BACKGROUND:Patients with end-stage renal disease (ESRD) undergoing hemodialysis have severe alterations in cell-mediated immunity (CMI) that increases their risk of contracting chronic hepatitis B virus (HBV) infection and decreases their protective responses to HBV vaccine. In an effort to improve the humoral response to an accelerated HBV vaccine protocol in these patients, the ability of an immunomodulator, AM3, to improve seroconversion was investigated. METHODS: A total of 269 patients were enrolled in a multicenter trial. All patients received a DNA recombinant vaccine (40 microg HBsAg/dose/day) on days 0, 10, 21, and 90. AM3 or placebo (3 g/day) was given orally for 30 consecutive days beginning 15 days prior to the first vaccine dose. Anti-HBsAg titers were measured on days 120 and 270 after the beginning of the trial. RESULTS: After one month, 207 patients could be evaluated and 132 patients after six months. The placebo and AM3-treated groups had comparable seroconversion and protective response rates one month after the final vaccine dose. The AM3 treatment group, but not the placebo group, maintained these protective titers up to six months after the final vaccine dose. At this time, the percentage of high responders (anti-HBsAg>100 IU/L) and mean anti-HBsAg titers in the AM3 group was significantly higher than in the placebo group. CONCLUSIONS:AM3 is a safe and easily tolerated oral agent that potentiates long-term serological immunity to hepatitis B in hemodialysis patients after vaccination.
RCT Entities:
BACKGROUND:Patients with end-stage renal disease (ESRD) undergoing hemodialysis have severe alterations in cell-mediated immunity (CMI) that increases their risk of contracting chronic hepatitis B virus (HBV) infection and decreases their protective responses to HBV vaccine. In an effort to improve the humoral response to an accelerated HBV vaccine protocol in these patients, the ability of an immunomodulator, AM3, to improve seroconversion was investigated. METHODS: A total of 269 patients were enrolled in a multicenter trial. All patients received a DNA recombinant vaccine (40 microg HBsAg/dose/day) on days 0, 10, 21, and 90. AM3 or placebo (3 g/day) was given orally for 30 consecutive days beginning 15 days prior to the first vaccine dose. Anti-HBsAg titers were measured on days 120 and 270 after the beginning of the trial. RESULTS: After one month, 207 patients could be evaluated and 132 patients after six months. The placebo and AM3-treated groups had comparable seroconversion and protective response rates one month after the final vaccine dose. The AM3 treatment group, but not the placebo group, maintained these protective titers up to six months after the final vaccine dose. At this time, the percentage of high responders (anti-HBsAg>100 IU/L) and mean anti-HBsAg titers in the AM3 group was significantly higher than in the placebo group. CONCLUSIONS: AM3 is a safe and easily tolerated oral agent that potentiates long-term serological immunity to hepatitis B in hemodialysis patients after vaccination.
Authors: Diego Serrano-Gómez; Rocío T Martínez-Nuñez; Elena Sierra-Filardi; Nuria Izquierdo; María Colmenares; Jesús Pla; Luis Rivas; Javier Martinez-Picado; Jesús Jimenez-Barbero; José Luis Alonso-Lebrero; Salvador González; Angel L Corbí Journal: Antimicrob Agents Chemother Date: 2007-04-23 Impact factor: 5.191
Authors: S Martín-Vilchez; F Molina-Jiménez; J L Alonso-Lebrero; P Sanz-Cameno; Y Rodríguez-Muñoz; I Benedicto; P Roda-Navarro; M Trapero; L Aragoneses-Fenoll; S González; J P Pivel; A L Corbí; M López-Cabrera; R Moreno-Otero; P L Majano Journal: Br J Pharmacol Date: 2008-04-14 Impact factor: 8.739
Authors: Diego Fernández-Lázaro; Cesar I Fernandez-Lazaro; Juan Mielgo-Ayuso; David P Adams; Juan Luis García Hernández; Jerónimo González-Bernal; Marcela González-Gross Journal: Front Immunol Date: 2021-06-17 Impact factor: 7.561