A Phase 3 interventional study of VPM1002 and Placebo in Infection, Respiratory Tract, sponsored by Vakzine Projekt Management GmbH. Completed at 12 sites in Germany. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-26.
Sponsored by Vakzine Projekt Management GmbH · Phase 3, Interventional, and Prevention
The aim of this study is to investigate whether vaccination of elderly with VPM1002 could reduce hospital admissions and/or severe respiratory infectious diseases in the SARS-CoV-2 pandemic .
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.
Based on the evidence that BCG [Bacille Calmette-Guérin] vaccine
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 (for more information, please revert to the IB). 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 the hospital admissions and clinical consequences of SARS-CoV-2 infections in the elderly population in the SARS-CoV-2 pandemic by modulating the immune system.
A total of 2038 adults aged 60 or above will be enrolled across involved clinical trial sites 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 (0.1 ml) of either VPM1002 or Placebo.
All subjects will be requested to sign into a web-based tool designed for this trial. Every subject is encouraged to name a designated caregiver who may provide follow-up data in case of hospitalisation or severe illness of the study subject. All subjects will be followed-up entirely remotely. The questionnaires will be designed to collect data regarding hospitalisation, adverse events (AE)/serious adverse events (SAE), ICU admissions and other secondary endpoints. The investigators will review the outcome and safety data.
The duration of follow-up will be 240 days. Subjects with confirmed SARS-CoV-2 infection (with or without symptoms) will be followed for at least 6 weeks (from the date of test result), independent of the total trial duration.
4,453 studies on the registry are indexed under Communicable Diseases; 521 are open to participants now.
This study's enrollment of 2,038 is above the median of 122 across 2,719 interventional studies indexed under Communicable Diseases.
Browse Communicable Diseases studies →Vakzine Projekt Management GmbH is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Severely immunocompromised subjects, including:
The active ingredient of the recombinant BCG vaccine, VPM1002, is Mycobacterium bovis rBCGΔureC::hly, freeze-dried and standardized to the number of viable mycobacteria (colony forming units; CFU) per application. Dose: 2-8 x 10e5 CFU VPM1002 administered in 0.1 ml reconstituted suspension.
Biological: VPM1002
Physiological saline 0.1ml
Biological: Placebo
The investigational product will be administered via intradermal injection with a 1.0-ml syringe, sub-graduated into hundredths of ml (1/100 ml), and fitted with a short bevel needle (25G/0.50 mm or 26G/0.45 mm, 10 mm in length).
The investigational product will be administered via intradermal injection with a 1.0-ml syringe, sub-graduated into hundredths of ml (1/100 ml), and fitted with a short bevel needle (25G/0.50 mm or 26G/0.45 mm, 10 mm in length).
Number of days with severe respiratory disease at hospital and/or at home
Time frame: From day 0 to day 240
Cumulative incidence of hospital admissions
Time frame: From day 0 to day 240
Cumulative incidence of documented SARS-CoV-2 infection
Time frame: From day 0 to day 240
Number of days with self-reported fever (≥ 38 ºC)
Time frame: From day 0 to day 240
Number of days with self-reported acute respiratory symptoms
Time frame: From day 0 to day 240
Cumulative incidence of self-reported acute respiratory symptoms
Time frame: From day 0 to day 240
Cumulative incidence of death for any reason
Time frame: From day 0 to day 240
Cumulative incidence of death due to documented SARS-CoV-2 infection
Time frame: From day 0 to day 240
Cumulative incidence of ICU admission for any reason
Time frame: From day 0 to day 240
Cumulative incidence of ICU admission due to documented SARS-CoV-2 infection
Time frame: From day 0 to day 240
Cumulative incidence of hospital admission due to documented SARSCoV- 2 infection
Time frame: From day 0 to day 240
Plan to share: No — There is uncertainty whether the European Union General Data Protection Regulation allows dissemination of individual participant data to other researchers. Some reasons why the EU Regulation would not allow this are the lack of suitable safeguards when personal data are transferred to any researcher asking for it and the impairment of the rights of the subjects for erasure of their data once they are disseminated.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Vakzine Projekt Management GmbH