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EASL 2014: Sci-B-Vac Bests Engerix-B for Preventing Mother-to-Child HBV Transmission

An investigational vaccine known as Sci-B-Vac given to babies born to women with hepatitis B was more effective at preventing HBV infection than the widely used Engerix-B vaccine, according to a report at the EASL International Liver Congress this month in London.

In countries where HBV is endemic, the virus is commonly transmitted from mother to child during pregnancy or delivery. Post-exposure prophylaxis for newborns using hepatitis B immune globulin (HBIG) and the first shot in the HBV vaccine series reduces the risk.

Rifaat Safadi from Holy Family Hospitalin Nazareth and colleagues compared the effectiveness of Sci-B-Vac -- a next-generation vaccine being developed by SciGen Limited -- versus Engerix-B in preventing vertical HBV transmission. Sci-B-Vac contains 3 HBV surface proteins while Engerix-B contains only 1. Vertical transmission is common among the Arab population in Israel despite a national universal HBV immunization program, the researchers noted as background.

This prospective multicenter study included 120 infants born to hepatitis B surface antigen (HBsAg) positive women at 4 hospitals in Jerusalem and Nazareth. Half were randomized to receive active immunization with Sci-B-Vac and half with Engerix-B. In addition, all received passive immunization using HBIG (injected antibodies).

Newborns were tested at 1 year of age for HBsAg, hepatitis B surface antibodies (HBsAb or anti-HBs), and hepatitis B core antibodies (HBcAb or anti-HBc).

Results

• All 60 newborns who received Engerix-B vaccine were evaluated at 1 year, as were 28 of 60 in the Sci-B-Vac group.
• All 28 Sci-B-Vac recipients tested negative for HBsAg, while 10% of Engerix-B recipients tested HBsAg positive.
• 23% of Sci-B-Vac recipients tested positive for HBc antibodies compared with 14% of Engerix-B recipients.
• 82% of Sci-B-Vac recipients attained HBs antibody titers >100 mIU/mL -- considered the threshold for protection -- compared with 62% of Engerix-B recipients.
• Conversely, none of the Sci-B-Vac recipients had HBs antibody levels <10 mIU/mL, compared with 13% of Engerix-B recipients.

"Sci-B-Vac is superior to Engerix-B for preventing HBV vertical transmission, probably due to a faster and higher response," the researchers concluded.

4/29/14

References

N Saed, M Hakim, Y Nijim, R Safadi, et al. Sci-B-Vac is superior to Engerix-B for preventing HBV vertical transmission. 49th European Association for the Study of the Liver International Liver Congress (EASL 2014). London, April 9-13, 2014. Abstract O121.