Immunization; InfectionStikoSeroNCT03107312
Bioarray for the Serological Assessment of Immunity Against Vaccine-preventable Infections
An observational study of Immunization; Infection, run by Jena University Hospital at 1 site in Germany.
Trial summary
Recent observations in Germany revealed above-average high proportions of refugees affected by infectious diseases of public health significance. Scrutiny of the vaccination status showed sizeable presence of seronegative subjects, with conspicuously higher prevalence among children and adolescents, thus indicating… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immunization; Infection
- What is being tested?
- Single blood sample collection
- Type of treatment
- Vaccines, Surgery or procedure
- How many people
- 900 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2017to 31 Mar 2018
- 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: Subjects with verified/complete or non-verified/incomplete vaccination history
Who may be able to join
- Age above 18 years
- Signed informed consent
Who cannot join
- Acute infectious condition
- Glucocorticoid medication above 0.3 mg/kg Prednisolone equivalent over the preceding 30 days
- Treatment with recognized T cell immunosuppressant or nucleoside analogues during the preceding 90 days
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Center for Infectious Diseases and Infection Control, Jena University Hospital
Jena, Thuringia, 07747
Benjamin Schleenvoigt, M.D., +4936419324652, benjamin.schleenvoigt@med.uni-jena.de
About this study
Official title: Bioarray Compilation for the Serological Assessment of Immunity Against Vaccine-preventable Infections of Available Prophylaxis in Refugees and Immigrants
Recent observations in Germany revealed above-average high proportions of refugees affected by infectious diseases of public health significance. Scrutiny of the vaccination status showed sizeable presence of seronegative subjects, with conspicuously higher prevalence among children and adolescents, thus indicating urgent necessity of i) rapid identification of carriers of vaccine-preventable diseases and ii) adjustment of protection against such infections to European Standards. Rapid immune status check needs comprehensive diagnostic tool permitting simultaneous assessment of seropositivity. Validation of such tools requires comparisons of the immune status of subjects with known vaccination history with that of migrants with incomplete or missing health and vaccination records.
Read the detailed description
The current massive inflow of refugees and migrants poses urgent necessity of i) rapid identification of carriers of communicable diseases and ii) adjustment of protection against vaccine-preventable infections to European standards. While universal vaccination is supposed to ensure the intended degree of protection, targeted vaccination on the basis of previous assessment of the immune status (seropositivity) was repeatedly shown to be a cost-efficient alternative. Currently, the broad use of immune status assessment prior to targeted vaccination is impeded by the necessity to apply separate seropositivity detection assays for each individual condition. This drawback can be overcome by the introduction of a comprehensive diagnostic tool permitting simultaneous assessment of seropositivity for several vaccine-preventable infections.
The objective of the present study consists in compilation of an array of sera from
- subjects with known history of immunization against vaccine-preventable infections for which vaccines are routinely available (measles, mumps, rubella, varicella, tetanus, pertussis, poliomyelitis, diphtheria, meningococcal infection) and
- new migrants/refugees without reliable vaccination records and undefined immune status to be subsequently used for the validation of a multi-pronged diagnostic tool for seropositivity detection
- Conditions
- Immunization; Infection
- Being tested
- Single blood sample collection
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single blood sample collectionProcedure or surgery
Collection of single blood sample of 10 ml volume by venepuncture
| Study group | Role | What they receive |
|---|---|---|
| Known vaccination history | Single blood sample collection from subjects with verified records of vaccination or recent booster immunization against measles, mumps, rubella, varicella, tetanus, pertussis, poliomyelitis, diphtheria, meningococcal infection Receives: Procedure: Single blood sample collection | |
| Migrants | Single blood sample collection from recent migrants to Germany without verified vaccination records Receives: Procedure: Single blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum sample array compilation
Collection of individual serum samples from participants with different vaccination history
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start1 Apr 2017
- Primary completion31 Mar 2018 (estimated)
- Study completion31 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunization; InfectionStudies 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
- Cross-sectional
- Enrolment
- 900 participants (estimated)
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, M.D., Principal investigator, Center for Infectious Diseases and Infection Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107312
- Sponsor's protocol ID
- StikoSero
- Acronym
- StikoSero
- Status last verified
- May 2017
- First submitted
- 5 Apr 2017
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioarray Compilation for the Serological Assessment of Immunity Against Vaccine-preventable Infections of Available Prophylaxis in Refugees and Immigrants
- ClinicalTrials.gov ID
- NCT03107312
- Acronym / sponsor ID
- StikoSero / StikoSero
- Conditions
- Immunization; Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Mar 2018 (estimated)
- Study completion
- 31 Mar 2018 (estimated)
- First posted
- 11 Apr 2017 (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.
