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A phase 4, open-label study to evaluate the short-term innate immune response after administration of a COVID-19 mRNA vaccine (Comirnaty JN.1®) in healthy adults aged 18 to 40 years.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-520304-26-00
Acronym
INNATE-GAP-CLIN
Enrollment
20
Registered
2025-03-25
Start date
2025-05-05
Completion date
2025-05-27
Last updated
2025-05-27

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

Conditions

COVID-19

Brief summary

Before, 6 hours after, and 24 hours after the study intervention administration: - Levels of inflammatory biomarkers, such as but not limited to interferon gamma and interleukin-1 alpha and beta (geometric mean, median and quartiles), Before, 6 hours after, and 24 hours after the study intervention administration: - Immune profiling of PBMCs by cell surface protein expression analyses using barcoded antibodies against these marker proteins. - Transcriptomic analyses in PBMCs by single cell RNA sequencing.

Detailed description

Throughout the study duration: - Occurrence of any SAEs related to the vaccine administration as per the judgment of the investigator (percentage of participants).

Interventions

Sponsors

University Of Antwerp
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Before, 6 hours after, and 24 hours after the study intervention administration: - Levels of inflammatory biomarkers, such as but not limited to interferon gamma and interleukin-1 alpha and beta (geometric mean, median and quartiles), Before, 6 hours after, and 24 hours after the study intervention administration: - Immune profiling of PBMCs by cell surface protein expression analyses using barcoded antibodies against these marker proteins. - Transcriptomic analyses in PBMCs by single cell RNA sequencing.

Secondary

MeasureTime frame
Throughout the study duration: - Occurrence of any SAEs related to the vaccine administration as per the judgment of the investigator (percentage of participants).

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026