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Wang J, Liu CH, Ma Y, Zhu X, Luo L, Ji Y, Tang H. Two-year immune effect differences between the 0-1-2-month and 0-1-6-month HBV vaccination schedule in adults. BMC Infect Dis 2022; 22:159. [PMID: 35180842 PMCID: PMC8855546 DOI: 10.1186/s12879-022-07151-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/28/2021] [Accepted: 02/11/2022] [Indexed: 02/08/2023] Open
Abstract
Background The short-term 0–1–2-month hepatitis B virus (HBV) vaccination schedule was previously implemented in the adult population; however, its long-term immune effect remains unclear. The present study aimed to investigate (1) the 2-month and 2-year immune effects of HBV vaccination and (2) the compliance rate between the 0–1–2-month and 0–1–6-month vaccination schedules in adults. Method A total of 1281 subjects tested for hepatitis B surface antigen HBsAg(−) and hepatitis B surface antibody (anti-HBs)(−) were recruited. Participants from two distant counties were inoculated with the hepatitis B yeast vaccine at 10 µg per dose, with vaccination schedules of 0, 1, and 2 months (n = 606) and 0, 1, and 6 months (n = 675); sequential follow-up was performed at 2 months and 2 years after the 3rd injection. Results There were no significant differences in the anti-HBs seroconversion rates between the those in the 0–1–2-month and 0–1–6-month vaccination schedule groups at 2 months (91.96% vs. 89.42%, p = 0.229) and 2 years (81.06% vs. 77.14%, p = 0.217). The quantitative anti-HBs level in those in the 0–1–2-month vaccination schedule group was not different from that in those in the 0–1–6-month vaccination schedule group at 2 months (anti-HBs1) (342.12 ± 378.42 mIU/ml vs. 392.38 ± 391.96 mIU/ml, p = 0.062), but it was higher at 2 years (anti-HBs2) (198.37 ± 286.44 mIU/ml vs. 155.65 ± 271.73 mIU/ml, p = 0.048). According to the subgroup analysis, the 0–1–2-month vaccination schedule induced better maintenance (p = 0.041) and longer reinforcement (p = 0.019) than the 0–1–6 vaccination schedule. The 0–1–2-month vaccination schedule group also had a higher 3rd injection completion rate (89.49% vs. 84.49%, p = 0.010). Conclusion The 0–1–2-month vaccination schedule was associated with a similar short-term immune effect and might induce better long-term immune memory and a higher completion rate in the adult population. Trial registration None Supplementary Information The online version contains supplementary material available at 10.1186/s12879-022-07151-6.
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Affiliation(s)
- Juan Wang
- Center of Infectious Diseases, West China Hospital of Sichuan University, No.37 Guoxue Alley, Chengdu, 610041, Sichuan Province, China.,Division of Infectious Diseases, State Key Laboratory of Biotherapy and Center of Infectious Disease, West China Hospital, Sichuan University, Chengdu, China
| | - Chang-Hai Liu
- Center of Infectious Diseases, West China Hospital of Sichuan University, No.37 Guoxue Alley, Chengdu, 610041, Sichuan Province, China.,Division of Infectious Diseases, State Key Laboratory of Biotherapy and Center of Infectious Disease, West China Hospital, Sichuan University, Chengdu, China
| | - Yuanji Ma
- Center of Infectious Diseases, West China Hospital of Sichuan University, No.37 Guoxue Alley, Chengdu, 610041, Sichuan Province, China.,Division of Infectious Diseases, State Key Laboratory of Biotherapy and Center of Infectious Disease, West China Hospital, Sichuan University, Chengdu, China
| | - Xia Zhu
- Center of Infectious Diseases, West China Hospital of Sichuan University, No.37 Guoxue Alley, Chengdu, 610041, Sichuan Province, China.,Division of Infectious Diseases, State Key Laboratory of Biotherapy and Center of Infectious Disease, West China Hospital, Sichuan University, Chengdu, China
| | - Liru Luo
- Center of Infectious Diseases, West China Hospital of Sichuan University, No.37 Guoxue Alley, Chengdu, 610041, Sichuan Province, China.,Division of Infectious Diseases, State Key Laboratory of Biotherapy and Center of Infectious Disease, West China Hospital, Sichuan University, Chengdu, China
| | - Yulin Ji
- Department of Respiratory and Critical Care Medicine, West China Hospital of Sichuan University, Chengdu, China
| | - Hong Tang
- Center of Infectious Diseases, West China Hospital of Sichuan University, No.37 Guoxue Alley, Chengdu, 610041, Sichuan Province, China. .,Division of Infectious Diseases, State Key Laboratory of Biotherapy and Center of Infectious Disease, West China Hospital, Sichuan University, Chengdu, China.
