On 25 November 2020, the Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, authorised the first phase 1 clinical trial of a peptide vaccine against COVID-19 in Germany. The authorisation is the result of a careful assessment of the potential risk/benefit profile of the preventive vaccine candidate. The vaccine highly specifically stimulates the T-cell response.
T-cells, which are part of the immune system recognise and destroy cells infected with SARS-CoV-2 – thus providing an important system that complements the humoral immune response, which functions by neutralising antibodies. “The peptide vaccine complements the portfolio of COVID-19 vaccine platforms by another promising approach”, said Professor Klaus Cichutek, president of the Paul-Ehrlich-Institut. “This multitude is important, since we will need a variety of vaccine products to fulfil the high demand throughout the world.”
The provision of authorised safe and efficacious COVID-19 vaccines is a central aim in managing the SARS-CoV-2 pandemic. First clinical tests had the aim to identify the general tolerability of vaccine candidates and to determine their ability to create a specific immune response against the pathogen.
The Paul-Ehrlich-Institut, which is responsible for the authorisation of clinical trials and the evaluation and marketing authorisation of vaccines, supports the COVID-19 vaccine development with the highest priority. Early and extensive scientific advice by experts of the Paul-Ehrlich-Institut accelerate the development of vaccines in a targeted manner – a prerequisite for the timely availability of COVID-19-vaccines. In this context, safety and efficacy always have priority.
The peptides used for the vaccination originate from various proteins (including spike, nucleocapsid) of the SARS-Coronavirus-2, which, in the case of an infection, and presented on the surface of infected cells, are immediately recognised by the immune system based on the previous vaccination, thus marking the infected cells for the elimination by the immune system – a principle which has already been used in oncology, however, in that area, not for prevention but for cancer immune therapy.
The immune reaction to peptides in the vaccine is enhanced by an adjuvant especially developed for this purpose at Tübingen University where the active ingredient is also produced. The peptides used play an important role in developing long-term immunity after a natural SARS-CoV-2-infection.
In the first part of the clinical trial, 12 healthy subjects aged between 18 and 55 years are vaccinated. The next step also includes elderly persons with preliminary disease. The study includes a screening appointment and six control visits within a period of six months.
The clinical trial of a preventive, specific COVID-19 vaccine candidate in humans, which the Paul-Ehrlich-Institut has authorised is another step toward developing a safe and efficacious COVID-19 vaccine in Germany as soon as possible – and to making it available in Germany and world-wide after it has obtained the marketing authorisation, since, in combating the SARS Coronavirus-2 pandemic, several vaccine products are required in order to ensure sufficient supplies.
Paul-Ehrlich-Institut photo NIAD