Table 1 Summary of studies investigating the response to hepatitis B vaccine in adults.
From: Factors influencing immunologic response to hepatitis B vaccine in adults
Author | Year | Study design | Age (years) | Population characteristics | Country | Male/Female | BMI | Schedule (months) | Follow-up (After last does of vaccine) | Vaccine detail | Injection pathway | Geometric mean titer (IU/L) | Seroprotection reached n/% (>=10 mlU/mL) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Zajac B. A. et al. | 1986 | Retrospective cohort | 20–70 | Healthy adults | USA | NA | NA | 0-1-6 | 1–6 months | 10 μg recombinant vaccine | IM | a) 300 IU/L (2.5 ug); b) 350 IU/L (5 ug); c) 1250 IU/L (10 ug); d) 1000 IU/L (20 ug) | a) 98% (2.5 ug); b) 89% (5 ug); c) 97% (10 ug); d) 87% (20 ug) |
Jilg W. et al. | 1989 | Randomized trials | a) 24.7 ± 2.1 b) 24.4 ± 1.7 c) 24.6 ± 1.8 | Healthy medical students | Germany | a) 12/17; b) 16/14; c) 16/14 | NA | a) 0-1-2-12; b) 0-1-6; c) 0-1-12 | 12 months | 10 μg recombinant vaccine | IM | a) 53 IU/I (0-1-2); b) 5846 IU/L (0-1-6); c) 19912 IU/L (0-1-12) | Seroconversion rate in all three groups was 100% after the third dose. |
Morris C. A. et al. | 1989 | Retrospective cohort | 19–60+ | Health care volunteers | United Kingdom | 79/136 | NA | 0-1-6 | 1–2 months | 2 μg recombinant vaccine, Engerix-B | ID | NA | 80.9% |
Westmoreland D. et al. | 1990 | Retrospective cohort | 17–71 | Occupational risk of infection | United Kingdom | 304/1016 | NA | 0-1-6 | 6–8 weeks | 20 μg recombinant vaccine, Engerix-B | IM | NA | 90.50% |
Guan R. et al. | 1990 | Retrospective cohort | 40 ± 7.7 range: 23–54 | Chronic renal failure | Singapore | 11/18 | NA | 0-1-2-6 | 6 months | 40 μg recombinant vaccine, Engerix-B | IM | 112 IU/L | 69% (>2.1 IU/L, 79%) |
Dahl-Hansen E. et al. | 1990 | Randomized trials | 21–62 | Healthy adults | Norway | 30/109 | NA | 0-1-6 | 3 months | recombinant vaccine,20 μg Engerix-B and 10 μg Recombivax | IM | a) 189 IU/L (SKR 20 ug); b) 99 IU/L (MSD 10 ug) | 100.0% |
Dentico P. et al. | 1992 | Randomized trials | 18–60 | Volunteer employees | Italy | a) 43/57; b) 35/65 | NA | 0-1-6 | 1–42 months | a) 10 μg recombinant vaccine b) 20 μg recombinant vaccine | IM | a) 1252 IU/L (10 ug); b) 1340 IU/L (20 ug) | a) 87% (10 ug); b) 97% (20 ug) |
Roome A. J. et al. | 1993 | Retrospective cohort | Mean: 39.3 range: 14–74 | Healthy adults | USA | 510/18 | NA | 0-1-6 | 1–6 months | recombinant vaccine, Recombivax HB | NA | 235 IU/L | 88.1% |
McMaster K. R. 3rd et al. | 1993 | Retrospective cohort | NA | Most firefighters | USA | NA | NA | 0-1-2-6 | 1–2 months | 2 μg recombinant vaccine, Engerix-B | ID | NA | 90.5% |
Jaiswal S. B. et al. | 1995 | Retrospective cohort | NA | Chronic renal failure | India | 29/11 | NA | 0-1-6 | 1 month | 40 μg recombinant vaccine, Engerix-B | IM | NA | 50.0% |
Bock H. L. et al. | 1996 | Prospective cohort | 28 ± 10.6 | Health care staff and their relatives | Germany | 176/704 | NA | 0-1-6 | 1 month | 20 μg recombinant vaccine, Engerix-B | IM | 1989 IU/L | 97.8% |
Averhoff F. et al. | 1998 | Retrospective cohort | 41 | Health care workers | USA | 1335/416 | NA | 0-1-6 | 1 month | recombinant vaccine, 20 μg Engerix-B and 10 μg Recombivax | IM | <40 years of age: a) 2138 IU/L in Engerix-B, b) 1047 IU/L in Recombivax-HB; ≥40 years of age: a) 1000 IU/L in Engerix-B, b) 288 IU/L in Recombivax-HB | a) 90% in Engerix-B; b) 86% in Recombivax-HB |