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Bayhan GI, Balli SE, Demir H, Baydar Z. How does the immunogenicity of hepatitis B vaccine change over the years in childhood? Hum Vaccin Immunother 2021; 17:2768-2772. [PMID: 33793388 DOI: 10.1080/21645515.2021.1902724] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/21/2022] Open
Abstract
Hepatitis B is the leading cause of chronic hepatitis, cirrhosis, and hepatocellular carcinoma worldwide. The incidence of HBV infection has significantly decreased with hepatitis B vaccination. Hepatitis B vaccine is administered to children at 0, 1 and 6 months of age according to the national schedule. There is a high rate of protective antibody (anti-HBs) development after hepatitis B vaccination. We conducted the study to investigate how the hepatitis B surface antibody (anti-HBs) positivity rates and the titers change over time in childhood following vaccination. Patients who presented at the general pediatric outpatient clinic of Yenimahalle Education and Training Hospital and the HBsAg and anti-HBs titers were tested for any reason between July 2011 and May 2018 were retrospectively evaluated. The cutoff level for protection by the anti-HBs titer was accepted as ≥10 mIU/mL with lower levels indicating no protection. Anti-HBs positivity was compared by age group. Anti-HBs levels were studied in 4326 children. The mean age of the included in the study was 127 ± 62 months. A protective anti-HBs level (≥10 mIU/mL) was present in 2292 children (69.2%). The highest anti-HBs antibody positivity rate was in the under 3 years' age group. The positivity rate significantly decreased after age 7 years. The HBsAg level was determined in all children in the study and five had a positive result. In conclusion, our study found that the anti-HBs positivity rate and the anti-HBs level decreased with age. However, the anti-HBs antibody result remained positive in more than half of the children.
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Affiliation(s)
- Gulsum Iclal Bayhan
- Department of Pediatric Infectious Disease, Faculty of Medicine, Yenimahalle Educational and Training Hospital, Yildirim Beyazit University, Ankara, Turkey
| | - Sidika Elif Balli
- Department of General Pediatrics, Yenimahalle Educational and Training Hospital, Yildirim Beyazit University, Ankara, Turkey
| | - Hatice Demir
- Department of General Pediatrics, Yenimahalle Educational and Training Hospital, Yildirim Beyazit University, Ankara, Turkey
| | - Zekiye Baydar
- Department of General Pediatrics, Yenimahalle Educational and Training Hospital, Yildirim Beyazit University, Ankara, Turkey
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Short-term immunogenicity of standard and accelerated hepatitis B virus vaccination schedules in healthy adults: a comparative field study in China. Biosci Rep 2018; 38:BSR20180846. [PMID: 30201691 PMCID: PMC6435458 DOI: 10.1042/bsr20180846] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/28/2018] [Revised: 08/15/2018] [Accepted: 08/29/2018] [Indexed: 02/05/2023] Open
Abstract
World Health Organization recommends hepatitis B virus (HBV) immunization at 0, 1, and 6 months. However, studies have suggested that shortening the interval between the first and last HBV immunization can improve completion rates. Less clear is whether accelerated immunization is as immunogenic as standard immunization. Thus, the present study aimed to compare the short-term immunogenicity of yeast-derived hepatitis B vaccine in healthy adults immunized on an accelerated or standard schedule. Between June 2013 and March 2014, individuals from Jinfeng and Longmen, China were randomly assigned to receive the vaccine on an accelerated schedule (at 0, 1, and 2 months; n=201) or a standard schedule (at 0, 1, and 6 months; n=206). Subjects filled out a questionnaire asking about demographic and other health data, and they underwent physical examination. Blood was assayed for HBV surface antigen and HBV surface antibody (HBsAb) at 1–2 months after the three-dose schedule. Multivariate binary logistic regression was used to determine whether the rate of anti-HBs seroconversion differed with immunization schedule. Covariance analysis was used to compare geometric mean HBsAb concentration between the two schedules. The anti-HBs seroconversion rate was 84.6% in the accelerated group and 90.3% in the standard group. After controlling for several potential confounders, the accelerated schedule was associated with significantly lower anti-HBs seroconversion rate (OR: 0.560, 95% CI: 0.318–0.988). Similarly, the accelerated schedule was associated with significantly lower geometric mean HBsAb concentration. These results suggest that the standard schedule is more likely to lead to anti-HBs seroconversion and higher HBsAb levels in adults.
