A Phase III, Double-blind, Randomized, Placebo-controlled Multicentre Clinical Trial to Assess the Efficacy and Safety of VPM1002 in Reducing Healthcare Professionals' Absenteeism in the SARS-CoV-2 Pandemic by Modulating the Immune System
试验速览
- 阶段
- 3 期
- 入组人数
- 59
- 试验地点
- 6
- 主要终点
- Number of days absent from work due to respiratory disease (with or without documented SARS-CoV-2 infection)
研究概览
简要总结
The aim of this study is to investigate whether vaccination of healthcare professionals with VPM1002 could reduce the number of days absent from work due to respiratory disease (with or without documented SARS-CoV-2 infection).
VPM1002 is a vaccine that is a further development of the old Bacillus Calmette-Guérin (BCG) vaccine, which has been used successfully as a vaccine against tuberculosis for about 100 years, especially in developing countries. VPM1002 has been shown in various clinical studies to be significantly safer than the BCG vaccine.
VPM1002 strengthens the body's immune defence and vaccination with BCG reduces the frequency of respiratory diseases. It is therefore assumed that a VPM1002 vaccination could also provide (partial) protection against COVID-19 disease caused by the new corona virus "SARS-CoV 2".
A total of 1200 health care professionals (doctors, nurses and paramedical staff) with high expected exposure to SARSCoV-2 infected patients will receive a single dose of either VPM1002 or Placebo. All subjects will be requested to enter data regarding absenteeism, adverse events / serious adverse events, hospitalizations, intensive care unit admissions into an online questionnaire.
详细描述
Based on the evidence that BCG vaccine
- can potentiate immune responses to other vaccines through induction of trained innate immunity and heterologous adaptive immunity and
- can reduce the incidence of respiratory infections, exert antiviral effects in experimental models, and reduce viremia in an experimental human model of viral infection,
it is hypothesized that BCG vaccination may induce (partial) protection against the susceptibility to and/or severity of SARS- CoV-2 infection.
VPM1002 is being developed with the aim to replace BCG by a vaccine that has a better safety profile and superior efficacy. Evidence from pre-clinical and clinical studies demonstrate that VPM1002 is safer and is more immunogenic than the existing BCG vaccine. It is therefore anticipated that VPM1002 will also perform better in reducing the severity of the symptoms of an infection with the SARS CoV-2 than the BCG vaccine. Further, manufacturing of VPM1002 using state-of-the-art production methods will help hasten the production of millions of doses in a very short time and thus would be beneficial in the current SARS-CoV-2 pandemic situation.
The current trial will assess the efficacy and safety of VPM1002 to reduce health care professionals ' absenteeism in the SARS-CoV-2 pandemic by modulating the immune system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The reconstitution and administration of trial intervention will be done by unblinded site personnel who will not be involved in the collection or evaluation of outcome data.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (≥18 years)
- •Male or female
- •Hospital personnel with expected high SARS-CoV-2 exposure
- •Subject is contractually capable, able to understand information on study and has signed informed consent sheet
- •Subject has access to an internet-enabled electronic device
- •Women of childbearing potential who are currently using reliable methods of birth control, have a negative pregnancy test during screening and have no intention to become pregnant for at least 3 months post-vaccination.
排除标准
- •Known hypersensitivity or allergy to (components of) the VPM1002 vaccine or serious adverse reactions to prior BCG administration
- •Known active or latent Mycobacterium tuberculosis infection or with another mycobacterial species. A history with or suspicion of M. tuberculosis infection.
- •Fever (>38 °C) within the past 24 hours
- •Pregnant or breast-feeding
- •Suspicion of active viral or bacterial infection
- •Participation of subject in another study within 30 days before screening and during this study
- •Person is an employee of the sponsor, a relative of the investigator or in direct reporting line to clinical trial staff at the clinical trial site
- •Severely immunocompromised subjects, such as:
- •subjects with known infection with the human immunodeficiency virus (HIV);
- •subjects with solid organ transplantation;
- •subjects with bone marrow transplantation;
- •subjects under chemotherapy, immunotherapy and radiotherapy;
- •subjects with primary immunodeficiency;
- •treatment with any anti-cytokine therapies;
- •treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months
- •Active solid or non-solid malignancy or lymphoma in the past 5 years
- •Direct involvement in the design or the execution of the present clinical trial
- •Expected absence from work of ≥4 of the following 12 weeks due to any reason (holidays, maternity leave, retirement, planned surgery etc)
- •Employed to the hospital < 22 hours per week
- •Previous positive SARS-CoV-2 test result
结局指标
主要结局
Number of days absent from work due to respiratory disease (with or without documented SARS-CoV-2 infection)
时间窗: From day 0 to day 240
次要结局
- Number of days of self-reported fever (≥ 38 °C)(From day 0 to day 240)
- Cumulative incidence of ICU admission for any reason(From day 0 to day 240)
- Cumulative incidence of self-reported acute respiratory symptoms(From day 0 to day 240)
- Number of days absent from work due to documented SARS-CoV-2 infection(From day 0 to day 240)
- Cumulative incidence of documented SARS-CoV-2 infection(From day 0 to day 240)
- Number of days of self-reported acute respiratory symptoms(From day 0 to day 240)
- Cumulative incidence of ICU admission due to documented SARS-CoV-2 infection(From day 0 to day 240)
- Number of days absent from work due to symptoms of respiratory disease, documented SARS-CoV-2 infection, or fever (≥ 38 °C)(From day 0 to day 240)
- Cumulative incidence of death for any reason(From day 0 to day 240)
- Cumulative incidence of hospital admission due to documented SARS-CoV-2 infection(From day 0 to day 240)
- Number of days absent from work due to exposure to person with documented SARS-CoV-2 infection(From day 0 to day 240)
- Cumulative incidence of death due to documented SARS-CoV-2 infection(From day 0 to day 240)
- Cumulative incidence of hospital admission for any reason(From day 0 to day 240)