BridgeMD
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.
EU CTIS ID: 2024-520304-26-00
What this study is testing
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®.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- A male or female aged 18 to 40 years at the time of the study intervention administration.
- 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.
- Participants who have received previously a SARS-CoV-2 vaccine, being administered at least 3 months prior to study vaccination.
You likely can't join if
- 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).
- Body Mass Index < 18.0 or > 27.0 kg/m2.
- 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).
- 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).
- Any history of myocarditis or pericarditis.
- Serious or unstable chronic illness.
See the full eligibility criteria
- A male or female aged 18 to 40 years at the time of the study intervention administration.
- 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.
- Participants who have received previously a SARS-CoV-2 vaccine, being administered at least 3 months prior to study vaccination.
- 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).
- Body Mass Index < 18.0 or > 27.0 kg/m2.
- 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).
- 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).
- Any history of myocarditis or pericarditis.
- Serious or unstable chronic illness.
- 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).
- 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.
- 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.
- Administration of any SARS-CoV-2 vaccine during the 3 months preceding the study intervention administration.
- Pregnant or lactating female participant.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.