Randomized trial to determine safety and immunogenicity of two strategies for hepatitis B vaccination in healthy urban adolescents in the United States
Coleen K Cunningham, Bret J Rudy, Jiahong Xu, James Bethel, Bill G Kapogiannis, Sushma Ahmad, Craig M Wilson, Patricia M Flynn, Adolescent Medicine Trials Network for HIV/AIDS Interventions, Lawrence J D'Angelo, Connie Trexler, Rita Hagler, Amy Klamberg, Jaime Martinez, Lisa Henry-Reid, Kelly Bojan, Rachel Jackson, Donna Futterman, Elizabeth Enriquez-Bruce, Maria Campos, Pat Flynn, Sarah Stender, Kristen Branum, Mary Dillard, Tina Culley, Carla McKinley, Thomas Wride, Sue Ellen Abdalian, Alyne Baker, Trina Jean-jacques, Leslie Kozina, Barbara Moscicki, Coco Auerswald, Lisa D Irish, J B Molaghan, Ligia Peralta, Leonel Flores, Reshma S Gorle, Irma L Febo, Hazel T Ayala-Flores, Anne T F Gomez, Patricia Emmanuel, Jorge Lujan-Zilbermann, Diane M Straub, Silvia Callejas, Priscilla C Julian, Amayvis Rebolledo, Coleen K Cunningham, Bret J Rudy, Jiahong Xu, James Bethel, Bill G Kapogiannis, Sushma Ahmad, Craig M Wilson, Patricia M Flynn, Adolescent Medicine Trials Network for HIV/AIDS Interventions, Lawrence J D'Angelo, Connie Trexler, Rita Hagler, Amy Klamberg, Jaime Martinez, Lisa Henry-Reid, Kelly Bojan, Rachel Jackson, Donna Futterman, Elizabeth Enriquez-Bruce, Maria Campos, Pat Flynn, Sarah Stender, Kristen Branum, Mary Dillard, Tina Culley, Carla McKinley, Thomas Wride, Sue Ellen Abdalian, Alyne Baker, Trina Jean-jacques, Leslie Kozina, Barbara Moscicki, Coco Auerswald, Lisa D Irish, J B Molaghan, Ligia Peralta, Leonel Flores, Reshma S Gorle, Irma L Febo, Hazel T Ayala-Flores, Anne T F Gomez, Patricia Emmanuel, Jorge Lujan-Zilbermann, Diane M Straub, Silvia Callejas, Priscilla C Julian, Amayvis Rebolledo
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 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.
Trial registration: ClinicalTrials.gov NCT00107042.
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Source: PubMed