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Immunogenicity and protective efficacy of low dose recombinant DNA hepatitis B vaccine in normal and high-risk
A Assateerawatt1, V S Tanphaichitr, V Suvatte
1Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Insights
A low-dose recombinant hepatitis B vaccine effectively prevents perinatal hepatitis B virus transmission in low-risk infants. However, efficacy is reduced in high-risk infants born to HBeAg-positive mothers.
Area of Science:
- Immunology
- Vaccinology
- Hepatology
Background:
- Perinatal transmission of hepatitis B virus (HBV) poses a significant public health challenge.
- Hepatitis B surface antigen (HBsAg) carrier mothers are a primary source of HBV transmission to newborns.
- Risk stratification of neonates is crucial for effective prevention strategies.
Purpose of the Study:
- To evaluate the efficacy of a low-dose recombinant DNA hepatitis B vaccine (HB-VAX II) in preventing perinatal HBV transmission.
- To assess vaccine effectiveness in both normal and high-risk neonates born to HBsAg carrier mothers.
- To determine seroconversion rates and antibody titers following vaccination.
Main Methods:
- A prospective study involving 90 neonates from HBsAg carrier mothers, divided into three groups based on maternal HBeAg status.
- Administration of a 2.5 microgram dose of recombinant hepatitis B vaccine at 0, 1, 2, and 12 months of age.
- Monitoring of infants for persistent HBsAg carriage, seroconversion, and anti-HBs antibody titers at various time points.
Main Results:
- Zero incidence of persistent HBsAg carriage in low-risk groups (mothers HBsAg-negative or HBeAg-negative/HBsAg-carrier).
- 30.4% incidence of persistent HBsAg carriage in high-risk group (mothers HBeAg-positive/HBsAg-carrier).
- Protective efficacy of 65.7% in high-risk infants; seroconversion rates reached 100% by 13 months in all groups.
Conclusions:
- The low-dose recombinant hepatitis B vaccine is effective in preventing perinatal HBV transmission in low-risk infants.
- Vaccine efficacy is reduced in high-risk infants born to HBeAg-positive mothers.
- Further strategies may be needed to enhance protection in high-risk neonates.
Abstract:
A low dose of recombinant DNA hepatitis B vaccine (HB-VAX II, MSD) was tested for efficacy in the prevention of perinatal hepatitis B virus (HBV) transmission in normal and high-risk neonates born from HBsAg carrier mothers. A dose of 2.5 micrograms recombinant vaccine was injected intramuscularly at 0, 1, 2 and 12 months of age to 30 newborns from HBsAg negative mother (group I), 30 from HBeAg negative/HBsAg carrier mother (group II) and 30 from HBeAg positive/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, II and III, respectively. The protective efficacy in high risk infants in group III was 65.7 percent. The seroconversion at month 4, after the third dose of vaccination was 96.3, 95.7 and 100 percent in group I, group II and group III, respectively. After a booster dose of vaccination at 12 months of age, the seroconversion rose to 100 percent at month 13 in all three groups. The geometric mean titer (GMT) of anti-HBs antibody at 13 months of age were 2,092, 1,657 and 1,938 mIU/ml in group I, group II and group III, respectively. It is concluded that the low dose (2.5 micrograms) recombinant hepatitis B vaccine using alone is effective in prevention of perinatal HBV transmission in low risk infants (groups I and II), but it is less effective in high risk infants (group III).(ABSTRACT TRUNCATED AT 250 WORDS)