title: Immunogenicity and safety of 1 vs 2 doses of quadrivalent meningococcal conjugate vaccine in youth infected with human immunodeficiency virus.
abstract: OBJECTIVE
  To compare the immunogenicity of 1 vs 2 doses of meningococcal polysaccharide conjugate vaccine (MCV4) in youth infected with human immunodeficiency virus (HIV).
  
  
  METHODS
  P1065 was a phase I/II immunogenicity and safety trial of MCV4 in 324 youth infected with HIV performed at 27 sites of the International Maternal Pediatric Adolescent AIDS Clinical Trials Group network in the US. At entry subjects received 1 dose of MCV4. At 24 weeks, those with screening cluster of differentiation 4 (CD4)% ≥ 15 were randomized to receive a second dose or not, and all with screening CD4% <15 received a second dose. Immunogenicity was evaluated as the proportion of subjects with a ≥ 4-fold rise from entry in serum bactericidal antibody against each meningococcal serogroup (SG) at weeks 28 and 72. Logistic regression models adjusting for HIV disease severity were used to evaluate the effect of 1 vs 2 MCV4 doses among those with screening CD4% ≥ 15.
  
  
  RESULTS
  Subjects randomized to receive 2 vs 1 MCV4 dose had significantly higher response rates to all SGs at week 28 and to all except Neisseria meningitidis SG Y at week 72, with adjusted ORs of 2.5-5.6. In 31 subjects with screening CD4% <15 who received 2 MCV4 doses, response rates ranged from 22%-55% at week 28 and 6%-28% at week 72.
  
  
  CONCLUSIONS
  In youth infected with HIV with a CD4% ≥ 15, a second dose of MCV4 given 6 months after the initial dose significantly improves response rates at 28 and 72 weeks. Subjects with CD4% <15 at entry had lower response rates despite 2 doses of MCV4.
authors.affiliation: University of South Florida College of Medicine, Tampa, FL, USA.
authors.forename: Jorge
authors.initials: J
authors.lastname: Lujan-Zilbermann
authors.forename: Meredith G
authors.initials: MG
authors.lastname: Warshaw
authors.forename: Paige L
authors.initials: PL
authors.lastname: Williams
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Spector
authors.forename: Michael D
authors.initials: MD
authors.lastname: Decker
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Abzug
authors.forename: Barb
authors.initials: B
authors.lastname: Heckman
authors.forename: Adam
authors.initials: A
authors.lastname: Manzella
authors.forename: Bill
authors.initials: B
authors.lastname: Kabat
authors.forename: Patrick
authors.initials: P
authors.lastname: Jean-Philippe
authors.forename: Sharon
authors.initials: S
authors.lastname: Nachman
authors.forename: George K
authors.initials: GK
authors.lastname: Siberry
mesh_terms: D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000032:analysis; D002648:Child; D005260:Female; D015658:HIV Infections / Q000276:immunology*; D006801:Humans; D008297:Male; D008589:Meningococcal Infections / Q000517:prevention & control; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000276:immunology; D050296:Microbial Viability / Q000276:immunology; D009345:Neisseria meningitidis / Q000145:classification; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000276:immunology; D055815:Young Adult
chemical_list: D000907:Antibodies, Bacterial; D022401:Meningococcal Vaccines; D018074:Vaccines, Conjugate