|Year : 2020 | Volume
| Issue : 2 | Page : 135-138
Accelerated hepatitis B vaccination: Efficacy in young, regular blood donors
Maryam Zadsar1, Esmail Sanei Moghaddam2, Seyed Moayed Alavian3, Fariba Seighali1
1 Research Center, High Institute of Education and Research in Transfusion Medicine, Tehran, Iran
2 Iranian Blood Transfusion Organization Research Center, High Institute of Education and Research in Transfusion Medicine, Zahedan, Iran
3 Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Baqiyatallah University of Medical Sciences; Middle East Liver Diseases Research Center; Iran Hepatitis Network, Tehran, Iran
|Date of Submission||10-Aug-2020|
|Date of Decision||12-Aug-2020|
|Date of Acceptance||12-Sep-2020|
|Date of Web Publication||13-Nov-2020|
Research Center, High Institute of Education and Research in Transfusion Medicine, Tehran
Source of Support: None, Conflict of Interest: None
Background and Objectives: Hepatitis B (HB) – a vaccine-preventable, transfusion-transmitted infection – has been estimated to have high residual risk, especially in medium- and high-endemic areas. This potent immunogenic vaccine is routinely injected at 0, 1, and 6 months. Accelerated schedule has been recommended in adults to increase the completion rate. We studied the response rate of accelerated schedule in young, regular blood donors in a high-prevalence area for HB virus (HBV) in Iran. Methods: Young, regular nonimmunized blood donors were vaccinated with recombinant DNA HB surface antigen vaccine (Pasteur Institute of Iran) containing 20 μg of material in 1-ml solution injected intramuscularly to the deltoid muscle at 0, 1, and 2 months. HB surface antibody (HBsAb) was titered 1 month after the completion of doses. Nonresponders took one additional dose and tested a month later. Results: A total of 357 donors with a mean age of 26 ± 3.5 years were enrolled, of whom 287 donors completed three doses of vaccination (80% adherence rate). HBsAb titer was >10 IU/ml in 274 donors (95.5% response rate), whereas after one booster dose injection, the titer in 13 nonresponder persons (4.5%) increased to >10 IU/ml. Conclusion: Accelerated HBV vaccination with near 100% response rate and 80% adherence rate in young, regular blood donors has been successful in the immunization of young blood donors. This strategy improves not only blood safety but also donors' health.
Keywords: Accelerated schedule, hepatitis B vaccine, immunization, Iran, response rate, Sistan and Baluchistan, transfusion-transmitted infections, Zahedan
|How to cite this article:|
Zadsar M, Moghaddam ES, Alavian SM, Seighali F. Accelerated hepatitis B vaccination: Efficacy in young, regular blood donors. Glob J Transfus Med 2020;5:135-8
|How to cite this URL:|
Zadsar M, Moghaddam ES, Alavian SM, Seighali F. Accelerated hepatitis B vaccination: Efficacy in young, regular blood donors. Glob J Transfus Med [serial online] 2020 [cited 2020 Nov 24];5:135-8. Available from: https://www.gjtmonline.com/text.asp?2020/5/2/135/300627
| Introduction|| |
Hepatitis B (HB) is one of the most important transfusion-transmitted infections (TTIs). The carrier rate of HB surface antigen (HBsAg) varies from 0.1% to 20% in the general population globally. It is more prevalent in endemic areas such as Africa and some parts of Asia (South East and Eastern Mediterranean regions).
In the Middle East, the endemicity of HB virus (HBV) is intermediate with a prevalence rate of 2%–7%. Among countries in this region, Iran, Kuwait, and Bahrain are near low endemic.,,
The prevalence rate of HBsAg in Iranian blood donors is significantly lower than that of the general population and is decreasing in recent years. This rate has been reported to be 0.41% in 2007 by Amini Kafiabadet al. (ranged from 0.34% in Fars province to 1.15% in Sistan). Zahedan, the capital city of Sistan province, has higher prevalence rate (3.38%) of HBV in comparison to other provinces.
HBV infection can be prevented by a vaccine that is a potent immunogenic vaccine with positive immune response in almost 95% of healthy adults. HBV vaccination for infants has been implemented as Expanded Program of Immunization in Iran since 1993. After that, the Iranian Ministry of Health (MOH) held the campaign of mass immunization against HBV for those born since 1989–2007 with a coverage rate of 90%.
