LUMC and CHDR to test Janssen Vaccines’ candidate corona vaccine
Leiden University Medical Center (LUMC) and the Centre for Human Drug Research (CHDR) are taking part in the phase 2 clinical trial of Janssen Vaccines’ candidate coronavirus vaccine. The vaccine will be tested on 45 test participants in Leiden from 14 September onwards.
The aim of the trial is to determine the vaccination schedule and the optimum dose needed to generate an immune response. ‘In the phase 2a clinical study, we will study which dose and vaccination schedule is most effective at generating an immune response in test participants,’ Meta Roestenberg explains. Roestenberg is an infectious disease specialist at the LUMC and the medical researcher in this trial. ‘The trial won’t yet enable us to determine whether the immune response is also sufficient to prevent coronavirus from making people ill. That will have to wait until the phase 3 trial,’ adds Ingrid de Visser-Kamerling, principal researcher from CHDR.
Vaccination schedule
In this double-blind trial, the vaccine will be administered to healthy test participants according to different schedules. ‘As we are testing different periods between the vaccinations, we will also be able to study the impact of a possibe delay in the vaccination schedule should the virus flare up again, for instance,’ says Roestenberg. ‘We also want to study whether a lower dose of the vaccine can also generate immunity. If that dose proves effective, that will be of huge benefit given how many people need to receive the vaccination,’ says De Visser. A lower dose will mean more people can be vaccinated.
The candidate vaccine will be tested on 550 participants, 45 of whom LUMC and CHDR will be responsible for. The participants will be intensively monitored until 12 months after the second vaccination. The trial will take 13 to 15 months.
Collaboration
The two researchers have been working closely together for years, and this is set to continue with the Janssen vaccine research. The vaccinations will be administered at CHDR and the check-ups will be performed at LUMC. ‘The infrastructure makes this collaboration very logical. CHDR is a stone’s throw away from LUMC,’ says Roestenberg. But that is not the only reason. ‘The LUMC vaccination clinic has a lot of knowledge and experience of vaccination technologies and CHDR has a lot of experience with industrial parties and early-phase drug trials.’
‘We’re a perfect match,’ says De Visser.
Contribution
Both researchers think it is fantastic to be able to work on this study. ‘It’s an enormous challenge,’ says Roestenberg.
De Visser says, ‘It’s important that this research is done quickly and well. I’m pleased to be able to contribute to a study that could mean so much to the world.’
Source: LUMC