Evidence · Randomised trial
Safety, Tolerability and Pharmacokinetics of MEDI8897, an Extended Half-life Single-dose Respiratory Syncytial Virus Prefusion F-targeting Monoclonal Antibody Administered as a Single Dose to Healthy Preterm Infants.
- Infection
- Medical
- Neurodevelopmental follow-up
- Neurology
- Respiratory
- Seizures
This paper is from 2018, more than five years ago. Newer evidence may have been published since.
Summary
This phase 1b/2a randomised, placebo-controlled dose-escalation trial evaluated MEDI8897 (nirsevimab), an extended half-life monoclonal antibody targeting the RSV prefusion F protein, in healthy preterm infants of 32-35 weeks' gestation. Infants received a single intramuscular dose or placebo and were followed for 360 days for safety, pharmacokinetics, neutralising antibody response and antidrug antibodies. The antibody showed an extended serum half-life and a safety profile comparable to placebo, supporting single-dose protection across a typical RSV season. It is relevant to clinicians involved in RSV prophylaxis for preterm infants.
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- Licence:
- Open (Creative Commons)
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