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Bioarray for the Serological Assessment of Immunity Against Vaccine-preventable Infections

Bioarray Compilation for the Serological Assessment of Immunity Against Vaccine-preventable Infections of Available Prophylaxis in Refugees and Immigrants

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03107312
Acronym
StikoSero
Enrollment
900
Registered
2017-04-11
Start date
2017-04-01
Completion date
2018-03-31
Last updated
2017-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunization; Infection

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.

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

Interventions

PROCEDURESingle blood sample collection

Collection of single blood sample of 10 ml volume by venepuncture

Sponsors

Jena University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age above 18 years * Signed informed consent

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Serum sample array compilation1 yearCollection of individual serum samples from participants with different vaccination history

Countries

Germany

Contacts

Primary ContactMathias Pletz, M.D.
mathias.pletz@med.uni-jena.de+4936419324667
Backup ContactBenjamin Schleenvoigt, M.D.
bejamin.schleenvoigt@med.uni-jena.de+4936419324652

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026