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Serological and molecular epidemiological outcomes after two decades of universal infant hepatitis B virus (HBV) vaccination in Nunavut, Canada. Vaccine 2017; 35:4515-4522. [DOI: 10.1016/j.vaccine.2017.07.040] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/13/2017] [Revised: 06/28/2017] [Accepted: 07/13/2017] [Indexed: 12/12/2022]
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van den Ende C, Marano C, van Ahee A, Bunge EM, De Moerlooze L. The immunogenicity of GSK’s recombinant hepatitis B vaccine in children: a systematic review of 30 years of experience. Expert Rev Vaccines 2017; 16:789-809. [DOI: 10.1080/14760584.2017.1338569] [Citation(s) in RCA: 16] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/05/2023]
Affiliation(s)
| | | | - Ayla van Ahee
- Pallas Health Research and Consultancy, Rotterdam, The Netherlands
| | - Eveline M. Bunge
- Pallas Health Research and Consultancy, Rotterdam, The Netherlands
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Li J, Yao J, Shan H, Chen Y, Jiang ZG, Ren JJ, Xu KJ, Ruan B, Yang SG, Wang B, Xie TS, Li Q. Comparison of the effect of two different doses of recombinant hepatitis B vaccine on immunogenicity in healthy adults. Hum Vaccin Immunother 2016; 11:1108-13. [PMID: 25607773 DOI: 10.4161/21645515.2014.988547] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/12/2022] Open
Abstract
The aim of this study was to evaluate the one-month immune response to 2 different doses (10 and 20 μg) of recombinant hepatitis B vaccine in adults aged 20-46 y. Subjects who were negative for hepatitis B surface antigen (HBsAg), hepatitis B antibody (anti-HBs), and hepatitis B core antibody (anti-HBc) were recruited. The participants were divided into 2 groups: group I received 3 doses of 10 μg hepatitis B vaccine at 0, 1 and 3 months, and group II received 3 doses of 20 μg at the same time points. The anti-HBs levels were measured one month after the third vaccination. Among 739 subjects, 62 (9.70%) were positive for HBsAg, and 317 subjects were eligible. The anti-HBs seroprotection rates (anti-HBs ≥ 10 mIU/mL was considered to indicate seroprotection) after the third vaccination were 88.05% and 94.06% in group I and group II respectively, and the geometric mean titers were 91.69 and 290.23 mIU/mL respectively. The difference in the seroprotection rate was not significant (χ(2) = 2.566, P > 0.05), but the GMT after the third dose was significantly lower for group I than for group II (F = 20.587, P < 0.05). Better responses were observed in young adults, especially in group I. In group I, the seroprotection rate and GMT were significantly higher in the 20-35 y group than in the 36-46 y group (P < 0.05); there was no significant difference compared to group II (P > 0.05). The hepatitis B vaccine has good immunological effect; the 20 μg dose can be used in adults aged 20-46 y and the 10 μg dose can be used in subjects aged 20-35 years, and it should be tested on a larger number of subjects before recommending it for adult routine vaccination.
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Affiliation(s)
- Jing Li
- a School of Medicine; Ningbo University ; Ningbo , China
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Schönberger K, Riedel C, Rückinger S, Mansmann U, Jilg W, Kries RV. Determinants of Long-term protection after hepatitis B vaccination in infancy: a meta-analysis. Pediatr Infect Dis J 2013; 32:307-13. [PMID: 23249904 DOI: 10.1097/inf.0b013e31827bd1b0] [Citation(s) in RCA: 53] [Impact Index Per Article: 4.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/05/2023]
Abstract
BACKGROUND The duration of protection after hepatitis B vaccination in early infancy is unclear and may be related to vaccination schedule, dosage, vaccine type and population characteristics. Factors potentially influencing waning immunity were assessed. METHODS A systematic review was performed. The main outcomes were prevalence of anti-hepatits B antibodies ≥ 10 mIU/mL after primary or booster vaccination. Factors potentially influencing protection were assessed in an adjusted random-effects meta-analysis model by age for both outcomes. Results of both meta-analyses were combined in a prognostic model. RESULTS Forty-six studies reporting on the anti-hepatits B antibodies ≥ 10 mIU/mL 5 to 20 years after primary immunization and 29 on booster response were identified. The adjusted meta-analyses identified maternal carrier status (odds ratio [OR]: 2.37 [1.11; 5.08]), lower vaccine dosage than presently recommended (OR: 0.14 [0.06; 0.30]) and gap time between last and preceding dose of the primary vaccine series (OR: 0.44 [0.22; 0.86]) as determinants for persistence of anti-hepatits B antibodies ≥ 10. A lower vaccine dosage was also associated with failure to respond to booster (OR: 0.20 [0.10; 0.38]). The prognostic model predicted long-term protection of 90% [77%; 100%] at the age of 17 years for offspring of noncarrier mothers vaccinated with a presently recommended dose and vaccination schedule. CONCLUSIONS Based on meta-analyses, predictors of waning immunity after hepatitis B vaccination in infancy could be identified. A prognostic model for long-term protection after hepatitis B vaccination in infancy was developed.
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Affiliation(s)
- Katharina Schönberger
- Institute of Social Pediatrics and Adolescent Medicine, Division of Epidemiology, Biostatistics and Epidemiology, Ludwig Maximilians University of Munich, Germany.
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Rapid immunization scheme for spouses of individuals estabilished as hepatitis B carriers during premarital tests. Clin Dev Immunol 2012; 2012:843134. [PMID: 23304191 PMCID: PMC3530868 DOI: 10.1155/2012/843134] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/13/2012] [Revised: 11/27/2012] [Accepted: 11/28/2012] [Indexed: 11/17/2022]
Abstract
BACKGROUND The aim of this study was to monitor the cases identified as hepatitis B carriers during premarital tests, to vaccinate their prospective spouses with a rapid vaccination scheme, and to compare the anti-HBs responses with the traditional vaccination scheme. METHODS Blood samples of 1250 couple spouses were tested for HBsAg and anti-HBs. HBsAg positive cases' fiancées which were found HBV negative were administered a rapid three-dose vaccination scheme on days 0, 7, and 21. Forty controls with similar age and gender were also were administered three doses of the same vaccine. RESULTS Out of 1250 cases (625 couples), 46 (3.6%) were HBsAg positive, and 40 of them aged between 18 and 39 were admitted to the rapid vaccination program. CONCLUSION Upon determination of HBsAg positivity in premarital tests, a rapid vaccination program provides early protection, but the 6th and 12th month vaccinations are also required. Anti-HBs response should be monitored.
