The immunogenicity and the protective efficacy of a recombinant DNA hepatitis B vaccine, GenHevac B Pasteur with or without passive immunization with hepatitis B immunoglobulin (HBIG) in high risk neonates born from HBsAg and HBeAg positive mothers was evaluated. Twenty-six neonates (group A) received HBIG 100 IU intramuscularly at birth plus GenHevac B Pasteur 20 micrograms at birth, 1, 2 and 12 months of age while another 23 neonates (group B) received only GenHevac B Pasteur vaccine. Forty high risk newborns who received no immunization served as control group. It was found that at months 4, 12, 13 and 24 the seroconversion rate in both group A and B were very high in the range of 95-100% with the GMT ranging from 10-160,000 mlU/ml. In the control group of infants, 85% had HBsAg positive at one year of age but it was only 3.8% and 8.7% in vaccinated groups A and B, respectively. The protective efficacy in neonates group A and B were 95.5% and 89.8% at one year, respectively, with no statistically significant difference. In 46 normal school children (group C) and 48 healthy adults (group D) who received the same dose of GenHevac B Pasteur the seroconversion rates at month 4 after receiving 3 doses of vaccination were 97.8% and 83.3% in group C and group D, respectively. At month 12, the seroconversion rate in group C rose to 100% and was significantly higher than the 89.6% of group D.(ABSTRACT TRUNCATED AT 250 WORDS)

Immunogenicity and efficacy of a recombinant DNA hepatitis B vaccine, GenHevac B Pasteur in high risk neonates, school children and healthy adults

A low dose of recombinant DNA hepatitis B vaccine (HB·YAX II® , MSD) was tested for efficacy In the prevention of perinatal hepatitis B virus (HBY) transmission In normal and high-risk neonates born from HBsAg carrier mothers. A dose of 2.5 pg recombinant vaccine was Injected Intramuscularly at 0, 1,2 and 12 months of age to 30 newborns from H BsAg negative mother (group I), 30 from H BeAg negativetHBsAg carrier mother (group II) and 30 from HBeAg posltlve/HBsAg carrier mother (group III). The Incidence of persistent HBsAg carrier Infants at 13 months of age was 0, 0, and 30.4 percent In groups I, " and III, respectively. The protective efficacy In high risk Infants In group III was 65.7 percent. The seroconverslon at month 4, after the third dose of vaccination was 96.3, 95.7 and 100 percent In group I, group 1/ and group III, respectively. After a booster dose of vaccination at 12 months of age, the seroconverslon rose to 100 percent at month 131n all three groups. The geometric mean titer (GMT) of antl·HBs antibody at 13 months of age were 2,092, 1,657 and 1,936 mlU/ml In group I, group 1/ and group III, respectively. It Is concluded that the low dose (2.5 j.tg) recombinant hepatitis B vaccine using alone Is effective In prevention of perinatal HBY transmission In low risk Infants (groups I and II), but It is less effective in high risk Infants (group III). The low dose hepatitis B vaccine regimen should be combined with HBIG given at birth for the tull protection of pertnatal HBY transmission In the high risk neonates born from the HBeAg posltlvel HBsAg carrier mothers which comprised approximately 3 percent ot all newborns In the endemic area. This approach would certainly reduce the cost of hepatitis B Immunization and It could be applied economically for the national program of HBY transmission contorl In neonates.

Immunogenicity and protective efficacy of low dose recombinant DNA hepatitis B vaccine in normal and high-risk neonates.

The purpose of the present study was to determine the frequency of hepatitis B virus (HBV) markers in families of HBsAg-positive patients with chronic liver disease. Serum anti-HBc, HBsAg and anti-HBs were determined by enzyme immunoassay and four subpopulations were considered: genetically related (consanguineous) and non-genetically related (non-consanguineous) Asian subjects and genetically related and non-genetically related Western subjects. A total of 165 and 186 relatives of Asian and Western origin were enrolled, respectively. The occurrence of HBsAg and anti-HBs antibodies was significantly higher (P < 0.0001) in family members of Asian origin (81.8%) than in family members of Western origin (36.5%). HBsAg was also more frequent among brothers (79.6 vs 8.5%; P < 0.0001), children (37.9 vs 3.3%; P < 0.0001) and other family members (33.9 vs 16.7%; P < 0.0007) of Asian than Western origin, respectivelly. No difference between groups was found for anti-HBs, which was more frequently observed in fathers, spouses and other non-genetic relatives. HBV infection was significantly higher in children of Asian than Western mothers (P < 0.0004). In both ethnic groups, the mothers contributed more to their children's infection than the fathers (P < 0.0001). Furthermore, HBsAg was more frequent among consanguineous members and anti-HBs among non-consanguineous members. These results suggest the occurrence of vertical transmission of HBV among consanguineous members and probably horizontal sexual transmission among non-consanguineous members of a family cluster. Thus, the high occurrence of dissemination of HBV infection characterizes family members as a high-risk group that calls for immunoprophylaxis. Finally, the study showed a high familial aggregation rate for both ethnic groups, 18/19 (94.7%) and 23/26 (88.5%) of the Asian and Western origin, respectively.

