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During the COVID-19 pandemic, French research was criticised for its inability to develop a vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) faster than its global competitors. However, according to a press release from the French National Research Institute for Agriculture, Food, and the Environment (INRAE), France is making a strong comeback with a novel approach to vaccination against the virus. The University Hospital of Tours, Tours, France, and the ANRS Emerging Infectious Diseases are set to initiate a clinical trial of a nasal spray vaccine against SARS-CoV-2, developed by the start-up Lovaltech.

Nasal vaccines against respiratory viruses offer the advantage of providing both local protection at the site of virus entry (the nasal mucosa) and systemic protection, similar to traditional vaccines, including messenger RNA (mRNA) vaccines. This dual action can rapidly slow viral replication and limit its spread within the body. The vaccine that will be tested contains the spike protein and a non-mutated nucleoprotein of SARS-CoV-2 and aims to reduce the transmission of COVID-19.

First Results Expected Soon

The clinical trial, named MUCOBOOST First in Human, will be conducted in two phases. Phase 1 will begin in early April 2025 at the Clinical Investigation Centre of the University Hospital of Tours and, later in June, at the Cochin-Pasteur Clinical Investigation Centre in Paris, France.

The study will enrol 36 healthy volunteers aged 18-55 years to determine the appropriate vaccine dose. Three groups of 12 participants each will receive a different dose, starting with the lowest dose and applying dose escalation protocols. Each participant will undergo eight medical visits over a 12-month period: One for eligibility and confirmation of enrolment, one for vaccine administration, and six follow-up visits for biologic sample collection. The initial results are expected in the fall of 2025.

Phase 2 is scheduled to begin in early 2026, recruiting 202 healthy volunteers from five centres: Tours, Saint-Étienne, Lyon, Cochin, and Dijon. The primary goal of this study was to demonstrate the superiority of nasal vaccines over mRNA vaccines in reducing the transmission of SARS-CoV-2.

Private Company to Expand Production

The nasal vaccine originated from public research led by a team from the INRAE and the University of Tours. The development of the nasal vaccine in 2020 was based on a process previously confirmed for a nasal vaccine against toxoplasmosis. In 2021, a trial on hamsters showed that the vaccine effectively blocked viral transmission between animals.

Lovaltech was founded in 2022 to initiate industrial development. The company has conducted regulatory toxicity and immunogenicity studies to confirm the safety and efficacy of the vaccine candidate in animals before progressing to human trials.

Lovaltech’s ambitions extend beyond SARS-CoV-2. According to the company’s president, Patrick Barillot, the vaccine developed against the SARS-CoV-2 virus “represents a strategic opportunity to rethink immunisation, improve immune coverage, and address future global health challenges.” It aims to “establish French leadership in biotechnology and health innovation.”

This story was translated from Univadis France using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.