Clinical development partner

Update COVID-19: Safeguarding health and safety

05

Mar

2020

As a result of the COVID-19 pandemic, CR2O has adapted its contingency plan aimed to guarantee the safety and well-being of patients, employees, clients and continuity of our services. By following recommendations from Regulatory Authorities (local, EMA and FDA), CR2O continues to focus on patient safety and maintaining compliance with GCP under the current restrictive circumstances.

CR2O will remain fully operational during the COVID-19 pandemic.

If you have any question, please contact us on: info@CR2O.nl / +31 (0)85-071 74 01.

ISOLDA aims at the development of improved vaccines against viral infections for older adults

Isolda

09

Jan

2020

The EU Research and Innovation programme HORIZON 2020 has awarded a contract worth up to 6 million euro’s to a consortium led by Stiftung Tieraerztliche Hochschule Hannover (TiHo), aimed at developing improved vaccines against viral infections for older adults.

The average age of citizens of the European Union (EU) is increasing, with currently 20% aged over 65. Ageing is one of the main health-related challenges within the EU, and promoting healthy ageing is a key priority. Increased susceptibility to infectious diseases and their associated complications, related to altered immune responses, threatens the health of older adults. In addition, senescence-related reduced immune function negatively affects the effectiveness of vaccination and contributes to lower protection provided by current vaccines in older adults. Another challenge is related to increased risk of adverse reactions in individuals over 60 following vaccination, in particular with live-attenuated vaccines. Identifying key factors causing poor and/or adverse responses to vaccination in older adults, and devising counter-strategies to circumvent these issues, are essential to improve vaccine-induced immune responses and achieve better vaccination-mediated protection against viral infections in this expanding vulnerable population.

In this consortium, 7 partners have joined to develop improved vaccines against viral infections for older adults. As one of the partners CR2O BV will coordinate the clinical trial and will offer project office support.

CEPI awards contract worth up to US$12.5 million to consortium led by Wageningen Bioveterinary Research to develop a human vaccine against Rift Valley fever

Rift Valley Fever

05

Aug

2019

Wageningen Bioveterinary Research (WBVR), part of Wageningen University & Research, and the Coalition for Epidemic Preparedness Innovations (CEPI) have announced a new partnering agreement. With support from the European Union’s (EU’s) Horizon 2020 programme, CEPI will provide up to US$12.5 million for vaccine manufacturing, preclinical research, and a phase 1 study to assess the safety, tolerability, and immunogenicity of a single-dose vaccine candidate (RVFV-4s) against Rift Valley fever virus for use in humans.

About the Vaccine Development Consortium

WBVR will lead the preclinical safety and efficacy evaluation of RVFV-4s vaccine candidate; BunyaVax BV will provide the vaccine technology, undertake project management and enabling science; IDT Biologika GmbH will manufacture the vaccine; TiHo RIZ, University of Veterinary Medicine Foundation, Research Centre for Emerging Infections and Zoonoses will undertake studies to establish correlates of protection. CR2O BV will coordinate the clinical trial; CEVAC Clinical Trial Unit of Ghent University Hospital will implement and sponsor the clinical trial; and CEVAC Immunomonitoring Laboratory of Ghent University will handle biological material.

The official CEPI and WBVR Press Release can be found here.

Product Development and Clinical Investigation of a MERS-CoV Vaccine based on highly efficient scalable recombinant MVA technology

MERS Coronavirus

17

Sep

2018

CEPI awarded a program which is aimed at the manufacturing and stockpiling of clinical supplies of MVA-MERS-S and the concomitant clinical development to a stage where outbreak deployment readiness is demonstrated. As such the project targets the outbreak preparedness for the Middle East Respiratory Syndrome coronavirus (MERS-CoV), which is under WHO public health surveillance.

Middle East respiratory syndrome (MERS) is a viral respiratory disease caused by a novel coronavirus (MERS‐CoV) that was first identified in Saudi Arabia in 2012. Symptoms are those of fever, cough and shortness of breath. Pneumonia and gastrointestinal symptoms, including diarrhoea, have also been reported. All known cases so far have been linked to travel or residence in and around the Arabian Peninsula. But in 2015, the virus affected 186 people in South Korea infected by a single person who came back from middle-east, approximately 35 % of reported patients with MERS died. This was the largest outbreak so far. Since 2012, 27 countries have reported cases of MERS and approximately 80 % of human cases have been reported by Saudi Arabia. Globally, 2036 laboratory-confirmed cases of infection with MERS-CoV including at least 710 (34.8 %) related deaths have been reported to the WHO.

To protect high risk individuals in endemic areas, who potentially contract and spread the virus into the general population and non-infected regions, as well as to prevent future outbreaks of MERS, consortium of IDT / DZIF / UKE / EMC / DUKE propose a MVA-MERS vaccine from preclinical studies through Phase 2 clinical trials based on a new DF-1 technology, a rather new approach which gives us the opportunity to react fast and scalable on increasing demand of vaccine doses in case of an emergency. The vaccine lead candidate is a live but replication-incompetent viral vector vaccine based on recombinant Modified Vaccinia virus Ankara expressing the MERS-CoV Spike (S) protein (MVA-MERS-S). The MERS-CoV S protein, a characteristic structural component of the virion membrane, is considered a key component of vaccines against MERS-CoV, similar to S proteins in other coronavirus infections. So the MVA technology provides the immunological advantages of a live, replication-deficient vector that initiates T cell as well as antibody formation.

In this consortium 6 partners have joined to develop a MVA-MERS vaccine. As one of the partners CR2O BV will coordinate the phase I and II clinical trials.