Immunogenicity and safety in newborns of a new recombinant hepatitis B vaccine containing the S and pre-S2 antigens

• Published in: Vaccine Vol. 9; no. 8; pp. 545 - 548
• Main Authors: Soulié, J.C., Devillier, P., Santarelli, J., Goudeau, A., Vermeulen, P., Guellier, M., Saliou, P., Hillion, A.M., Tron, F., Huchet, J.
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 01.08.1991; Elsevier
• Subjects: Antigens, Differentiation; Biological and medical sciences; Female; Fundamental and applied biological sciences. Psychology; Hepatitis B; Hepatitis B Antibodies - biosynthesis; Hepatitis B Antibodies - blood; Hepatitis B Surface Antigens - genetics; Hepatitis B Surface Antigens - immunology; Hepatitis B Vaccines; Hepatitis B virus - immunology; Humans; Immunization; Immunoglobulins - administration & dosage; Immunoglobulins - immunology; Infant, Newborn; Male; Microbiology; newborn; pre-S2; Protein Precursors - genetics; Protein Precursors - immunology; recombinant vaccine; Risk Factors; S antigens; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies; Vaccines, Synthetic - administration & dosage; Vaccines, Synthetic - adverse effects; Vaccines, Synthetic - immunology; Viral Hepatitis Vaccines - administration & dosage; Viral Hepatitis Vaccines - adverse effects; Viral Hepatitis Vaccines - immunology; Virology; recombinant vaccine; pre-S2; newborn; S antigens; Hepatitis B; Human; Newborn; Immune response; Immunogenicity; Antibody; Vaccination; Vaccine; Kinetics; Recombinant protein; Humoral immunity
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/0264-410X(91)90240-7

A study to evaluate the safety and immunogenicity of a recombinant hepatitis B vaccine containing the S and pre-S2 antigens (GenHevac B Pasteur) was conducted in healthy newborn infants. All infants received 20 μg of vaccine within 24 h of birth and at 1 and 2 months with a booster injection at month 12. The vaccine was administered alone in 19 infants born to low risk mothers, i.e. surface antigen (HBsAg)-negative and antibody to the core antigen (Anti-HBc)-positive mothers. The vaccine was administered in combination with 100 IU hepatitis B immune globulin (HBIg) at birth and 1 month in 18 infants born to high risk mothers, i.e. HBsAg positive mothers. In the group not receiving HBIg, the anti-HBs seroconversion rate at the 10 mIU ml −1 threshold was 50% 1 month after the first injection. In both groups, the anti-HBs seroconversion rates were 100% 1 month after the third injection and > 85% 1 month after the second injection. After the booster injection > 90% of the infants had an anti-HBs titre > 1000 mIU ml −1 which will probably provide them with adequate protection for several years. The kinetics of the anti-pre-S2 response was similar to that of the anti-HBs response and 100% of infants in both groups had seroconverted 1 month after the second injection of the vaccine. The side effects were scarce, all mild and transient. Given the protective role of the anti-pre-S2 antibodies, the precocity of the response to pre-S2 antigen may therefore increase the effectiveness of hepatitis vaccination. We conclude that GenHevac B vaccine is highly immunogenic and safe for use in newborn infants, alone or in combination with HBIg.