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

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ClinicalTrials.gov Identifier: NCT03107312
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
Mathias Pletz, 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.

Condition or disease Intervention/treatment
Immunization; Infection 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

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Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Bioarray Compilation for the Serological Assessment of Immunity Against Vaccine-preventable Infections of Available Prophylaxis in Refugees and Immigrants
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : March 31, 2018
Estimated Study Completion Date : March 31, 2018

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




Primary Outcome Measures :
  1. Serum sample array compilation [ Time Frame: 1 year ]
    Collection of individual serum samples from participants with different vaccination history


Biospecimen Retention:   Samples Without DNA
Serum


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects with verified/complete or non-verified/incomplete vaccination history
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03107312


Contacts
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Contact: Mathias Pletz, M.D. +4936419324667 mathias.pletz@med.uni-jena.de
Contact: Benjamin Schleenvoigt, M.D. +4936419324652 bejamin.schleenvoigt@med.uni-jena.de

Locations
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Germany
Center for Infectious Diseases and Infection Control, Jena University Hospital Recruiting
Jena, Thuringia, Germany, 07747
Contact: Benjamin Schleenvoigt, M.D.    +4936419324652    benjamin.schleenvoigt@med.uni-jena.de   
Sponsors and Collaborators
Jena University Hospital
Investigators
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Principal Investigator: Mathias Pletz, M.D. Center for Infectious Diseases and Infection Control

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Responsible Party: Mathias Pletz, Director, Center for Infectious Diseass and Infection Control, Jena University Hospital
ClinicalTrials.gov Identifier: NCT03107312     History of Changes
Other Study ID Numbers: StikoSero
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs