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Immunogenicity of a recombinant DNA hepatitis B vaccine in neonates
A Meheus1, A Alisjahbana, R Vranckx
1Department of Epidemiology, University of Antwerp, Belgium.
Insights
Newborns vaccinated with a recombinant DNA hepatitis B vaccine showed high seroconversion rates. This hepatitis B vaccine is safe and effective for infants, including those born to mothers with hepatitis B surface antigen.
Area of Science:
- Immunology
- Vaccinology
- Pediatrics
Background:
- Hepatitis B virus (HBV) infection poses a significant global health risk.
- Infants born to HBV-positive mothers are at high risk of perinatal transmission.
- Effective vaccination strategies are crucial for preventing chronic HBV infection.
Purpose of the Study:
- To evaluate the safety and immunogenicity of a recombinant DNA hepatitis B vaccine in newborns.
- To assess seroconversion rates and antibody titers in infants receiving the vaccine.
- To compare vaccine response in infants born to HBsAg-positive mothers versus those born to mothers without HBV markers.
Main Methods:
- A 10 microgram dose of recombinant DNA hepatitis B vaccine administered within 24 hours of birth.
- Vaccination schedule: 0, 1, and 2 months, with a booster dose at 12 months.
- Groups included infants of HBsAg-positive mothers (Group I) and infants without maternal HBV markers (Group II).
Main Results:
- 86% seroconversion in Group I and 100% in Group II at two months post-third dose.
- Anti-HBs geometric mean titers were 80 IU/l (Group I) and 266 IU/l (Group II).
- No adverse reactions were reported during the study period.
Conclusions:
- The recombinant DNA hepatitis B vaccine is safe and highly immunogenic in newborns.
- Early vaccination in infancy is effective in preventing hepatitis B.
- This vaccine shows promise for protecting infants against hepatitis B virus infection.
Abstract:
Infants of HBsAg-positive mothers (Group I) as well as those born to women without HBV markers (Group II) were vaccinated with a 10 micrograms dose of a recombinant DNA hepatitis B vaccine within 24 hours after birth according to a 0, 1, and 2 month schedule, with a booster dose planned 12 months later. Vaccination results in 14 (Group I) and 47 (Group II) neonates showed that at two months after the third dose of vaccine, 86% (6/7) and 100% (37/37), respectively, seroconverted, with anti-HBs geometric mean titres of 80 IU/l and 266 IU/l in the respective groups. No adverse reactions to the vaccine were observed. These preliminary results indicate that the recombinant DNA hepatitis B vaccine is safe and highly immunogenic in newborns.