Infection, Respiratory Tract Clinical Trial
Official title:
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
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.
Based on the evidence that BCG vaccine
1. can potentiate immune responses to other vaccines through induction of trained innate
immunity and heterologous adaptive immunity and
2. 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.
A total of 1200 health care professionals (doctors, nurses and paramedical staff) with high
expected exposure to SARSCoV-2 infected patients (e.g. those employed in emergency
departments, intensive care unit, infectious disease ward, COVID-19 isolation wards,
respiratory wards, etc.) will be enrolled, across hospitals in Germany. Informed consent will
be obtained from the subjects willing to take part in the trial. This will be followed by
assessment of the eligibility criteria. Subjects who fulfil the inclusion/exclusion criteria
will be centrally randomized in a 1:1 ratio to receive a single dose of either VPM1002 or
Placebo.
All subjects will be requested to sign into a web-based tool designed for this trial. All
subjects will be followed-up entirely remotely. The web-based questionnaires will be designed
to collect data regarding absenteeism, adverse events / serious adverse events,
hospitalizations, intensive care unit admissions and other secondary endpoints. The
investigators will review the outcome and safety data.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04435379 -
Study to Assess VPM1002 in Reducing Hospital Admissions and/or Severe Respiratory Infectious Diseases in Elderly in COVID-19 Pandemic
|
Phase 3 |