2024-520304-26-00招募中4 期
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.
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
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®.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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/m
- •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.
结局指标
主要结局
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: - 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.
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.
次要结局
- Throughout the study duration: - Occurrence of any SAEs related to the vaccine administration as per the judgment of the investigator (percentage of participants).
研究者
Principal Investigator
Scientific
University Of Antwerp
研究点 (1)
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