title: Diagnostic Immunization with Bacteriophage ΦX 174 in Patients with Common Variable Immunodeficiency/Hypogammaglobulinemia.
abstract: OBJECTIVE
  Use of the T cell-dependent neoantigen bacteriophage ΦX 174 has been described since the 1960s as a method to assess specific antibody response in patients with primary immunodeficiencies. We reviewed a cohort of patients at Duke University Medical Center who received immunization with bacteriophage and report the clinical utility and safety of the immunization, as well as patient characteristics.
  
  
  METHODS
  A retrospective chart review was performed of all Duke Immunology Clinic patients (pediatric and adult) who received immunizations with bacteriophage, from 1976 to 2012. Subjects were selected for inclusion if their diagnosis at the time of bacteriophage was either presumed or confirmed common variable immunodeficiency (CVID), hypogammaglobulinemia, transient hypogammaglobulinemia, or antibody deficiency unspecified. Follow up post-immunization was also recorded.
  
  
  RESULTS
  One hundred twenty-six patients were identified, 36 adults and 90 pediatric patients. Diagnoses prior to bacteriophage were CVID (n = 100), hypogammaglobulinemia (n = 23), and antibody deficiency (n = 3). Post-immunization diagnoses were CVID (n = 65), hypogammaglobulinemia (n = 19), unknown (n = 23), no primary immune deficiency (n = 10), and other primary immunodeficiency (n = 9). Seventy-five patients had abnormal bacteriophage results, 37 were normal, and 14 were borderline. There were 257 recorded administrations of the immunization. Information was available on adverse reactions for 171 administrations. Fourteen immunizations were associated with minor adverse events. Nineteen patients stopped their immunoglobulin replacement therapy based on reported normal responses to immunization.
  
  
  CONCLUSIONS
  Bacteriophage ΦX 174 immunization is a safe, well-tolerated, and clinically useful method to assess antibody response in patients with suspected antibody-mediated immunodeficiencies, particularly those who are on immunoglobulin replacement therapy at the time of immunization.
authors.affiliation: Division of Pediatric Allergy and Immunology, Department of Pediatrics, Duke University Medical Center , Durham, NC , USA.
authors.forename: Lauren L
authors.initials: LL
authors.lastname: Smith
authors.affiliation: Division of Pediatric Allergy and Immunology, Department of Pediatrics, Duke University Medical Center , Durham, NC , USA ; Department of Immunology, Duke University School of Medicine , Durham, NC , USA.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Buckley
authors.affiliation: Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Duke University Medical Center , Durham, NC , USA.
authors.forename: Patricia
authors.initials: P
authors.lastname: Lugar
keywords: bacteriophage ΦX 174; common variable immunodeficiency; hypogammaglobulinemia; primary immunodeficiency