/pdf/a-prospective-study-of-hepatitis-b-virus-markers-in-patients-47p2ucbf2b.pdf

A prospective study of hepatitis B virus markers in patients with chronic HBV infection from Brazilian families of Western and Asian origin

Objective Despite implementing hepatitis B immunoglobulin (HBIG) and vaccination, data suggest it would not be sufficient to reach the elimination targets. Tenofovir disoproxil fumarate (TDF) has been added to the Thai national standards of care for prevention of transmission of the hepatitis B virus during birth. To optimise national strategies in Thailand, we assessed TDF’s effectiveness for prevention of mother-to-child transmission and conducted cost-effectiveness analyses of different TDF-based strategies. Research design and methods We retrospectively reviewed medical records of mother and infant pairs whose mothers were positive for hepatitis B e-antigen (HBeAg) and received TDF to prevent maternal transmission of viral hepatitis B during 2018–2020. Based on the available data on transmission rate, we also applied a decision tree to estimate the cost-effectiveness of different TDF-based strategies to eligible mothers. These included: (1) HBIG for all hepatitis B virus (HBV) exposed infants; (2) HBIG for only infants of HBeAg-positive mothers (‘HBIG for e-positive’) and (3) without HBIG to infants (‘HBIG-free’). The incremental cost-effectiveness ratio between the different strategies and baseline intervention without TDF was calculated. The one-way sensitivity analysis was used to adjust prevalence of HBeAg-positive mothers, cost of HBIG, cost of TDF and transmission rate. Results Of 223 infants enrolled, 212 (95.0%) received HBIG, while 11 (5.0%) did not. None of the infants had chronic HBV infection. The most cost-saving intervention was ‘HBIG-free’ followed by ‘HBIG for e-positive’. The one-way sensitivity demonstrated that the results were reasonably robust to changes. The cost-saving was greater with a higher hepatitis B virus surface antigen (HBsAg) prevalence. The HBIG-free strategy remained best at 0%–1.4% transmission rates, meeting the additional target for eliminations. Conclusion The study is the first cost-effectiveness analyses to provide evidence supporting an HBIG-free strategy in an antiviral era. This approach should be considered to prevent mother-to-child transmission in resource-constrained settings, particularly in countries with a high HBsAg prevalence.

Cost-effectiveness of tenofovir prophylaxis during pregnancy for the elimination of mother-to-child transmission of the hepatitis B virus: real-world analysis from Thailand

SUMMARY Thispaper usesmeta-analysis ofpublished dataandadeterministic mathematical modelof hepatitis Bvirus (HBV)transmission todescribe thepatterns ofHBV infection inhigh endemicity areas. We describe theassociation between theprevalence ofcarriers andasimple measure oftherateofinfection, theageatwhichhalf thepopulation havebeeninfected (A50), andassess thecontribution ofhorizontal andperinatal transmission tothis association. We found that thetwomainhyper-endemic areas ofsub-Saharan Africa andeast Asiahavesimilar prevalences ofcarriers andvalues ofA50, andthat there isanegative nonlinear relationship between A50andtheprevalence ofcarriers inhighendemicity areas (Spearman's Rank,P= 00086). Wequantified therisk ofperinatal transmission andtheage-dependent rate of infection toallow acomparison between themainhyper-endemic areas. EastAsiawasfound tohavehigher prevalences ofHBeAgpositive mothers andagreater risk ofperinatal transmission fromHBeAgpositive mothers thansub-Saharan Africa, though thedifferences werenotstatistically significant. However, thetwoareas havesimilar magnitudes andagedependent rates ofhorizontal transmission. Results ofasimple compartmental modelsuggest that similar rates ofhorizontal transmission aresufficient togenerate thesimilar patterns between A50andtheprevalences ofcarriers. Interrupting horizontal transmission bymass immunization isexpected tohaveasignificant, nonlinear impact ontherateofacquisition of newcarriers.

Epidemiological patterns ofhepatitis Bvirus (HBV)inhighly endemic areas

The vertical transmission of the hepatitis B surface antigen (HBsAG) from HBsAg carrier mothers to their infants and children were studied in 42 mother-infant pairs, 27 siblings aged under 5 years and 34 fathers of these families. Thirteen out of 42 (30.9%) infants born from these mothers became HBsAg carriers at 3 to 6 months of age. Vertical transmission to their infants (76.5%) and other siblings (88.9%) occurred only in those mothers with e-antigen (HBeAg) positive but none in HBsAg carrier mothers without HBeAg. Most of the HBsAg carrier babies (70.5%) and their siblings (77.7%) born from the carrier mothers with HBeAg positive also had HBeAg in their sera. Good correlation of the presence of HBeAg and higher titer of HBsAg was found both in HBsAg carrier mothers and in their off-springs. This study clearly shows that HBsAg carrier Thai mothers with HBeAg transmitted hepatitis B virus vertically to their infants and children more readily than do the HBsAg carrier mothers without HBeAg.

Vertical transmission of the hepatitis B surface antigen in Thailand.

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Vertical transmission of the hepatitis B surface antigen in Thailand.