Since June 2020, the BioMAP research team of the INRAE-Université de Tours Infectiology and Public Health (ISP) joint research unit, a member of the Carnot Institute’s France Futur Elevage network, has been working on the development of a nasal vaccine against the SARS-CoV-2 virus, with the support of several teams from universities, academia and INRAE.
An original and robust vaccine concept, supported by ANRS | Maladies infectieuses émergentes
Pre-clinical tests had demonstrated the efficacy of the vaccine candidate following two nasal immunisations delivered three weeks apart, in terms of immune response associated with early neutralisation of the original virus and its variants, and significant reduction of the risk of contamination by a vaccinated individual. The results of this non-adjuvanted protein vaccine were confirmed at the end of 2021 by new pre-clinical trials on rodents validating its effectiveness against the Delta variant. The vaccine, composed of the spike protein and other viral proteins, non-subject to mutation, would therefore protect against currently circulating strain of SARS-CoV2 despite multiple mutations.
The support of the ANRS | Maladies infectieuses émergentes on this vaccine candidate will allow the consolidation of the design as well as the monitoring of all the phases upstream of the market launch.
Decisive upcoming steps: fund-raising, vaccine batches production and first clinical trials
Founded by Isabelle Dimier-Poisson from the UMR ISP and head of the BioMAP research team at the origin of the project and Patrick Barillot, former development director at Recipharm, the start-up LoValTech (for Loire Valley Technology) has held an exclusive licence to exploit the vaccine candidate since its creation in January 2022, granted jointly by the Université de Tours and INRAE. Mathieu Epardaud (INRAE researcher) and Nicolas Aubrey (associate professor at the Université de Tours), both members of BioMAP, are also part of the adventure as partners and scientific consultants for the startup. The ANR and the Centre-Val-de-Loire region provided an initial funding of €500,000 for scientific development. The Ministry of Higher Education, Research and Innovation allocated a further €1.5 million and the ANRS | Maladies infectieuses émergentes a €0.9 million, reaching a total €2.4 million, to the Université de Tours in order to carry out the production of the vaccine proteins following GMP (Good Manufacturing Practice) environment, requiered for clinical trials. From the first quarter of 2022, the challenge will be to produce this biomedicine through the Toulouse-based company GTP Bioways and to launch the production of clinical batches for clinical trials during the second quarter.
At the same time, the specific instillation systems – an inovative design – to inoculate this vaccine by intranasal route is the topic of collaborative exchanges with two specialised companies, Resyca and Aptar Pharma.
Lastly, discussions on the design of the clinical trials and the drafting of the phase I protocol will be initiated over the next few weeks with the support and expertise of the ANRS | Maladies infectieuses émergentes, sponsor of these future clinical trials. The Clinical Investigation Centre of the CHRU (the Tours Regional University Hospital, a joint structure of the University Hospital, the University and Inserm) has already committed to conduct these clinical trials with other investigators.
Non-invasive and requiring minimal logistics, this vaccine will allow for a wider distribution:
- As a booster for countries with an already satisfactory vaccination coverage in order to strengthen the immune response - particularly the mucosal one - to protect the vaccinated population from symptomatic forms of the disease and, above all, to avoid transmission of the virus.
As a first choice vaccine for countries where the population has not yet access to primary vaccination.
This vaccine was first tested in vivo in a pre-clinical murine model. Two nasal applications, three weeks apart, induced a strong humoral immune response – in particular of the mucosal immunoglobulin A (IgA) with a neutralising and polyspecific activity, i.e. effective against the different variants of SARS-CoV-2 – along with a strong cellular response in the nasal cavities and lungs.
 Created on 1 January 2021, the ANRS/ Maladies infectieuses émergentes is the new autonomous agency of INSERM, created by the merger of the REACTing consortium and the National Agency for AIDS Research (ANRS) under the joint impetus of its two supervisory ministries, the Ministry of Higher Education, Research and Innovation and the Ministry for Solidarity and Health.
LoValTech, SAS, is located in the MAME incubator in Tours. Created on 17 January 2022, the LoValTech start-up aims to carry on the development of the MUCOVID vaccine, stemming from university research in Tours, and to bring it to the market. The LoValTech team is an ideal bridge between academic research represented by Isabelle Dimier-Poisson, associate professor at the Université de Tours (future general manager of LoValTech), Mathieu Epardaud (INRAE researcher) and Nicolas Aubrey (associate professor at the Université de Tours), and industry represented by Patrick Barillot (former development director at Recipharm and President of LoValTech).
ANRS | Maladies infectieuses émergentes
Created on 1 January 2021, ANRS | Maladies infectieuses émergentes is an autonomous agency of Inserm. Its mission is to lead, evaluate, coordinate and fund research on HIV/AIDS, viral hepatitis, sexually transmitted infections, tuberculosis as well as emerging and re-emerging infectious diseases (in particular emerging respiratory infections, including Covid-19, viral haemorrhagic fevers and arboviral diseases). The agency covers all fields of research: basic, clinical, public health as well as human and social sciences; its organisation emphasises innovation and the strengthening of international partnerships. With a One Health approach, addressing human and animal health and the impact of humans on the environment, the agency is preparing the response to the scientific challenges posed by emerging diseases and its deployment in times of crisis. The ANRS | Maladies infectieuses émergentes is placed under the aegis of the Ministry of Higher Education, Research and Innovation and the Ministry for Solidarity and Health. Its director is Professor Yazdan Yazdanapanah.
www.anrs.fr (in French)
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