Bioarray for the Serological Assessment of Immunity Against Vaccine-preventable Infections
StikoSero
Bioarray Compilation for the Serological Assessment of Immunity Against Vaccine-preventable Infections of Available Prophylaxis in Refugees and Immigrants
1 other identifier
observational
900
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 5, 2017
CompletedFirst Posted
Study publicly available on registry
April 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2018
CompletedMay 15, 2017
May 1, 2017
12 months
April 5, 2017
May 11, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Serum sample array compilation
Collection of individual serum samples from participants with different vaccination history
1 year
Study Arms (2)
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
Migrants
Single blood sample collection from recent migrants to Germany without verified vaccination records
Interventions
Collection of single blood sample of 10 ml volume by venepuncture
Eligibility Criteria
Subjects with verified/complete or non-verified/incomplete vaccination history
You may qualify if:
- Age above 18 years
- Signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Infectious Diseases and Infection Control, Jena University Hospital
Jena, Thuringia, 07747, Germany
Biospecimen
Serum
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Mathias Pletz, M.D.
Center for Infectious Diseases and Infection Control
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Center for Infectious Diseass and Infection Control
Study Record Dates
First Submitted
April 5, 2017
First Posted
April 11, 2017
Study Start
April 1, 2017
Primary Completion
March 31, 2018
Study Completion
March 31, 2018
Last Updated
May 15, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share