A preventive treatment against respiratory syncytial virus (RSV), which causes bronchiolitis, is in clinical trials with newborns. Several university hospitals in France are looking for volunteers.
The children wanted. A preventive treatment against the respiratory syncytial virus (RSV), responsible for bronchiolitis, has been being tested since September for newborns in various French hospitals.
The serum, approved at the end of 2022 by the European Commission, still needs volunteers to carry out clinical trials.
• What is the planned study?
The study, dubbed “Harmony,” is expected to last 12 months. Volunteers are first injected into their thighs with either nirsevimab, a serum developed by Sanofi and AstraZeneca laboratories, or its placebo.
An electronic notebook must then be filled in by the family for six months, in order to gather information on the efficacy of the developed antibody. Finally, after a year, a telephone switchboard between the volunteer’s parents and the vaccine study center must conclude the trial.
• Who can volunteer?
The vaccine is intended for children up to one year of age. More precisely, any child born after February 6, 2022 can participate in this clinical trial. Hospitals from all over France are participating in this trial, such as in Rouen, Bordeaux or Lille.
In total, doctors hope to test the serum on thousands of children, up to 28,860 in total. The process is open to children residing in France, but also to residents of Germany and the United Kingdom.
• What do we know about the serum tested?
The serum, which will be sold under the name Beyfortus, isn’t exactly a vaccine. But it is, like a vaccine, a preventive cure.
Unlike vaccines that use traditional technologies, serum consists of a monoclonal antibody, i.e. a synthetic antibody, developed in the laboratory. This particularity means that it offers a so-called passive immunity to the child.
In the case of a classic vaccine, the treatment allows an organism to develop its own antibodies.
• Why is study essential?
The study has one goal: to prevent the development of respiratory syncytial virus (RSV), responsible for bronchiolitis, in newborns, while France is experiencing a particularly strong epidemic this winter, in addition to flu and Covid.
While bronchiolitis is mostly mild, this respiratory disease can take on serious forms, especially in infants, requiring a visit to the emergency room, or even hospitalization.
Pfizer estimates that approximately 102,000 babies die of RSV each year worldwide, half of them under the age of six months.
• How is this the first?
There is currently no vaccine against bronchiolitis. Only one preventive treatment against the disease has been developed, it is palivizumab, marketed under the name Synagis by the AstraZeneca laboratory.
It consists of an intramuscular injection to be performed every four weeks during the epidemic season. It is feasible only in a hospital setting.
A restrictive dosage is therefore reserved for children most at risk or very premature. A vaccine open to all newborns would therefore be a more effective way to fight the disease.
• Are there other vaccines in the pipeline?
In addition to the serum developed by Sanofi and AstraZeneca, the Pfizer laboratory is also working on a vaccine against bronchiolitis. It announced in early November that it had achieved positive results, paving the way for future approvals.
Last summer, according to the scientific journal, some thirty vaccines or monoclonal antibodies were also undergoing clinical trials Lancet Infectious Diseases.
