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news.MedImmune has enrolled children aged between six months and two years in its trials to develop a vaccine to tackle common respiratory infections which affect children.
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Maryland-based MedImmune said it has begun dosing at-risk children six months to 24 months of age in a phase I trial of a vaccine designed to help prevent respiratory syncytial virus (RSV) and parainfluenza virus type 3 (PIV-3) infections, which it claims are two of the most important causes of lower respiratory tract illness and hospitalization in infants and young children.
The group said a previously completed study in healthy adults and non-susceptible older children demonstrated that this RSV/PIV-3 vaccine candidate had an acceptable safety profile and was well tolerated.
“As a leader in pediatric medicine, MedImmune is dedicated to developing additional therapies that can help protect infants and young children against potentially serious, even fatal, respiratory illnesses,” said Dr Genevieve Losonsky, vice president of clinical development in infectious disease.
Designed to evaluate safety, tolerability, immunogenicity, and vaccine shedding in the nose, MedImmune’s phase I dose-escalation trial is a multi-center Northern Hemisphere study to be initiated when RSV is not widely circulating in the community. In the study, more than 140 study participants will be followed through the end of the subsequent RSV season or for 180 days after the final dose, whichever occurs later.
In addition to the RSV/PIV-3 vaccine candidate to be used in this study, MedImmune said its researchers are working through a cooperative R&D agreement with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, to develop live, attenuated intranasal vaccines designed to reduce the consequences of disease caused by RSV; PIV types 1, 2 and 3; and human metapneumovirus. These viruses are responsible for more than half of all hospitalizations for pediatric respiratory tract disease and are important causes of bronchiolitis, pneumonia and croup.