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Randomized Controlled Trial
. 2011 Apr;56(4):325-32.
doi: 10.1097/QAI.0b013e318203e9f2.

Hepatitis B vaccination in HIV-infected youth: a randomized trial of three regimens

Patricia M Flynn  1 , Coleen K Cunningham, Bret Rudy, Craig M Wilson, Bill Kapogiannis, Carol Worrell, James Bethel, Dina Monte, Kelly Bojan; Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)
Collaborators, Affiliations
Randomized Controlled Trial

Hepatitis B vaccination in HIV-infected youth: a randomized trial of three regimens

Patricia M Flynn et al. J Acquir Immune Defic Syndr. 2011 Apr.

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.

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Figures

Figure 1
Figure 1
Patient flow based on intent-to-treat analysis.
Figure 1
Figure 1
Patient flow based on intent-to-treat analysis.
Figure 2
Figure 2
Proportion of subjects with HBsAb of ≥ 10 IU/mL by treatment arm at Weeks 28, 48, and 72.
See this image and copyright information in PMC

References

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