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1.
A combined hepatitis A/B vaccine (Twinrix Adult) has been licensed in Germany since 1997. We investigated possible differences in immunogenicity and safety when changing over from vaccinations with monovalent vaccines made by different manufacturers to vaccinations with the combined hepatitis A/B vaccine in an open, randomized, multicenter trial. We therefore compared four different schemes changing over from concomitant vaccinations with monovalent vaccines against hepatitis A and B (Havrix 1440+Engerix-B or Vaqta+Gen H-B-Vax) to combined vaccination against hepatitis A+B with three injections of the combined hepatitis A/B vaccine (0, 1, and 6 month schedule). Local and general symptoms were mostly mild in all five groups. With complete three-dose course using the combined vaccine or an early changeover from monovalent vaccines to the combined vaccine, higher overall anti-HBs seroprotection rates and geometric mean concentrations (GMCs) against hepatitis B could be achieved as early as after 2 months as compared to those groups switching later to the combined vaccine. This study demonstrated for the first time that switching from monovalent hepatitis A and B vaccinations to the combined hepatitis A and B vaccination has no negative influence on the tolerability and improves the immunogenicity.  相似文献   

2.
目的评价新兵接种甲、乙型肝炎联合疫苗安全性和2年免疫效果。方法300名符合条件新兵分为A组、B组和AB组,均按0、1、6个月免疫程序分别接种单价甲肝疫苗,单价乙肝疫苗和甲、乙型肝炎联合疫苗。观察首次免疫后7个月和24个月的免疫效果。结果AB组局部副反应发生率和全身副反应发生率分别为11.8%和9.1%,与对照组相比差异无显著性,局部副反应主要是接种部位的疼痛,全身副反应主要是低热。AB组和A组的抗-HAV阳性率在7个月和24个月时均为100%,AB组抗-HAV几何平均滴度(GMT)在7个月和24个月时均高于A组(P<0.05)。AB组抗-HBs阳性率和几何平均滴度(GMT)在7个月和24个月时均高于B组,但差异均无显著性(P>0.05)。结论新兵接种甲、乙型肝炎联合疫苗与单价甲肝疫苗和单价乙肝疫苗相比有相同的安全性,而且在首次免疫后7个月和24个月时点具有较高的免疫原性。  相似文献   

3.
BACKGROUND: Increasing travel stresses the requirement for rapid protection against infections such as hepatitis A and B. METHODS: This randomised, multicentre study investigated an accelerated vaccination schedule using a combined hepatitis A and B vaccine (Twinrix, Smithkline Beecham Biologicals) compared with simultaneous administration of the two corresponding monovalent vaccines. The combined vaccine was administered on days 0, 7 and 21, whereas the comparison group received hepatitis A vaccine on day 0 and hepatitis B vaccine on days 0, 7 and 21. All subjects received booster vaccination at month 12. RESULTS: At month 1, 100% of subjects in the combined group and 99% of the controls were seropositive for anti-HAV antibodies. The corresponding seroprotection rates for anti-HBs antibodies were 82.0 and 83.9%, respectively. Examination of the 95% confidence intervals (CIs) for the treatment differences showed the two vaccines to be equivalent in terms of immunogenicity 1 week after the initial vaccination course. Just prior to the booster, the seropositivity rate for anti-HAV was 96.2% in the combined group and 95% in the control group. For anti-HBs, this was 94 and 91.6%, respectively. All subjects were seropositive for anti-HAV and seroprotected against hepatitis B at month 13. The anti-HAV GMCs were 9571mIU/ml with the combined vaccine and 5206mIU/ml in control subjects. The anti-HBs titre was 26002 and 29,196mIU/ml, respectively. Both groups had a similar reactogenicity profile. CONCLUSIONS: The accelerated schedule of the combined vaccine provides a good immune response against hepatitis A and B antigens and is suitable for last minute immunisation.  相似文献   

