Immunogenicity of two recombinant hepatitis B vaccines in older individuals

Thomas L. Treadwell, Emmet B. Keeffe, John Lake, Alexandra Read, Lawrence S. Friedman, Ira S. Goldman, Charles D. Howell, Maria DeMedina, Eugene R Schiff, Donald M. Jensen, Raymond S. Koff

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Abstract

PURPOSE: Currently available hepatitis B vaccines are recombinant, yeast-derived preparations given in 10-μg or 20-μg doses. The optimum dose remains controversial. We sought to assess the relative immunogenicity of two hepatitis B vaccines, given in different doses, in older individuals. PATIENTS AND METHODS: In a multicenter, double-blind, randomized clinical trial, a total of 460 healthy subjects between 39 and 70 years of age were screened and immunized with either Engerix-B 20 μg or Recombivax HB 10 μg in standard, intramuscular, 3-dose regimens. Of these, 397 subjects were eligible to continue vaccination. Immunogenicity was measured by determination of antibody to hepatitis B surface antigen (anti-HBs). Seroconversion and seroprotection rates, and geometric mean titers of anti-HBs were calculated at 1, 3, 6, and 8 months after the initial dose of vaccine. RESULTS: Seroprotection rates for subjects receiving the 20-μg dose of vaccine were slightly, but not significantly, greater than for subjects receiving the 10-μg dose, at each time point. However, at 3 months, males receiving the higher dose had significantly higher seroprotection rates than males receiving the lower dose: 63% versus 37% (p <0.001). At 8 months, geometric mean titers for the group receiving Engerix-B 20 μg were significantly greater than that for the group receiving Recombivax HB 10 μg: 840 mIU/mL versus 340 mIU/mL (p = 0.001). CONCLUSIONS: Immunization with the 20-μg dose of recombinant hepatitis B virus vaccine appeared to result in more rapid development of seroprotective anti-HBs titers in older men and in higher titers of anti-HBs at the completion of vaccination when compared to the 10-μg dose. The latter data suggest that the 20-μg dose may result in a longer duration of seroprotective anti-HBs titers.

Original languageEnglish
Pages (from-to)584-588
Number of pages5
JournalAmerican Journal of Medicine
Volume95
Issue number6
StatePublished - Dec 1 1993

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Hepatitis B Vaccines
Synthetic Vaccines
Vaccination
Vaccines
Hepatitis B Surface Antigens
Hepatitis B virus
Immunization
Healthy Volunteers
Randomized Controlled Trials
Yeasts
Antibodies
Engerix-B
Recombivax HB

ASJC Scopus subject areas

  • Nursing(all)

Cite this

Treadwell, T. L., Keeffe, E. B., Lake, J., Read, A., Friedman, L. S., Goldman, I. S., ... Koff, R. S. (1993). Immunogenicity of two recombinant hepatitis B vaccines in older individuals. American Journal of Medicine, 95(6), 584-588.

Immunogenicity of two recombinant hepatitis B vaccines in older individuals. / Treadwell, Thomas L.; Keeffe, Emmet B.; Lake, John; Read, Alexandra; Friedman, Lawrence S.; Goldman, Ira S.; Howell, Charles D.; DeMedina, Maria; Schiff, Eugene R; Jensen, Donald M.; Koff, Raymond S.

In: American Journal of Medicine, Vol. 95, No. 6, 01.12.1993, p. 584-588.