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Viana SS, Araujo GS, Faro GBDA, da Cruz-Silva LL, Araújo-Melo CA, Cipolotti R. Antibody responses to Hepatitis B and measles-mumps-rubella vaccines in children who received chemotherapy for acute lymphoblastic leukemia. Rev Bras Hematol Hemoter 2012; 34:275-9. [PMID: 23049440 PMCID: PMC3460395 DOI: 10.5581/1516-8484.20120071] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/05/2012] [Accepted: 04/26/2012] [Indexed: 11/29/2022] Open
Abstract
Objective To evaluate viral vaccine antibody levels in children with acute lymphoblastic leukemia after chemotherapy and after vaccine booster doses. Methods Antibody levels against hepatitis B, rubella, measles and mumps vaccine antigens were evaluated in 33 children after completing chemotherapy (before and after vaccine booster doses) and the results were compared to the data of 33 healthy children matched for gender, age and social class. Results After chemotherapy, 75.9%, 67.9%, 59.3% and 51.7% of the patients showed low antibody titers that would be unlikely to protect against exposure to measles, rubella, hepatitis B and mumps, respectively. After receiving a vaccine booster dose for these antigens the patients had high antibody levels consistent with potential protection against measles, mumps and hepatitis B, but not against rubella. Conclusion Extra doses of measles-mumps-rubella plus hepatitis B vaccines are recommended in acute lymphoblastic leukemia patients submitted to treatment after hematologic recovery. After this, viral vaccine antibody levels should be verified to define the individual's protective status.
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Schönberger K, Riedel C, Rückinger S, Mansmann U, Jilg W, von Kries R. Impact of maternal carrier status on immunologic markers for protection after hepatitis B vaccination in infancy: A meta-analysis. Vaccine 2012; 30:6314-26. [DOI: 10.1016/j.vaccine.2012.07.080] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/27/2012] [Revised: 07/27/2012] [Accepted: 07/30/2012] [Indexed: 12/21/2022]
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Poorolajal J, Mahmoodi M, Haghdoost A, Majdzadeh R, Nasseri-Moghaddam S, Ghalichi L, Fotouhi A. Booster dose vaccination for preventing hepatitis B. Cochrane Database Syst Rev 2010:CD008256. [PMID: 21069704 DOI: 10.1002/14651858.cd008256.pub2] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/05/2023]
Abstract
BACKGROUND Antibodies against hepatitis B surface antigen (HBs) wane over time after vaccination for hepatitis B (HB); hence, the duration of protection provided by the vaccine is still unknown but may be evaluated indirectly by measuring the anamnestic immune response to booster doses of vaccine. OBJECTIVES To assess the benefits and harms of booster dose hepatitis B vaccination for preventing HB infection. SEARCH STRATEGY We searched The Cochrane Hepato-biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 4, 2010) in The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded, conference databases, and reference lists of articles to May 2010. We also contacted authors of articles and manufacturers. SELECTION CRITERIA Randomised clinical trials addressing anamnestic immune response to booster of HB vaccine five years or more after primary vaccination in apparently healthy participants, vaccinated in a 3-dose or 4-dose schedules of HB vaccine without receiving additional dose or immunoglobulin. DATA COLLECTION AND ANALYSIS Two authors made the decisions if the identified publications on studies met the inclusion criteria or not. Primary outcome measures included the proportion with anamnestic immune response in non-protected participants and signs of hepatitis B virus infection. Secondary outcomes were the proportion with local and systemic adverse event events developed following booster dose injection. Weighted proportion were planned to be reported with 95% confidence intervals. MAIN RESULTS There were no eligible randomised clinical trials fulfilling the inclusion criteria of this review. AUTHORS' CONCLUSIONS We were unable to identify randomised clinical trials on the topic. We need randomised clinical trials to formulate future booster policies for preventing hepatitis B infection.
