Non-Randomized Clinical Trial to Interrupt Vertical Hepatitis B Viral Infection

Abstract

Background: Hepatitis is an inflammation of the liver, can be self-limiting or progress to fibrosis, cirrhosis, or hepatocellular carcinoma, HB occurs as a result of parenteral contact with infected body fluids, could be vertical from mother to baby or horizontal. Aim of the study: To assess the effectiveness of HB vaccine alone versus HBIG combined with HB vaccine in the interruption of neonatal HB viral infection. Methods: A Non-randomized clinical trial was conducted, 228 subjects distributed into two groups, the control group: newborns of mothers with inactive HBV infection were given HBIG and HB vaccine and, the intervention group: Newborns of mothers with inactive HBV infection were given HB vaccine alone. Results: showed that the two immunization regimens were effective in preventing HB vertical infection, GMT of the infants who vaccinated with HB vaccine alone (207.64 IU/L) higher than the infants who vaccinated with HB vaccine combined with HBIG (180.87 IU/L), the overall non-protective rate was 6.6% (15/228), (7.89%) among the control group compared to (5.26%) among the intervention group, RR 2.63, HBV incidence rate was zero. Conclusion: HB vaccine alone completely prevents HBV vertical infection and it`s not inferior to HB vaccine combined with HBIG.