Immunogenicity and safety in newborns of a new recombinant hepatitis B vaccine containing the S and pre-S2 antigens.
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 micrograms 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 greater than 85% 1 month after the second injection. After the booster injection greater than 90% of the infants had an anti-HBs titre greater than 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.(ABSTRACT TRUNCATED AT 250 WORDS)
Soulié
J C
JC
Centre d'Hémobiologie Périnatale, Hôpital Jean-Verdier, Bondy, France.
Devillier
P
P
Santarelli
J
J
Goudeau
A
A
Vermeulen
P
P
Guellier
M
M
Saliou
P
P
Hillion
A M
AM
Tron
F
F
Huchet
J
J
D000943:Antigens, Differentiation; D005260:Female; D006510:Hepatitis B Antibodies / Q000096:biosynthesis* / Q000097:blood; D006514:Hepatitis B Surface Antigens / Q000235:genetics / Q000276:immunology*; D017325:Hepatitis B Vaccines; D006515:Hepatitis B virus / Q000276:immunology*; D006801:Humans; D007114:Immunization; D007136:Immunoglobulins / Q000008:administration & dosage / Q000276:immunology*; D007231:Infant, Newborn; D008297:Male; D011498:Protein Precursors / Q000235:genetics / Q000276:immunology; D012307:Risk Factors; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D014761:Viral Hepatitis Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*
D000943:Antigens, Differentiation; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D007136:Immunoglobulins; D011498:Protein Precursors; D014614:Vaccines, Synthetic; D014761:Viral Hepatitis Vaccines; C050807:presurface protein 2, hepatitis B surface antigen; C045213:hepatitis B hyperimmune globulin