title: Safety and immunogenicity of quadrivalent meningococcal conjugate vaccine in 2- to 10-year-old human immunodeficiency virus-infected children.
abstract: BACKGROUND
  Human immunodeficiency virus (HIV)-infected children are at increased risk of meningococcal infection and poor response to quadrivalent meningococcal conjugate vaccine (MCV4), but MCV4 has not been studied in preadolescent HIV-infected children.
  
  
  METHODS
  The P1065 trial enrolled 2- to 10-year-old HIV-infected children with CD4 ≥ 25% to receive MCV4 at entry and at week 24. Rates of response (≥ 4-fold increase in rabbit serum bactericidal antibody) against each meningococcal serogroup (A, C, Y, W-135), geometric mean titers, and rates of seroprotection (rabbit serum bactericidal antibody titer ≥ 1:128) were determined from sera obtained at entry and weeks 4, 24, 28, and 72. Adverse events were assessed for 6 weeks after each MCV4 dose.
  
  
  RESULTS
  At entry, 47% of the 59 participants were male, 56% black, 31% Latino, median age was 6 years, 88% were receiving antiretroviral therapy, and 75% had viral load <400 copies/mL. There were no serious adverse events within 6 weeks after MCV4 doses; all vaccination reactions were mild. Response after a single MCV4 dose was high to serogroup A (92%) and W-135 (98%); responses improved after a second dose for serogroup C (43%-80%) (P < 0.0001) and Y (76%-84%) (P = 0.38). By week 72, seroprotection rates were 93%, 91%, 78%, and 46% for serogroups W-135, Y, A, and C, respectively.
  
  
  CONCLUSIONS
  Two doses of MCV4 were safe and immunogenic in 2- to 10-year-old HIV-infected children. The second dose increased the proportion of children who made a response to serogroup C. Seroprotection waned substantially for serogroups A and C within 1 year of last MCV4 dose.
authors: Pediatric, Adolescent, and Maternal AIDS Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA. siberryg@mail.nih.gov
authors: George K
authors: GK
authors: Siberry
authors: Meredith G
authors: MG
authors: Warshaw
authors: Paige L
authors: PL
authors: Williams
authors: Stephen A
authors: SA
authors: Spector
authors: Michael D
authors: MD
authors: Decker
authors: Patrick
authors: P
authors: Jean-Philippe
authors: Ram
authors: R
authors: Yogev
authors: Barbara E
authors: BE
authors: Heckman
authors: Adam
authors: A
authors: Manzella
authors: Jhoanna
authors: J
authors: Roa
authors: Sharon
authors: S
authors: Nachman
authors: Jorge
authors: J
authors: Lujan-Zilbermann
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood* / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D004168:Diphtheria Toxoid / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D005260:Female; D015658:HIV Infections / Q000276:immunology*; D006801:Humans; D008297:Male; D008589:Meningococcal Infections / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D038381:Neisseria meningitidis, Serogroup A / Q000276:immunology; D038542:Neisseria meningitidis, Serogroup C / Q000276:immunology; D038582:Neisseria meningitidis, Serogroup W-135 / Q000276:immunology; D038581:Neisseria meningitidis, Serogroup Y / Q000276:immunology; D012703:Serotyping; D058248:Serum Bactericidal Antibody Assay; D016896:Treatment Outcome; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*
chemical_list: D000907:Antibodies, Bacterial; D004168:Diphtheria Toxoid; D022401:Meningococcal Vaccines; D018074:Vaccines, Conjugate