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Affiliation(s)
- Jalal Poorolajal
- Department of Epidemiology and Biostatistics, Research Centre for Health Sciences, Faculty of Health, Hamadan University of Medical Sciences (UMSHA), Shahid Fahmideh Avenue, Hamadan, Hamadan, Iran, 6517838695
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Lin C, Zhu J, Zheng Y, Chen Y, Wu Z, Chong Y, Gao Z. Effect of GM-CSF in combination with hepatitis B vaccine on revacination of healthy adult non-responders. J Infect 2010; 60:264-70. [PMID: 20138189 DOI: 10.1016/j.jinf.2010.01.011] [Citation(s) in RCA: 13] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/17/2009] [Revised: 01/07/2010] [Accepted: 01/31/2010] [Indexed: 02/07/2023]
Abstract
OBJECTIVE To assess the immune effects and safety of using GM-CSF with the yeast-recombinant hepatitis B virus (HBV) vaccine for the re-vaccination of healthy adults who did not respond to a previous vaccination. METHODS Study participants included 1784 healthy adults and 100 individuals diagnosed as non-responders. These healthy non-responders were randomly assigned to one of the three treatment groups: Group A (34 individuals) was given 150 microg of granulocyte-macrophage colony stimulating factor (GM-CSF) the first day, then 20 microg of the vaccine; Group B (33 individuals) was given 40 microg of the vaccine only; and, group C (33 individuals) was injected with 20 microg of vaccine each time. All participants were injected three times, at time of study enrollment and one and six months later. Anti-HB surface antigen (HBs) antibody titers were tested before treatment and at one (T1), two (T2) and eight (T8) months post-first injection. RESULTS At T1, the rate of anti-HBs antibody(+) in groups A, B and C was 26.47%, 48.48% and 18.18%, respectively (p = .027). At T8, the seropositive rate of group A (64.71%) and group B (75.76%) was significantly higher than in group C (39.39%) (p = .011); the geometric mean of the antibody titer for groups A and B was higher than for group C (p = .0173). All three treatments were safe and well-tolerated. CONCLUSIONS Augmentation of the vaccine dose and co-administration of GM-CSF and the standard vaccine dose are effective for HBV vaccine non-responders. In fact, changing the vaccine dose had a better seropositive response than injecting the vaccine in combination with GM-CSF.
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Affiliation(s)
- Chaoshuang Lin
- Department of Infectious Diseases, The Third Affiliated Hospital, Sun Yat-sen University, Tianhe Road No. 600, Guangzhou 510630, China
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Brim N, Zaller N, Taylor LE, Feller E. Twinrix®vaccination schedules among injecting drug users. Expert Opin Biol Ther 2007; 7:379-89. [PMID: 17309329 DOI: 10.1517/14712598.7.3.379] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/05/2022]
Abstract
Twinrix is the only licensed vaccine that provides dual protection against infection with hepatitis A virus (HAV) and hepatitis B virus (HBV). The standard vaccination schedule for Twinrix is 0, 1 and 6 months. However, many high-risk populations, such as injecting drug users (IDUs), do not complete the vaccination series and, thus, do not acquire sufficient immunity against HAV and HBV. Twinrix can be administered using an accelerated vaccination schedule of 0, 7 and 21 days, with a booster recommended at 12 months. This manuscript reviews the available literature on vaccinating IDUs against HAV and HBV. The authors conclude that there is insufficient evidence regarding whether the accelerated Twinrix HAV/HBV vaccination schedule would yield a greater number of IDUs protected against both HAV and HBV.
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Affiliation(s)
- Nancy Brim
- Brown Medical School, Providence, Rhode Island, USA, 2The Miriam Hospital, 164 Summit Ave, Providence, RI 02906, USA.
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Hussain Z, Ali SS, Husain SA, Raish M, Sharma DR, Kar P. Evaluation of immunogenicity and reactogenicity of recombinant DNA hepatitis B vaccine produced in India. World J Gastroenterol 2005; 11:7165-8. [PMID: 16437665 PMCID: PMC4725092 DOI: 10.3748/wjg.v11.i45.7165] [Citation(s) in RCA: 15] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/23/2004] [Revised: 01/23/2005] [Accepted: 01/26/2005] [Indexed: 02/06/2023] Open
Abstract
AIM (1) To gain information on immune responses to an accelerated schedule of 0, 1, and 2 mo in paramedical staff and BDS students who are at an increased risk of getting hepatitis B infection and come under high risk groups. (2) To assess the efficacy and safety of Enivac-HB in different age groups, using genetically modified yeast strain Pichia pastoris, a new recombinant hepatitis B vaccine developed and manufactured in India. METHODS A prospective, comparative, and single blinded trial of rapid (0, 1, and 2 mo) hepatitis B immunization schedule was reported. A total of three hundred and seven (212 females and 95 males) healthy volunteers divided into three age groups (18-29, 30-39, and 40-49) were enrolled after screening for markers of hepatitis B. All the volunteers received 20 mg of the vaccine intramuscularly at 0, 1, and 2 mo. RESULTS Geometric mean titers were calculated pre and post vaccination. Before immunization the GMT was 0.0124 mIU/mL. One month after the administration of the third dose of recombinant vaccine 296/307 (96.5%) subjects achieved seroprotective levels of anti-HBs. The geometric mean anti-HBs titers achieved after one month of the third dose was 2 560.0 mIU/mL. The geometric mean anti-HBs titer of males was 2 029.0 mIU/mL, while that of the females was 2 759.0 mIU/mL. In the age group of 18-29 years, anti-HBs titer was 3 025.0 mIU/mL, while that in the age group of 30-39 years was 2 096.0 mIU/mL. In third age group of 40-49 years, anti-HBs titer was 1 592.0 mIU/mL. Hyper-responses (anti-HBs> or =100 mIU/mL) were shown in 88.0% (271/307) of subjects. Eleven (3.5%) subjects responded poorly to the vaccine in the age group of 40-49 years. There was only mild pain at the site of injection otherwise there were no other adverse drug reactions (ADRs). CONCLUSION This vaccine (Enivac-HB) is safe and efficacious, providing significant protection after the third dose and rapid hepatitis B immunization schedule of 0, 1, and 2 mo can be recommended whenever rapid protection is the goal.
