BACKGROUND: The immunogenicity of vaccines, including vaccine against hepatitis A virus (HAV), is impaired in patients with HIV infection, requiring revised immunization regimens. METHODS: We evaluated the immunological efficacy and safety of a 3-dose schedule of hepatitis A vaccine in HIV-infected adults. HAV-seronegative HIV-infected adults were randomized to receive either 3 doses of 1440 UI of hepatitis A vaccine (HAVRIX; GlaxoSmithKline, Marly le Roi, France) at weeks 0, 4, and 24 (46 patients) or 2 doses 24 weeks apart (49 patients). RESULTS: At week 28, seroconversion, defined as an anti-HAV antibody >or=20 mIU/mL, occurred in 82.6% and 69.4% of patients in the 3-dose and the 2-dose group, respectively (P = 0.13, intent-to-treat analysis, missing data = nonresponder), and in 88.4% and 72.3% of patients in the 3-dose and the 2-dose group, respectively (P = 0.06, observed analysis). Only 37.9% of patients experienced seroconversion after 1 vaccine dose (intent-to-treat analysis). Anti-HAV antibody geometricmean titers were 323 and 132 mIU/mL in the 3-dose group and 138 and 67 mIU/mL in the 2-dose group, respectively, 28 (P = 0.03) and 72 weeks (P = 0.05) after the first vaccine dose. There were no serious adverse events associated with the vaccine. Multivariate analysis showed no treatment group effect but indicated that absence of tobacco smoking (odds ratio = 2.92, 95% confidence interval: 1.07 to 7.97; P = 0.04) was an independent predictor of response to HAV vaccine. CONCLUSIONS: In HIV-infected adults, immunogenicity of hepatitis A vaccine is poor. Three doses of vaccine were safe and increased antibody titers.
RCT Entities:
BACKGROUND: The immunogenicity of vaccines, including vaccine against hepatitis A virus (HAV), is impaired in patients with HIV infection, requiring revised immunization regimens. METHODS: We evaluated the immunological efficacy and safety of a 3-dose schedule of hepatitis A vaccine in HIV-infected adults. HAV-seronegative HIV-infected adults were randomized to receive either 3 doses of 1440 UI of hepatitis A vaccine (HAVRIX; GlaxoSmithKline, Marly le Roi, France) at weeks 0, 4, and 24 (46 patients) or 2 doses 24 weeks apart (49 patients). RESULTS: At week 28, seroconversion, defined as an anti-HAV antibody >or=20 mIU/mL, occurred in 82.6% and 69.4% of patients in the 3-dose and the 2-dose group, respectively (P = 0.13, intent-to-treat analysis, missing data = nonresponder), and in 88.4% and 72.3% of patients in the 3-dose and the 2-dose group, respectively (P = 0.06, observed analysis). Only 37.9% of patients experienced seroconversion after 1 vaccine dose (intent-to-treat analysis). Anti-HAV antibody geometric mean titers were 323 and 132 mIU/mL in the 3-dose group and 138 and 67 mIU/mL in the 2-dose group, respectively, 28 (P = 0.03) and 72 weeks (P = 0.05) after the first vaccine dose. There were no serious adverse events associated with the vaccine. Multivariate analysis showed no treatment group effect but indicated that absence of tobacco smoking (odds ratio = 2.92, 95% confidence interval: 1.07 to 7.97; P = 0.04) was an independent predictor of response to HAV vaccine. CONCLUSIONS: In HIV-infected adults, immunogenicity of hepatitis A vaccine is poor. Three doses of vaccine were safe and increased antibody titers.
Authors: Nancy F Crum-Cianflone; Kenneth Wilkins; Andrew W Lee; Anthony Grosso; Michael L Landrum; Amy Weintrob; Anuradha Ganesan; Jason Maguire; Stephanie Klopfer; Carolyn Brandt; William P Bradley; Mark R Wallace; Brian K Agan Journal: J Infect Dis Date: 2011-06-15 Impact factor: 5.226
Authors: Patricia M Flynn; Coleen K Cunningham; Bret Rudy; Craig M Wilson; Bill Kapogiannis; Carol Worrell; James Bethel; Dina Monte; Kelly Bojan Journal: J Acquir Immune Defic Syndr Date: 2011-04 Impact factor: 3.731
Authors: Pierre Alex Crisinel; Klara Maria Posfay-Barbe; Christoph Aebi; Jean-Jacques Cheseaux; Christian Kahlert; Christoph Rudin; David Nadal; Claire-Anne Siegrist Journal: Clin Vaccine Immunol Date: 2012-08-29
Authors: Adriana Weinberg; Amanda A Allshouse; Samantha Mawhinney; Jennifer Canniff; Lorie Benning; Eryka L Wentz; Howard Minkoff; Mary Young; Marek Nowicki; Ruth Greenblatt; Mardge H Cohen; Elizabeth T Golub Journal: J Acquir Immune Defic Syndr Date: 2012-05-01 Impact factor: 3.731
Authors: Ji Hyeon Baek; Chang Oh Kim; Jun Yong Park; Su Jin Jeong; Nam Soo Koo; Hye Won Kim; Sang Hoon Han; Jun Yong Choi; Young Goo Song; June Myung Kim Journal: J Korean Med Sci Date: 2012-07-25 Impact factor: 2.153