Randomized trial to determine safety and immunogenicity of two strategies for
hepatitis B vaccination in healthy urban adolescents in the United States.
Author(s): Cunningham CK, Rudy BJ, Xu J, Bethel J, Kapogiannis BG, Ahmad S, Wilson CM, Flynn
PM; Adolescent Medicine Trials Network for HIV/AIDS Interventions.
Collaborators: D'Angelo LJ, Trexler C, Hagler R, Klamberg A, Martinez J,
Henry-Reid L, Bojan K, Jackson R, Futterman D, Enriquez-Bruce E, Campos M, Flynn
P, Stender S, Branum K, Dillard M, Culley T, McKinley C, Wride T, Abdalian SE,
Baker A, Jean-jacques T, Kozina L, Moscicki B, Auerswald C, Irish LD, Molaghan
JB, Peralta L, Flores L, Gorle RS, Febo IL, Ayala-Flores HT, Gomez AT, Emmanuel
P, Lujan-Zilbermann J, Straub DM, Callejas S, Julian PC, Rebolledo A.
Affiliation(s): Department of Pediatrics, Duke, Durham, NC, USA. coleen.cunningham@duke.edu
Publication date & source: 2010, Pediatr Infect Dis J. , 29(6):530-4
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 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.
RESULTS: 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.
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.
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