Accelerated schedules that are used to increase the completion rate of vaccination, have been studied in Australia with near 90% seroprotection rate.
Response rate could be affected by factors such as age older than 40; injecting drug users; smoking; obesity; male sex; and predisposing diseases such as cirrhosis, chronic renal failure, and celiac disease in children; organ transplant recipients; and immunosuppressed patients.,
In facing the challenges of HBV, the policymakers at Zahedan Blood Transfusion Center in cooperation with the MOH decided to vaccinate young, regular blood donors who were not immunized against HBV. They choose the accelerated schedule in order to get more adherence rate.
Young, safe regular donors are treasures for any transfusion services due to their long period of donation eligibility; in addition, vaccine response is much more effective in young population and regular donors are much safer than lapsed and first-time donors. The vaccination campaign had focused on young, regular blood donors in Zahedan as it is an area with higher prevalence rate of HBV in Iran.
In this study, we checked the response rate to accelerated vaccination program and its interfering factors in this population.
| Materials and Methods|| |
Regular blood donors at the center of Sistan Baluchistan province, Zahedan city, aged 20–35 years – who were HBsAg, human immunodeficiency virus antibody (Ab), and hepatitis C virus Ab negative – were enrolled randomly, based on blood donation software (Negareh, Iran Blood Transfusion Organization), during 1-year period. Those who have not been already vaccinated against HB were immunized by accelerated method after signing the informed consent. Vaccination was done with recombinant DNA HBsAg vaccine (Pasteur Institute of Iran) containing 20 μg of material in 1-ml solution injected intramuscularly to the deltoid muscle. Vaccination was done for donors whose initial test of HBsAb and HB core Ab (HBcAb) was negative, in three doses (0, 1, and 2 months).
In this study, we called vaccinated donors to study response rate at least 1 month after the last dose. After signing the informed consent, donors filled in a questionnaire which consisted of two parts, as follows: (a) demographic characteristics and donation history and past, personal, and familial medical history related to hepatitis and jaundice and (b) factors that interfere with response to vaccination. Two-ml blood sample was taken and centrifuged, and serum was tested for HBsAb and HBcAb, with anti-HBs II Behring kit and mono kit Behring, respectively.
The SPSS 16 Package program for statistical analysis (SPSS Inc., Chicago) was used. Data were presented as mean ± standard deviation or, when indicated, as an absolute number, frequencies, and percentage. Chi-square test, paired sample t-test, univariate analysis, and multivariate analysis were used for the evaluation of risk factors. P ≤ 0.05 was considered statistically significant.
| Results|| |
A total of 4000 young, regular blood donors were immunized by recombinant HBV vaccine. Among these, 357 blood donors were randomly recalled to study vaccination efficacy. A total of 286 donors completed the whole study evaluation.
The mean age of donors in the studied group was 26 ± 3.5 years; the age group distribution was as follows: 191 (53.5%), 20–24 years old; 111 (31%), 25–29 years old; and 55 (15.5%), 30–35 years old. More than 98% of the donors were male and 56% were single. In the context of graduation characteristics, 36% were high school graduated, 11% had completed bachelors degree, 26% were graduated as MA or MS, and 25% were undergraduates.
Postvaccination antibody titer was detected in 287 donors as follows: 13 (4.5%) below 10 IU/ml, 103 (36%) in the range of 10–100 IU/ml, and 171 (59.5%) more than 100 IU/ml, as shown in [Table 1]. In this group, 4.5% of donors were nonresponders. The distribution of postvaccination HBV Ab titer by age group is shown in [Table 2]. No statistically significant differences were detected in demographic characteristics between responders and nonresponders by univariate analysis (P > 0.05).
The factors which could interfere with response to HBV vaccination such as cigarette or pipe smoking and high body mass index were also studied. No significant differences were found between responders and nonresponders by univariate analysis, as shown in [Table 3]. Multivariate analysis also showed no significant difference between multiple interfering factors and postvaccination antibody titer (P > 0.05). All nonresponders were recommended to receive an additional booster dose 1–2 months after the last dose. Antibody titer was more than 10 IU/ml in all donors, which led to 100% response rate after one booster dose.
|Table 3: Distribution of interfering factors related to nonresponsiveness|
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| Discussion|| |
TT-HBV (TT-HBV) is one of the main TTIs that has high residual risk despite screening tests. It is important to reduce the incidence of TT-HBV infection, especially in medium- and high-endemic areas.
