Par Chloé Berry
Published on
Every winter, 30% of children under two are affected by bronchiolitis. This year’s outbreak – still ongoing, according to Public Health France – was particularly severe and early.
And, like every year, this respiratory virus which affects infants clutters pediatric services. Sanofi et AstraZeneca plan to change that. The two laboratories have joined forces to develop a preventive treatment, Beyfortus (nirsevimab).
Protection for five months
The antibody specifically targets the respiratory syncytial virus (RSV), which causes bronchiolitis, in the body. In one shotit protects babies during five monthsor throughout the RSV season, which runs from October to March.
Several test phases have made it possible to prove the effectiveness of the antibody. The latest, the Phase III MELODY trial, has proven that the Beyfortus has 79.5% efficiency against lower respiratory tract infections caused by RSV.
These promising results enabled Sanofi and AstraZeneca to receive the approval of the European Commission in November 2022 for market their quick fix. But, before being offered to the general public, the antibody must pass a final test: the clinical trial. Harmonycurrently in progress everywhere in France.
Volunteers wanted until February 5
If the effectiveness of the product is no longer to be proven, the purpose of this last step is to obtain medico-economic data, which will make it possible to decide on the product refund. The trial, which began in early September, still looking for volunteers.
“Recruitment will continue until the end of the RSV epidemic, at least until February 5 » 2023, precise to actu.fr Dr. Florence Flamein, national coordinator of the clinical trial and head of the study at the University Hospital of Lille. A date that could well be postponed due to the longevity of the epidemic. “The Germans are still in the peak,” she recalls.
To get the best result, clinicians hope to test the antibody on nearly 30,000 babies in France, but also in Germany and the United Kingdom. If the study is also carried out in our neighbours, it is because they take charge of bronchiolitis in the same way as in France.
But this figure risks not being reached according to the head of the study: “Currently, we are between 4,500 and 5,000 babies. I don’t know if we will reach 30,000, it was very ambitious at the same time, ”she underlines. On the other hand, not reaching this figure in no way affects the viability of the study, as confirmed by the national coordinator.
Pediatric emergencies, city paediatricians, social networks… If the information of the clinical trial has been well disseminated, Dr. Florence Flamein deplores a “lack of information” about his study: “There are still people who don’t know about it. The only way to get this treatment is to participate,” she argues.
Can your baby take part in the clinical trial?
Would you like your child to have a chance to receive this preventive treatment? We explain how to proceed.
Babies aged from 0 to 12 months can enroll in the clinical trial, more precisely those born after the February 6, 2022. “One of the study’s inclusion criteria is to be in their first season of RSV, and therefore to be less than a year old. As it runs until February, that’s why the limit was set there,” says Florence Flamein.
But this is not the only criterion for participating in the study. In fact, you should not:
- Have a bronchiolitis or the fever at the time of inclusion;
- Have some contraindication to intramuscular injection;
- To be born very premature (i.e. before 29 weeks of amenorrhea);
- Be eligible for the other treatment for bronchiolitis, the Synagogue (reserved for premature babies or babies with heart problems).
If your baby ticks all of these boxes, he can participate in the Harmonie clinical trial.
How is the trial going?
On the study site, all you have to do is complete a pre-screening questionnaire. Both parents must sign a consent letter then you can make an appointment for the injection.
During the clinical examination, a doctor validates or not the participation of the infant on the basis of his medical file. We take his temperature and his weight.
It’s time for the injection. But beware : the child’s participation in the clinical trial does not guarantee that he will receive the antibody. Indeed, the serum will be randomly assigned to one of the two study groups: one group will receive the antibody while another will not be pricked.
During this medical appointment, the parents download a application. Each month, whether your baby has received Beyfortus or not, information must be filled in. Data is recorded in real time. This follow-up lasts six months.
A follow-up one year later
If your child has symptoms of bronchiolitis, the medical team contacts you by telephone to ask you for details.
12 months after the injection, the experiment ends with a follow-up phone call. ” It is a non-binding study in terms of availability,” notes Dr. Florence Flamein.
Parents can decide to withdraw their child from the study at any time. This will have no impact on his medical follow-up.
Where is the study taking place?
In France, several hospitals participate in the clinical trial, like the CHI of Créteil (Val-de-Marne).
To find out if a hospital near you is on the list, just go to the Harmonie website.
A carte interactive lists the different University Hospitals participating in the clinical trial. “The main University Hospitals participated”, concludes Dr. Florence Flamein.
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