Comparative immunogenicity of two vaccination schedules of a combined hepatitis A and B vaccine in healthy volunteers

[Guest guest]

http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2893.2010.01365.x/abstract

Comparative immunogenicity of two vaccination schedules of a combined hepatitis

A and B vaccine in healthy volunteers

A. De Schryver1,2, K. Verstrepen1, L. Vandersmissen1, N. Vandermeeren1, I.

Vernaillen1, R. Vranckx3, P. Van Damme4, M. van Sprundel2

Article first published online: 24 AUG 2010

DOI: 10.1111/j.1365-2893.2010.01365.x

© 2010 Blackwell Publishing Ltd

Issue

Journal of Viral Hepatitis

Volume 18, Issue 4, pages e5–e10, April 2011

Summary.  In 1996, a combined vaccine against both hepatitis A and B was

licensed and commercialized and has been recommended for healthcare personnel in

Belgium. This study compares the immunogenicity against hepatitis B virus (HBV)

and safety of two vaccination schedules (0–1–12 months and 0–1–6 months)

with this vaccine. This is a randomized, stratified and controlled study in

healthy adult workers, who are not occupationally exposed to HBV. Seroconversion

(≥1 IU/L) and seroprotection (≥10 IU/L) rates were compared using Fisher’s

exact test; geometric mean concentrations (GMCs) of anti-HBs were compared using

one-way ANOVA. All statistical analyses were carried out with SPSS 11 on Apple

Macintosh. A total of 399 subjects were enrolled in the study, and 356 were

analysed according to the protocol. The rate of ≥10 IU/L at 6 months was 70.6%

in the group 0–1–12 and 79.9% in the group 0–1–6; this rate decreased to

55.9% at 12 months in the first group. Seroconversion and seroprotective rates

against HBV measured at month 13 in group 0–1–12 (98.9% and 95.6%) and

measured at month 7 in group 0–1–6 (99.4% and 97.1%) were not statistically

significantly different. GMC of anti-HBs after the 0–1–12 schedule was more

than two fold higher than after 0–1–6 schedule (P < 0.001). Reported side

effects were comparable in both groups with a slight tendency to fewer side

effects in the 0–1–12 group after the third dose. The results from our study

show that the completed schedule 0–1–12 offers at least equal protective

immunogenicity against HBV as the completed 0–1–6 schedule. People not

receiving their third dose at 6 months can be given this dose up to 12 months

after the first dose. The drawback of this flexibility, however, is the longer

time period before the protection becomes effective.

[Guest guest]

http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2893.2010.01365.x/abstract

Comparative immunogenicity of two vaccination schedules of a combined hepatitis

A and B vaccine in healthy volunteers

A. De Schryver1,2, K. Verstrepen1, L. Vandersmissen1, N. Vandermeeren1, I.

Vernaillen1, R. Vranckx3, P. Van Damme4, M. van Sprundel2

Article first published online: 24 AUG 2010

DOI: 10.1111/j.1365-2893.2010.01365.x

© 2010 Blackwell Publishing Ltd

Issue

Journal of Viral Hepatitis

Volume 18, Issue 4, pages e5–e10, April 2011

Summary.  In 1996, a combined vaccine against both hepatitis A and B was

licensed and commercialized and has been recommended for healthcare personnel in

Belgium. This study compares the immunogenicity against hepatitis B virus (HBV)

and safety of two vaccination schedules (0–1–12 months and 0–1–6 months)

with this vaccine. This is a randomized, stratified and controlled study in

healthy adult workers, who are not occupationally exposed to HBV. Seroconversion

(≥1 IU/L) and seroprotection (≥10 IU/L) rates were compared using Fisher’s

exact test; geometric mean concentrations (GMCs) of anti-HBs were compared using

one-way ANOVA. All statistical analyses were carried out with SPSS 11 on Apple

Macintosh. A total of 399 subjects were enrolled in the study, and 356 were

analysed according to the protocol. The rate of ≥10 IU/L at 6 months was 70.6%

in the group 0–1–12 and 79.9% in the group 0–1–6; this rate decreased to

55.9% at 12 months in the first group. Seroconversion and seroprotective rates

against HBV measured at month 13 in group 0–1–12 (98.9% and 95.6%) and

measured at month 7 in group 0–1–6 (99.4% and 97.1%) were not statistically

significantly different. GMC of anti-HBs after the 0–1–12 schedule was more

than two fold higher than after 0–1–6 schedule (P < 0.001). Reported side

effects were comparable in both groups with a slight tendency to fewer side

effects in the 0–1–12 group after the third dose. The results from our study

show that the completed schedule 0–1–12 offers at least equal protective

immunogenicity against HBV as the completed 0–1–6 schedule. People not

receiving their third dose at 6 months can be given this dose up to 12 months

after the first dose. The drawback of this flexibility, however, is the longer

time period before the protection becomes effective.