EUCTR2021-004550-33-FR进行中（未招募）1 期
Immunogenicity and reactogenicity following a booster dose of COVID-19 mRNA vaccine (Pfizer-BioNtech) and two adjuvanted sub-unit vaccines (SP/GSK) administered in adults who received 2 doses of Pfizer-BioNTech mRNA vaccine as a primary vaccination: A randomized, single-blinded multicenter clinical trial - CoviBOOST
Assistance publique Hopitaux de Paris/ DRCI0 个研究点目标入组 300 人开始时间: 2021年9月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Age = 18 years
- •2.Adult in a healthy condition or with a stable health status if pre-existing medical history. Stable health status is defined as an existing disease that has not required a significant change in treatment or hospitalization for worsening in the 3 months before enrollment, and for which neither a significant change in treatment or hospitalization for worsening is expected in the near future
- •3.For women of childbearing age: a negative highly sensitive pregnancy urinary test during the inclusion visit AND use of an effective contraceptive method at least 4 weeks prior to vaccination and until at least 12 weeks after the vaccination
- •4.Who has received 2 doses of mRNA vaccine (Pfizer-BioNTech) with an interval of 3 to 6 weeks
- •5.Second dose of mRNA vaccine (Pfizer-BioNTech) administered at least 6 months before the booster dose
- •6.Understands and agrees to comply with the study procedures
- •7.Written informed consent signed by both the participant and the investigator
- •8.Subject affiliated to the French Social Security System
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1.Acute febrile infection (body temperature = 38.0°C) within the previous 72 hours and/or presenting symptoms suggestive of COVID-19 within the previous 28 days or having been in contact with an infected individual for the last 14 days before the inclusion visit;
- •2.Virologically documented history of COVID-19 (PCR or serology);
- •3.Immunosuppressive therapy such as corticosteroids > 10 mg prednisone equivalent/day (excluding topical preparations and inhalers) within 3 months prior to inclusion or within 6 months for chemotherapies;
- •4.Treatment with immunoglobulins or other blood derivatives within 3 months prior to inclusion or scheduled administration of immunoglobulins or blood derivatives before the end of the study;
- •5.Known HIV, HCV or HBV infection;
- •6.Any medical condition, such as cancer, that might impair the immune response;
- •7.Use of experimental immunoglobulins, experimental monoclonal antibodies or convalescent plasma is not permitted during the study;
- •8.Pregnancy or breastfeeding currently ongoing;
- •9.History of severe adverse events following vaccine administration including anaphylactic reaction and associated symptoms such as rash, breathing problems, angioedema, and abdominal pain, or a history of allergic reaction that could be triggered by a component of the SARS-COV-2 vaccine at the time of the first vaccine injection;
- •10.Participant who has received BCG (tuberculosis) vaccine within the previous year
- •11.Has received a vaccine within 4 weeks prior to the boost injection or is scheduled to receive a registered vaccine 4 weeks after the boost injection
- •12.Any bleeding disorder considered as a contraindication to an intramuscular injection, previous phlebotomy or receipt of anticoagulants
- •13.Participation in other research involving humans (French classification Jardé 1 or Jardé 2) within 4 weeks prior to the inclusion visit, or participation in any other vaccine trial
- •14.Subject under legal protection (e.g. guardianship, tutorship)
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