Clinical trial NCT03107312: Bioarray for the Serological Assessment of Immunity Against Vaccine-preventable Infections
Official title: Bioarray Compilation for the Serological Assessment of Immunity Against Vaccine-preventable Infections of Available Prophylaxis in Refugees and Immigrants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Immunization; Infection
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with verified/complete or non-verified/incomplete vaccination history

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

Eligibility 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

Primary outcomes:
measure: Serum sample array compilation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Center for Infectious Diseases and Infection Control, Jena University Hospital
state: Thuringia
Study officials:
affiliation: Center for Infectious Diseases and Infection Control
name: Mathias Pletz, M.D.
role: PRINCIPAL_INVESTIGATOR
References: