Dose and vaccination schedule
‘In a phase 2a clinical study we are investigating which dose and vaccination schedule is most effective in inducing an immune response in subjects’, explains Meta Roestenberg, internist infectiologist at the LUMC and medical responsible for this study. ‘With this study it is not yet possible to determine whether the immune response that is induced is also sufficient to prevent someone from becoming ill from the coronavirus. This will have to become apparent from a subsequent phase 3 study ‘, adds Ingrid de Visser-Kamerling, principal investigator from the CHDR.
Vaccination schedule
In this double-blind study, healthy subjects are each given the vaccine three times according to different time schedules. ‘Because we test multiple time periods between vaccinations, we can also investigate the impact of a possible delay in the vaccination schedule due to, for example, a revival of the virus,’ says Meta.
Low dose effect
‘We also want to investigate whether a lower dose of the vaccine can also induce immunity. If that dose is effective, it is very beneficial as many people have to be vaccinated, ‘says Ingrid. More people can be vaccinated by using a lower dose.
Tested in total on 550 participants
The candidate vaccine is being tested on a total of 550 participants. The LUMC and CHDR will together take care of 45 test subjects. Participants are monitored closely and followed up to 12 months after the second vaccination. ‘The study will therefore take 13 to 15 months,’ says Ingrid.
Cooperation
Meta and Ingrid have been working together intensively for years, including now on Janssen vaccine research. The vaccinations are administered in the CHDR and the controls take place in the LUMC. ‘The infrastructure makes this collaboration very logical, the CHDR is located a stone’s throw from the LUMC’, says Meta. But that is not the only reason. Meta: ‘The vaccination clinic at the LUMC has a lot of knowledge and experience with vaccination technologies and the CHDR has a lot of experience with parties from the industry and early phase drug research.’ Ingrid: ‘So we complement each other perfectly.’
Contribute
Both researchers are thrilled to be working on this study. “It’s a huge challenge,” says Meta. Ingrid: ‘It is important that this research can be carried out properly and quickly and I am happy to be able to contribute to a research that can mean so much for the world.’
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