Hepatitis B vaccination in HIV-infected youth: a randomized trial of three regimens
Patricia M Flynn, 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), Audrey Smith Rogers, Leslie Serchuck, Patrick Jean-Phillippe, Jonas H Ellenberg, George Seage, Linda Levin, Anna Puga, Esmine Leonard, Zulma Eysallanne, Amy Inman, Marvin Belzer, Diane Tucker, Robert Garofolo, Julia Brennan, Jennifer Kershaw, 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, Linda Levin-Carmine, Mary Geiger, Angela Lee, Sarah Stender, Kristen Branum, Mary Dillard, Tina Culley, Carla McKinley, Thomas Wride, Sue Ellen Abdalian, Alyne Baker, Leslie Kozina, Trina Jeanjacques, Barbara Moscicki, Coco Auerswald, 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, Cathryn Samples, Susan Sommer, Helen Mahoney West, Martha Cavallo, Stephen A Spector, Ronaldo M Vianni, Kimberly A Norris, Lisa Stangl, Robert Pass, Marilyn Crain, Newana Beatty, Felicia Wiley, Mobeen H Rathore, Ayesha Mirza, Nizar Maraqa, Ann Usitalo, Ellen Moore, Elizabeth Secord, Ulyssa Hancock, Ellen R Cooper, Barbara Damon Marinaccio, Desiree Jones-Eaves, Debra A McLaud, Mark J Abzug, Myron J Levin, Emily A Barr, Jody Maes, Elizabeth McFarland, Suzanne Paul, Carol Salbenblatt, Adriana Weinberg, Michael Gomez, Percy McNeil, Robert Orlander, Marva Jervis, Chanelle Diggins, Midnela Acevedo, Milagros Gonzalez, Thalita F Abreu, Lourdes Angeli, Wanda Marrero, Elvia Perez, Ricardo Hugo Oliveira, Maria C Sapia, Christina B Hofer, Elizabeth Machado, Maria Leticia S Cruz, Esaú C João Filho, Angela Beatriz N Carvalho, Claudette A Cardoso, Eduarda Gusmão, Elaine Santos, Jorge Pinto, Flávia Gomes Faleiro Ferreira, Mónica D Brandáio, Marinella Della Negra, Wladimir Queiroz, Yu Ching Lian, Marisa Márcia M Mussi-Pinhata, Geraldo Duarte, Carolina S Vieira, Conrado M Continho, Tatiana C Matsubara, Tammy Meyers, Hermien Gous, Janet Grab, Lee Kleynhaus, Sally Naidoo, Merleesa Naidoo, Angela Oosthuizen, Megan Palmer, Patricia M Flynn, 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), Audrey Smith Rogers, Leslie Serchuck, Patrick Jean-Phillippe, Jonas H Ellenberg, George Seage, Linda Levin, Anna Puga, Esmine Leonard, Zulma Eysallanne, Amy Inman, Marvin Belzer, Diane Tucker, Robert Garofolo, Julia Brennan, Jennifer Kershaw, 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, Linda Levin-Carmine, Mary Geiger, Angela Lee, Sarah Stender, Kristen Branum, Mary Dillard, Tina Culley, Carla McKinley, Thomas Wride, Sue Ellen Abdalian, Alyne Baker, Leslie Kozina, Trina Jeanjacques, Barbara Moscicki, Coco Auerswald, 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, Cathryn Samples, Susan Sommer, Helen Mahoney West, Martha Cavallo, Stephen A Spector, Ronaldo M Vianni, Kimberly A Norris, Lisa Stangl, Robert Pass, Marilyn Crain, Newana Beatty, Felicia Wiley, Mobeen H Rathore, Ayesha Mirza, Nizar Maraqa, Ann Usitalo, Ellen Moore, Elizabeth Secord, Ulyssa Hancock, Ellen R Cooper, Barbara Damon Marinaccio, Desiree Jones-Eaves, Debra A McLaud, Mark J Abzug, Myron J Levin, Emily A Barr, Jody Maes, Elizabeth McFarland, Suzanne Paul, Carol Salbenblatt, Adriana Weinberg, Michael Gomez, Percy McNeil, Robert Orlander, Marva Jervis, Chanelle Diggins, Midnela Acevedo, Milagros Gonzalez, Thalita F Abreu, Lourdes Angeli, Wanda Marrero, Elvia Perez, Ricardo Hugo Oliveira, Maria C Sapia, Christina B Hofer, Elizabeth Machado, Maria Leticia S Cruz, Esaú C João Filho, Angela Beatriz N Carvalho, Claudette A Cardoso, Eduarda Gusmão, Elaine Santos, Jorge Pinto, Flávia Gomes Faleiro Ferreira, Mónica D Brandáio, Marinella Della Negra, Wladimir Queiroz, Yu Ching Lian, Marisa Márcia M Mussi-Pinhata, Geraldo Duarte, Carolina S Vieira, Conrado M Continho, Tatiana C Matsubara, Tammy Meyers, Hermien Gous, Janet Grab, Lee Kleynhaus, Sally Naidoo, Merleesa Naidoo, Angela Oosthuizen, Megan Palmer
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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Source: PubMed