In Iran, more than two million units of whole blood are donated annually. It seems donor vaccination against HB is one of the options in order to reach safe blood as well as healthy population, especially in areas with high prevalence rate [Table 4].
|Table 4: Trend of hepatitis B surface antigen positivity rate among Sistan and Baluchistan blood donors during 6 years (P≤0.05)|
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Vaccination of adult population in routine protocol needs 6-month follow-up to complete the course. There are different types of accelerated schedules recommended for adult population. One of those is 0-, 1-, and 2-month intramuscular injection with a response rate of almost 82%.,,, Hans et al. studied the immunogenicity of a recombinant HB vaccine in adults who have been vaccinated three different rapid vaccination schedules as follows: Group A (0, 1, and 2 months); Group B (0, 14, and 28 days); and Group C (0, 7, and 21 days); 1 month after the completion of vaccination, the seroprotection rate by the definition of anti-HBS more than 10 IU/ml was 89.0% (Group A); 78.5% (Group B); and 76.4% (Group C). The advantages of rapid schedule are high adherent rate and higher completion rate in adults.
The overall response rate in healthy adults is expected to be about 95%, which decreases with aging and reaches even below 50% in the sixth decade. A meta-analysis revealed that the efficacy of vaccine was 86.3% in the general population. The efficacy was significantly related to the year of publication, age, and gender., Nearly 95% response rate in our study among healthy young blood donors seems desirable. We did not detect any differences in age and sex between responders and nonresponders, which may be because of the special age of vaccinated group.
This vaccine is also immunogenic in patients who are expected to have immunologic abnormality, such as multitransfused patients.
There is also a significant correlation between post-vaccination HBsAb titer and smoking; occupation; time lasting from the completion of schedule; conditions such as cirrhosis or chronic renal failure; organ transplant recipients; children with celiac disease; immunosuppressed patients; and especially hemodialysis.,, It is recommended to do vaccination as soon as possible in young adults.
Another group of nonresponders is healthy individuals that genetically cannot produce the HBs Ab due to the lack of a gene controlling the antibody production. Technical errors such as intragluteal injection or poor transport or storage condition of vaccine may cause nonrespondant.
In cases with Ab titer below 10 IU/L, a booster dose or revaccination is suggested., It is recommended to inject one to three doses of vaccine to nonresponders who have 25%–50% anti-HBS response after additional dose injection., It is not recommended to do booster vaccination in all adults who have been vaccinated in infancy because immunity is preserved even when there is expected high-risk behavior.,
We found 4.5% of nonresponders by first series of vaccination. None of them had any of the abovementioned clinical conditions. Because of the small number of nonresponder group, the study cannot be extended to the general population.
In the management of nonresponders, especially in endemic regions, HBsAg testing of vaccines should be considered. All our vaccines were HBsAg negative and responded to an additional dose.
The results of this study cannot be generalized to the whole society because of low sample size and inclusion of a special healthy age group.
| Conclusion|| |
In moderate-to-high-endemic area for HBV infection, vaccination is a way to improve blood safety as well as population health. We found that accelerated schedule for vaccination effectively immunizes donors as well as increases the adherence rate of donors to complete the immunization course. It may cause adherence to blood services and return of donors. We need to check return of same population to donate. The authors suggest further studies on larger population of donors and long-term follow-up for measuring the impact on blood safety.
The authors would like to acknowledge the cooperation of Zahedan Blood Transfusion Center's staf, Fariba Heidari, Soheila Khosravi and also Iranian Centers for Disease Control and Prevention department of vaccine preventable disease Mohsen Zahraii, Abdolraza Esteghamati and Mohammad Mahdi Gooya the head of Iranian Centers for Disease Control and Prevention for their cooperation and support.
Maryam Zadsar and Fariba Seighali implemented the research, analyzed the data, and wrote the paper.
Financial support and sponsorship
The research was supported financially by Iranian Blood Transfusion Organization.
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]