4.
The first combined vaccine against hepatitis A and B: an overview   总被引:14,自引:0,他引:14  
Hepatitis A and B infections are prevalent world-wide and are a significant cause of morbidity and mortality. A vaccine providing dual protection against hepatitis A and B is now available (Twinrix, SmithKline Beecham Biologicals). Six pivotal vaccine trials, involving 843 healthy adults, aged between 17 and 60 years and vaccinated following a 0, 1, 6 month schedule are discussed. At month 2 more than 99% of the vaccinees were seropositive for anti-HAV and 84% were protected against hepatitis B. The third dose induced a 12-fold increase in geometric mean titres (GMTs) to 5404 mIU/ml. One month after completion of the vaccination course nearly all vaccinees had protective titres against hepatitis B with a GMT of 4818 mIU/ml. Long term follow-up data until month 48 is available for two studies. At month 48 all 129 vaccinees sampled were still positive for anti-HAV antibodies and > 95% were still protected against hepatitis B. The combined hepatitis A and B vaccine Twinrix proves to be consistently safe, well tolerated and highly immunogenic and compares well with serological responses reached with monovalent vaccines. This combined hepatitis A and B vaccine offers more convenience, potentially better compliance and lower administration costs.  相似文献   

5.
Combining hepatitis A and B vaccination in children and adolescents   总被引:1,自引:0,他引:1  
Van Damme P  Van der Wielen M 《Vaccine》2001,19(17-19):2407-2412
Hepatitis A and B are common infections worldwide and their severity is related to the individual's age upon initial infection. Furthermore, when hepatitis B infection occurs in infants, the risk of becoming a chronic carrier is 90%. For hepatitis A, the lower incidence of disease arising from an improvement in living conditions leaves a greater number of children, adolescents and young adults susceptible to residual circulating virus. Consequently, initial infection occurs later in life when clinical illness is more frequent and the rate of morbidity and mortality higher. Although both viruses differ greatly, including their modes of transmission, the overlap in their epidemiology warrants the combination of hepatitis A and B vaccination. The immune response elicited by the combined hepatitis A and B vaccine following a three-dose schedule compares well with the anti-hepatitis A virus (HAV) and anti-hepatitis B sero-responses obtained with monovalent vaccines. In addition, it was shown that the seroprotection rate for anti-hepatitis B increased more rapidly with the administration of the combined vaccine, with values of more than 80% within 1 month after the first two doses (schedule, 0, 1 and 6 months). Currently, according to the World Health Organization recommendations, more than 116 countries are vaccinating their infants and/or adolescents against hepatitis B. Recently, several countries were considering or have decided to begin mass vaccination against HAV (more than fifteen states in the US, Spain (Catalonia), Italy (Puglia)). For these countries, the combination of hepatitis A and B antigens in one single vaccine offers the following advantages: fewer injections for protection against two infections, better compliance, lower implementation costs, and fewer missed vaccination opportunities. Further simplification of the schedule, by reducing the number of doses, would improve the compliance rate as well as being more convenient for the vaccinee. This should translate into a reduction in costs associated with vaccine administration. In some recent vaccine studies, the immunogenicity and safety profile of a two-dose schedule (0 and 6 months) of the adult formulation of the combined hepatitis A and B vaccine was investigated in children aged 1-11 years, as well as in adolescents aged 12-15 years. Current results indicate that this two-dose schedule of the adult formulation could be considered a viable alternative for immunization of children and adolescents.  相似文献   

