An interventional study of Vaccination against hepatitis A and No Intervention in Other Condition That May be a Focus of Clinical Attention, sponsored by Federal University of São Paulo. Completed at 2 sites in Brazil. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-11.
Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Basic science
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.
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 34 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The comparison will consider nightworkers versus dayworkers.
Biological: Vaccination against hepatitis A · Other: No Intervention
Vaccination against hepatitis A (2 doses) into the deltoid muscle of the nondominant arm twice, i.e., at 0 and 6 months.
No Intervention
Antibodies against hepatitis A virus (anti-HAV)
Change in antibodies against hepatitis A virus (anti-HAV) production
Time frame: Baseline, 30 days, 60 days and 90 days
Intracellular cytokines
Change in intracellular IL-4, IFN-γ, IL-2 e TNF-α cytokine levels
Time frame: Baseline, 30 days, 60 days and 90 days
Catecholamines
Change in cathecolamines levels
Time frame: Baseline, 30 days, 60 days and 90 days
Prolactin
Change in prolactin levels
Time frame: Baseline, 30 days, 60 days and 90 days
Growth hormone
Change in growth hormone levels
Time frame: Baseline, 30 days, 60 days and 90 days
Cortisol
Change in cortisol levels
Time frame: Baseline, 30 days, 60 days and 90 days
Sleep disorders
Assessment of sleep disorders
Time frame: Baseline
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Federal University of São Paulo