EUCTR2021-000509-26-FR进行中（未招募）1 期
A phase II trial assessing immunogenicity and safety of COVID-19 mRNA Vaccine BNT162b2 in adult volunteers with no history of SARS CoV-2 infection administered with two doses of vaccine (D1-D29) and in adult volunteers with documented history of SARS CoV-2 infection (of more than 6 months) administered with only one dose of vaccine - NA
Inserm-ANRS0 个研究点目标入组 300 人开始时间: 2021年2月3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. 18 to 45 years old or at least 65 years old,
- •2. Healthy adults or stable medical condition for adults with pre-existing medical conditions. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrolment, nor expected to require any significant change in therapy or hospitalization for worsening disease in foreseeable future.
- •3. Group 1: Healthy adults with no previous history of SARS CoV-2 infection (PCR-, antigenic test- or chest TDM- or serology SARS-CoV-2-)
- •Group 2: Healthy adults with history of documented infection with SARS-CoV-2 (PCR+, antigenic test+ or chest TDM+ or serology SARS-CoV-2+ of more than 6 months)
- •4. A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
- •- Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile.
- •- OR Is of childbearing potential and agrees to use an effective contraceptive method from at least 4 weeks prior to vaccination until at least 4 weeks after the last vaccination. A participant of childbearing potential must have a negative blood pregnancy test at enrolment visit.
- •5. Understands and agrees to comply with the study procedures (visits, phone calls) based on Investigator judgement
- •6. Written and informed consent signed by the person and the investigator (no later than the day of pre-inclusion and prior to any examination realized in the frame of the trial) (article L1122-1-1 of the Public Health Code)
- •7. Person affiliated or beneficiary of a social security scheme (article L1121-11 of the Public Health Code) (AME is not a social security scheme)
- •8. A person who agrees to be registered in the national file of persons who lend themselves to biomedical research (article L1121-16 of the Public Health Code).
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •1. Subject is ill or febrile (body temperature = 38.0°C) within 72 prior hours or and/or symptoms suggestive of COVID-19 or being contact subject within the past 14 days at enrolment visit.
- •(Ill or febrile participants may be re-scheduled within the inclusion period when no longer presenting symptoms, except if condition is COVID19)
- •2. Participants with positive serology SARS-CoV-2 at the enrolment visit (only for the group 1)
- •3. Participants who already received another anti-SARS-CoV-2-vaccine
- •4. Participants who received BCG within the last year.
- •5. Use of immunosuppressive drugs like e.g. corticosteroids at a dosage > 10mg equivalent prednisone /day (excluding topical preparations and inhalers) within 3 months prior to enrolment or 6 months for chemotherapies
- •6. Received immunoglobulin or other blood product within 3 months prior to enrolment or planned receipt of immunoglobulin or a blood product through study completion.
- •7. Received any vaccination within 4 weeks prior to first injection or plan to receive a licensed vaccine 4 weeks after the last injection.
- •8. History of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as rash, respiratory difficulty, laryngeal oedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the anti-SARS-CoV-2-vaccine.
- •9. History of severe allergic event
- •10. Known HIV, active HCV or HBV infection
- •11. Any pathological condition, such as cancer (i.e. for which the treatment was completed less than two years ago) or others which may be susceptible of reducing immunity response
- •12. Any bleeding disorder considered as contraindication to intramuscular injection or phlebotomy
- •13. The use of investigational Ig, investigational monoclonal antibodies or convalescent serum are not allowed during the study
- •14. Any condition which in the opinion of the investigator may interfere with the aim of the study
- •15. Pregnant or breastfeeding or positive pregnancy urine test at enrolment visit.
- •16. An immediate family member or household member of study staff.
- •17. Participation in another investigational clinical study (Jardé 1 or Jardé 2) within 4 weeks before the enrolment visit or still in an exclusion period from another clinical trial or participation in another investigational clinical study planned before the study completion.
- •18. Participant under legal protection measure (tutorship, curatorship or safeguard measures)
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