Hepatitis B Vaccination Safety

2002 ◽  
Vol 36 (3) ◽  
pp. 370-374 ◽  
Author(s):  
Mark R Geier ◽  
David A Geier

BACKGROUND: Recent studies have suggested that adult hepatitis B vaccination may be associated with adverse reactions. OBJECTIVE: To further examine the relative risk, percentage association, and statistical significance of arthritic, immunologic, and gastrointestinal adverse reactions reported after adult hepatitis B vaccination compared with control vaccines. DESIGN: The Vaccine Adverse Events Reporting System (VAERS) database was analyzed for the incidence of adverse reactions after adult hepatitis B immunization compared with the incidence of adverse reactions reported to VAERS about vaccine control groups. SETTING: The medical and scientific communities have generally accepted that hepatitis B vaccine, a highly purified, genetically engineered single-antigen vaccine, is a safe vaccine. METHODS: The VAERS database was analyzed from 1997 to 2000 for adverse reactions associated with adult hepatitis B vaccination and from 1991 to 2000 for adverse reactions reported about vaccine control groups. RESULTS: The results showed a statistically significant increase in the incidence of adverse reactions reported after adult hepatitis B vaccination when compared with the incidence of adverse reactions reported to VAERS about control vaccines. CONCLUSIONS: Patients and physicians need to be fully informed of the potential adverse reactions associated with hepatitis B vaccination so that together they can make an informed consent decision about the risk versus the benefit. Patients who may have had an associated adverse reaction to hepatitis B vaccine should be made aware that they may be eligible for compensation from the no-fault Vaccine Compensation Act, administered by the US Court of Claims. TRASFONDO: Estudios recientes sugieren que la vacunación para hepatitis B en adultos podría estar asociada con reacciones adversas.

Vaccines ◽  
2021 ◽  
Vol 10 (1) ◽  
pp. 19
Author(s):  
Xinyao Liu ◽  
Wuqi Qiu ◽  
Yan Liang ◽  
Wei Zhang ◽  
Qian Qiu ◽  
...  

Evidence on the effectiveness of hepatitis B virus (HBV) infection screening and vaccination programs remains rare in China. We used a quasi-experimental method, propensity score matching, to evaluate the effects of a community-based HBV infection detection combined with vaccination (HBVIDV) program in a pilot. Data were retrieved from the HBVIDV program implemented between July 2019 and June 2020. Outcomes were the difference between the treatment and control groups in hepatitis B vaccination (≥1 dose), hepatitis B vaccine series completion (≥3 doses), and serologic evidence of vaccine-mediated immunity. Altogether, 26,180 individuals were included, where 6160 (23.5%) individuals were assigned to the treatment group, and 20,020 (76.5%) individuals were assigned to the control group. After propensity score matching, 5793 individuals were matched. The rates of hepatitis B vaccination, hepatitis B vaccine series completion, and prevalence of vaccine-mediated immunity in the treatment and control groups were 29.0% vs. 17.8%, 22.1% vs. 13.1%, and 38.2% vs. 27.6%, respectively. The HBVIDV program was significantly associated with increased hepatitis B vaccination rate (OR, 1.884, 95% CI 1.725–2.057), hepatitis B vaccine series completion rate (OR, 1.872, 95% CI 1.696–2.065), and prevalence of vaccine-mediated immunity (OR, 1.623, 95% CI 1.501–1.755). The greater magnitude of association between HBVIDV program and outcomes was observed among adults aged 35–54 years and adults who live in rural areas. The HBVIDV program was effective in increasing the hepatitis B vaccination rate, hepatitis B vaccine series completion rate, and prevalence of vaccine-mediated immunity among adults in the pilot. Further focusing the program on special populations and regions may produce more effective results.


2008 ◽  
Vol 61 (1-2) ◽  
pp. 55-59 ◽  
Author(s):  
Ilija Rosic ◽  
Sead Malicevic ◽  
Snezana Medic

Introduction. Hepatitis B viral infection can create serious health problems, such as acute and chronic hepatitis, cirrhosis of liver and hepatocellular carcinoma. Athletes have bigger risk of hepatitis B infection due to frequent injuries with bleeding, their style of living (promiscuity), close contact with teammates, etc. The aim of this study was to investigate the immune response to hepatitis B vaccine among elite athletes, compared to corresponding control group of male subjects from general non-athlete population, and to test out reaction in relation to age. Method. There were 21 elite football players and 30 control non-athlete males. After written consent, they all received three doses of hepatitis B vaccine (Euvax B, Sanofi Pasteur) during 6 months. Eight weeks later, their immune response (as anti-HBs antibody titre in serum) was assessed and statistical significance of the findings was tested. The level of immune response was also evaluated in different age clusters within test groups. Results. None of the footballers was without response to the vaccine. One of the subjects from the control group did not develop it. The group of athletes was with better mean values of antibody titre (1626621 mIU/ml vs. 1568455 mIU/ml), but without statistical significance (t=0.375; p > 0.05), and with a greater deal of subjects who developed very good immune response (titre over 2000 miU/ml). Younger football players had better immune reaction than older (age 18-24, 1795560 miU/ml, vs. age 25-29 years, 1597470 mIU/ml vs. age 30 and more, 1360904 miU/ml), but without statistical importance (II - 1.593; p > 0.05). Conclusion. Our study has shown that elite athletes respond very well to hepatitis B vaccination and have good immune response. Vaccination against hepatitis B of elite athletes is very important, because viral infection can seriously affect their health and stop their careers. .


