Pneumococcal InfectionsPhase 4NCT02637583
Sequential Versus Simultaneous Pneumococcal Vaccination in Elderly: Immunological Memory and Antibody Levels
A Phase 4 study testing PCV13 and PPV23 in people with Pneumococcal Infections, run by Jena University Hospital at 1 site in Germany.
Trial summary
The purpose of the present study is to compare the immunological response of pneumococcal serotype specific B-cells, the humoral immune response and safety after sequential vaccination versus simultaneous vaccination with 13-valent pneumococcal conjugate vaccine (PCV13) and 23-valent polysaccharide vaccine (PPV23)… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- PCV13 and PPV23
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteGermany
- Study dates
- 18 Oct 2017to 6 Nov 2023
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Unvaccinated adults >= 60 years
- Written informed consent
Who cannot join
- Hypersensitivity against substances included in both vaccines
- Previous pneumococcal vaccination
- Pneumonia within the last two months
- Active infection
- Autoimmune disease
- Ongoing or planned immunosuppressive therapy (including corticosteroid treatment with prednisolon equivalent dose >= 5 mg/d)
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- Active malignant disease
- Drug abuse or alcoholic abuse
- Expectation of life < 2 years
- Coagulation disorders
- Burns or injury on the injection site
- Plegia or paresis of extremity where injection is planned
- Shock
- parallel participation in other clinical trial with intervention
- Infusion of blood products within the last half year
Trial locations and contacts
1 site in 1 country.
Germany1 site
Center of Infectious Diseases and Infection Control, Jena University Hospital
Jena
About this study
Official title: Sequential Versus Simultaneous Vaccination With Pneumococcal Conjugate Vaccine (Prevenar 13) and Pneumococcal Polysaccharide Vaccine (Pneumovax 23) in Elderly: Immunological Memory and Antibody Levels
The purpose of the present study is to compare the immunological response of pneumococcal serotype specific B-cells, the humoral immune response and safety after sequential vaccination versus simultaneous vaccination with 13-valent pneumococcal conjugate vaccine (PCV13) and 23-valent polysaccharide vaccine (PPV23) versus single vaccination with PPV23 in a prospective, randomized controlled monocentric head-to head clinical study in elderly. The hypothesis of this study is that simultaneous vaccination with PCV13 and PPV23 might achieve an improved immune-response compared to sequential vaccination or single vaccination.
Adults >=60 years without previous pneumococcal vaccination will be randomized in three groups and receive either PCV13 on day 0 plus PPV23 6 months later (sequential vaccination) or they receive PCV13 plus PPV23 simultaneous on day 0 (simultaneous vaccination) or they receive PPV23 on day 0 (single vaccination). Blood will be taken for pneumococcal serotype-specific B-memory cells against four vaccine-serotypes (ST), included in PCV13 and PPV23, vaccine-serotype 3 (ST3), vaccine-serotype 14 (ST14), vaccine-serotype 19A (ST19A) and vaccine-serotype 23F (ST23F) at visit 1, 2,4,5,7 and 8 and for antibody levels against the 12 vaccine-serotypes included in PCV13 and PPV23 at visit 1, 3, 4, 6, 7 and 8 in all three groups. Adverse events will be recorded for 28 days after each vaccination.
- Conditions
- Pneumococcal Infections
- Being tested
- PCV13, PPV23
- Keywords
- conjugate vaccine, polysaccharide vaccine
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCV13Drug
Also called Prevenar 13
Intramuscular injection of 13-valent pneumococcal conjugate vaccine once
PPV23Drug
Also called Pneumovax (MSD)
Intramuscular injection of 23-valent pneumococcal polysaccharide vaccine once
| Study group | Role | What they receive |
|---|---|---|
| Sequential vaccination PCV13 and PPV23 | Active comparator | PCV13 0.5 ml intramuscular injection once on day 0 PPV23 0.5 ml intramuscular injection once 6 months later Receives: Drug: PCV13; Drug: PPV23 |
| Simultaneous vaccination PCV13 and PPV23 | Experimental | PCV13 0.5ml intramuscular injection once on day 0 followed by PPV23 0.5ml intramuscular injection on day 0 Receives: Drug: PCV13; Drug: PPV23 |
| Single vaccinationPPV23 | Active comparator | PPV23 0.5ml intramuscular injection on day 0 Receives: Drug: PPV23 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response of B-memory cells
Change of immune response of B memory cells against 4 pneumococcal serotypes ST3,ST14,ST19A und ST23F compared to day 0 will be determined by multiparameter flow cytometry. Pneumococcal specific B-cells will be identified by labeling with fluorochrome-coupled polysaccharide antigen, B-memory cells will be identified by expression of characteristic membrane proteins and quantified.
Measured: 27-28 weeks after first vaccination
Secondary outcomes (3)
Immune response of B-memory cells
Change immune response of B memory cells against 4 pneumococcal serotypes ST3,ST14,ST19A und ST23F compared to day 0 will be determined by multiparameter flow cytometry. Pneumococcal specific B-cells will be identified by labeling with fluorochrome-coupled polysaccharide antigen, B-memory cells will be identified by expression of characteristic membrane proteins and quantified.
