Other Condition That May be a Focus of Clinical Attention
Conditions
Keywords
Shift work, Hepatitis A vaccination, humoral response, cellular response
Brief 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.
Interventions
BIOLOGICALVaccination against hepatitis A
Vaccination against hepatitis A (2 doses) into the deltoid muscle of the nondominant arm twice, i.e., at 0 and 6 months.
OTHERNo Intervention
No Intervention
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
Federal University of São Paulo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibodies against hepatitis A virus (anti-HAV) | Baseline, 30 days, 60 days and 90 days | Change in antibodies against hepatitis A virus (anti-HAV) production |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intracellular cytokines | Baseline, 30 days, 60 days and 90 days | Change in intracellular IL-4, IFN-γ, IL-2 e TNF-α cytokine levels |
| Catecholamines | Baseline, 30 days, 60 days and 90 days | Change in cathecolamines levels |
| Prolactin | Baseline, 30 days, 60 days and 90 days | Change in prolactin levels |
| Growth hormone | Baseline, 30 days, 60 days and 90 days | Change in growth hormone levels |
| Cortisol | Baseline, 30 days, 60 days and 90 days | Change in cortisol levels |
| Sleep disorders | Baseline | Assessment of sleep disorders |
Countries
Brazil
Outcome results
None listed