Humoral and Cellular Response in Shift Workers

F

Federal University of São Paulo

Status

Completed

Conditions

Other Condition That May be a Focus of Clinical Attention

Treatments

Biological: Vaccination against hepatitis A
Other: No Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT01528280
CEPE2012FRuiz

Details and patient eligibility

About

The purpose of this study is to access whether shift workers (morning, afternoon or night) vaccinated against hepatitis A would have some humoral and cellular response impairment.

Full description

Sleep regulates immune functions. In this sense, we asked whether shift workers (morning, afternoon or night) vaccinated against hepatitis A would have some humoral and cellular response impairment. Men (18 to 55 years) will be recruited through different forms of media (electronic, newspapers, radio and magazines). The shift workers sleep pattern will be recorded polysomnographically. Subsequently, the volunteers will be underwent vaccination against hepatitis A (2 doses) and after 30, 60 and 90 days, blood samples will be collected to assess the humoral response in the experimental groups. The hormones prolactin, growth hormone, cortisol, adrenaline and noradrenaline will also be evaluated. Indeed, stimulations in culture will be conducted to assess the cellular response profile against the vaccination through the production assessment of IL-4, IFN-γ, IL-2 and TNF-α.

Enrollment

34 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • shift workers
  • naive immune status against hepatitis A confirmed by hepatitis A virus (HAV) antibodies levels below 5 mIU/mL

Exclusion criteria

  • smokers
  • individuals with complaints and/or sleep disorders
  • acute or chronic disease
  • use of medication during the study period.
  • acute illnesses

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

34 participants in 1 patient group

Shiftwork
Experimental group
Description:
The comparison will consider nightworkers versus dayworkers.
Treatment:
Other: No Intervention
Biological: Vaccination against hepatitis A

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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