On 2 September, a clinical study involving a candidate vaccine for the coronavirus will begin at UMC Utrecht. A total of 45 healthy volunteers will be participating in the study. The researchers will be looking at both the immune response that the vaccine induces in the human body as well as at its side effects. A total of 550 people in Europe will be participating in the study, which was set up by Janssen Vaccines.
Janssen has long been committed to tackling global health crises and will continue to work closely with partners around the world to combat the current COVID-19 pandemic, taking a multi-pronged approach.
Clinical microbiologist Prof. Marc Bonten (UMC Utrecht), principal investigator of the Utrecht part of the study: ‘In this study – the first in the Netherlands to test a coronavirus vaccine in humans – we will be investigating the effects of the candidate vaccine in 45 subjects. We are looking for healthy volunteers – both men and women – in the age groups of 18-55 and of 65 and older. The participants will receive three injections each. All participants will be followed up for over a year to investigate whether the vaccine is safe, well tolerated and induces the desired immune response.'
One of the approaches to combating the pandemic is the clinical development of the SARS-CoV-2 vaccine candidate. The clinical phase 2a study involving this Janssen vaccine is currently starting. This phase 2a study will be carried out with a total of 550 participants in the Netherlands, Germany and Spain.
The Dutch study centres are the Centre for Human Drug Research/Leiden University Medical Center in Leiden, PRAHealthSciences in Groningen and UMC Utrecht. Each study centre will include 45 participants in the study, divided into two groups: aged 18-55 and aged 65 and older.
Purpose of the study
- To determine whether lower doses of the vaccine induce immunity, to possibly be used for dose-sparing strategies, thus increasing the available supply of vaccine by using lower doses.
- To evaluate potential vaccination schedules at intervals of one, two and three months to determine the most effective schedule involving two doses, should a two-dose schedule be more effective than a single dose.
- To assess the extent to which vaccination leads to possible long-term immunity.
Source: UMC Utrecht