Safety and Efficacy of MEDI8897 Against RSV

Safety and Efficacy of MEDI8897 Against RSV

Protocol Description

Based on advice from the US Food and Drug Administration, this study funded by Medimmune will help determine whether healthy preterm infants 29 weeks to 34 weeks entering their first RSV season benefit from receiving a single dose of MEDI8897 in reducing lower respiratory tract infections caused by RSV for which those infants generally require medical attention, in the inpatient or outpatient setting.

RSV is the most frequently occurring cause of lower respiratory illness in infants and young children. Lower respiratory illness from RSV is the most common reason for hospitalization in the first year of life. RSV is serious and can be fatal in some cases. Currently, infants born before 29 weeks gestation and infants with chronic illnesses, such as congenital heart disease or chronic lung disease, are treated with 5 monthly administrations of Palivizumab (Synagis) during the winter (November through March). Premature infants who do not meet strict criteria for the 5 monthly Synagis immunizations do not receive any protection from RSV.

That is why we are studying MEDI8897, a drug that is only administered once early in the respiratory season and is expected to provide 5-month protection, in healthy preterm infants 29 weeks to 34 weeks who would otherwise not be eligible to receive Synagis. Infants enrolled in the study will be carefully followed for 1 year.

Benefits

Children enrolled in the study will have careful monitoring and follow-up for lower respiratory tract infections for 1 year from the time of administration. There will be no charges for study related visits. Our clinical team is available by phone, 24 hours a day.

Eligibility Criteria

Healthy preterm infants born between 29 and 34 weeks entering their first RSV season are randomized 2:1 to receive a single 50 mg intramuscular dose of MEDI8897 or placebo (2 out of 3 chances of receiving medication). 

Requirements

  • Enrollment and randomization visit between October 1 and March 31, 2017 with 2:1 randomization of study product: placebo – single injection
  • 5 additional study visits over the course of 1 year, 3 blood draws.
  • Study team will examine infants with cold symptoms within 48 hours of any symptom suggestive of a lower respiratory tract infection and obtain a nasal swab to test for RSV.

Status: Open to Enrollment

Source(s) of Support

Medimmune

Primary Investigator

Alejandro Hoberman, MD

Contact Information

For information or to enroll, please contact:

412-692-7382