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

• Conditions: Immunization; Infection
• Interventions: Procedure: Single blood sample collection

• Registration Number: NCT03107312
• Lead Sponsor: Jena University Hospital

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

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-04-05
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-11
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-11
• Last Update Posted: 2017-05-15
• Primary Completion: 2018-03-31
• Study Completion: 2018-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 900

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Known vaccination history	Single blood sample collection	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	Single blood sample collection from recent migrants to Germany without verified vaccination records

Primary Outcome Measures

Name	Time	Method
Serum sample array compilation	1 year	Collection of individual serum samples from participants with different vaccination history

Trial Locations

Locations (1)

Center for Infectious Diseases and Infection Control, Jena University Hospital; 🇩🇪 Jena, Thuringia, Germany