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

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.

Study Overview

• Status: Unknown
• Conditions: Immunization; Infection
• Intervention / Treatment: Procedure: Single blood sample collection

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 Type: Observational
• Enrollment (Anticipated): 900

Contacts and Locations

• Study Contact: Name: Mathias Pletz, M.D.; Phone Number: +4936419324667; Email: mathias.pletz@med.uni-jena.de
• Study Contact Backup: Name: Benjamin Schleenvoigt, M.D.; Phone Number: +4936419324652; Email: bejamin.schleenvoigt@med.uni-jena.de

Study Locations

• Germany
  • Thuringia
    • Jena, Thuringia, Germany, 07747
      • Recruiting
      • Center for Infectious Diseases and Infection Control, Jena University Hospital
      • Contact: Benjamin Schleenvoigt, M.D.; Phone Number: +4936419324652; Email: benjamin.schleenvoigt@med.uni-jena.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with verified/complete or non-verified/incomplete vaccination history

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Procedure: Single blood sample collection; Collection of single blood sample of 10 ml volume by venepuncture
Migrants; Single blood sample collection from recent migrants to Germany without verified vaccination records	Procedure: Single blood sample collection; Collection of single blood sample of 10 ml volume by venepuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum sample array compilation	Collection of individual serum samples from participants with different vaccination history	1 year

Collaborators and Investigators

• Sponsor: Jena University Hospital
• Investigators: Principal Investigator: Mathias Pletz, M.D., Center for Infectious Diseases and Infection Control

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Anticipated): March 31, 2018
• Study Completion (Anticipated): March 31, 2018

Study Registration Dates

• First Submitted: April 5, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): May 15, 2017
• Last Update Submitted That Met QC Criteria: May 11, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: StikoSero

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No