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

Immunization; Infection Clinical Trial

— StikoSero  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03107312
• Other study ID #: StikoSero
• Status: Recruiting
• Phase: N/A
• First received: April 5, 2017
• Last updated: May 11, 2017
• Start date: April 1, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: May 2017
• Source: Jena University Hospital
• Contact: Mathias Pletz, M.D.
• Phone: +4936419324667
• Email: mathias.pletz[@]med.uni-jena.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Immunization; Infection
• Infection

Intervention

Procedure:
• Single blood sample collection
Collection of single blood sample of 10 ml volume by venepuncture

Locations

Country	Name	City	State
Germany	Center for Infectious Diseases and Infection Control, Jena University Hospital	Jena	Thuringia

Sponsors (1)

Lead Sponsor	Collaborator
Jena University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum sample array compilation	Collection of individual serum samples from participants with different vaccination history	1 year