Research output: Contribution to journalArticle

Treadwell, TL, Keeffe, EB, Lake, J, Read, A, Friedman, LS, Goldman, IS, Howell, CD, DeMedina, M, Schiff, ER, Jensen, DM & Koff, RS 1993, 'Immunogenicity of two recombinant hepatitis B vaccines in older individuals', American Journal of Medicine, vol. 95, no. 6, pp. 584-588.
Treadwell TL, Keeffe EB, Lake J, Read A, Friedman LS, Goldman IS et al. Immunogenicity of two recombinant hepatitis B vaccines in older individuals. American Journal of Medicine. 1993 Dec 1;95(6):584-588.
Treadwell, Thomas L. ; Keeffe, Emmet B. ; Lake, John ; Read, Alexandra ; Friedman, Lawrence S. ; Goldman, Ira S. ; Howell, Charles D. ; DeMedina, Maria ; Schiff, Eugene R ; Jensen, Donald M. ; Koff, Raymond S. / Immunogenicity of two recombinant hepatitis B vaccines in older individuals. In: American Journal of Medicine. 1993 ; Vol. 95, No. 6. pp. 584-588.
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abstract = "PURPOSE: Currently available hepatitis B vaccines are recombinant, yeast-derived preparations given in 10-μg or 20-μg doses. The optimum dose remains controversial. We sought to assess the relative immunogenicity of two hepatitis B vaccines, given in different doses, in older individuals. PATIENTS AND METHODS: In a multicenter, double-blind, randomized clinical trial, a total of 460 healthy subjects between 39 and 70 years of age were screened and immunized with either Engerix-B 20 μg or Recombivax HB 10 μg in standard, intramuscular, 3-dose regimens. Of these, 397 subjects were eligible to continue vaccination. Immunogenicity was measured by determination of antibody to hepatitis B surface antigen (anti-HBs). Seroconversion and seroprotection rates, and geometric mean titers of anti-HBs were calculated at 1, 3, 6, and 8 months after the initial dose of vaccine. RESULTS: Seroprotection rates for subjects receiving the 20-μg dose of vaccine were slightly, but not significantly, greater than for subjects receiving the 10-μg dose, at each time point. However, at 3 months, males receiving the higher dose had significantly higher seroprotection rates than males receiving the lower dose: 63{\%} versus 37{\%} (p <0.001). At 8 months, geometric mean titers for the group receiving Engerix-B 20 μg were significantly greater than that for the group receiving Recombivax HB 10 μg: 840 mIU/mL versus 340 mIU/mL (p = 0.001). CONCLUSIONS: Immunization with the 20-μg dose of recombinant hepatitis B virus vaccine appeared to result in more rapid development of seroprotective anti-HBs titers in older men and in higher titers of anti-HBs at the completion of vaccination when compared to the 10-μg dose. The latter data suggest that the 20-μg dose may result in a longer duration of seroprotective anti-HBs titers.",
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AU - Read, Alexandra

AU - Friedman, Lawrence S.

AU - Goldman, Ira S.

AU - Howell, Charles D.

AU - DeMedina, Maria

AU - Schiff, Eugene R

AU - Jensen, Donald M.

AU - Koff, Raymond S.

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N2 - PURPOSE: Currently available hepatitis B vaccines are recombinant, yeast-derived preparations given in 10-μg or 20-μg doses. The optimum dose remains controversial. We sought to assess the relative immunogenicity of two hepatitis B vaccines, given in different doses, in older individuals. PATIENTS AND METHODS: In a multicenter, double-blind, randomized clinical trial, a total of 460 healthy subjects between 39 and 70 years of age were screened and immunized with either Engerix-B 20 μg or Recombivax HB 10 μg in standard, intramuscular, 3-dose regimens. Of these, 397 subjects were eligible to continue vaccination. Immunogenicity was measured by determination of antibody to hepatitis B surface antigen (anti-HBs). Seroconversion and seroprotection rates, and geometric mean titers of anti-HBs were calculated at 1, 3, 6, and 8 months after the initial dose of vaccine. RESULTS: Seroprotection rates for subjects receiving the 20-μg dose of vaccine were slightly, but not significantly, greater than for subjects receiving the 10-μg dose, at each time point. However, at 3 months, males receiving the higher dose had significantly higher seroprotection rates than males receiving the lower dose: 63% versus 37% (p <0.001). At 8 months, geometric mean titers for the group receiving Engerix-B 20 μg were significantly greater than that for the group receiving Recombivax HB 10 μg: 840 mIU/mL versus 340 mIU/mL (p = 0.001). CONCLUSIONS: Immunization with the 20-μg dose of recombinant hepatitis B virus vaccine appeared to result in more rapid development of seroprotective anti-HBs titers in older men and in higher titers of anti-HBs at the completion of vaccination when compared to the 10-μg dose. The latter data suggest that the 20-μg dose may result in a longer duration of seroprotective anti-HBs titers.

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