6.
Nolan T  Hogg G  Darcy MA  Skeljo M  Carlin J  Boslego J 《Vaccine》2001,19(15-16):2127-2137
We evaluated the immunogenicity and reactogenicity of a new liquid pentavalent combination vaccine, which incorporates a diphtheria, tetanus and whole-cell pertussis vaccine (DTP) with Hib (PRP-OMPC) and hepatitis B vaccine (HB), in a series of three studies involving 2156 infants. The vaccination schedule was 2, 4, 6 and 18 months for all studies. In addition, subjects in the third study also received a dose of monovalent hepatitis B vaccine at birth. The principal study was a randomised double blind trial of two separate, but concurrently administered vaccines in each of three groups: pentavalent vaccine [DTP-Hib-HB] plus placebo (Group A, n=619); quadrivalent vaccine [DTP-HB] plus Hib vaccine (Group B, n=620); and bivalent vaccine [Hib-HB] plus DTP (Group C, n=226). The second study (Group D, n=231) was an open trial of three separate, but concurrently administered licensed control vaccines (DTP, Hib and HB). The third study (Group E, n=460) administered a dose of monovalent hepatitis B vaccine at birth followed by pentavalent vaccine as for Group A. Subjects were bled prior to the 2- and 18-month vaccinations, and a month after the 6- and 18-month vaccinations. A diary card was used to record subject temperatures and other systemic and local clinical signs for 7 days after each vaccination. The pentavalent vaccine, whether or not preceded by a birth dose of hepatitis B vaccine, was generally well tolerated at all administration times, and had a reactogenicity profile similar to that observed for licensed vaccine controls. Diphtheria and tetanus antibody levels were substantially above protective levels in all study groups. The anti-HBs responses (% > or = 10 mIU/ml) following the 6-month dose of vaccines were, respectively, for Groups A-E: 83.2, 91.7, 96.5, 98.8 and 93.9%, and following the 18-month doses: 87.9, 97.5, 98.8, 98.8 and 92.8%. Anti-PRP responses (% > or = 1.0 microg/ml) following the 6-month dose for Groups A-D were 86.0, 90.5, 91.2, and 74.4%, and after the 18-month dose for Groups A-E were 97.3, 98.3, 98.1, 97.0, and 99.5%. Consistently higher geometric mean titres (GMTs) for pertussis antibodies to agglutinogens (Agg2, Agg3) and pertactin were recorded for the pentavalent vaccine compared to the licensed control vaccine, though they were somewhat lower for pertussigen (PT). Except for the hepatitis B response, antibody responses induced by the pentavalent vaccine to all antigens with a schedule commencing at 2 months of age and completed at 18 months were equivalent to responses to the same antigens induced by the separate, but concurrently administered licensed control vaccines. A regimen of a birth dose of hepatitis B vaccine followed by pentavalent vaccine at 2, 4, 6 and 18 months was not countered by any clinically significant decrease in seroresponses.  相似文献   

7.
甲乙型肝炎联合疫苗临床研究综述   总被引:2,自引:0,他引:2  
我国是甲、乙型肝炎高发区,病毒的感染和疾病的流行已对人群健康构成了严重威胁。甲、乙型肝炎联合疫苗能够用于预防甲、乙型肝炎,国内外临床研究结果表明,联合疫苗的安全性和免疫效果可与单价疫苗媲美,应用联合疫苗可以减少接种次数、减轻受种者痛苦,降低费用,而且会增加预防接种人群的比例,联合疫苗也是当今疫苗的发展方向。  相似文献   

8.
Challenged by contrasting data on low immune responses in the elderly with a combined hepatitis A/B vaccine, a randomised, controlled study was conducted to assess the immunogenicity of three hepatitis A and B vaccination regimens (group 1: combined hepatitis A/B vaccine Twinrix [GSK]; group 2: co-administered hepatitis A vaccine, Havrix [GSK]+hepatitis B vaccine Engerix -B [GSK], group 3: co-administered hepatitis A vaccine, Vaqta [Sanofi-Pasteur MSD]+hepatitis B vaccine HB VAX PRO [Sanofi-Pasteur MSD]) and the effect of influencing factors in subjects >40 years. On completion of the full vaccination course, anti-HBs seroprotection (SP) rates were 92, 80 and 71% in groups 1, 2 and 3, respectively; anti-HAV seropositivity (S+) rates were 97, 99 and 99%, respectively. In group 1, anti-HBs SP rate was non-inferior as well as superior and anti-HAV S+ rate was non-inferior to that in groups 2 and 3. Anti-HBs response was most significantly influenced by the vaccine regimen, followed by age, gender and BMI (stepwise multiple regression analysis). BMI had the most significant influence on HAV response followed by age, gender and vaccine regimen. In conclusion, Twinrix induced superior hepatitis B SP rates and similar hepatitis A S+ rates compared to concomitant administration of monovalent vaccines in subjects aged >40 years.  相似文献   

9.
In 1998, the Department of Health of Catalonia (Spain) began universal vaccination of preadolescents against hepatitis A by replacing the simple hepatitis B vaccine with a combined hepatitis A+B vaccine. Economic analyses were made of the two alternative strategies: to continue with the simple hepatitis B vaccination or to replace the simple vaccine with a combined hepatitis A+B vaccine. The analysis was made from the societal perspective and the time horizon considered was 25 years. In the base case, (estimated annual hepatitis A incidence of 15 per 100,000 and incremental price of the hepatitis A+B vaccine over the simple hepatitis B vaccine of 1.98) the net present value of the programme was positive (+533,708) and the benefit-cost ratio was 2.58. If the estimated disease incidence were reduced by half, the programme would still be efficient.  相似文献   

