RBR-4dk4rss尚未招募1 期
VAC18193RSV2008 A Randomized, observer-blind, phase 1 study to evaluate innate and pro-inflammatory responses of an Ad26.RSV.preF-based vaccine, Ad26.COV2.S vaccine and Ad26.ZEBOV vaccine in adults aged 18 to 59 years
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 18Y 至 59Y（—）
入选标准
- •Participant must have a body mass index less than 35.0 kilograms per meter square. In the investigator’s clinical judgment, participant may have a stable and well-controlled medical condition including comorbidities associated with an increased risk of progression to severe coronavirus disease-2019, as long as their symptoms and signs are stable at the time of vaccination, and these conditions receive routine follow-up by the participant’s healthcare provider. Participants will be included on the basis of relevant medical history, vital signs, and body mass index measurement at screening. - Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine. Before randomization, participants must be either: (a) Not of childbearing potential; (b) Of childbearing potential and practicing an acceptable effective method of contraception and agrees to remain on such a method of contraception from signing the consent until 3 months after the last dose of study vaccine (including optional Ad26.COV2.S vaccination on Day 29 in Groups 2 and 3). Use of hormonal contraception should start at least 28 days before the first administration of study vaccine
排除标准
- •Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence). Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including any of the excipients of the study vaccine, or trace residues [chicken and/or egg proteins, gentamicin]). Per medical history, participant has chronic active hepatitis B or hepatitis C infection. Per medical history, participant has human immunodeficiency virus type 1 or type 2 infection. Participant has a history of acute polyneuropathy (example, Guillain-Barré Syndrome) or chronic inflammatory demyelinating polyneuropathy. Participant has abnormal function of the immune system resulting from: (a) Clinical conditions (example, autoimmune disease or immunodeficiency) expected to have an impact on the immune response elicited by the study vaccine. Participants with autoimmune disease (example, autoimmune-mediated thyroid disease, autoimmune inflammatory rheumatic disease such as rheumatoid arthritis, and Type 1 diabetes) that is stable and inactive without the use of systemic immunomodulators, and glucocorticoids may be enrolled at the discretion of the investigator; (b) Use of systemic corticosteroids within 2 months before administration of the first study vaccine until 28 days after first study vaccination. A substantial immunosuppressive steroid dose is considered to be greater than (>) 2 weeks of daily receipt of 20 milligrams (mg) prednisone or equivalent. Note: Ocular, topical, or inhaled steroids are allowed; (c) Administration of antineoplastic and immunomodulating agents, example, cancer chemotherapeutic agents, or radiotherapy within 6 months before administration of study vaccine until 28 days after first study vaccination
研究者
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