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Affiliation(s)
- Zahid Hussain
- Department of Medicine, Maulana Azad Medical College, New Delhi 110002, India
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Fioredda F, Plebani A, Hanau G, Haupt R, Giacchino M, Barisone E, Balbo L, Castagnola E. Re-immunisation schedule in leukaemic children after intensive chemotherapy: a possible strategy. Eur J Haematol 2005; 74:20-3. [PMID: 15613102 DOI: 10.1111/j.1600-0609.2004.00340.x] [Citation(s) in RCA: 31] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/27/2022]
Abstract
The aim of this retrospective study was to test the residual humoral immunity to compulsory vaccines after the end of chemotherapy for acute lymphoblastic leukaemia in a cohort of 70 Italian children. All the patients, who had been immunised according to the Italian schedule prior to the disease, were tested for antibody levels against tetanus and hepatitis B at a median of 10 months after the end of therapy. Median age at diagnosis of leukaemia was 48 months, and median age at vaccine titration was 84 months. The protective level of antibodies for tetanus and hepatitis B was shown in 83% and 81% of patients, respectively; the remaining 17% and 19% were not protected against the two pathogens. Double negativity was observed in only four of 62 (6%) patients in the cohort. These data were comparable with published data regarding healthy children of the same age and from the same geographical areas. Therefore, given the direct and indirect costs of performing laboratory tests, as well as the cost of revaccination, our proposal is to continue the vaccination schedule according to the child's age without any titration screening 6 months after the end of therapy. Larger studies are needed to confirm these observations.
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Affiliation(s)
- Francesca Fioredda
- Department of Pediatric Hematology, Oncology and Bone Marrow Transplantation, Scientific Directorate, G. Gaslini Children's Hospital, Genova, Italy.
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Bock HL. Rapid hepatitis B immunisation for the traveller: comparison of two accelerated schedules with a 2-month schedule. BioDrugs 2004; 17 Suppl 1:11-3. [PMID: 12785872 DOI: 10.2165/00063030-200317001-00003] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/02/2022]
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Saltoğlu N, Inal AS, Tasova Y, Kandemir O. Comparison of the accelerated and classic vaccination schedules against Hepatitis B: three-week Hepatitis B vaccination schedule provides immediate and protective immunity. Ann Clin Microbiol Antimicrob 2003; 2:10. [PMID: 14622443 PMCID: PMC293476 DOI: 10.1186/1476-0711-2-10] [Citation(s) in RCA: 28] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/14/2003] [Accepted: 11/17/2003] [Indexed: 11/10/2022] Open
Abstract
Background Hepatitis B virus infection although preventable by vaccination remains an important health issue throughout the world due to its morbidity, mortality and economical losses. Early seroprotection is desirable for people at high risk of exposure. The aim of this study was to determine whether three-week hepatitis B vaccination (on days 0, 10 and 21) provide seroprotection or not. Methods The 120 subjects enrolled into the study were divided into two groups and vaccinated by the classic (months 0, 1, and 2) or the accelerated (days 0, 10, and 21) schedules and antibody response determined on days 30, 60, and 90 and, if below 10 mIU/ml-1, again on day 180. For each individual in the classic group (B) three subjects were enrolled in the accelerated group (A). Recombinant hepatitis B vaccine (Gen-Hevac B, Pasteur) was given as 20 micrograms intramuscular injections via the deltoid muscle. A booster dose on day 365 was administered for each group. Family members of hepatitis B carriers and volunteer health personnel were enrolled into group A. To the B group only volunteers who wanted vaccination against hepatitis B were included. Results After three doses of vaccine, Anti-HBs titers reached protective levels in both groups. The number of vaccinees with seroprotective levels of Anti-HBs (≥10 mIU/ml-1) on day 30 was 53 (58.9%) in group A and 9 (30.0%) in group B (p < 0.05). On day 60, there was no difference between group A and B, with response rates of 84.4% (n = 76) and 80.0% (n = 24) respectively (p > 0.05). On day 90 there was no difference between group B and group A; with 26 (86.7%) and 79 (87.7%) responders respectively. In both groups those with Anti-HBs levels <10 mIU/ml-1 attained protective levels by day 180. Conclusion In this study, the three-week vaccination provided protective antibody titers within a shorter time compared to the classic schedule. Therefore, in order to provide rapid antibody production against hepatitis B virus, the accelerated vaccination schedule seems to be a good preference.