10.
Among the infectious virus hepatitis diseases, types A and B can be successfully prevented with vaccinations. WHO recommend effective control of hepatitis A through immunisation, especially among populations with indirect or high endemicity. Since 1991 WHO has been recommending vaccinations against hepatitis B. It is planned to introduce it in all countries by the year 2007. Vaccinations against hepatitis A & B are recommended for people travelling to the regions endemic for these infections or for those with high professional risk of HAV and HBV. Presented here are the characteristic features of the vaccine, the analysis concerning the evaluation of its effectiveness, comparison of this effectiveness with monovalent vaccine effectiveness, as well as evaluation of the tolerance and safety.  相似文献   

11.
Kurugöl Z  Mutlubaş F  Ozacar T 《Vaccine》2005,23(22):2876-2880
A combined hepatitis A and B vaccine, Twinrix, in a paediatric formulation for ages 1-15 years and in an adult formulation for those ages 16 years and older, became commercially available in Turkey as well as in many countries. It is administered according to a three-dose schedule (0, 1 and 6 months). A reduction in the number of doses would improve the compliance rate and reduce administration costs. Therefore, we planned a trial evaluation of the immunogenicity, safety and reactogenicity profile of a high-dose combined hepatitis A and B vaccine, administered in two doses, compared with the profile of a paediatric-dose combined vaccine, administered in three doses, in healthy children aged 6-15 years. One hundred children were randomly attributed to the two study groups. The first group (paediatric-dose vaccine group) received the licensed Twinrix Paediatric, at months 0, 1 and 6; the second group (high-dose vaccine group) received the high-dose vaccine, following a 0, 6 months schedule. The reactogenicity was assessed after each vaccine dose. The immunogenicity was evaluated by testing for anti-HBs and anti-HAV antibodies. Seroconversion rates and geometric mean titres (GMTs) were compared. Both formulations of the combined vaccine were well tolerated. The high-dose combined vaccine administered in two doses, elicits satisfactory immunogenicity profiles, similar to those elicited by the paediatric vaccine administered in three doses. On completion of the vaccination schedule in the two groups all children were protected against hepatitis B and immune for hepatitis A. Anti-HAV GMTs after completion of the vaccination schedule were 7163 mlU/ml in the paediatric-dose group, 8241 mlU/ml in the high-dose group; anti-HBs GMTs were 8679 and 4583 mlU/ml, respectively. These results indicate that a two-dose schedule, compared with the standard three-dose schedule, offers fewer injections for satisfactory protection against the two infections. This means fewer clinic visits, lower administration costs, better compliance, and higher coverage rate. Therefore, this two-dose schedule can be considered an appropriate regimen for the immunization of children and adolescents against hepatitis A and B infection, in the context of school-based immunization programmes.  相似文献   

12.
A recombinant hepatitis B vaccine was administered to high-risk hospital personnel by intramuscular (20 micrograms) or intradermal (2 micrograms) injections for the primary immunization (n = 69) with three doses and booster immunization (n = 51) with one dose. Basic vaccination performed intramuscularly gave rise to significantly higher seroconversion levels (97.2% versus 78.1%) and geometric mean titres of antibody (1649 versus 126 IUl-1) as compared with the intradermal route. Intradermal administration did not boost antibody titres in patients previously vaccinated intradermally. Adverse reactions were not serious or severe. The intramuscular route is recommended as the procedure of choice when vaccinating against hepatitis B.  相似文献   

13.
Viral hepatitis remains a major contributor to the global disease burden. Mass immunisation strategies against hepatitis B have been adopted by more than 90 developing and industrialised countries. Countries with low hepatitis A endemicity are experiencing cyclical outbreaks and an epidemiological shift, with larger numbers of individuals at risk of infection at an older age, resulting in increased morbidity. The high cost of outbreaks in these countries has made immunisation strategies cost-effective. The development of a vaccine against hepatitis A and a combined vaccine against hepatitis A and hepatitis B offers potentially exciting opportunities for a preventative approach in areas of both low and high endemicity. Existing mass immunisation programmes against hepatitis B will facilitate the adoption of joint strategies illustrated by the examples of Puglia (Italy) and Catalonia (Spain).  相似文献   

