The Vaccine Research Unit of the Research Foundation of HM hospitals (Fihm) is among the world’s leading recruiters in two studies on respiratory syncytial virus (RSV). The first of the studies, Matisse, is a global maternal immunization trial Phase 3 trial for Pfizer’s RSV bivalent vaccine candidate. This vaccine contains the F subunit in its pre-fusion state of RSV types A and B) gives positive first-line results in pregnant women.
On the other hand, the European Commission communicated the authorization in November 2022 of nirsevimab, a monoclonal antibody for the prevention of RSV lower respiratory tract infection in neonates and infants. The European Medicines Agency (EMA) has recommended a marketing authorization in the European Union (EU) for Beyfortus (nirsevimab) for the prevention of lower respiratory tract infection in newborns and infants caused by RSV during their first season exposed to the virus, when there is a risk of infection in the community.
Patients involved in the trials
In both clinical trials, the Unit was among the best recruiters. “O pregnant vaccination would generate newborns with antibodies that would protect them against RSV at an early age, when infection with this virus is more severe. Last season was devastating for medical services, generating the collapse of pediatric emergencies and UCIS. It was of such magnitude that in many countries the school year was suspended for weeks to stop the circulation of the virus. This demonstrates the importance of these advances for children’s health”, says Silvina Natalini, director of the Fihm Vaccine Research Unit.
The overall study involved approx. 7,400 healthy pregnant women up to 49 years of age, who were randomized in a 1:1 ratio to receive a single 120 µg dose of vaccine or placebo during the second or third trimester of pregnancy. The trial also assessed the safety and immunogenicity of the vaccine in pregnant women and their babies, including women from 18 countries. It started in June 2020 and lasted for several VRS seasons, in both the northern and southern hemispheres.
The other research related to RSV in which the Unit has participated in the group of the main global recruiters also represents a substantial advance in the fight against this pathology that puts the lives of many children at risk every year. “With the nirsevimab approval (Ac monoclonal VRS los ríosgo patients will experience a significant improvement in their adherence to the treatment since, until then, it only counts with Synagis (AC monoclonal), but its administration is produced monthly and via IM, unlike nirsevimab what is it? a single dose“, clarifies Natalini.
Trial in the pediatric population
On the other hand, the results of another investigation in which the HM Hospitales Research Foundation Vaccines Unit were published in the prestigious magazine The New England Newspaper. The results of this study show the effectiveness of the third dose of the BNT 162b2 Covid-19 vaccine in children under 5 years of age. Fihm’s Vaccines Unit was chosen by Pfizer as one of the centers for carrying out this clinical trial in the pediatric population.
Currently, the Vaccine Research Unit has several vaccine trials underway, including RSV, not only for infants but also for over 65 years old, where the infection can also be severe. In addition, it also develops clinical trials for pneumococcal, influenza and Covid-19 vaccines. The Unit also responds to the need to centralize all clinical research activity related to vaccines carried out in the Group’s hospitals. “The development of a vaccine against RSV will be a milestone in pediatrics. The beginnings were not happy in the 1960s and this led to the abandonment of research on this vaccine for almost 30 years. But thanks to the new vaccine platforms it is already a reality and this vaccine will change the health of our children, like others like Sabin, BCG, pneumococcus, meningococcus, etc. changed at the time”, highlights Natalini.
Another fundamental aspect that governs its performance is the appreciation of all surveillance protocols, traceability and safety that apply to a field as sensitive as vaccines.
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