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Sleep, Shift work and the COVID-19 vaccine immune Response Efficacy

Sleep, Shift work and the COVID-19 vaccine immune Response Efficacy - S-CORE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51248
Enrollment
100
Registered
2021-04-02
Start date
2021-04-19
Completion date
Unknown
Last updated
2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 vaccination

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Night shift workers in healthcare (18-50 years old) working predominantly night shifts (defined as at least 6 hours between 10PM and 7 AM) or work rotating shifts (morning, evening and night shifts). The control group are healthcare workers (18-50 years old) who only work during the day, with regular sleeptimes, an average sleep duration of at least 7 hours, and no history of night shift work in the last 6 months.

Exclusion criteria

Exclusion criteria: - Younger than 18 years or older than 50 years old. - Pregnant or have a wish to become pregnant within 6 months. - Regular medication regimen known to affect sleep [ or alertness - All regular contra-indications of the vaccines will be applied -Indication of prior exposure to COVID-19. -participants diagnosed with an immunedeficiency syndrome, any auto-immune or auto-inflammatory disease except atopic disease

Design outcomes

Primary

MeasureTime frame
• The immune response against SARS CoV-2 vaccination at several timepoints • Sleep duration and sleep quality measured objectively and subjectively around each vaccination.timepoint

Secondary

MeasureTime frame
• Circadian clock markers at baseline • Profile of gut microbiota by fecal samples • SARS-CoV-2 specific T cell responses • Immune response over time • Adverse reactions after SARS-CoV-2 vaccinations

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)