Author(s):  
Elena V Esaulenko ◽  
Aleksey A Yakovlev ◽  
Genady A Volkov ◽  
Anastasia A Sukhoruk ◽  
Kirill G Surkov ◽  
...  

Abstract Background This study compares the immunogenicity and safety of a 3-antigen (S/pre-S1/pre-S2) hepatitis B (HepB) vaccine (3AV), to a single antigen vaccine (1AV) in adults to support the registration of 3AV in Russia. Methods We conducted a randomized, double-blind, comparative study of 3-dose regimens of 3AV (10 μg) and 1AV (20 µg) in adults aged 18–45 years. We evaluated immunogenicity based on hepatitis B surface (HBs) antibody titers at days 1, 28, 90, 180, and 210, adverse and serious adverse events (SAEs) to study day 210. The primary outcome was based on the difference in rates of seroconversion at day 210 (lower bound 95% confidence interval [CI]: > − 4%). Secondary outcomes were seroprotection rates (SPR), defined as anti-HBs ≥10 mIU/mL and anti-HBs geometric mean concentration (GMC). Results Rate of seroconversion in 3AV (100%) was noninferior to 1AV (97.9%) at study day 210 (difference: 2.1%, 95% CI: −2.0, 6.3%]) but significantly higher at study day 28. SPR at study day 210 was >97% in both arms. Anti-HBs titers were significantly higher at study days 90 (P = .001) and 180 (P = .0001) with 3AV. Sex, age, and body mass index (BMI) had no impact on anti-HBs titers. The rates of local reactions related to vaccination were similar between vaccine arms (3AV vs 1AV) after the first (30% vs 18.8%, P = .15), second (20.0% vs 14.6%, P = .33), and third vaccination (14.9% vs 23.4%, P = .22). No SAEs were reported. Conclusions 3AV was noninferior to 1AV. 3AV induced high SPR, and there were no safety concerns. Clinical Trials Registration. NCT04209400.


2021 ◽  
Vol 27 (1) ◽  
Author(s):  
Mingjuan Yin ◽  
Yongzhen Xiong ◽  
Dongmei Liang ◽  
Hao Tang ◽  
Qian Hong ◽  
...  

Abstract Background An estimated 5–10 % of healthy vaccinees lack adequate antibody response following receipt of a standard three-dose hepatitis B vaccination regimen. The cellular mechanisms responsible for poor immunological responses to hepatitis B vaccine have not been fully elucidated to date. Methods There were 61 low responders and 56 hyper responders involved in our study. Peripheral blood samples were mainly collected at D7, D14 and D28 after revaccinated with a further dose of 20 µg of recombinant hepatitis B vaccine. Results We found low responders to the hepatitis B vaccine presented lower frequencies of circulating follicular helper T (cTfh) cells, plasmablasts and a profound skewing away from cTfh2 and cTfh17 cells both toward cTfh1 cells. Importantly, the skewing of Tfh cell subsets correlated with IL-21 and protective antibody titers. Based on the key role of microRNAs involved in Tfh cell differentiation, we revealed miR-19b-1 and miR-92a-1 correlated with the cTfh cell subsets distribution and antibody production. Conclusions Our findings highlighted a decrease in cTfh cells and specific subset skewing contribute to reduced antibody responses in low responders.


2021 ◽  
Vol 2 (1) ◽  
pp. 57-62
Author(s):  
A S Obekpa ◽  
A O Malu ◽  
R Bello ◽  
M Duguru

Health care workers are high-risk group for contracting hepatitis B and C virus infections. Hepatitis B and C can be contracted in the hospital setting by needle prick injury, contact with blood (and body fluids) and during invasive medical procedures. This study aims to assess the risk of exposure, the concern or perception of healthcare workers about getting infected (with HBV and/or HCV) from the workplace and the level of HBV vaccination uptake among them. The study was carried out during a capacity building workshop organized for health care workers from all the Local Government Areas in Benue State. A self-administered questionnaire was distributed to 168 participants in attendance, after obtaining verbal consent. One hundred and thirty-eight (138) questionnaires were properly filled and returned, 115 (83.3%) have had needle prick injury, 127 (92%) have had blood spilling on them and 118 (85.5%) have been involved in the management of hepatitis patients. One hundred and nineteen (86.2%) were afraid of contracting hepatitis infection from their place of work, 133 (96.4%) were aware of hepatitis B vaccine for adult, 87 (63%) had received at least one dose of hepatitis B vaccine but only 56 (40.6%) received the complete three doses. Health care workers in Benue State are aware of the risk of contracting viral hepatitis at their workplace and are concerned about this risk. However, the uptake of hepatitis B vaccination among them remains poor.


