Randomized trial to determine safety and immunogenicity of two strategies for hepatitis B vaccination in healthy urban adolescents in the United States.

TitleRandomized trial to determine safety and immunogenicity of two strategies for hepatitis B vaccination in healthy urban adolescents in the United States.
Publication TypePublication
Year of Publication2010
AuthorsCunningham CK, Rudy BJ, Xu J, Bethel J, Kapogiannis BG, Ahmad S, Wilson CM, Flynn PM
Corporate AuthorsAdolescent Medicine Trials Network for HIV/AIDS Interventions
JournalPediatr Infect Dis J
Volume29
Issue6
Pagination530-4
Date Published2010 Jun
ISSN1532-0987
KeywordsAdolescent, Child, Female, Hepatitis A Vaccines, Hepatitis B, Hepatitis B Antibodies, Hepatitis B Vaccines, Humans, Immunization Schedule, Male, Single-Blind Method, United States, Urban Population, Vaccines, Combined, Vaccines, Synthetic
Abstract

<p><b>BACKGROUND: </b>Multiple studies have shown excellent response rates after hepatitis B immunization in youth; however, one previous study conducted in urban youth demonstrated poor responses.</p><p><b>METHODS: </b>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 microg hepatitis B surface antigen) or Twinrix (20 microg 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.</p><p><b>RESULTS: </b>A total of 123 subjects were enrolled and 102 had week 28 serum samples available for antibody measure. A positive response (serum antibody > or =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.</p><p><b>CONCLUSIONS: </b>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.</p>

DOI10.1097/INF.0b013e3181d285c7
Alternate JournalPediatr. Infect. Dis. J.
PubMed ID20173677
PubMed Central IDPMC3274492
Grant ListM01 RR001271-22 / RR / NCRR NIH HHS / United States
U01 HD 040533 / HD / NICHD NIH HHS / United States
M01RR00083-42 / RR / NCRR NIH HHS / United States
U01 HD040533 / HD / NICHD NIH HHS / United States
U01 HD 040474 / HD / NICHD NIH HHS / United States
M01 RR005096-10A1 / RR / NCRR NIH HHS / United States
U01 HD040474 / HD / NICHD NIH HHS / United States
M01 RR020359-01 / RR / NCRR NIH HHS / United States
M01RR05096 / RR / NCRR NIH HHS / United States
U54 HD061221 / HD / NICHD NIH HHS / United States
UM1 AI069415 / AI / NIAID NIH HHS / United States
M01 RR005096 / RR / NCRR NIH HHS / United States
M01 RR001271 / RR / NCRR NIH HHS / United States
U01 HD040533-01 / HD / NICHD NIH HHS / United States
M01RR01271 / RR / NCRR NIH HHS / United States
U01 HD040474-05 / HD / NICHD NIH HHS / United States
M01RR020359 / RR / NCRR NIH HHS / United States
U01 HD040470 / HD / NICHD NIH HHS / United States
M01 RR000083-42 / RR / NCRR NIH HHS / United States
M01 RR000083 / RR / NCRR NIH HHS / United States
M01 RR020359 / RR / NCRR NIH HHS / United States