Clinical Trials Directory

Trials / Completed

CompletedNCT01528280

Humoral and Cellular Response in Shift Workers

Vaccination Against Hepatitis A Virus in Shift Workers: Evaluation of the Humoral and Cellular Immune Response

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
34 (actual)
Sponsor
Federal University of São Paulo · Academic / Other
Sex
Male
Age
18 Years – 55 Years
Healthy volunteers
Accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALVaccination against hepatitis AVaccination against hepatitis A (2 doses) into the deltoid muscle of the nondominant arm twice, i.e., at 0 and 6 months.
OTHERNo InterventionNo Intervention

Timeline

Start date
2013-01-01
Primary completion
2014-09-01
Completion
2016-12-01
First posted
2012-02-08
Last updated
2018-01-11

Locations

2 sites across 1 country: Brazil

Source: ClinicalTrials.gov record NCT01528280. Inclusion in this directory is not an endorsement.