14.
In the hexavalent meningococcal B OMV vaccine (HexaMen), two of the six Porin A proteins present are weakly immunogenic in mice and humans. We investigated the possibility that the lower immunogenicity of these serosubtypes (P1.7-2,4 and P1.19,15-1) could be overcome by using HexaMen and monovalent OMVs in heterologous immunisation protocols. Whereas HexaMen priming on day 0 followed by a monovalent P1.7-2,4 OMV boosting on day 28 (specific boost) did not result in higher titres against P1.7-2,4 (on day 42), the reverse order of immunisations (specific priming) resulted in significantly higher ELISA and SBA titres, but with lower avidity. For the strongly immunogenic PorA P1.5-1,2-2, all strategies gave high antibody responses, while avidity was highest after two monovalent P1.5-1,2-2 OMV immunisations. Based on the improved antibody titres obtained by specific priming with the weakly immunogenic PorA, we extended our study with combined P1.7-2,4 and P1.19,15-1 priming followed by two HexaMen booster immunisations. This resulted in higher ELISA and SBA titres against these weakly immunogenic PorAs, while the response against the other four PorAs was unaffected. Also, we observed an increase in antibody avidity using this schedule, indicating that affinity maturation has occurred. In conclusion, we found that specific priming, rather than specific boosting with monovalent OMVs, gave a significant rise in the serosubtype-specific immune response against a weakly immunogenic PorA, with high avidity antibodies in an extended immunisation schedule.  相似文献   

15.
Czeschinski PA  Binding N  Witting U 《Vaccine》2000,18(11-12):1074-1080
The vaccination success and side effects of hepatitis A and hepatitis B immunisation of health care employees when using a combined vaccine were compared to those observed with simultaneous or single immunisations. The immunological response of two groups of healthy participants (75 each) receiving either single HAV or HBV vaccination was compared with that of two groups (75 each) vaccinated either simultaneously with both vaccines or with the combined vaccine. There were no non or low responders with respect to hepatitis A vaccination. Only one participant failed to build up an anti-HBs titer after combined vaccination. The good tolerance of separate, simultaneous and combined vaccinations was confirmed. Both combined and simultaneous vaccination led to significantly higher anti-HAV titers than single immunisation, while markedly but not significantly higher anti-HBs titers were found only with simultaneous vaccination. Considering the additional advantage of the higher acceptance of only one injection with the combined vaccine, this vaccination should be recommended for employees at risk for both hepatitis A and hepatitis B.  相似文献   

16.
This study was conducted to compare the reactogenicity, immunogenicity and safety of a combined two-dose (0, 6 months) hepatitis A and B vaccine (720ELU HAV, 20 mcg HBsAg) with the established three-dose (0, 1 and 6 months) hepatitis A and B vaccine (360ELU HAV, 10 mcg HBsAg). A total of 511 children aged 1-11 years who had not previously received a hepatitis A or B vaccine were enrolled in the study. Both vaccines were well tolerated, and were shown to be safe and immunogenic. The analysis, stratified according to two age groups (1-5 year and 6-11-year-old children) demonstrated that the reactogenicity profile of the two-dose schedule was at least as good as that of the established schedule. Both vaccines and schedules provided at least 98% seroprotection against hepatitis B and 100% seroconversion against hepatitis A, 1 month after the end of the vaccination course (Month 7).  相似文献   

17.
Ekwall E  Ulgemo A  Watson M  Boisnard F  Thomas S  Goullet F 《Vaccine》2006,24(20):4450-4457
This study investigated the suitability of Avaxim and Vaqta as Hepatitis A booster vaccines 6 months after priming with the combined Hepatitis A/typhoid vaccine, Viatim. One hundred and twenty adults were randomly assigned to one of the three groups. Group A (reference group) received Avaxim then Avaxim (n = 40), Group B received Viatim then Avaxim (n = 41) and Group C received Viatim then Vaqta (n = 39). One month after booster vaccination, anti-Hepatitis A virus (anti-HAV) antibodies geometric mean concentrations (GMC) of subjects primed with Viatim were non-inferior to the group primed and boosted with the monovalent Hepatitis A vaccine Avaxim. Anti-Salmonella typhi capsular polysaccharide virulence antigen (anti-Vi) GMCs in groups primed with Viatim were protective and all vaccines were well-tolerated. Therefore, Viatim may be used as a primary HAV vaccine with either Avaxim or Vaqta as Hepatitis A boosters and it will provide the same protection as two doses of Avaxim.  相似文献   

