Study on COVID-19 vaccine delivery via the skin started

Within a year from the start of the COVID-19 outbreak, the first vaccination campaigns have already been rolled out across the globe. A great accomplishment, but vaccinating the world against COVID-19 still has its challenges. For example, currently there are not enough supplies to vaccinate everyone at the same time, resulting in long lead times worldwide. Skin vaccination might speed up the process, considering a significantly smaller amount of vaccine is needed compared to the currently used intramuscular administration route, while it might provide equally good protection. Therefore, Anna Roukens, internist and infectious disease specialist at LUMC, has initiated a trial to examine the safety and efficacy of COVID-19 vaccination delivery via the skin. CHDR is contributing to this trial by providing project management support and providing access to our database of healthy volunteers.

Skin vaccination is not new. Research on this delivery method has been going on for centuries. For some vaccines, studies have demonstrated that vaccination delivery via the skin is equally effective as, or even more effective than the conventional intramuscular administration route. In addition, skin vaccination requires less antigen to trigger an immune response as the density of antigen-presenting cells in the skin is much higher than in muscle tissue. If COVID-19 vaccines are also proven suitable for immunisation via the skin, this would allow more people to be vaccinated from the same amount of vaccine, resulting in an accelerated rollout of worldwide vaccination programs.

During the current study, volunteers receive an intradermal injection of the Moderna COVID-19 vaccine (mRNA-1273) at a dose of 1/10th or 1/5th of the normal intramuscular dose. The study consists of three phases. In phase 1, volunteers receive a topical injection of 1/10th of the dose. In phase 2, they receive either an intradermal or an intramuscular injection of 1/5th of the dose. In phase 3, they are given an intradermal injection of 1/5th of the dose or a normal intramuscular dose. A couple of weeks ago phase 1 started, and out of the 10 volunteers that needed to be included, CHDR contributed in total 9 volunteers: 6 volunteers from our beReady protocol – a pre-screened pool of 100 healthy volunteers ready to enter a clinical vaccine study – and 3 from the reserve list of another COVID-19 vaccine study run at CHDR. 

The study is partly funded through the ongoing #wakeuptocorona crowdfunding campaign (https://www.steunleiden.nl/project/wakeuptocorona?locale=en). Thanks to thousands of donors of #wakeuptocorona, the LUMC was able to set up a second Biosafety Level 3 lab to study the coronavirus, and researchers could quickly scale up their research into virus inhibitors, medicines and vaccines. CHDR is very pleased to contribute to this innovative initiative of the LUMC. If you want to support COVID-19 research too, this can be done by donating now!