Immunogenicity and reactogenicity of a recombinant hepatitis B vaccine in subjects over age of forty years and response of a booster dose among nonresponders

Abstract

AIM:The study was initiated to evaluate the reactogenicity and immunogenicity of a recombinant hepatitis B vaccine in age group >40 years and to study the response of a single booster dose in primary non-responders to the hepatitis B vaccination. METHODS:A total of 102 volunteers without markers of hepatitis B infection (negative for HBsAg, anti-HBc antibody, HBeAg and anti-HBs antibody) received 20 µg of recombinant HB vaccine intramuscularly at 0, 1, and 6 months. Anti HBs titers were evaluated by a quantitative Elisa kit at 90 and 210 days. A booster dose of 20 µg HB vaccine was given after 6 months of the 3 rd vaccine dose to the 15 nonresponders and anti-HBs titers were measured after 1 month. RESULTS:Seroprotection (anti-HBs GMT³ 10 IU/L) was achieved in 85.3 % (87/102) volunteers. The mean GMT titers of the vaccine responders was 136.1 IU/L. Of the seroprotected individuals, there were 32.4 % (33/102) hyporesponders (antiHBs titers <10-99 mlU/ml) and 52.9 % (54/102) were responders (anti-HBs titers >100 IU/L). All the non-responders (15/15) responded to a single dose of the booster dose of recombinant HB vaccine and their mean anti-HBs antibody titers were more than 100.5 mIU/ml after the booster dose. CONCLUSION:Recombinant hepatitis B vaccine offers good seroprotection in the age group >40 years and has a good safety profile. A single booster dose after 6 months in primary non-responders leads to good seroprotective anti-HBs antibody titers. However, larger population based studies are needed to evaluate the role of a booster dose in selected group of non-responders and whether such an approach will be cost effective.Das K, Gupta RK, Kumar V, Kar P. Immunogenicity and reactogenicity of a recombinant hepatitis B vaccine in subjects over age of forty years and response of a booster dose among nonresponders.

Response to Hepatitis B Vaccination in Patients with Celiac Disease

“…In a meta-analysis by Fisman et al [12], it is shown that an increased risk of unresponsiveness to HBV vaccination was found among older individuals, even when older individuals were defined as being as young as 30 years. In a study on non-smoking and non-obese healthy volunteers older than 40 years, the response rate to HBV vaccination was observed to be lower than the general population and the rate was elevated with an additional dose of vaccination [13]. In our study, the majority of the patients were female and there was no significant difference of gender distribution between CD patients and control subjects.…”

Comparison of Nine Commercially Available Assays for Quantification of Antibody Response to Hepatitis B Virus Surface Antigen

“…Therefore, some countries set the lower limit of the anti-HBs level proving a good response to vaccination at 100 IU/liter (Table 15); individuals with lower levels determined 4 to 8 weeks after the third vaccination receive an additional dose. Another possibility would be regular administration of a fourth vaccine dose at month 12, which may result in a higher proportion of vaccine responders (6). Several countries recommend a fourth vaccine dose in high-risk settings, as well as a booster dose after 5 years (4,7,11).…”

Soroprevalência da hepatite B e avaliação da resposta imunológica à vacinação contra a hepatite B por via intramuscular e intradérmica em profissionais de um laboratório de saúde pública

“…Com relação à faixa etária, observamos, assim como outros autores (12,20,27,28) , melhor resposta imunológica dos indivíduos com menos de 40 anos de idade.…”