Overview of clinical studies with hepatitis B vaccine made by recombinant DNA

“…40 After age 40, the proportion of persons who have a protective antibody response after a 3-dose vaccination regimen declines below 90%, and by age 60, protective levels of antibody develop in only 75% of vaccinated persons. 43,44 In addition to age, other host factors (e.g., smoking, obesity, genetic factors, and immune suppression) contribute to a decreased HBV vaccine response. 20,[45][46][47] At present, there are no special recommendations for populations older than 40 years, immune compromised individuals or individuals who have difficultly responding to the HBV vaccine.…”

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confidence: 99%

Strategy vaccination against Hepatitis B in China

Liao

Liang²

2015

Human Vaccines & Immunotherapeutics

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Hepatitis B (HB) is a serious public health problem in China. Up to now, the hepatitis B virus (HBV) vaccination was the most cost-effective way to prevent HBV infection. Since 1992, when the Chinese government prioritized implementing the HBV vaccinations for newborns, China began to see a larger reduction in HBV infections. For children under 5 years, the prevalence of hepatitis B surface antigen (HBsAg) has decreased to 1.0%. However, many additional challenges for the prevention and control of HBV infection in China remain. There is a lack of knowledge of the significant impact of the HBV vaccination for the general public with 93 million HBV carriers and chronic HBV patients as infection sources. Therefore, the HBV vaccine application should focus on the optimization of immunization strategies according to HBV prevalence characteristics, improve the public's knowledge of HBV vaccinations, and help to ensure the protective effects of the HBV vaccine.

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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.…”

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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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Overview of clinical studies with hepatitis B vaccine made by recombinant DNA

Cited by 173 publications

References 7 publications

Coverage and Long-Term Immunogenicity of Hepatitis B Vaccine in Healthcare Workers

Coverage and Long-Term Immunogenicity of Hepatitis B Vaccine in Healthcare Workers

Strategy vaccination against Hepatitis B in China

Adult Hepatitis B Vaccination Using A Novel Triple Antigen Recombinant Vaccine

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