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Affiliation(s)
- Nese Saltoğlu
- Department of Clinical Bacteriology and Infectious Diseases, Çukurova University Medical Faculty, Turkey
| | - A Seza Inal
- Department of Clinical Bacteriology and Infectious Diseases, Çukurova University Medical Faculty, Turkey
| | - Yesim Tasova
- Department of Clinical Bacteriology and Infectious Diseases, Çukurova University Medical Faculty, Turkey
| | - Ozlem Kandemir
- Department of Clinical Bacteriology and Infectious Diseases, Mersin University Medical Faculty, Adana, Turkey
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Belloni C, De Silvestri A, Tinelli C, Avanzini MA, Marconi M, Strano F, Rondini G, Chirico G. Immunogenicity of a three-component acellular pertussis vaccine administered at birth. Pediatrics 2003; 111:1042-5. [PMID: 12728086 DOI: 10.1542/peds.111.5.1042] [Citation(s) in RCA: 76] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/24/2022] Open
Abstract
OBJECTIVE To evaluate within the first 6 months of birth the immunogenicity of a 3-component acellular pertussis (aP) vaccine containing filamentous hemagglutinin (FHA), pertactine (PRN), and genetically detoxified pertussis toxin (PT) in infants who received a dose of vaccine at birth, in addition to the recommended schedule administered at 3, 5, and 11 months. Furthermore, we investigated the influence of maternal antibodies on aP vaccine response. METHODS We used enzyme-linked immunosorbent assay to evaluate immunoglobulin G antibody levels in 45 infants immunized at birth and at 3, 5, and 11 months (group 1) and in 46 infants immunized at the ages of 3, 5, and 11 months (group 2). All mothers were also tested at delivery. RESULTS At the age of 5 months the geometric mean titer of anti-PT, anti-FHA, and anti-PRN was significantly greater in group 1 (who had received 2 doses) than in group 2 (1 dose). At 6 months geometric mean titers were significantly higher in group 1 than in group 2 for anti-PRN and anti-FHA, whereas no significant differences were observed for anti-PT. CONCLUSIONS Immunization at birth may be important for an earlier prevention of the pertussis disease in infants under 6 months, especially in Italy, where the recommended ages for aP vaccine administration are 3, 5, and 11 months.
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MESH Headings
- Adhesins, Bacterial/administration & dosage
- Adhesins, Bacterial/immunology
- Adhesins, Bacterial/therapeutic use
- Adolescent
- Adult
- Antibodies, Bacterial/biosynthesis
- Antibodies, Bacterial/blood
- Antigens, Bacterial/administration & dosage
- Antigens, Bacterial/immunology
- Antigens, Bacterial/therapeutic use
- Bacterial Outer Membrane Proteins/administration & dosage
- Bacterial Outer Membrane Proteins/immunology
- Bacterial Outer Membrane Proteins/therapeutic use
- Bordetella pertussis/immunology
- Female
- Hemagglutinins/administration & dosage
- Hemagglutinins/immunology
- Hemagglutinins/therapeutic use
- Humans
- Immunization Schedule
- Immunoglobulin G/biosynthesis
- Immunoglobulin G/blood
- Infant
- Infant, Newborn
- Injections, Intramuscular
- Italy
- Male
- Mothers
- Pertussis Toxin/administration & dosage
- Pertussis Toxin/immunology
- Pertussis Toxin/therapeutic use
- Pertussis Vaccine/administration & dosage
- Pertussis Vaccine/immunology
- Pertussis Vaccine/therapeutic use
- Virulence Factors, Bordetella/administration & dosage
- Virulence Factors, Bordetella/immunology
- Virulence Factors, Bordetella/therapeutic use
- Whooping Cough/prevention & control
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Affiliation(s)
- Cesare Belloni
- Division of Neonatology and Neonatal Intensive Care, IRCCS Policlinico San Matteo Pavia, Italy.
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Keating GM, Noble S. Recombinant hepatitis B vaccine (Engerix-B): a review of its immunogenicity and protective efficacy against hepatitis B. Drugs 2003; 63:1021-1051. [PMID: 12699402 DOI: 10.2165/00003495-200363100-00006] [Citation(s) in RCA: 171] [Impact Index Per Article: 7.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
Engerix-B (Hep-B[Eng]) is a noninfectious recombinant DNA vaccine containing hepatitis B surface antigen (HBsAg). It is produced from genetically engineered yeast (Saccharomyces cerevisiae). Intramuscular Hep-B(Eng) [0-, 1-, 6-month schedule] has excellent immunogenicity in healthy neonates and infants, children, adolescents and adults, with seroprotection rates of 85-100% seen approximate, equals 1 month after the final dose of vaccine; seroprotection was defined as an antibody against HBsAg (anti-HBs) titre of > or =10 IU/L. The use of alternative Hep-B(Eng) immunisation schedules (e.g. a 0-, 1-, 2-, 12-month schedule in neonates and infants, 0-, 12-, 24-month or two-dose schedules in children and adolescents, and accelerated schedules in adults) have also been associated with high rates of seroprotection. Seroprotection rates were generally similar with Hep-B(Eng) and the recombinant vaccine Recombivax HB (Hep-B[Rax]) or plasma-derived vaccines (PDVs) approximate, equals 1 month after the final dose (although anti-HBs geometric mean titres were significantly higher with Hep-B[Eng] than with Hep-B[Rax]). One month after the final dose, adults had significantly higher seroprotection rates with the recombinant triple-antigen vaccine Bio-Hep-B (Hep-B[Bio]) than with Hep-B(Eng), although seroprotection rates in healthy infants were similar with Hep-B(Eng) and Hep-B(Bio). Hep-B(Eng) had excellent immunogenicity in several groups considered at high risk of acquiring hepatitis B (e.g. neonates born to hepatitis B carrier mothers and healthcare workers). The immunogenicity of Hep-B(Eng) was reduced in patients with conditions associated with impaired immune function (e.g. patients undergoing haemodialysis or being treated for malignancy), although it had good immunogenicity in patients with diabetes mellitus.Hep-B(Eng) had excellent protective efficacy against HBsAg carriage in healthy infants and children, and in neonates born to hepatitis B carrier mothers (protective efficacy of 95-99%). Hep-B(Eng) also demonstrated good protective efficacy in a number of other high-risk groups. Hep-B(Eng) is generally well tolerated with a tolerability profile similar to that of Hep-B(Rax), Hep-B(Bio) and PDVs. In conclusion, Hep-B(Eng) is a well established, highly immunogenic hepatitis B vaccine with good tolerability and excellent protective efficacy; it offers flexibility through a variety of immunisation schedules. In addition, it appears that Hep-B(Eng) confers immunity for at least 10 years. Hep-B(Eng) has an important role in mass vaccination campaigns against hepatitis B, as well as in groups considered at high risk of acquiring hepatitis B.