Recent observations in Germany revealed above-average high proportions of refugees affected by infectious diseases of public health significance. Scrutiny of the vaccination status showed sizeable presence of seronegative subjects, with conspicuously higher prevalence among children and adolescents, thus indicating urgent necessity of i) rapid identification of carriers of vaccine-preventable diseases and ii) adjustment of protection against such infections to European Standards. Rapid immune status check needs comprehensive diagnostic tool permitting simultaneous assessment of seropositivity. Validation of such tools requires comparisons of the immune status of subjects with known vaccination history with that of migrants with incomplete or missing health and vaccination records.
Detailed description
The current massive inflow of refugees and migrants poses urgent necessity of i) rapid identification of carriers of communicable diseases and ii) adjustment of protection against vaccine-preventable infections to European standards. While universal vaccination is supposed to ensure the intended degree of protection, targeted vaccination on the basis of previous assessment of the immune status (seropositivity) was repeatedly shown to be a cost-efficient alternative. Currently, the broad use of immune status assessment prior to targeted vaccination is impeded by the necessity to apply separate seropositivity detection assays for each individual condition. This drawback can be overcome by the introduction of a comprehensive diagnostic tool permitting simultaneous assessment of seropositivity for several vaccine-preventable infections.
The objective of the present study consists in compilation of an array of sera from
- subjects with known history of immunization against vaccine-preventable infections for which vaccines are routinely available (measles, mumps, rubella, varicella, tetanus, pertussis, poliomyelitis, diphtheria, meningococcal infection) and
- new migrants/refugees without reliable vaccination records and undefined immune status to be subsequently used for the validation of a multi-pronged diagnostic tool for seropositivity detection
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Known vaccination history | – | Procedure: Single blood sample collectionSingle blood sample collection from subjects with verified records of vaccination or recent booster immunization against measles, mumps, rubella, varicella, tetanus, pertussis, poliomyelitis, diphtheria, meningococcal infection |
| Migrants | – | Procedure: Single blood sample collectionSingle blood sample collection from recent migrants to Germany without verified vaccination records |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with verified/complete or non-verified/incomplete vaccination history
Key inclusion criteria (2 listed)
- Age above 18 years
- Signed informed consent
Key exclusion criteria (3 listed)
- Acute infectious condition
- Glucocorticoid medication above 0.3 mg/kg Prednisolone equivalent over the preceding 30 days
- Treatment with recognized T cell immunosuppressant or nucleoside analogues during the preceding 90 days
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 |
|---|---|---|
| Single blood sample collectionCollection of single blood sample of 10 ml volume by venepuncture | Procedure or surgery | Known vaccination history, Migrants |
Primary outcome
Serum sample array compilation
Time frame: 1 year
Collection of individual serum samples from participants with different vaccination history
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Individual participant dataSharing planned: No
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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, M.D. principal investigator
Center for 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?
An observational study of Immunization; Infection, 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 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 15 May 2017. 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.
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 Mathias Pletz, M.D. (+4936419324667, mathias.pletz@med.uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum sample array compilation (time frame: 1 year). 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 15 May 2017.