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

Levie, Karin;Gjorup, I;Skinhoj, P;Stoffel, M.
(2002) Scandinavian Journal of Infectious Diseases — Vol. 34, n° 8, p. 610-614 (2002)

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  • Levie, KarinUCLouvain
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  • Gjorup, I
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  • Skinhoj, P
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  • Stoffel, M.
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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 greater than or equal to 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.
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Levie, K., Gjorup, I., Skinhoj, P., & Stoffel, M. (2002). A 2-dose regimen of a recombinant hepatitis B vaccine with the immune stimulant AS04 compared with the standard 3-dose regimen of Engerix (TM)-B in healthy young adults. Scandinavian Journal of Infectious Diseases, 34(8), 610-614. https://doi.org/10.1080/00365540110080881 (Original work published 2002)