Phase 1 evaluation of the respiratory syncytial virus-specific monoclonal antibody palivizumab in recipients of hematopoietic stem cell transplants

J Infect Dis. 2001 Aug 1;184(3):350-4. doi: 10.1086/322043. Epub 2001 Jun 28.

Abstract

Intravenous palivizumab (15 mg/kg) was investigated in 2 phase 1 studies among recipients of hematopoietic stem cell transplants (HSCTs). Study 1 included 6 HSCT patients without active respiratory syncytial virus (RSV) infection. Study 2 included 15 HSCT patients with RSV upper respiratory tract infection (URTI; n=3) or RSV interstitial pneumonia (IP; n=12), all of whom also received aerosolized ribavirin. Peak serum concentrations of palivizumab in the 2 studies were similar. The mean serum half-life was 22.4 days in study 1, which mainly included autologous HSCT recipients, and 10.7 days in study 2, which mainly included allogeneic HSCT recipients. No antibodies to palivizumab were detected in study 1. No adverse events were attributed to palivizumab in the 2 studies. In study 2, all 3 patients with RSV URTI recovered without progression to lower respiratory tract disease, and 10 (83%) of the 12 patients with RSV IP survived the 28-day study period. Thus, palivizumab appears to be safe and well tolerated in HSCT recipients.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adolescent
  • Adult
  • Antibodies, Monoclonal / adverse effects*
  • Antibodies, Monoclonal / blood
  • Antibodies, Monoclonal / pharmacokinetics
  • Antibodies, Monoclonal, Humanized
  • Antiviral Agents / adverse effects
  • Antiviral Agents / blood
  • Bone Marrow Transplantation*
  • Child
  • Child, Preschool
  • Disease Outbreaks
  • Drug Monitoring
  • Ethnic Groups
  • Female
  • Hematopoietic Stem Cell Transplantation*
  • Humans
  • Infant
  • Male
  • Middle Aged
  • Palivizumab
  • Respiratory Syncytial Virus Infections / epidemiology
  • Respiratory Syncytial Virus Infections / immunology
  • Respiratory Syncytial Virus Infections / prevention & control*
  • Respiratory Syncytial Viruses / immunology*
  • Safety
  • Transplantation, Autologous
  • Transplantation, Homologous
  • United States

Substances

  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Antiviral Agents
  • Palivizumab