Anti-HBs characteristics after hepatitis B immunisation with plasma-derived and recombinant DNA-derived vaccines

Heijtink, R. A.; Bergen, P. van; Paulij, Wilma P.; Man, Robert A. de; Osterhaus, A.D.M.E.

doi:10.1016/s0264-410x(99)00433-8

Cited by 13 publications

(10 citation statements)

References 30 publications

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“…From published data [Jilg et al, , 1988Heijtink et al, 1985;Papaevangelou et al, 1985;Weber et al, 1985;Stevens et al, 1987;Crovari et al, 1988;Taylor et al, 1988;Marinho et al, 1988;Shaw et al, 1989;West, 1989;Zajac et al, 1989;Dahl-Hansen et al, 1990;Hadler, 1990;Street et al, 1990;Dentico et al, 1991;Renzulli et al, 1992;Oates et al, 1993;Treadwell et al, 1993;Wood et al, 1993;Chiaramonte et al, 1996;Pride et al, 1998;Jones et al, 1999;Heijtink et al, 2000] and national vaccination guidelines [UK Department of Health Advisory Group on Hepatitis, 1993; Morgan, 1995], we anticipated that the protection rate in healthy normal younger adults would be 90 to 95% with the standard three-dose regimen of current single antigen vaccines, and since this study allowed all ages to be recruited with randomisation strati®ed for age group (above or below 40 years) to ensure balance, we anticipated the overall Recombivax-HB protection rate would be at the lower end of the above range.…”

Section: Discussionmentioning

confidence: 99%

“…Although they are approved as safe and effective, they are known to be less immunogenic than the ®rst generation plasma-derived vaccines [Heijtink et al, 1985]. Furthermore, all hepatitis B vaccines to date show a decreased response in certain subjects such as older adults, males, smokers, and the obese and when given intradermally or in the buttocks rather than in the deltoid muscle [Jilg et al, , 1988Zanleck et al, 1984;Heijtink et al, 2000;Papaevangelou et al, 1985;Ukana et al, 1985;Weber et al, 1985;Stevens et al, 1987;Marinho et al, 1988;Taylor et al, 1988;Andre, 1989;Shaw et al, 1989;West, 1989;Zajac et al, 1989;Westmoreland et al, 1990;Hadler, 1990;Street et al, 1990;Centers for Disease Control, 1991;Dentico et al, 1991;Rogan and Duguid, 1991;Oates et al, 1993]. All present vaccines for hepatitis B are given in a 6month/three-dose (0, 1, and 6 months) regimen [Engerix-B;Recombivax-HB, Package Insert, 1999].…”

Section: Introductionmentioning

confidence: 99%

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Comparison of a triple antigen and a single antigen recombinant vaccine for adult hepatitis B vaccination*

Young¹,

Gooch²,

Zuckerman³

et al. 2001

Journal of Medical Virology

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Hepatitis B and its sequelae are a major public health problem. Vaccines have been available for almost 20 years; however the disease still remains a global problem. Many factors contribute to the failure to control hepatitis B, including the limited nature of the vaccination programs implemented initially. Only relatively recently has mass childhood vaccination begun to be implemented and vaccination of high-risk groups, other than healthcare workers, is still not general policy. Additional factors contributing to continued persistence of hepatitis B in the developed world are that the present vaccines are not fully used by those recommended to be vaccinated and even when vaccination is carried out appropriately, there remain some who fail to achieve adequate protection. Clearly, the protection of at-risk groups who have inadequate response to current vaccines, and those who are unwilling or unable to comply with protracted multi-dose vaccine regimens, could be improved if there were a more potent vaccine and/or a shorter vaccination regimen available. Adults who had never been vaccinated against hepatitis B were randomised to receive a vaccination course of either a present single antigen (S) vaccine (Recombivax-HB) or a novel triple antigen (S, pre-S1, and pre-S2) recombinant vaccine (Hepacare Medeva Pharma plc). Doses were given at baseline and 1 month and 6 months later. Hepatitis B surface antibody (anti-HBs) levels were measured at 2, 4, 6, and 7 months after beginning vaccination. The primary efficacy parameter was the degree of protection, measured as the percentage of subjects with anti-HBs titres > or = 10 IU/L, 6 or 7 months (26 +/- 2 weeks) after beginning vaccination. A total of 303 adult subjects entered the study and were vaccinated. Of these, 11 failed to complete the study (4 on Hepacare and 7 on Recombivax-HB); however all but 2 (1 to receive the triple antigen vaccine and 1 to receive Recombivax-HB) were included in the intent-to-treat population for efficacy evaluation. Treatment randomisation was stratified at entry based on age (above and below 40 years old) and gender. The standard three-dose/6-month vaccination regimen of the single antigen vaccine protected 83% of subjects by 7 months after starting vaccination whereas the triple antigen vaccine as a two-dose/1-month regimen protected 88% within 6 months and as a three-dose/6-month regimen protected 97% by 7 months after starting vaccination. Thus the protection rate provided by the shortened (0, 1) regimen of the novel vaccine was "essentially equivalent" (i.e., not statistically inferior) to that provided by the full (0, 1, and 6) regimen of today's vaccine (88% vs. 81%, P < 0.001), and the protection rate provided by a three-dose/6-month (0, 1, and 6) regimen of the new vaccine was significantly superior to that provided by present vaccines (97% vs. 83% P < 0.001). The percentage of subjects protected increases with time after beginning vaccination and at all time points up to and including 6 months was significantly greater with the ...

