Clinical development partner

CEPI to invest up to $25.9 million, with support from the EU, in trials in East Africa to assess a vaccine candidate against Rift Valley Fever (RVF) in people most at risk of infection

10

Oct

2023

The Coalition for Epidemic Preparedness Innovations (CEPI) is expanding its partnership with Wageningen Bioveterinary Research (WBVR) to advance WBVR’s vaccine candidate against Rift Valley fever (RVF) through a multi-site Phase I/IIa clinical trial. Subject to regulatory and ethical approvals, the anticipated trials are scheduled to begin in 2025 in Kenya and Uganda, two countries where the mosquito-borne disease poses a significant threat to the lives and livelihoods of people in rural communities. Backed with up to US$25.9 million in funding from CEPI, with support from the European Union’s Horizon Europe programme, the studies will be the first to assess the safety and immunogenicity of WBVR’s RVF vaccine in countries where RVF is endemic.

WBVR’s live-attenuated vaccine known as hRVFV-4s, and being further developed under Wageningen spin-off Bunyavax, is currently being evaluated in a Phase I clinical trial in Belgium under a previous CEPI/ EU grant. In addition to the anticipated trials in Kenya and Uganda, CEPI will fund an extension of the ongoing Phase I study to assess immunogenicity up to 24 months; manufacturing of clinical trial materials; epidemiological research to assess the burden of infection and the risk of ‘spillover’ transmission from animals to humans in Kenya and Uganda; and regulatory engagement, including a strategy for achieving licensure of the vaccine. The work will be a combined effort of WBVR with consortium partners Batavia Biosciences BV, Bunyavax BV, CR2O BV, University of Veterinary Medicine Hannover, and Integrum Scientific, LLC.

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

First clinical trial authorisation under ECTR is a fact

29

Jul

2022

The clinical trial application of the LARISSA study is the first application submitted successfully by CR2O under the new European Clinical Trial Regulation (ECTR).

The ECTR is the new regulation for receiving ethical and regulatory approval in the European Union and European Economic Area by using the Clinical Trial Information System (CTIS) centralized portal to submit clinical trial applications.

LARISSA is a first in human Phase 1 study to assess the safety, tolerability, and immunogenicity of a single-dose vaccine candidate against Rift Valley fever (RVF) virus in healthy adult subjects. The vaccine is a novel live-attenuated RVF vaccine virus to generate a lasting immune response against the disease. The study will be performed at the Centre of Vaccinology in Belgium and first subject randomized is expected in August 2022.

Official approval was obtained on July 26th, which made CR2O one of the first successful users of the new ECTR regulation!

Please refer to https://www.larissa.online/ for more information.

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.