Long-term persistence of immunity after vaccination of pre-adolescents with low doses of a recombinant hepatitis B vaccine

Background and aims: Recent studies have shown no detectable antibodies and no response to a challenge dose of vaccine 10-20 y after receiving low doses (2.5-5 mu g) of recombinant hepatitis B vaccine during first months of life. Little information is available on long-term persistence of immunity after vaccinating pre-adolescents with low doses of hepatitis B vaccine. Materials and Methods: This randomized trial was initiated in 1996 with the main objective to assess the persistence of antibodies and immune memory 5, 10 and 15 y after vaccinating 8-10 y-old children with three doses of Recombivax 2.5 mu g, as well as the short and long-term effect of a booster dose given at different intervals. Results: The results of 560 subjects were included in this analysis. All subjects had a seroprotective antibody titer ( 10 IU/L) one month post-primary vaccination; 5, 10 and 15 y post-vaccination 95%, 95% and 87% had detectable antibodies, and 82%, 86%, and 68% had a seroprotective antibody titer; GMTs were 73 IU/L, 89 IU/L, and 28 IU/L, respectively. More than 99.4% of subjects had an anamnestic response to a challenge dose of vaccine given 5, 10, or 15 y post-vaccination. Five and ten years post-booster dose 97% and 95% of subjects still have a seroprotective anti-HBs titer with GMTs 16-18-fold higher when compared with those observed 5-10 y post-primary vaccination. Conclusions: Virtually all children vaccinated at the age of 8-10 y with low doses of hepatitis B vaccine still have an excellent immune memory up to age of 25 y. The results of this study do not support the use of booster doses.