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临床试验/NCT02873286
NCT02873286已完成2 期

A Randomized, Single-blind, Placebo Controlled, Dose-ranging Phase II Trial in ≥ 55 Year Old Adults to Evaluate the Safety and Immunogenicity of the Recombinant MVA-BN-RSV Vaccine

Bavarian Nordic12 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2016年9月1日最近更新:
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适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
420
试验地点
12
主要终点
PRNT (Subtype A) GMT
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A total of 400 subjects will be recruited into five treatment subject groups à 80 subjects.Subject will receive two administrations 4 weeks apart which will consist of MVA-BN-RSV Dose 1, MVA-BN-RSV Dose 2 or Placebo (TBS).

86 subjects from 2 treatment groups (43 per treatment group) are supposed to receive one (booster) dose of MVA-BN-RSV vaccine approximately one year after their first vaccination. In this booster substudy, eligible subjects will receive the same dose they received during the main trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
55 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •(Main study):
  • •Male and female subjects, ≥ 55 years of age.
  • •Prior to performance of any trial specific procedures, the subject has read, signed and dated an informed consent form, having been advised of the risks and benefits of the trial in a language understood by the subject, and has signed the Health Insurance Portability and Accountability Act (HIPAA) authorization form.
  • •Subjects without symptomatic cardiopulmonary and/or metabolic disease. Note that subjects who have any active symptoms related to cardiac and/or pulmonary and/or metabolic disease (including e.g. uncontrolled asthma, angina pectoris, hyperglycaemia or other episodic symptoms), or who receive ongoing therapy to control current, active symptoms, are not eligible. Subjects on stable treatment (no change in ≥ 1 month) for previous and controlled symptoms or conditions are eligible. The following are examples of subjects who may bear cardiopulmonary or metabolic diagnoses but who would remain eligible:
  • •Subjects on stable (no change in ≥ 1 month) therapy for findings (e.g. hypertension, hyperlipidemia) which are not associated with current symptoms or disability.
  • •Subjects with type II diabetes mellitus are considered eligible as long as they are stable on oral antidiabetics and have either a documented glycated hemoglobin (HbA1c) of ≤ 8 % within three months prior to trial participation or confirmation of controlled blood glucose level must be obtained at the SCR (screening) visit by a lab test.
  • •Subjects who receive short term treatment for temporary conditions.
  • •Other clinically insignificant findings not deemed to be associated with increased risk for respiratory viral infections as determined by the investigator.
  • •Able to comply with trial requirements; including access to transportation for trial visits.
  • •Body mass index (BMI) ≥ 18.5 and ≤ 39.9
  • •BMI formula for pounds and inches:
  • •BMI = (bodyweight in pounds) * 703 (bodyheight in inches)2
  • •Women of childbearing potential (WOCBP) must have used an acceptable method of contraception for at least 30 days prior to the first vaccination, must agree to use an acceptable method of contraception (as defined in Section 8.2.11) during the trial, and must avoid becoming pregnant for at least 28 days after the last vaccination. WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to each vaccination
  • •Not clinically significant laboratory values as defined in the protocol, excluding any Grade ≥ 3 toxicity.
  • •Negative human immunodeficiency virus antibody test (anti-HIV), negative hepatitis B surface antigen (HBsAG) and negative antibody test to hepatitis C virus.
  • •Electrocardiogram (ECG) without clinically significant acute findings (e.g. findings suggestive of current ischemia, ventricular arrhythmias, congestive heart failure and ventricular hypertrophy).

