Phase II Clinical Trial of the COVID-19 Vaccine of Janssen Authorised in Germany

The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, has approved the Phase II clinical trial of the SARS-CoV-2 vaccine candidate Ad26 COV2.S by Janssen against COVID-19 in Germany. The phase 2a study will examine the safety, tolerability (e.g. swelling or local inflammation at the injection site) and the ability to generate an immune response in three study centres in Germany, Spain, and the Netherlands. The vaccine candidate will be tested as single-dose and two-dose design in 550 healthy adults aged between 18 and 55 years as well as adults aged 65 years and older. The selection of the study centres was performed in close co-operation with the competent health authorities based on epidemiological data.

The vaccine candidate of Janssen is a vector vaccine in which a viral vector transfers the genetic information for the construction of the spike protein of SARS-CoV-2 into a few body cells.

According to the World Health Organization (WHO) as of September 3, 2020, 34 COVID-19 vaccine candidates are currently undergoing clinical trials worldwide. The increasing number of clinical trials worldwide is an important indication of the ongoing development of COVID-19 vaccine products.

Further information can be found on the homepage of the Paul-Ehrlich-Institut and on the homepage of Janssen.