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Young BWY, Lee SS, Lim WL, Yeoh EK. The long-term efficacy of plasma-derived hepatitis B vaccine in babies born to carrier mothers. J Viral Hepat 2003; 10:23-30. [PMID: 12558908 DOI: 10.1046/j.1365-2893.2003.00386.x] [Citation(s) in RCA: 32] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/09/2022]
Abstract
The long-term efficacy of a childhood hepatitis B vaccination programme was evaluated. A total of 112 newborn babies of hepatitis B carrier mothers were given hepatitis B immune globulin (HBIG) and a 10-microg three-dose regimen of plasma-derived vaccine administered at a conventional (0, 1, 6 months), delayed (2, 3, 8 months) or accelerated (0, 1, 2 months) schedule. The vaccinees were followed up to determine their anti-HBs status over a 16-year period. Upon completion of the vaccination schedules, 92.6% developed antibody against surface antigen (anti-HBs) seroconverion, the rate of which fell to 33.3% at year 16. The three schedules were equally effective in preventing chronic infection, with a protective efficacy of 88.9% from hepatitis B surface antigen (HBsAg) carriage, compared with historical control. Vaccinees on the delayed schedule had a slightly higher seroconversion rate over years, and were better able to maintain an anti-HBs level of > or = 100 iu/L. Overall, a quarter demonstrated evidence of exposure to the virus, being positive for antibody against core antigen or HBsAg, or mounting a rise in anti-HBs during the follow-up period. We conclude that a three-dose hepatitis B vaccination regimen is generally effective in protecting newborns of hepatitis B carrier mothers from infection and chronic carriage. Booster is not needed even after 16 years of monitoring.
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Affiliation(s)
- B W Y Young
- Pamela Youde Nethersole Eastern Hospital, Hong Kong, China
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Pérez-García R, Pérez-García A, Verbeelen D, Bernstein ED, Villarrubia VG, Alvarez-Mon M. AM3 (Inmunoferón) as an adjuvant to hepatitis B vaccination in hemodialysis patients. Kidney Int 2002; 61:1845-52. [PMID: 11967036 DOI: 10.1046/j.1523-1755.2002.00335.x] [Citation(s) in RCA: 22] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022]
Abstract
BACKGROUND Patients with end-stage renal disease (ESRD) undergoing hemodialysis have severe alterations in cell-mediated immunity (CMI) that increases their risk of contracting chronic hepatitis B virus (HBV) infection and decreases their protective responses to HBV vaccine. In an effort to improve the humoral response to an accelerated HBV vaccine protocol in these patients, the ability of an immunomodulator, AM3, to improve seroconversion was investigated. METHODS A total of 269 patients were enrolled in a multicenter trial. All patients received a DNA recombinant vaccine (40 microg HBsAg/dose/day) on days 0, 10, 21, and 90. AM3 or placebo (3 g/day) was given orally for 30 consecutive days beginning 15 days prior to the first vaccine dose. Anti-HBsAg titers were measured on days 120 and 270 after the beginning of the trial. RESULTS After one month, 207 patients could be evaluated and 132 patients after six months. The placebo and AM3-treated groups had comparable seroconversion and protective response rates one month after the final vaccine dose. The AM3 treatment group, but not the placebo group, maintained these protective titers up to six months after the final vaccine dose. At this time, the percentage of high responders (anti-HBsAg>100 IU/L) and mean anti-HBsAg titers in the AM3 group was significantly higher than in the placebo group. CONCLUSIONS AM3 is a safe and easily tolerated oral agent that potentiates long-term serological immunity to hepatitis B in hemodialysis patients after vaccination.
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