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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Of Antwerp

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Immune system processes [G12], Diseases [C] - Virus Diseases [C02]

Trial duration

5 May 2025 → 27 May 2025

Decision date (initial)

2025-03-25

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Others, Prophylaxis

To evaluate the humoral innate immune response induced by the vaccination with Comirnaty JN.1®.
To evaluate cell-mediated innate immunity induced by the vaccination with Comirnaty JN.1®.

Secondary objectives 1

1. To evaluate the safety and reactogenicity of vaccination with Comirnaty JN.1®.

Conditions and MedDRA coding

COVID-19

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. A male or female aged 18 to 40 years at the time of the study intervention administration.
2. Participants who are medically stable in the opinion of the investigator at the time of the study intervention administration. Participants with chronic stable medical conditions with or without specific treatment, such as hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable and without potential influence on the innate immune response as to the opinion of the investigator.
3. Participants who have received previously a SARS-CoV-2 vaccine, being administered at least 3 months prior to study vaccination.

Exclusion criteria 11

1. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention, including a known history of severe allergic reaction (e.g., anaphylaxis).
2. Any confirmed or suspected immunosuppressive condition, resulting from disease (e.g., current malignancy, human immunodefiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory required).
3. Any history of myocarditis or pericarditis.
4. Serious or unstable chronic illness.
5. Recent SARS-CoV-2 infection within 3 months prior to the study intervention administration. Timelines to be determined from symptoms onset or positive COVID-19 test (if infection was asymptomatic).
6. Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention during the period beginning 30 days before the administration of the study intervention and ending at the completion of the study.
7. Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the completion of the study.
8. Administration of any SARS-CoV-2 vaccine during the 3 months preceding the study intervention administration.
9. Pregnant or lactating female participant.
10. Body Mass Index < 18.0 or > 27.0 kg/m2.
11. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 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)
2. 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 endpoints 1

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Of Antwerp

Sponsor organisation

University Of Antwerp

Address

Drie Eikenstraat 663

City

Edegem

Postcode

2650

Country

Belgium

Scientific contact point

Organisation

University Of Antwerp

Contact name

Principal Investigator

Public contact point

Organisation

University Of Antwerp

Contact name

Secretariat Centre for the Evaluation of vaccination

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 23 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications