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Randomized Trial to Determine Safety and Immunogenicity of Two Strategies for Hepatitis B Vaccination in Healthy Urban Adolescents in the United States

Cunningham, Coleen K. MD*; Rudy, Bret J. MD†; Xu, Jiahong MS, MPH‡; Bethel, James PhD‡; Kapogiannis, Bill G. MD§; Ahmad, Sushma MB BS‡; Wilson, Craig M. MD¶; Flynn, Patricia M. MD∥; the Adolescent Medicine Trials Network for HIV/AIDS Interventions

Pediatric Infectious Disease Journal:
doi: 10.1097/INF.0b013e3181d285c7
Original Studies
Abstract

Background: Multiple studies have shown excellent response rates after hepatitis B immunization in youth; however, one previous study conducted in urban youth demonstrated poor responses.

Methods: Urban youth, ages 12 to 17 years, at participating Adolescent Medicine Trials Network for HIV/AIDS Interventions Clinical/Research sites were randomized to receive either 2 doses of Recombivax HB (10 μg hepatitis B surface antigen) or Twinrix (20 μg hepatitis B surface antigen and 720 EL.U hepatitis A antigen) at 0 and 24 weeks. Safety data were collected and antibody measures performed at 0, 28, and 76 weeks.

Results: A total of 123 subjects were enrolled and 102 had week 28 serum samples available for antibody measure. A positive response (serum antibody ≥10 mIU/mL) to hepatitis B antigen was documented in 41 of 47 (87.2%; 95% confidence interval [CI] 74.3%–95.2%) Recombivax HB recipients and in 52 of 55 (94.6%; 95% CI, 84.9%–98.9%) Twinrix recipients (P = 0.295). In an adjusted analysis, those identified as Hispanic ethnicity (N = 86) were more likely to have a positive response (odds ratio 7.38, 95% CI, 1.56–34.95; P = 0.0018); whereas those who identified as not heterosexual (N = 9) were less likely to respond (odds ratio = 0.12, 95% CI, 0.02–0.74). The majority of youth in the Twinrix arm were hepatitis A antibody positive at baseline (26/51; 51%); however, 24 of 25 hepatitis A antibody negative youth responded to the hepatitis A component. Both vaccines were safe.

Conclusions: Response rate to 2 doses of Recombivax HB in urban youth is lower than previous studies suggest. The factors associated with diminished response are not known.

Author Information

From the *Department of Pediatrics, Duke, Durham, NC; †Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA; ‡Westat, Rockville, MD; §Pediatric, Adolescent and Maternal AIDS Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Bethesda, MD; ¶Department of Epidemiology and Pediatrics, UAB, Birmingham, AL; and ∥Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN.

Accepted for publication December 3, 2009.

Supported by The Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) from the National Institutes of Health (U01 HD 040533 and U01 HD 040474) through the Eunice Kennedy Shriver National Institute of Child Health and Human Development (B. Kapogiannis, R. Hazra, S. Lee, C. Worrell), with supplemental funding from the National Institutes on Drug Abuse (N. Borek) and Mental Health (P. Brouwers, S. Allison). Additional support for this study was provided by grants from the General Clinical Research Center (GCRC) Program of the National Center for Research Resources, National Institutes of Health, and Department of Health and Human Services. The following grants provided support: Children's National Medical Center, GCRC Grant M01RR020359; Tulane University/Louisiana State University, GCRC Grant M01RR05096; and University of California at San Francisco, GCRC Grant M01RR00083–42 and Pediatric Clinical Research Grant M01RR01271.

No financial conflicts of interest. The vaccine products used in this study were purchased and the manufacturers did not support or contribute to the study in any way.

Clinicaltrials.gov registration number NCT00107042.

Address for correspondence: Coleen K. Cunningham, MD, Box 3499 Duke University Medical Center, Erwin Ave, Durham, NC 27710. E-mail: coleen.cunningham@duke.edu.

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© 2010 Lippincott Williams & Wilkins, Inc.