Measured: 1-2 weeks, 26 weeks, 52 weeks, 104 weeks
Humoral immune response
Change of serotype-specific immunoglobulin G concentrations against 12 pneumococcal vaccine-serotypes included in both vaccines PCV13 and PPV23 compared to day 0
Measured: 4 weeks, 26 weeks, 30 weeks, 52 weeks, 104 weeks
Safety (Adverse events and serious adverse events)
Adverse events and serious adverse events
Measured: 28 days after each vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study start18 Oct 2017
- Primary completion7 Nov 2022
- Study completion6 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal InfectionsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathias Pletz, Jena University Hospital
- Investigators
- Mathias Pletz, MD, PhD, Principal investigator, University Hospital of Jena, Center of Infectious Diseases and Infection Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637583
- Sponsor's protocol ID
- EudraCT 2014-004013-85
- Status last verified
- Nov 2023
- First submitted
- 21 Oct 2015
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Versus Simultaneous Vaccination With Pneumococcal Conjugate Vaccine (Prevenar 13) and Pneumococcal Polysaccharide Vaccine (Pneumovax 23) in Elderly: Immunological Memory and Antibody Levels
- ClinicalTrials.gov ID
- NCT02637583
- Acronym / sponsor ID
- EudraCT 2014-004013-85
- Conditions
- Pneumococcal Infections
- Keywords
- conjugate vaccine, polysaccharide vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 6 Nov 2023 (actual)
- First posted
- 22 Dec 2015 (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 the present study is to compare the immunological response of pneumococcal serotype specific B-cells, the humoral immune response and safety after sequential vaccination versus simultaneous vaccination with 13-valent pneumococcal conjugate vaccine (PCV13) and 23-valent polysaccharide vaccine (PPV23) versus single vaccination with PPV23 in a prospective, randomized controlled monocentric head-to head clinical study in elderly. The hypothesis of this study is that simultaneous vaccination with PCV13 and PPV23 might achieve an improved immune-response compared to sequential vaccination or single vaccination.
Adults >=60 years without previous pneumococcal vaccination will be randomized in three groups and receive either PCV13 on day 0 plus PPV23 6 months later (sequential vaccination) or they receive PCV13 plus PPV23 simultaneous on day 0 (simultaneous vaccination) or they receive PPV23 on day 0 (single vaccination). Blood will be taken for pneumococcal serotype-specific B-memory cells against four vaccine-serotypes (ST), included in PCV13 and PPV23, vaccine-serotype 3 (ST3), vaccine-serotype 14 (ST14), vaccine-serotype 19A (ST19A) and vaccine-serotype 23F (ST23F) at visit 1, 2,4,5,7 and 8 and for antibody levels against the 12 vaccine-serotypes included in PCV13 and PPV23 at visit 1, 3, 4, 6, 7 and 8 in all three groups. Adverse events will be recorded for 28 days after each vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequential vaccination PCV13 and PPV23 | Active comparator | Drug: PCV13, Drug: PPV23PCV13 0.5 ml intramuscular injection once on day 0 PPV23 0.5 ml intramuscular injection once 6 months later |
| Simultaneous vaccination PCV13 and PPV23 | Experimental | Drug: PCV13, Drug: PPV23PCV13 0.5ml intramuscular injection once on day 0 followed by PPV23 0.5ml intramuscular injection on day 0 |
| Single vaccinationPPV23 | Active comparator | Drug: PPV23PPV23 0.5ml intramuscular injection on day 0 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Unvaccinated adults >= 60 years
- Written informed consent
Key exclusion criteria (15 listed)
- Hypersensitivity against substances included in both vaccines
- Previous pneumococcal vaccination
- Pneumonia within the last two months
- Active infection
- Autoimmune disease
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 |
|---|---|---|
| PCV13Also: Prevenar 13Intramuscular injection of 13-valent pneumococcal conjugate vaccine once | Drug | Sequential vaccination PCV13 and PPV23, Simultaneous vaccination PCV13 and PPV23 |
| PPV23Also: Pneumovax (MSD)Intramuscular injection of 23-valent pneumococcal polysaccharide vaccine once | Drug | Sequential vaccination PCV13 and PPV23, Simultaneous vaccination PCV13 and PPV23, Single vaccinationPPV23 |
Primary outcome
Immune response of B-memory cells
Time frame: 27-28 weeks after first vaccination
Change of immune response of B memory cells against 4 pneumococcal serotypes ST3,ST14,ST19A und ST23F compared to day 0 will be determined by multiparameter flow cytometry. Pneumococcal specific B-cells will be identified by labeling with fluorochrome-coupled polysaccharide antigen, B-memory cells will be identified by expression of characteristic membrane proteins and quantified.
3 secondary outcomes
Immune response of B-memory cells
Time frame: 1-2 weeks, 26 weeks, 52 weeks, 104 weeks
Humoral immune response
Time frame: 4 weeks, 26 weeks, 30 weeks, 52 weeks, 104 weeks
Safety (Adverse events and serious adverse events)
Time frame: 28 days after each 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 1 Dec 2023.
Related trials for Pneumococcal Infections
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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.
Mathias Pletz, MD, PhD principal investigator
University Hospital of Jena, Center of Infectious Diseases and Infection Control
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 and PPV23 in people with Pneumococcal Infections, run by Jena University Hospital at 1 site in Germany.
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 15 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 1 Dec 2023. 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 Germany. 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?
Immune response of B-memory cells (time frame: 27-28 weeks after first vaccination). 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 1 Dec 2023.