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[The long-term efficacy of a recombinant hepatitis B vaccine in newborns]
J C Tejedor Torres1, S Reyes Pecharromán, A Pérez Rivilla
1Servicio de Pediatría, Hospital de Móstoles, Madrid.
Insights
This study shows that combining recombinant hepatitis B vaccine with immunoglobulin (IG) is highly effective and safe for newborns at high risk of hepatitis B virus infection, achieving 100% protection.
Area of Science:
- Hepatology
- Immunology
- Pediatrics
Background:
- Hepatitis B virus (HBV) infection poses a significant risk to newborns, particularly those born to infected mothers.
- Effective prevention strategies are crucial for reducing vertical transmission and long-term HBV complications.
Purpose of the Study:
- To evaluate the immunogenicity, protective efficacy, and safety of a recombinant hepatitis B vaccine combined with immunoglobulin (IG) in high-risk newborns.
- To assess the vaccine's performance in preventing HBV infection and establishing protective antibody levels.
Main Methods:
- A prospective study involving two groups of newborns at high risk for HBV infection.
- Administration of a single dose of recombinant hepatitis B vaccine (20 mcg) and 0.5 ml of IG at birth, followed by two additional vaccine doses at one and six months.
- Monitoring of anti-HBs seroconversion rates, anti-HBs titers, and HBsAG positivity at eight months and long-term follow-up.
Main Results:
- 100% anti-HBs seroconversion rate was observed by eight months of age in both study groups.
- No cases of positive HBsAG were detected, indicating complete protection against infection.
- Long-term follow-up (39 ± 5 months) showed sustained protective antibody levels in most infants, with only 5.6% having anti-HBs titers below 10 mUI/ml.
Conclusions:
- The combination of recombinant hepatitis B vaccine and immunoglobulin is highly immunogenic and provides excellent protective efficacy in newborns.
- This vaccination strategy is safe and effective in preventing hepatitis B virus infection in high-risk infants.
- Sustained protection is achieved, highlighting the long-term benefits of this intervention.
Abstract:
A prospective evaluation of the immunogenicity, protective efficacy and safety of the recombinant hepatitis B vaccine associated to the immunoglobulin (IG) in newborns with high risk of infection by the hepatitis B virus was carried out. Two groups of newborns were used. The first group was formed by children with HBsAG carrier mothers (56 children) and the second group consisted of newborns of mothers negative for HBsAG, but having a high risk of infection (21 children). Within the first few hours of life, all of the newborns received a dose (20 mcg) or recombinant vaccine and 0.5 ml of IG. New doses of vaccine were administered at one and six months of life. At eight months of age, the anti-HBs seroconversion rate in children belonging to groups 1 and 2 was 100%, with an elevated anti-HBs titer and with no detected cases of positive HBsAG. On a long term basis (39 +/- 5 months), only 5.6% of the children present an anti-HBs titer < 10 mUI/ml. The recombinant hepatitis B vaccine associated to IG is immunogenic and provides efficient protection in newborns. Important side effects were not observed.