NL-OMON51606已完成2 期
Establishing immunogenicity and safety of needle-free intradermal delivery by nanoporous ceramic skin patch of mRNA SARS-CoV-2 vaccine as a revaccination strategy in healthy volunteers - MILESTONE: iMmunogenicity IntradermaL cEramic Skin paTch sars-cOv-2 vacciNE
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •- Male or female participants between the ages of 18 and 50 years, inclusive at
- •randomisation.
- •- Previously vaccinated with Comirnaty (Pfizer) or Spikevax (Moderna) at least
- •3 months before inclusion.
- •- Healthy participants who are determined by medical history and clinical
- •judgment of the investigator to be eligible for inclusion in the study. Healthy
- •participants with preexisting stable disease, defined as disease not requiring
- •significant change in therapy or hospitalisation for worsening disease during
- •the 6 weeks before enrolment, can be included.
- •- Participants who are willing and able to comply with all scheduled visits,
- •vaccination plan, laboratory tests, lifestyle considerations, and other study
- •procedures.
- •- Participants are willing to postpone their regular COVID-19 revaccination
- •upon invitation by the municipal health center or general practitioner until
- •four weeks after receiving the intervention (after the last sampling of
- •D29+/-1).
- •- Capable of giving personal signed informed consent, which includes compliance
- •with the requirements and restrictions listed in the ICD and in this protocol.
排除标准
- •- Other medical or psychiatric condition including recent (within the past
- •year) or active suicidal ideation/behaviour or laboratory abnormality that may
- •increase the risk of study participation or, in the investigator*s judgment,
- •make the participant inappropriate for the study.
- •- History of severe adverse reaction associated with a vaccine and/or severe
- •allergic reaction (e.g., anaphylaxis) to any component of the study
- •intervention(s).
- •- Receipt of medications intended to prevent COVID-19.
- •- Previous microbiological diagnosis of COVID-19 less than 3 months ago.
- •- Previous COVID-19 (re)vaccination other than Comirnaty (Pfizer) or Spikevax
- •(Moderna) less than 3 months ago
- •- Individuals at high risk for severe COVID-19 (e.g. BMI > 40, diabetes, heart-
- •end/or lung disease), who are planned to receive COVID vaccine within the next
- •two months.
- •- Immunosuppressed individuals with known or suspected immunodeficiency, as
- •determined by history.
- •- Individuals with an active autoimmune disease requiring therapeutic
- •intervention.
- •- Receipt of systemic or topical corticosteroids.
- •- Bleeding diathesis or condition associated with prolonged bleeding that
- •would, in the opinion of the investigator, contraindicate intramuscular
- •- Women who are pregnant or breastfeeding.
- •- Planned pregnancy within four weeks after injection.
- •- Positive serological test for SARS-CoV-2 anti-N IgM and/or IgG antibodies at
- •screening visit.
- •- SARS-CoV-2 PCR-positive mid-turbinate/throat swab at the screening before
- •receipt of the vaccine dose.
- •- Participation in other studies involving study intervention within 28 days
- •prior to study entry and/or during study participation.
- •- Receipt of any other non-study vaccine within 28 days, before receipt of the
- •study dose.
- •- Anticipated receipt of any other non-study vaccine within 28 days, after the
- •study dose administration.
研究者
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