排除标准

  • •(Main Study):
  • •Pregnant or breast-feeding women.
  • •Uncontrolled serious infection, i.e. not responding to antimicrobial therapy.
  • •History or current clinical manifestation of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject or would limit the subject's ability to complete the trial.
  • •History of cerebrovascular disorders, including stroke. Patients with history of transient ischaemic attack (TIA) ≥ 1 year prior to trial participation remain eligible.
  • •History of myocardial infarction within ≤ 1 year prior to trial participation, current clinical manifestation of angina pectoris, current clinical manifestation of congestive heart failure ≥ New York Heart Association (NYHA) Grade II, uncontrolled high blood pressure defined as systolic blood pressure ≥ 150 mmHg and/or diastolic ≥ 100 mmHg within the last 2 months.
  • •History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded. Persons with rheumatoid arthritis not requiring immunomodulatory and/or immunosuppressant treatment are not excluded.
  • •Known or suspected impairment of immunologic functions including, but not limited to chronic inflammatory bowel disorders, diabetes mellitus type I.
  • •History of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision at least 6 months ago that is considered to have achieved cure. Subjects with history of skin cancer should not be vaccinated at the previous tumor site.
  • •Clinically significant mental disorder, not adequately controlled by medical treatment.
  • •Active or recent (within the time period of six months before trial participation) history of chronic alcohol abuse and/or intravenous and/or nasal drug abuse.
  • •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. tris(hydroxymethyl)-amino methane, chicken embryo fibroblast proteins, gentamycin.
  • •Known allergy to eggs or aminoglycosides.
  • •History of anaphylaxis or severe allergic reaction to any vaccine.
  • •Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior to or after trial vaccination.
  • •Having received any vaccinations or planned vaccinations with an inactivated vaccine within 14 days prior to or after trial vaccination.
  • •Chronic systemic administration (defined as more than 14 days) of > 5 mg prednisone (or equivalent)/day or any other immune-modifying drugs during a period starting from three months prior to first administration of the trial vaccination and ending at the last visit of the active trial phase. The use of topical, inhaled, ophthalmic and nasal glucocorticoids is permitted.
  • •Administration or planned administration of immunoglobulins and/or any blood products during a period starting from three months prior to first administration of the trial vaccination and ending at the last visit of the active trial phase.
  • •Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the first trial vaccination, or planned administration of such a drug between participation in the trial and until 4 weeks after last trial vaccination.
  • •Previous or planned vaccination with a RSV vaccine/vaccine candidate.
  • •Clinical trial personnel working on the current trial.
  • •Inclusion Criteria (Substudy):
  • •Prior to performance of any booster substudy specific procedures, the subject has read, signed and dated an informed consent form, having been advised of the risks and benefits of the trial in a language understood by the subject.
  • •Subject has completed all vaccinations of the main trial according to protocol.
  • •Exclusion Criteria (Substudy):
  • •Any condition that, in the opinion of the investigator, makes it unsafe for the subject to receive a further vaccination.
  • •An anaphylactic reaction following the administration of any vaccine(s).
  • •Clinical need for concomitant or ancillary therapy not permitted in the trial as outlined in Protocol Section 8.2.
  • •Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior to or after booster vaccination.
  • •Having received any vaccinations or planned vaccinations with an inactivated vaccine within 14 days prior to or after booster vaccination.
  • •Chronic systemic administration (defined as more than 14 days) of > 5 mg prednisone (or equivalent)/day or any other immune-modifying drugs during a period starting from 3 months prior to administration of the booster vaccine and ending at the last visit of the booster active trial phase. The use of topical, inhaled, ophthalmic and nasal glucocorticoids is permitted.
  • •Administration or planned administration of immunoglobulins and/or any blood products during a period starting from 3 months prior to administration of the booster vaccine and ending at the last visit of the booster active trial phase.
  • •Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the booster vaccination, or planned administration of such a drug during participation in the booster substudy and until 4 weeks after booster vaccination.
  • •Subject's request to discontinue
  • •Subject's refusal to receive booster vaccination.
  • •Subject unwilling or unable to comply with trial requirements. Any reason that, in the opinion of the investigator contradicts administration of the booster vaccination or otherwise requires early discontinuation of a subject.

