Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
8
pubmed:dateCreated
1992-2-24
pubmed:abstractText
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)
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Aug
pubmed:issn
0264-410X
pubmed:author
pubmed:issnType
Print
pubmed:volume
9
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
545-8
pubmed:dateRevised
2004-11-17
pubmed:meshHeading
pubmed:year
1991
pubmed:articleTitle
Immunogenicity and safety in newborns of a new recombinant hepatitis B vaccine containing the S and pre-S2 antigens.
pubmed:affiliation
Centre d'Hémobiologie Périnatale, Hôpital Jean-Verdier, Bondy, France.
pubmed:publicationType
Journal Article, Clinical Trial, Controlled Clinical Trial