A preventive treatment against the respiratory syncytial virus (RSV), responsible for bronchiolitis, is in clinical trial with infants. Several university hospitals in France are looking for volunteers.
Babies wanted. A preventive treatment against the respiratory syncytial virus (RSV), responsible for bronchiolitis, has been on trial since September for infants in various French hospitals.
The serum, approved at the end of 2022 by the European Commission, still needs volunteers to carry out the clinical trial.
• What is the planned study?
The study, named “Harmony”, should last 12 months. The volunteers are first injected into the thigh with nirsevimab, a serum developed by the Sanofi and AstraZeneca laboratories, or its placebo.
An electronic notebook must then be completed by the family for six months, in order to collect information on the effectiveness of the antibody developed. Finally, after one year, a telephone exchange between the parents of the volunteer and the vaccine study center must conclude the trial.
• Who can volunteer?
The vaccine is intended for babies up to one year old. More precisely, any child born after February 6, 2022 can participate in this clinical trial. Hospitals all over France are participating in this trial, such as in Rouen, Bordeaux or Lille.
In total, clinicians hope to test the serum on thousands of children, up to 28,860 in total. The trial is open to French resident children, but also German and UK residents.
• What do we know about the tested serum?
The serum, which is to be sold under the name Beyfortus, is not exactly a vaccine. But it is, like a vaccine, a preventive treatment.
Unlike vaccines using traditional technologies, the serum consists of a monoclonal antibody, that is to say a synthetic antibody, developed in the laboratory. This particularity means that it offers a so-called passive immunity to the infant.
In the case of a classic vaccine, the treatment allows an organism to develop its own antibodies.
• Why is the study essential?
The study has one objective: to prevent the development of the respiratory syncytial virus (RSV), responsible for bronchiolitis, in infants, while France is experiencing a particularly strong epidemic this winter, in addition to that of influenza and Covid.
If bronchiolitis is mostly mild, this respiratory disease can take serious forms, especially in infants, and which require a visit to the emergency room, or even hospitalization.
Pfizer estimates that around 102,000 children die of RSV each year worldwide, half of them under the age of six months.
• How is this a first?
Currently, there is 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 only feasible in a hospital setting.
A restrictive dosage therefore reserved for babies most at risk or very premature babies. A vaccine open to all infants 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. He announced in early November that he had obtained positive results, paving the way for future authorization.
About thirty vaccines or monoclonal antibodies were also in the clinical trial phase last summer, according to the scientific journal Lancet Infectious Diseases.