18.
Y Wang  P Xu  D Zhu  S Zhang  Y Bi  Y Hu  YH Zhou 《Vaccine》2012,30(39):5708-5713
Hepatitis B vaccine is effective in preventing hepatitis B virus (HBV) infection. However, 5-10% of vaccinees fail to produce sufficient antibody against hepatitis B surface antigen (anti-HBs). In this study, we investigated the association of genetic polymorphisms with long-term response to hepatitis B vaccine in 301 children who received the vaccine 5-7 years ago. Of them, 86 (28.6%) had anti-HBs <10mIU/ml (group A) and 215 (71.4%) had anti-HBs ≥10mIU/ml (group B). While the frequencies of T allele and TT genotype in single nucleotide polymorphisms (SNP) rs2243250 and rs2070874 of interleukin (IL)-4 in group A were higher than those in group B (all P<0.05 and q<0.2), the frequency of C allele in SNP rs2243250, rs2070874 and rs2227284 of IL-4 in group B was higher than that in group A (all P<0.05 and q<0.2). None of 11 other SNP in IL-2, IL-10, IL-1β, IL-13, IL-12B, tumor necrosis factor-α, and toll-like receptor-2 genes was found to associate with anti-HBs response. SNP rs2070874 was associated with humoral response to hepatitis B vaccine after analyzed by multivariable logistic regression analysis (P=0.015). The haplotype TT defined by SNP rs2243250 and rs2070874 in IL-4 was associated with the poor humoral response (adjusted P=0.037). Our findings demonstrate that IL-4 gene polymorphisms may affect the long-term immune response to hepatitis B vaccine.  相似文献   

19.
Two studies were undertaken to investigate the concomitant administration of combined hepatitis A/B vaccine with a diphtheria-tetanus-acellular pertussis-inactivated poliomyelitis vaccine mixed with Haemophilus influenzae vaccine (DTPa-IPV/Hib), or with a measles-mumps-rubella vaccine (MMR), during the second year of life. On completion of the vaccination course, all subjects were seropositive or seroprotected against all antigens except for one subject who was seronegative for anti-PT. Seropositivity and seroprotection rates for all other antibodies were comparable to reference values for each vaccine component, indicating that the immunogenicity of MMR, DTPa-IPV/Hib and combined hepatitis A/B vaccines is not impaired by co-administration. All vaccines were well tolerated.  相似文献   

20.
目的研究及时接种乙肝疫苗首针与完成乙肝疫苗、百白破疫苗和麻疹疫苗全程免疫的关系。方法利用2006年全国乙肝血清流调福建省资料,采用χ2检验比较组间各因素差异,logistic回归分析探讨影响完成3种疫苗全程免疫的影响因素,分层分析研究乙肝疫苗政策对上述关系的影响。结果本研究共有1 443名儿童纳入分析,χ2检验显示,乙肝疫苗首针接种不及时与及时组间(〉24hvs.≤24h)儿童完成3种疫苗全程免疫不同,及时组儿童显著高于不及时组儿童(χ2值分别为457.29,、42.96和74.95,P值均〈0.001)。logistic回归分析显示,及时接种乙肝疫苗首针者完成乙肝、百白破和麻疹疫苗全程免疫的OR值(95%CI)分别为24.36(14.46~41.05)、1.71(1.28~2.29)和2.35(1.68~3.30)。城区儿童完成百白破、麻疹疫苗的OR值分别为0.59(0.45~0.77)和0.36(0.26~0.48)。分层分析显示,乙肝疫苗政策有效降低了及时接种乙肝首针与完成乙肝全程免疫的关系(政策实施前后OR分别为68.09和5.67,差异有统计学意义P〈0.001)。结论及时接种乙肝首针能提高乙肝、百白破和麻疹疫苗全程免疫。  相似文献   

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