Hepatitis B Vaccination in HIV-infected Youth: A Randomized Trial of Three Regimens

J Acquir Immune Defic Syndr. 2011 Apr;56(4):325-32. doi: 10.1097/QAI.0b013e318203e9f2.

Abstract

Background: HIV-infected youth are at risk of hepatitis B infection and should be vaccinated. Previous reports suggest reduced response to standard hepatitis B vaccine regimens.

Methods: HIV-infected youth, aged 12 to younger than 25 years, were randomly assigned to one of three treatment arms: Arm 1: Engerix B, 20 μg HBsAg; Arm 2: Engerix B (GlaxoSmithKline, Rixensart, Belgium), 40 μg; and Arm 3: Twinrix (GlaxoSmithKline, Rixensart, Belgium), 20 μg HBsAg combined with 720 ELU hepatitis A antigen. Vaccines were administered at Weeks 0, 4, and 24.

Results: Characteristics of evaluable patients (n = 336) at entry were similar in the study arms. At enrollment, median CD4+ T-cell count was 460 cells/mm3 (interquartile range, 305-668); 13% were less than 200 cells/mm3. Among Engerix B, 20-μg recipients, 60.4% responded to vaccine (HBsAb 10 IU/mL or greater at Week 28). Improved vaccine response was seen in recipients of Engerix B, 40 μg (73.2% versus Arm 1, P = 0.04) and Twinrix (75.4% versus Arm 1, P = 0.02). In multivariate analysis, only baseline CD4+ T-cell count and study arm were independent predictors of vaccine response.

Conclusions: In HIV-infected youth, a three-dose vaccination regimen with Engerix B, 40 μg, or Twinrix and higher baseline CD4+ T-cell counts were independently associated with improved vaccine response.

Trial registration: ClinicalTrials.gov NCT00106964.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adolescent
  • Belgium
  • Female
  • HIV Infections / immunology*
  • Hepatitis A Vaccines / administration & dosage*
  • Hepatitis A Vaccines / immunology*
  • Hepatitis B / prevention & control*
  • Hepatitis B Antibodies / blood
  • Hepatitis B Vaccines / administration & dosage*
  • Hepatitis B Vaccines / immunology*
  • Humans
  • Immunization, Secondary / methods
  • Male
  • Vaccination / methods*
  • Vaccines, Combined / administration & dosage
  • Vaccines, Combined / immunology
  • Young Adult

Substances

  • Engerix-B
  • Hepatitis A Vaccines
  • Hepatitis B Antibodies
  • Hepatitis B Vaccines
  • Vaccines, Combined
  • twinrix

Associated data

  • ClinicalTrials.gov/NCT00106964