Cardell K. et al. | 1999 | Prospective cohort | Mean: 36 range: 19–63 | Health care workers | Sweden | 239/1167 | NA | 0-1-6 | 2 months | 2 μg recombinant vaccine, Engerix-B | ID | NA | 68.3% |
Ingardia C. J. et al. | 1999 | Retrospective cohort | 23.8 ± 5.6 range: 15–40 | Pregnant women | USA | 0/80 | 27.7 ± 7.0 range: 18–56 | 0-1-6 | 11.1 ± 5.1 weeks | 20 μg recombinant vaccine, Engerix-B | IM | NA | 45.0% |
Young M. D. et al. | 2001 | Randomized trials | a) 39.2 range: 18–65 b) 38.8 range: 18–65 | Healthy adults | USA | a) 62/90; | NA | 0-1-6 | 3–4 weeks | a) 20 ug recombinant vaccine; Hepacare; b) 20 ug recombinant vaccine; Engerix-B | IM | 90% of vaccinees had titers ≥100 IU/L in both groups. | a) 98% in Hepacare; |
b) 60/91 | b) 88% in Engerix-B | ||||||||||||
Wolters B. et al. | 2003 | Retrospective cohort | Mean: 54 range: 17–84 | Older adults | Germany | 51/53 | NA | 0-1-6 | 16.8 months (range 1–36 months) | 20 μg recombinant vaccine, Twinrix | IM | NA | 46.0% |
Martins R. M. et al. | 2004 | Randomized trials | a) 20–30 b) 31–40 | Healthy adults | Brazil | a) 364/114; b) 352/134 | NA | 0-1-6 | 28–100 days | a) 20 μg recombinant vaccine, Butang; b) 20 μg recombinant vaccine, Engerix-B | IM | a) Butang®, 351.1 in newborn infants, 3600.0 in children, 746.3 in adolescents, 453.5 in adults 20–30 years old, and 122.7 in adults 31–40 years old; b) Engerix-B, 1530.6 in newborn infants, 2753.1 in children, 1284.3 in adolescents, 1369.0 in adults 20–30 years old, and 686.2 in adults 31–40 years old | a) Butang, 93.7% in newborn infants, 100% in children, 95.1% in adolescents, 91.8% in adults 20–30 years old, and 79.8% in adults 31–40 years old; b) Engerix-B, 97.5% in newborn infants, 97.7% in children, 96% in adolescents, 95.5% in adults 20–30 years old, and 92.4% in adults 31–40 years old |
Yen Y. H. et al. | 2005 | Retrospective cohort | Mean: 36.6 range: 25–70 | Health care workers | China | 50/200 | NA | 0-1-6 | 8 months | 20 μg recombinant vaccine, Engerix-B | IM | 5 of 8 responders were 10.5, 199.3, 396.9, 822.2 and 1000 IU/L, respectively. | 86.4% |
Panhotra B. R. et al. | 2005 | Retrospective cohort | 34.6 ± 8.2 range: 21–60 | Health care workers | Saudi Arabia | 620/682 | NA | 0-1-6 | 3 months | 20 μg recombinant vaccine, Engerix | IM | NA | 92.2% |
Kulkarni P. S. et al. | 2006 | Prospective cohort | 33 ± 8.645 | Healthy adults | India | 766/22 | 22.4 ± 2.8 | 0-1-6 | 1 month | 20 μg recombinant vaccine, Batch | IM | 443 IU/L | 96.0% |
Estévez Z. C. et al. | 2006 | Randomized trials | 20–64 | Healthy adults | Cuba | 167/293 | NA | 0-1-2 | 1 month | 20 μg recombinant vaccine, Heberbiovac HB | IM | 931.18 IU/L | 97.0% |
Locquet C. et al. | 2007 | Retrospective cohort | 35 ± 10.4 range: 17–65 | Women healthcare workers | France | 0/880 | 23.4 ± 4.4 | a) 0-1-2-12; | 1–169 months | 20 μg recombinant vaccine, Genhevac Pasteur/20 μg recombinant vaccine, Engerix GlaxoSmithKline | IM | NA | 92.0% |
b) 0-1-6 | |||||||||||||
Sabidó M. et al. | 2007 | Retrospective cohort | 33 ± 10.51 | Health care workers | Spain | 437/1621 | 23.50 ± 3.76 | 0-1-6 | 1–6 months | 17.4% plasma-derived vaccine, Hevac-B; | IM | NA | 92.2% |
83.5% recombinant vaccine, Engerix-B | |||||||||||||
Oliveira L. C. et al. | 2007 | Randomized trials | a) 46.6 ± 10.9(alcoholics); b) 37.8 ± 9.7(non-alcoholics) | Healthy adults | Portugal | 60/0 | NA | 0-1-6 | 1 month | 20 μg recombinant vaccine, Euvax-B | IM | a) 511 ± 448 IU/L (alcoholics); b) 696 ± 410 IU/L (non-alcoholics) | a) 50% (alcoholics); b) 52.5% (non-alcoholics) |
