REGN2222-Prevention of Medically Attended RSV in Preterm Infants

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of a Human Monoclonal Antibody, REGN2222, for the Prevention of Medically Attended RSV Infection in Preterm Infants

• IRAS ID

  184667

• Contact name

  James Paton

• Contact email

  james.paton@glasgow.ac.uk

• Sponsor organisation

  Regeneron Pharmaceuticals, Inc.

• Eudract number

  2015-001714-96

• Clinicaltrials.gov Identifier

  NCT02325791

• Duration of Study in the UK

  0 years, 10 months, 19 days

• Research summary

  Respiratory Syncytial Virus (RSV) circulates seasonally, with infection peaking in the winter months. RSV infection is a leading cause of hospitalisation and urgent unplanned medical visits for care of infants. The majority of children are infected with RSV by the age of 3 years with most having a mild illness like a cold. However, RSV can also cause more serious lower respiratory tract infections, especially in infants under 6 months of age during their first RSV season.

  Currently the only preventative treatment for RSV is an antibody against RSV, Synagis® (palivizumab). Due to cost, this is usually only given to children classified as being at highest risk of serious illness from RSV (babies with certain heart or lung conditions) and therefore other children at risk miss out on preventative treatment.

  REGN2222 is a different antibody against RSV made by Regeneron Pharmaceuticals Inc.

  This study is to measure if REGN2222 can prevent urgent unplanned doctor or hospital attendances because of lower lung infection with RSV. Safety and the amount of REGN2222 in the blood will also be measured.

  Participants will be randomly assigned to one of 3 groups (505 participants in each group) to receive the following doses:
  • 1 REGN2222 and 1 Placebo
  • 2 REGN2222
  • 2 Placebo

  Children born prematurely and who are no more than 6 months of age (i.e. they will receive first dose of study medication before their 6 month birthday) when the RSV season occurs will be given REGN2222 or placebo by an injection into the muscle and will attend a total of 7 study visits over a 6 month period. Recent clinical history will be reviewed and a physical exam performed. Blood samples will be taken at 3 of 7 planned visits for analysis. All children will be monitored for any changes in their health.

• REC name

  West of Scotland REC 1

• REC reference

  15/WS/0153

• Date of REC Opinion

  1 Sep 2015

• REC opinion

  Further Information Favourable Opinion