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Comparison of a triple antigen and a single antigen recombinant vaccine for adult hepatitis B vaccination*

Young¹,

Gooch²,

Zuckerman³

et al. 2001

Journal of Medical Virology

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“…found that there was no significant difference in the quantity, quality or specificity of the anti‐HBs response induced by the RYHBV and PDHBV . On the other hand, reduced anti‐HBs levels after immunization with the RYHBV as compared with PDHBV was noted in several researches . Lin et al.…”

Section: Introductionmentioning

confidence: 98%

Higher disappearance rate of anti‐HBs in Taiwanese freshers neonatally vaccinated with recombinant yeast hepatitis B vaccine

Hsu

Chih

Lee

et al. 2017

Liver International

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“…From published data [5][6][7][8][9][10][11][12][13][14][37][38][39][40][41][42][43] and national vaccination guidelines, 29,43 we anticipated that the protection rate in healthy normal younger adults would be 90% to 95% with the standard 3-dose regimen of current single antigen vaccines, and because this study allowed all ages to be recruited with randomization stratified for age group (above or below 40 years) to ensure balance, we anticipated that the overall Engerix-B protection rate would be at the lower end of the above range.…”

Section: Methodsmentioning

confidence: 99%

“…First, all hepatitis B vaccines to date show a decreased response in certain subjects such as older adults, men, smokers, and the obese as well as when given intradermally or in the buttocks rather than in the deltoid muscle. [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19] Second, present vaccines are usually given in a 6-month/3-dose (0, 1, and 6 months) regimen. 20,21 This implies that protection is not provided to a significant number of adults until some 7 months after beginning a course of vaccination.…”

mentioning

confidence: 99%

Adult Hepatitis B Vaccination Using A Novel Triple Antigen Recombinant Vaccine

Young¹,

Schneider

Zuckerman

et al. 2001

Hepatology

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Present hepatitis B vaccines use multidose prolonged regimens, which even healthcare workers at risk do not always complete. Moreover, when vaccination is completed there remain some who fail to achieve adequate protection. The protection of adults at risk could be improved if there were a more potent vaccine and/or a shorter vaccination regimen available. Vaccine-naive adults were randomized to vaccination with either Engerix-B (SmithKline Biologicals, Rixensart, Belgium) or a novel triple antigen (S, pre-S1, and pre-S2) recombinant vaccine (Hepacare; Medeva Pharma Plc, Speke, UK). The primary efficacy parameter was the degree of seroprotection 6 or 7 months (26 ؎ 2 weeks) after beginning vaccination. A total of 304 adults entered the study. Of these, 16 failed to complete the study (9 on Hepacare and 7 on Engerix-B). With the Engerix-B standard (0, 1, 6) regimen, 88% of subjects were protected by month 7, whereas with the triple antigen vaccine a 2-dose regimen (0, 1) provided equivalent protection (91%) within 6 months and a 3-dose (0, 1, 6) regimen was significantly superior (98% seroprotected by 7 months after starting vaccination P < .001). With adults at risk for a suboptimal response (i.e., older adults, the obese, men, and smokers) the triple antigen vaccine produced a greater degree of protection. The vaccines had similar safety profiles. Both vaccines were well tolerated. In healthy normal adults, a triple antigen hepatitis B vaccine containing S and pre-S antigens produced an enhanced immunologic response and was as effective as a 2-and 3-dose regimen. (HEPATOLOGY 2001;34:372-376.)Although hepatitis B is largely a disease of the developing world, it is still a problem in the developed world. The estimated annual incidence of new infections of hepatitis B in the United States has varied from 200,000 to 300,000 new cases each year over the past decade. 1-3 Much of the disease is subclinical and a recent estimate 4 has suggested some 6-fold under-reporting with a true incidence of 1,000,000 new cases every year in Europe alone. All this is despite the availability of vaccines for over 2 decades.Although much of the problem has been the limited population in whom the vaccine was used initially there are other issues. First, all hepatitis B vaccines to date show a decreased response in certain subjects such as older adults, men, smokers, and the obese as well as when given intradermally or in the buttocks rather than in the deltoid muscle. [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19] Second, present vaccines are usually given in a 6-month/3-dose (0, 1, and 6 months) regimen. 20,21 This implies that protection is not provided to a significant number of adults until some 7 months after beginning a course of vaccination. The implication is reinforced by the development of a so-called "accelerated course" of 3 doses given within 2 months (0, 1, and 2 months) for those who require rapid protection. 20,22 Unfortunately, this course does not deliver longer-term protection, and a booster dose at 12 mon...

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Anti-HBs characteristics after hepatitis B immunisation with plasma-derived and recombinant DNA-derived vaccines

Cited by 13 publications

References 30 publications

Comparison of a triple antigen and a single antigen recombinant vaccine for adult hepatitis B vaccination*

Comparison of a triple antigen and a single antigen recombinant vaccine for adult hepatitis B vaccination*

Higher disappearance rate of anti‐HBs in Taiwanese freshers neonatally vaccinated with recombinant yeast hepatitis B vaccine

Adult Hepatitis B Vaccination Using A Novel Triple Antigen Recombinant Vaccine

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