UMC Utrecht is one of three study centers in the Netherlands where as of September 2 onwards 135 participants can participate in a Phase 2a study with the Janssen Vaccines candidate vaccine against COVID-19.

Vaccines against the novel coronavirus (SARS-CoV-2) are intended to prevent people from getting COVID-19. After someone who has been vaccinated comes into contact with the coronavirus, a strong immune response is triggered. This response blocks the virus from multiplying in the body, protecting the vaccinated person against the consequences of the infection.

Safety

Medical microbiologist Prof. Marc Bonten (UMC Utrecht), principal investigator of the Utrecht part of the study: “In this study - the first in the Netherlands in which a corona vaccine is tested in humans - we will investigate the effects of the candidate vaccine in 45 subjects. The study - which has already completed recruitment - will be performed in healthy volunteers - both men and women - in the age groups of 18-55 years and those of 65 years and older. Participants will each receive 3 injections. All participants are followed for over a year to investigate whether the vaccine is safe, well tolerated and elicits the desired immune response. ”

Volunteers

One approach to fighting the pandemic is the clinical development of SARS-CoV-2 vaccines. The clinical phase 2a study with this vaccine is now underway. This study will be conducted with a total of 550 participants in the Netherlands, Germany and Spain. The Dutch study centers are Center for Human Drug Research/LUMC in Leiden, PRA Health Sciences in Groningen and UMC Utrecht.

Study objectives

• To determine whether lower doses of the vaccine induce immunity, to potentially be used for dose-saving strategies and thus increase the available vaccine offering by using lower doses.
• To evaluate potential vaccination schedules at 1, 2 and 3 month intervals to determine the most effective 2-dose regimen, should a 2-dose regimen be more effective than a 1-dose regimen.
• Assess to what extent vaccination leads to possible long-term immunity.

Adenovirus vaccine

About ten years ago, the Beth Israel Deaconess Medical Center in Boston (USA) invented a technology to develop vaccines using Adenovirus 26 (Ad26), a common cold virus. Janssen Vaccines previously developed vaccines against Ebola and other infectious diseases based on Ad26, and the company also developed a vaccine against corona using this technology earlier this year. The candidate vaccine has now shown good protection against infection with the coronavirus in monkey studies. Phase 1 and 2 studies started in July and the company announced a Phase 3 study with 60,000 participants in August that is scheduled to start this September.