Arnhem – A large study in 22 hospitals in the Netherlands will start this week to investigate whether the vaccine against tuberculosis (the BCG vaccine) offers protection against the consequences of an infection with the coronavirus in vulnerable elderly people. Rijnstate is one of the hospitals participating in the study.
Arnhem – A large study in 22 hospitals in the Netherlands will start this week to investigate whether the vaccine against tuberculosis (the BCG vaccine) offers protection against the consequences of an infection with the coronavirus in vulnerable elderly people. Rijnstate is one of the hospitals participating in the study.
The Ministry of Health, Welfare and Sport attaches great importance to this research and has therefore asked ZonMw to include it as an urgent process in the research programming for COVID-19.
The corona virus appears to make vulnerable elderly people seriously ill and they therefore run the highest risk of dying from the infection. There is currently no specific vaccine against the coronavirus available. Previous research has already shown that the BCG vaccine not only protects against tuberculosis, but can also increase the resistance against other pathogens by giving the immune system a temporary ‘boost’. This boost may offer partial protection against infection with the coronavirus, which means that fewer people will be affected by the virus and the infection may also be milder.
Vulnerable elderly
For this placebo-controlled study, vulnerable patients aged 60 years and older are approached to enroll through the hospital where they are receiving treatment. The study looks at two primary endpoints: the number of corona infections that occur, or the occurrence of respiratory infections (including COVID-19) that require medical treatment.
In order to get results as quickly as possible, participating hospitals will recruit between 5,200 and 7,000 frail older people over the next two months, who will be followed for 6 months after vaccination. The first results are expected around the end of this year.
Marc Bonten, professor of molecular epidemiology of infectious diseases at UMC Utrecht and principal investigator of the study says: “In recent months, there have been increasing signals that the BCG vaccine does indeed protect against respiratory infections. This study should provide the definitive answer for frail older people in a short time. The importance of the study is already apparent from the fact that no fewer than 22 hospitals decided to cooperate in a short period of time. ”
For more information about participation in Rijnstate or questions about this study: [email protected]
Proven to be safe
The BCG vaccine is the most widely administered vaccine in the world and has been used around the world for decades to prevent tuberculosis. This has ensured that the vaccine is seen as proven safe and that the possible side effects are known. In addition, there is increasing evidence that the BCG vaccine stimulates the immune system and thus protects against respiratory infections in general.
Recente BCG-studies
The BCG-PRIME study is the fourth study in the Netherlands with the BCG vaccine against COVID-19 in a short time. In recent months, three other studies have already been started under the leadership of UMC Utrecht and Radboudumc Nijmegen into the possible protective effect of the BCG vaccine against the corona virus.
In the previously started studies, all participants have now been vaccinated and they are now systematically monitored, looking at whether they develop COVID-19 and the severity of the symptoms. The timeline for publication of the results depends on whether and how quickly differences arise between the number of corona cases and severity of the symptoms between the BCG group and the placebo group.
Broad collaboration
The BCG-PRIME study was set up by UMC Utrecht with support from the Ministry of Health, Welfare and Sport and was funded by a ZonMw grant of up to 8.5 million. The study includes the Dutch academic hospitals (Amsterdam UMC, Erasmus MC, LUMC, Radboudumc Nijmegen, UMC Groningen, UMC Maastricht, UMC Utrecht), the Santeon top clinical hospitals (Canisius-Wilhelmina Hospital Nijmegen, Catharina Hospital, Maasstad Hospital, Martini Hospital , Medisch Spectrum Twente, OLVG, St. Antonius Hospital) and further Amphia Hospital, Bernhoven Hospital, Haga Hospital, Ikazia Hospital, Jeroen Bosch Hospital, Meander Medical Center, Rijnstate Hospital and Zuyderland Hospital.
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