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A 2-dose regimen of a recombinant hepatitis B vaccine with the immune stimulant AS04 compared with the standard 3-dose regimen of Engerix-B in healthy young adults.

https://arctichealth.org/en/permalink/ahliterature56626
Source
Scand J Infect Dis. 2002;34(8):610-4
Publication Type
Article
Date
2002
Author
K. Levie
I. Gjorup
P. Skinhøj
M. Stoffel
Source
Scand J Infect Dis. 2002;34(8):610-4
Date
2002
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Belgium
Comparative Study
Denmark
Dose-Response Relationship, Drug
Female
Hepatitis B - prevention & control
Hepatitis B Antibodies - analysis
Hepatitis B Surface Antigens - analysis
Hepatitis B vaccines - administration & dosage
Humans
Immunity - physiology
Immunization - methods
Immunization Schedule
Male
Reference Values
Research Support, Non-U.S. Gov't
Sensitivity and specificity
Single-Blind Method
Vaccines, Synthetic - administration & dosage
Abstract
An open-label randomized study was undertaken to compare a 2-dose regimen (Months 0 and 6) of hepatitis B surface antigen (HBsAg) vaccine formulated with a novel adjuvant (HBsAg/AS04) with a standard 3-dose regimen (Months 0, 1 and 6) of licensed recombinant HBsAg vaccine in terms of immunogenicity and reactogenicity when administered to healthy subjects aged between 15 and 40 y. At 1 and 6 months after the full vaccination course there was a 100% seroprotection rate (anti-HBs > or = 10 mIU/ml) with the HBsAg/AS04 vaccine, compared with a 99% response rate with the licensed vaccine. The corresponding geometric mean titres were significantly higher for the novel vaccine compared to the standard vaccine: 15,468 and 2,745 mIU/ml at Months 7 and 12 vs. 6,274 and 1,883 mIU/ml, respectively. There was a higher prevalence of local symptoms with the adjuvant vaccine (90% of doses) than with the standard vaccine (48% of doses). However, these symptoms (pain, swelling and redness) were predominantly of mild-to-moderate intensity and resolved rapidly without treatment. A 2-dose regimen of the new HBsAg/AS04 adjuvant vaccine therefore compared favourably to the standard regimen in healthy young adults. It is anticipated that the simplified vaccination schedule may improve compliance and reduce costs.
PubMed ID
12238579 View in PubMed
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