研究组 & 干预措施

Group 1 - Single Low Dose / Booster

Experimental

First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)

干预措施: Placebo (Other)

Group 3 - Single High Dose / Booster

Experimental

First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)

干预措施: Placebo (Other)

Group 5 - Placebo

Experimental

First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)

干预措施: Placebo (Other)

Group 4 - Two High Doses

Experimental

First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)

干预措施: MVA-BN-RSV (Biological)

Group 3 - Single High Dose / Booster

Experimental

First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)

干预措施: MVA-BN-RSV (Biological)

Group 2 - Two Low Doses

Experimental

First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)

干预措施: MVA-BN-RSV (Biological)

Group 1 - Single Low Dose / Booster

Experimental

First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)

干预措施: MVA-BN-RSV (Biological)

结局指标

主要结局

PRNT (Subtype A) GMT

时间窗: Week 6 (Main Study) i.e., 2 weeks following the second vaccination

Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype A). Titers below the detection limit (DL) are included with a value of '10' (i.e. 1/2 DL)

次要结局

  • Percentage of Participants With Response by PRNT (Subtype A)(within 108 weeks)
  • PRNT (Subtype B) GMT(within 108 weeks)
  • PRNT (Subtype A) GMT(within 108 weeks)
  • ELISA (IgG) GMT(within 108 weeks)
  • Percentage of Participants With Response by PRNT (Subtype B)(within 108 weeks)
  • Percentage of Participants With Response by IgG ELISA(within 108 weeks)
  • ELISA (IgA) GMT(within 108 weeks)
  • Percentage of Participants With Response by IgA ELISA(within 108 weeks)
  • ELISA (Mucosal IgA) GMT(within 82 weeks)
  • Percentage of Participants With Response by Mucosal IgA ELISA(within 82 weeks)
  • ELISPOT (IFN-g, Peptide Pool: F) GMSFU(within 58 weeks)
  • ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU(within 58 weeks)
  • ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU(within 58 weeks)
  • ELISPOT (IFN-g, Peptide Pool: M2) GMSFU(within 58 weeks)
  • ELISPOT (IL-4, Peptide Pool: F) GMSFU(within 58 weeks)
  • ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU(within 58 weeks)
  • ELISPOT (IFN-g, Peptide Pool: N) GMSFU(within 58 weeks)
  • ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU(within 58 weeks)
  • ELISPOT (IL-4, Peptide Pool: M2) GMSFU(within 58 weeks)
  • Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)(within 58 weeks)
  • Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))(within 58 weeks)
  • Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))(within 58 weeks)
  • Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)(within 58 weeks)
  • ELISPOT (IL-4, Peptide Pool: N) GMSFU(within 58 weeks)
  • Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)(within 58 weeks)
  • Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)(within 58 weeks)
  • Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))(within 58 weeks)
  • Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))(within 58 weeks)
  • Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)(within 58 weeks)
  • Grade ≥ 3 Solicited General Adverse Events(within 8 days after vaccination)
  • Related Solicited General Adverse Events(within 8 days after vaccination)
  • Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)(within 58 weeks)
  • Memory B Cells (IgG) GMSFU(within 82 weeks)
  • Serious Adverse Events(within 108 weeks (Main Study + Booster Substudy))
  • Related Serious Adverse Events(within 108 weeks (Main Study + Booster Substudy))
  • Grade ≥ 3 Serious Adverse Events(within 108 weeks (Main Study + Booster Substudy))
  • Related Grade ≥ 3 Adverse Events(within 29 days after vaccination)
  • Solicited Local Adverse Events(within 8 days after vaccination)
  • Grade ≥ 3 Solicited Local Adverse Events(within 8 days after vaccination)
  • Solicited General Adverse Events(within 8 days after vaccination)
  • Unsolicited Non-serious Adverse Events(within 29 days after vaccination)
  • Related Unsolicited Non-serious Adverse Events(within 29 days after vaccination)
  • Grade ≥ 3 Unsolicited Non-serious Adverse Events(within 29 days after vaccination)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (12)

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