Luis Garegnani, Camila Micaela Escobar Liquitay, Ignacio Esteban, Mikaela Lenells, Chiara Russo, Matteo Bruschettini, Juan VA Franco
https://doi.org/10.1002/14651858.CD016224

Objectives

This is a protocol for a Cochrane Review (intervention). The objectives are as follows:

To assess the comparative effectiveness of monoclonal antibodies (mAbs) for preventing respiratory syncytial virus (RSV) infection in children, and to evaluate the relative rankings for benefits and harms of mAbs for preventing RSV in children.

Description of the condition

Respiratory syncytial virus (RSV) is the most common pathogen to cause lower respiratory tract infections (LRTIs) in children, and these infections are the primary cause of morbidity and mortality in young children. RSV alone accounts for 33 million acute LRTIs, 3.6 million hospitalisations, and 101,000 deaths globally each year amongst children under five years old. It is the second leading cause of infant deaths worldwide after malaria.

RSV is a single‐stranded, negative‐sense, enveloped ribonucleic acid (RNA) virus. It belongs to the Pneumoviridae family and Orthopneumovirus genus. Transmission occurs through contact with infected surfaces or hands or direct contact with respiratory secretions, and the incubation period is three to five days. By the age of two, 90% of infants and young children have been infected. Symptoms of RSV‐induced upper respiratory tract infection (URTI) include rhinitis, cough, nasal congestion, and sometimes fever, while symptoms of RSV‐induced LRTI include bronchiolitis or pneumonia with dyspnoea, difficulty feeding, wheezing, or apnoea. In temperate regions, RSV is distinctly seasonal, peaking during the colder season. In tropical and subtropical climates, RSV is less predictable and can occur throughout the year. Depending on the geographic location, there are differences in the severity of the disease, primarily attributed to socioeconomic, environmental, and genetic factors. The most severe forms tend to occur in children with underlying chronic conditions such as bronchopulmonary dysplasia; children with congenital heart disease, cystic fibrosis, Down's syndrome, or immunodeficiency; infants younger than three months; and preterm infants. Mortality is higher in children hospitalised with RSV in low‐income countries versus high‐income countries.

Description of the intervention and how it might work

Palivizumab (SYNAGIS), a monoclonal antibody (mAb) against RSV, was approved in 1998 by the U.S. Food and Drug Administration (FDA) and soon after by the European Medicines Agency (EMA) for the prevention of RSV disease in infants born before 29 weeks' gestational age and older infants with certain baseline risk factors. For many years, palivizumab was the main mAb treatment strategy, as phase III clinical trials of other mAbs (motavizumab and suptavumab) produced insufficient evidence to support their use.

See the protocol on the Cochrane Library