Paul-Ehrlich-Institut

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

The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, has approved a Phase II clinical trial of a vaccine against COVID-19 in Germany. The approval was preceded by intensive scientific consultation with the drug developer Janssen. It is the result of a careful assessment of the potential benefit-risk profile of the vaccine candidate. The testing of vaccine candidates in humans is an important milestone on the way to authorisation of safe and efficacious COVID-19 vaccines for the population in Germany and beyond.

Electron Microscopy SARS-CoV-2 (Source: www.niaid.nih.gov)

To contain the SARS Coronavirus 2 pandemic, the worldwide availability of safe and effecacious COVID-19 vaccines is an important milestone. After preclinical development, initial clinical trials - the first application of the vaccine candidate in humans - aim to determine the general tolerability of vaccine candidates, identify common risks and find out whether a specific immune response against the pathogen is generated. In a Phase II trial, dosage (active ingredient content per vaccine dose) and vaccination schedule (single vaccination or two vaccinations, time interval) as well as initial data on safety and efficacy are determined on a large number of volunteers, often several hundred. The Paul-Ehrlich-Institut, which is responsible for the approval of clinical trials and the evaluation and approval of vaccines in Germany, supports the COVID-19 vaccine development with the highest priority. It provides early advice on the development of vaccines and biomedicines against COVID-19, thus helping to avoid regulatory pitfalls and speeding up development processes without sacrificing careful testing.

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. The phase 2a study examines the safety, tolerability (e.g. swelling or local inflammation at the injection site) and the ability to generate an immune response. The SARS-CoV-2 vaccine candidate Ad26 COV2.S by Janssen will be tested as single dose and two-dose design in 550 health adults aged between 18 and 55 years as well as adults aged 65 years and older. The selection of study centres in Germany, Spain and the Netherlands will be performed in close co-operation with the competent health authorities based on epidemiological data.

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. The Paul-Ehrlich-Institut expects that further clinical trials of COVID-19 vaccine candidates will start in Germany in the next few months. A whole range of vaccine products will be needed to fight the pandemic and to ensure an adequate supply.

Background Vector Vaccines

An attenuated virus serves as a transport vehicle (vector) for a harmless part of the genetic information of SARS-CoV-2 into a few human body cells. The body cells use the blueprint to produce the spike protein of SARS-CoV-2. In response to this antigen, the body builds up an immune response and immune memory. The vector for Janssen's vaccine candidate is a non-replication and less common human adenovirus.

Further Information

Where can I get Information about the Participation in the Clinical Trial of the COVID-19 Vaccine?
EU Clinical Trials Register - COVID-19 Vaccine Janssen Study Phase II

Updated: 08.09.2020