Other Condition That May be a Focus of Clinical AttentionNCT01528280
Humoral and Cellular Response in Shift Workers
A study testing Vaccination against hepatitis A in people with Other Condition That May be a Focus of Clinical Attention, run by Federal University of São Paulo at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Other Condition That May be a Focus of Clinical Attention
- What is being tested?
- Vaccination against hepatitis A
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesBrazil
- Study dates
- Jan 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- shift workers
- naive immune status against hepatitis A confirmed by hepatitis A virus (HAV) antibodies levels below 5 mIU/mL
Who cannot join
- smokers
- individuals with complaints and/or sleep disorders
- acute or chronic disease
- use of medication during the study period.
- acute illnesses
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Centro de Estudos em Psicobiologia e Exercicio _ CEPE
São Paulo, São Paulo, 04020050
Centro de Estudos em Psicobiologia e Exercicio - CEPE
São Paulo, 04020050
About this study
Official title: Vaccination Against Hepatitis A Virus in Shift Workers: Evaluation of the Humoral and Cellular Immune Response
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.
Read the 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.
- Being tested
- Vaccination against hepatitis A, No Intervention
- Keywords
- Shift work, Hepatitis A vaccination, humoral response, cellular response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccination against hepatitis ABiological
Vaccination against hepatitis A (2 doses) into the deltoid muscle of the nondominant arm twice, i.e., at 0 and 6 months.
No InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Shiftwork | Experimental | The comparison will consider nightworkers versus dayworkers. Receives: Biological: Vaccination against hepatitis A; Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibodies against hepatitis A virus (anti-HAV)
Change in antibodies against hepatitis A virus (anti-HAV) production
Measured: Baseline, 30 days, 60 days and 90 days
Secondary outcomes (6)
Intracellular cytokines
Change in intracellular IL-4, IFN-γ, IL-2 e TNF-α cytokine levels
Measured: Baseline, 30 days, 60 days and 90 days
Catecholamines
Change in cathecolamines levels
Measured: Baseline, 30 days, 60 days and 90 days
Prolactin
Change in prolactin levels
Measured: Baseline, 30 days, 60 days and 90 days
Growth hormone
Change in growth hormone levels
Measured: Baseline, 30 days, 60 days and 90 days
Cortisol
Change in cortisol levels
Measured: Baseline, 30 days, 60 days and 90 days
Sleep disorders
Assessment of sleep disorders
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startJan 2013
- Primary completionSep 2014
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Condition That May be a Focus of Clinical AttentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Marco Tulio de Mello, Federal University of São Paulo
- Investigators
- Marco Tulio Mello, Associate Professor, Study director, Federal University of São PauloFrancieli Silva Ruiz, PhD, Study chair, Federal University of São PauloAndrea Maculano, PhD, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528280
- Sponsor's protocol ID
- CEPE2012FRuiz
- Status last verified
- Jan 2018
- First submitted
- 2 Feb 2012
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination Against Hepatitis A Virus in Shift Workers: Evaluation of the Humoral and Cellular Immune Response
- ClinicalTrials.gov ID
- NCT01528280
- Acronym / sponsor ID
- CEPE2012FRuiz
- Keywords
- Shift work, Hepatitis A vaccination, humoral response, cellular response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jan 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shiftwork | Experimental | Biological: Vaccination against hepatitis A, Other: No InterventionThe comparison will consider nightworkers versus dayworkers. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- shift workers
- naive immune status against hepatitis A confirmed by hepatitis A virus (HAV) antibodies levels below 5 mIU/mL
Key exclusion criteria (5 listed)
- smokers
- individuals with complaints and/or sleep disorders
- acute or chronic disease
- use of medication during the study period.
- acute illnesses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccination against hepatitis AVaccination against hepatitis A (2 doses) into the deltoid muscle of the nondominant arm twice, i.e., at 0 and 6 months. | Biological | Shiftwork |
| No InterventionNo Intervention | Other | Shiftwork |
Primary outcome
Antibodies against hepatitis A virus (anti-HAV)
Time frame: Baseline, 30 days, 60 days and 90 days
Change in antibodies against hepatitis A virus (anti-HAV) production
6 secondary outcomes
Intracellular cytokines
Time frame: Baseline, 30 days, 60 days and 90 days
Catecholamines
Time frame: Baseline, 30 days, 60 days and 90 days
Prolactin
Time frame: Baseline, 30 days, 60 days and 90 days
Growth hormone
Time frame: Baseline, 30 days, 60 days and 90 days
Cortisol
Time frame: Baseline, 30 days, 60 days and 90 days
Sleep disorders
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
- Fundação de Amparo à Pesquisa do Estado de São PauloLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Tulio Mello, Associate Professor study director
Federal University of São Paulo
Francieli Silva Ruiz, PhD study chair
Federal University of São Paulo
Andrea Maculano, PhD study chair
Federal University of São Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaccination against hepatitis A in people with Other Condition That May be a Focus of Clinical Attention, run by Federal University of São Paulo at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibodies against hepatitis A virus (anti-HAV) (time frame: Baseline, 30 days, 60 days and 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2018.