Korean J Pediatr Infect Dis.  1997 May;4(1):106-115. 10.14776/kjpid.1997.4.1.106.

Immunogenicity and Safety of Recombinant Hepatitis B Vaccine(HG-II®) in Healthy Infants and Children

• Kim MA
• Choi EH
• Jang MS
• Dong ES
• Jang SH
• Ahn YM
• Youn HS
• Sohn YM

• KMID: 2440363
• DOI: http://doi.org/10.14776/kjpid.1997.4.1.106

Abstract

OBJECTIVE
To evaluate the immunogenicity and safety afforded by the HG-II® recombinant hepatitis B vaccine given to healthy neonates and children and to find the influence of preceding BCG vaccination on immunogenicity.
METHODS
Three doses of recombinant hepatitis B vaccine with a dose of 10µg were given at birth, 1 and 6 months of age. This study was conducted in three hospitals (Gyeongsang National University Hospital(Group A), Kangnam General Hospital(Group B) and Younsei University Hospital(Group C)) from April, 1995 to June, 1996. Group A and Group B received 2nd dose of hepatitis B vaccine at 1 week after and before BCG vaccine, respectively. Antibidy levels, at 1 month after the 3rd dose of hepatitis B vaccine were determined by a radioimmunoassay.
RESULTS
1) One hundred four infants and ten children were enrolled : 55 infants and 43 infants received 2nd dose of hepatitis B vaccine at 1 week after( After BCG Group) and before BCG vaccine(Before BCG Group), respectively. 2) The seropositive rate was 99.1%, and geometric mean anti-HBs titer was 131.2mIU/ml. 3) The geometric mean titers were 105.5mIU/ml and 162.8mIU/ml in After BCG and Before BCG Group, respectively(p < 0.025). 4) Among 359 episodes of vaccination, the occurrence of systemic and local side reaction were reported in 7.8% and 1.4%, respectively.
CONCLUSION
Recombinant hepatitis B vaccine(HG-IIR)was highly immunogenic and safe. The significantly lower geometric mean antibody titer in the BCG preceding group was observed. Well-designed controlled study with the large number of sample size will be required to show the influence of preceding BCG vaccination.

Keyword

Recombinant hepatitis B vaccine; Immunogenicity; Safety

MeSH Terms

BCG Vaccine
Child*
Hepatitis B Vaccines
Hepatitis B*
Hepatitis*
Humans
Infant*
Infant, Newborn
Mycobacterium bovis
Parturition
Radioimmunoassay
Sample Size
Vaccination
BCG Vaccine
Hepatitis B Vaccines