16 / 2014
The first clinical phase I trial to be conducted in Germany with the candidate vaccine rVSV-ZEBOV will start within the next few weeks. When the epidemic was at an early stage, the Paul-Ehrlich-Institut, which is the German Federal Institute for Vaccines and Biomedicines, together with Professor Marylyn Addo and Professor Stephan Becker from the German Center for Infection Research (DZIF) linked up with Health Canada, the Canadian public health agency that developed the vaccine, and NewLink Genetics which holds the commercial licence, to organize a clinical trial in Germany. With financial support from the German Federal Ministry of Health, Professor Addo is now ready to start the clinical trial at the University Hospital Hamburg-Eppendorf.
The trial will enrol healthy adults, possibly including healthcare personnel involved in the care of Ebola patients in Germany or Africa, and investigate the potential benefit of the vaccine candidate as well as its risks.
With the steadily growing number of deaths and new infections in the Ebola-hit areas, preparations for clinical vaccine trials are running at full speed. "Early on during the Ebola outbreak, PEI and the Ministry of Health insisted on pressing ahead with the clinical development of vaccine candidates and therapeutics against the dangerous Ebola infection. Only controlled clinical trials allow the collection of reliable data needed for an accurate evaluation of the efficacy and safety of vaccines and therapeutics"
, stated Professor Klaus Cichutek, President of the Paul-Ehrlich-Institut. The Paul-Ehrlich-Institut decided to pursue an unconventional approach so as not to lose valuable time: Even before the official submission of the clinical trial application the institute’s regulators began assessing documents as they arrived. "The data on quality, on pre-clinical trials to investigate safety and efficacy in appropriate animal models, and the planned study design have been carefully evaluated."
explained Klaus Cichutek. Just as in the development process of any other vaccine candidate with promising pre-clinical results, the vaccine’s safety as well as the possible benefits have to be assessed in clinical trials on volunteers who have been thoroughly informed about potential risks. Comparable trials are currently under way in the US and will soon begin in Switzerland and Africa with the World Health Organization (WHO) taking a coordinating role.
Professor Marylyn Addo will lead the German clinical trial conducted at the University Hospital Hamburg-Eppendorf. This "Investigator Initiated Study" will be financially supported by the German Federal Ministry of Health.
The main goal of this trial is to gather initial data on the safety and immunogenicity of the vaccine. The trial involves the single administration of three different dosage levels (ten trial subjects per dosage level). To ensure the safety of the trial subjects, the trial will start with the lowest dosage level. Only if no adverse effects are observed will the next higher dosage level be tested. The study will also provide immunogenicity data focusing on the vaccine’s ability to elicit antibodies against Ebola virus in trial subjects. To this end, their blood samples will undergo multiple tests in the high security laboratory of Professor Stephan Becker, Marburg University, who is director of the DZIF "Emerging Infections" section. These data will help to find the lowest vaccine dose that is able to protect against an Ebola virus infection.
The vector vaccine rVSV-ZEBOV is based on the vesicular stomatitis virus (VSV) as transfer vehicle. Instead of its own receptor-binding protein, it carries the cellular receptor-binding protein of Ebola virus on its surface, against which the immune system of the vaccinee then develops antibodies. In case of a subsequent infection with Ebola virus, these antibodies are expected to prevent or at least limit the disease. In pre-clinical trials, 100% of the prophylactically vaccinated old world monkeys were protected from the deadly Ebola virus infection. It is important to note that the vector vaccine itself cannot induce an Ebola infection.
The Paul-Ehrlich-Institut as the Federal Institute for Vaccines and Biomedicines is an Agency of the German Federal Ministry of Health. The Paul-Ehrlich-Institut is also a member of one of the seven DZIF partner sites. DZIF was founded by the German Federal Ministry of Education and Research to specifically strengthen translational research and the early clinical development of prophylactic and therapeutic approaches against infectious diseases. Within the DZIF network, the Paul-Ehrlich-Institut researchers and regulators are involved in the development of novel vaccine platforms and innovative regulatory approaches. However, the assessment of clinical trial applications is carried out by DZIF-independent experts of the Paul-Ehrlich-Institut.
Press Contact:
Paul-Ehrlich-Institut
Press Office
Dr. Susanne Stöcker, Dr. Corinna Volz-Zang, Brigitte Morgenroth
Paul-Ehrlich-Straße 51-59
63225 Langen
GERMANY
Telefon: +49 6103 77 1030
Telefax: +49 6103 77 1262
Email: presse@pei.de
The Paul-Ehrlich-Institut, the Federal Institute for Vaccines and Biomedicines, in Langen near Frankfurt/Main is a senior federal authority reporting to the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG). It is responsible for the research, assessment, and marketing authorisation of biomedicines for human use and immunological veterinary medicinal products. Its remit also includes the authorisation of clinical trials and pharmacovigilance, i.e. recording and evaluation of potential adverse effects.
Other duties of the institute include official batch control, scientific advice and inspections. In-house experimental research in the field of biomedicines and life science form an indispensable basis for the manifold tasks performed at the institute.
The Paul-Ehrlich-Institut, with its roughly 800 members of staff, also has advisory functions nationally (federal government, federal states (Länder)), and internationally (World Health Organisation, European Medicines Agency, European Commission, Council of Europe etc.).
Updated: 07.11.2014
