PER-106-20招募中未知
COVID-19: A PHASE 2B/3, RANDOMIZED, OBSERVER-BLINDED, PLACEBO-CONTROLLED, MULTICENTER CLINICAL STUDY EVALUATING THE EFFICACY AND SAFETY OF INVESTIGATIONAL SARS-COV-2 MRNA VACCINE CVNCOV IN ADULTS 18 YEARS OF AGE AND OLDER
CureVac AG,0 个研究点目标入组 7,448 人开始时间: 2020年12月29日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 7,448
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
入选标准
- •1. Male or female subjects 18 years of age or older.
- •2. Provide written informed consent prior to initiation of any trial
- •procedures.
- •3. Expected compliance with protocol procedures and availability for
- •clinical follow-up through the last planned visit.
- •4. Females of non-childbearing potential defined as follows: surgically
- •sterile (history of bilateral tubal ligation, bilateral oophorectomy or
- •hysterectomy) or postmenopausal {defined as amenorrhea for
- •≥ 12 consecutive months prior to screening (Day 1)} without an
- •alternative medical cause). A follicle-stimulating hormone (FSH)
- •level may be measured at the discretion of the Investigator to confirm
- •postmenopausal status.
- •5. Females of childbearing potential: negative urine pregnancy test
- •{human chorionic gonadotropin (hCG)} within 24 hours prior to each
- •trial vaccination on Day 1 and Day 29.
- •6. Females of childbearing potential must use highly effective methods
- •of birth control from 2 weeks before the first administration of the trial
- •vaccine until 3 months following the last administration. The following
- •methods of birth control are considered highly effective when used
- •consistently and correctly:
- •· Combined (estrogen and progestogen containing) hormonal
- •contraception associated with inhibition of ovulation (oral,
- •intravaginal or transdermal);
- •· Progestogen-only hormonal contraception associated with
- •inhibition of ovulation (oral, injectable or implantable);
- •· Intrauterine devices (IUDs);
- •· Intrauterine hormone-releasing systems (IUSs);
- •· Bilateral tubal occlusion;
- •· Vasectomized or infertile partner;
- •· Sexual abstinence {periodic abstinence (e.g., calendar, ovulation,
- •symptothermal and post-ovulation methods) and withdrawal are
- •not acceptable}.
排除标准
- •1. History of virologically-confirmed COVID-19 illness.
- •2. For females: pregnancy or lactation.
- •3. Use of any investigational or non-registered product (vaccine or
- •drug) within 28 days preceding the administration of the first trial
- •vaccine or planned use during the trial.
- •4. Receipt of licensed vaccines within 28 days (for live vaccines) or
- •14 days (for inactivated vaccines) prior to the administration of the
- •first trial vaccine. 5. Prior administration of any investigational SARS-CoV-2 vaccine or
- •another coronavirus (SARS-CoV, MERS-CoV) vaccine or planned
- •use during the trial.
- •6. Any treatment with immunosuppressants or other immune-modifying
- •drugs (including but not limited to corticosteroids, biologicals and
- •methotrexate) for > 14 days total within 6 months preceding the
- •administration of trial vaccine or planned use during the trial. For
- •corticosteroid use, this means prednisone or equivalent, 0.5
- •mg/kg/day for 14 days or more. The use of inhaled, topical, or
- •localized injections of corticosteroids (e.g., for joint
- •pain/inflammation) is permitted.
- •7. Any medically diagnosed or suspected immunosuppressive or
- •immunodeficient condition based on medical history and physical
- •examination including known infection with human
- •immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C
- •virus (HCV); current diagnosis of or treatment for cancer including
- •leukemia, lymphoma, Hodgkin disease, multiple myeloma, or
- •generalized malignancy; chronic renal failure or nephrotic syndrome;
- •and receipt of an organ or bone marrow transplant.
- •8. History of angioedema (hereditary or idiopathic), or history of any
- •anaphylactic reaction and pIMD.
- •9. History of allergy to any component of CVnCoV vaccine.
- •10. Administration of immunoglobulins or any blood products within
- •3 months prior to the administration of trial vaccine or planned receipt
- •during the trial.
- •11. Subjects with a significant acute or chronic medical or psychiatric
- •illness that, in the opinion of the Investigator, precludes trial
- •participation (e.g., may increase the risk of trial participation, render
- •the subject unable to meet the requirements of the trial, or may
- •interfere with the subject’s trial evaluations). These include severe
- •and/or uncontrolled cardiovascular disease, gastrointestinal disease,
- •liver disease, renal disease, respiratory disease, endocrine disorder,
- •and neurological and psychiatric illnesses. However, those with
- •controlled and stable cases can be included in the trial.
- •12. Subjects with impaired coagulation or any bleeding disorder in whom
- •an intramuscular injection or a blood draw is contraindicated.
- •13. Foreseeable non-compliance with the trial procedures as judged by
- •the Investigator.
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