumococcal conjugate vaccine (PCV13)Healthy infants will receive 3 doses of the 13-valent pneumococcal conjugate vaccine (PCV13) at 2,4 and 6 months of age and blood and serum collection pre- dose, 7 days post- (only blood) and 28 days post- last dose. |
| 2+1 | – | Biological: 13-valent pneumococcal conjugate vaccine (PCV13)Healthy infants will receive 3 doses of the 13-valent pneumococcal conjugate vaccine (PCV13) at 2,4 and 12 months of age and blood and serum collection pre- dose, 7 days post- (only blood) and 28 days post- last dose. |
Who may qualify
- Ages
- 2 to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy infants 2-15 months of age living in Athens, Greece
Key inclusion criteria (1 listed)
- 2-15 months of age
Key exclusion criteria (4 listed)
- previously recorded allergy to PCV
- intravenous immunoglobulin (IVIG) given within the previous 6 months
- primary or secondary immunodeficiency
- any chronic medical condition
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 |
|---|---|---|
| 13-valent pneumococcal conjugate vaccine (PCV13)Also: Prevenar13Vaccination with PCV13 | Biological | 2+1, 3+0, 3+1 |
Primary outcome
immunoglobulin G (IgG) antibody serum titers (measured by ELISA)
Time frame: 28 days post last vaccine dose
measurement of IgG antibody titers in serum pre- and post- last dose of PCV13
switched immunoglobulin G (swIgG) B memory cell response (measured by flow cytometry)
Time frame: 28 days post last vaccine dose
phenotype characterisation of swIgG memory B cells pre- and post- last dose of PCV13
immunoglobulin M (IgM) B memory cell response (measured by flow cytometry)
Time frame: 28 days post last vaccine dose
phenotype characterisation of IgM memory B cells pre- and post- last dose of PCV13
1 secondary outcome
Transcriptional profile of Peripheral Blood Mononuclear Cells (PBMC) in response to PCV13 (measured by RNA-Sequencing)
Time frame: 7 days post last vaccine dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
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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.
Vana Spoulou, MD, PhD study chair
"Aghia Sophia" Children's Hospital
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 Immunogenicity, Vaccine and Immunologic Memory, 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 1 inclusion and 4 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 23 Jan 2018. 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.
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?
Contact Irene Tzovara, MD (0030 2107467620, itzovara@med.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immunoglobulin G (IgG) antibody serum titers (measured by ELISA) (time frame: 28 days post last vaccine dose). The study lists 3 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 23 Jan 2018.