Wolters B. et al. | 2009 | a) Prospective cohort b) Retrospective cohort | a) Mean: 38.9 range: 18–79 b) Mean: 39.9 range: 16–75 | Healthy adults | German | a) 109/65 b) 133/115 | a) 25.5 ± 4.8 b) 24.4 ± 3.8 | 0-1-6 | 1–2 months | Twinrix | NA | 1430 IU/L | 88.7% |
Kevorkyan A. K. et al. | 2011 | Retrospective cohort | 40.3 ± 2.6 | Health care workers | Bulgaria | 13/57 | NA | 0-1-6 | 1–2 months | 20 μg recombinant vaccine, Hepavax Gen | NA | NA | 92.8% |
Sheffield J. S. et al. | 2011 | Prospective cohort | 25.3 ± 5.2 | Pregnant women | USA | 0/168 | a) 26(responder); b) 36(non-responder) | 0-1-4 | 5–6 months | recombinant vaccine, Recombivax HB | IM | NA | 90.0% |
De Schryver A. et al. | 2011 | Randomized trials | a) 41.4 ± 10.4 b) 42.5 ± 9.8 | Healthy volunteers | Belgium | 310/61 | a) 26.1 ± 5.0 b) 26.6 ± 4.6 | a) 0-1-6; b) 0-1-12 | 1 month | 20 μg recombinant vaccine, Twinrix | IM | a) 1900.6 IU/L (0-1-12); b) 749.0 IU/L (0-1-6) | a) 95.6% (0-1-12); b) 97.1% (0-1-6) |
Tohme R. A. et al. | 2011 | Retrospective cohort | 82.2 ± 14.2 range: 45–102 | Older adults | USA | 7/25 | 25.4 ± 4.6 | 0-1-4 | 80–90 days | 20 μg recombinant vaccine, Engerix-B | IM | 4.8 IU/L | 33.3% |
Ren J. J. et al. | 2012 | Retrospective cohort | a) 32.45 ± 0.66 b) 33.69 ± 0.70 c) 31.71 ± 0.69 d) 32.20 ± 1.07 range: 16–49 | Healthy adults | China | a) 242/351; b) 182/283; c) 246/333; d) 101/134 | NA | 0-1-6 | 1 month | 10 μg recombinant vaccine producted by 4 different manufacturers | IM | a) 177.28 IU/L (Kangtai); b) 473.23 IU/L (Dalian HTB); c) 246.13 IU/L (GeneTech BP); d) 332.20 IU/L (GlaxoSmithKline) | a) 81.67% (Kangtai); b) 95.05% (Dalian HTB); c) 89.64% (GeneTech BP); d) 86.81% (GlaxoSmithKline) |
Williams R. E. et al. | 2012 | Retrospective cohort | Median: 79.5 range 45–101 | Older adults | USA | 39/47 | NA | 0-1-6 | 1–2 months | 1 mldose recombinant vaccine, Twinrix | IM | NA | 34.0% |
Chathuranga L. S. et al. | 2013 | Retrospective cohort | NA | Health care workers | Sri Lanka | 190/152 | NA | NA | 2 months-14 years | NA | NA | NA | 92.1% |
Bender T. J. et al. | 2014 | Retrospective cohort | Median: 60 range: 46–86 | Adults with assisted living facilities | USA | 17/10 | NA | 0-1-7 | 1–2 months | 1 mldose recombinant vaccine, Twinrix | IM | 91.7 IU/L | 81.0% |
Thomas R. J. et al. | 2015 | Retrospective cohort | 16–50 | Health care workers | India | 148/306 | NA | 0-1-6 | 1 month | 20 μg recombinant vaccine, GeneVac-B | IM | NA | 98.9% |
Nashibi R. et al. * | 2015 | Retrospective cohort | 31.9 ± 18.1 range: 20–55 | Health care workers | Iran | 43/196 | a) 31.6 ± 7.5(responder); b) 33.4 ± 5.6(non-responder) | NA | 1–6 months | NA | NA | NA | 94.1% |
a) Yao J. et al. | 2015 | Randomized trials | a) 32.75 ± 7.93 b) 33.31 ± 7.71 c) 33.16 ± 8.00 | Healthy adults | China | a) 354/519; b) 338/523; c) 259/445 | NA | a) 0-1-3; b) 0-1-6; c) 0-1-12 | 12 months | 10 ug recombinant vaccine | IM | a) 213.16 IU/L (0-1-3); b) 432.58 IU/L (0-1-6); c) 451.47 IU/L (0-1-12) | a) 100% (0-1-3); b) 99.9% (0-1-6); c) 97.9% (0-1-12) |
b) Yao J. et al. | 2015 | Randomized trials | a) Median: 30.23 range: 20.01–39.76 b) Median: 29.42 range: 20.01–39.92 c) Median: 30.25 range: 20.10–39.98 | Seronegative adults | China | a) 100/149; b) 111/118; c) 84/124 | NA | a) 0-1-3; b) 0-1-6; c) 0-1-12 | 1 month | 10 ug recombinant vaccine | IM | a) 61.19 IU/L (0-1-3); b) 214.04 IU/L (0-1-6); c) 345.78 IU/L (0-1-12) | a) 83.9% (0-1-3); b) 88.2% (0-1-6); c) 94.2% (0-1-12) |