Vaccine ◽  
1993 ◽  
Vol 11 (13) ◽  
pp. 1358-1359 ◽  
Author(s):  
Yehuda Carmeli ◽  
Tali De-Medina

1987 ◽  
Vol 8 (3) ◽  
pp. 102-107 ◽  
Author(s):  
Myron J. Tong ◽  
Ann M. Howard ◽  
Gary C. Schatz ◽  
Mark A. Kane ◽  
Deborah A. Roskamp ◽  
...  

AbstractPrior to offering the hepatitis B (HB) vaccine, a prescreen for hepatitis B virus (HBV) antibodies was conducted in a 565 bed hospital in Pasadena, California. Antibodies to the hepatitis B virus were detected in 14.5% of 1,745 employees tested. There was a significantly higher prevalence in those with a previous history of hepatitis, blood transfusions, exposure to nee-dlesticks, number of years in the same occupation, and in the same hospital work area. Employees of Asian extraction (33.3%) and blacks (23.1%) had a higher prevalence of antibodies to the hepatitis B virus than Hispanics (13.7%) and whites (10.2%). Anti-HBs was detected in 92.6% of 865 employees who received three doses of the hepatitis B vaccine. Only 28.6% of nonresponders receiving a fourth dose of hepatitis B vaccine produced anti-HBs. The nonresponders to the HB vaccine were older (average age 64.9 years) when compared to the responders (average age 37.5 years), and more males failed to produce anti-HBs after vaccination than females. Hepatitis B vaccination of the majority of individuals with either “low level” anti-HBs alone or anti-HBc alone did not elicit an anamnestic response after one dose of vaccine, implying that these “low level” antibodies are nonspecific and do not represent antiviral antibodies. Adverse reactions to the hepatitis B vaccine were minor and included a flulike syndrome, sore arm, and rash and swelling at the injection site. The reasons for nonparticipation were obtained from 179 individuals, and the main issue was concern about safety of the hepatitis B vaccine.


2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S156-S156 ◽  
Author(s):  
Katia Bruxvoort ◽  
Jeff Slezak ◽  
Runxin Huang ◽  
Lina S Sy ◽  
William Towner ◽  
...  

Abstract Background Less than 1 in 3 US adults who initiated the 3-dose (0, 1, 6 months) hepatitis B vaccine series have completed it. HepB-CpG (Heplisav-B; Dynavax) is a new licensed adjuvanted vaccine that requires only 2 doses (0, 1 month). As part of a cluster study performed at Kaiser Permanente Southern California, we compared compliance with second dose and series completion for HepB-CpG vs. comparator vaccine (Engerix-B; GlaxoSmithKline) recipients. Methods The cohort included adults not on dialysis who received their first dose of hepatitis B vaccine in family or internal medicine departments from 8/7/2018 to 2/1/2019. Second dose compliance was assessed for the full cohort, but series completion was assessed for a subset vaccinated from August 7, 2018 to September 30, 2018 to allow at least 6 months’ follow-up. Compliance rates were estimated using the Kaplan Meier method. Adjusted hazard ratios (aHR) were estimated using Cox proportional hazard regression with robust variance to account for within medical center correlation, adjusting for age, race/ethnicity, census block income and education, prior healthcare utilization, and factors that trigger alerts for hepatitis B vaccination (diabetes and testing for sexually transmitted infections). Results There were 6500 HepB-CpG and 7733 comparator vaccine recipients (1,442 and 2,604 prior to September 30, 2018). Rates of second dose compliance at 60 days were 32.9% for HepB-CpG and 29.1% for comparator vaccine, and rates of series completion at 210 days were 56.9% and 20.6%. There was no significant difference in second dose compliance (aHR 1.14, 95% CI: 0.91, 1.47), but HepB-CpG recipients were 5 times more likely to complete the series (aHR 5.17; 95% CI: 3.84, 6.98). Second dose compliance and series completion were significantly less likely among Blacks compared with Whites and significantly more likely among Asians, adults ≥60 years compared with those < 30 years, and adults living in census blocks with a median annual income of $40,000–69,000 compared with < $40,000. Conclusion Overall, second dose compliance was similar, but series completion was better for HepB-CpG recipients than comparator vaccine recipients, suggesting that the 2-dose vaccine could lead to improvements in coverage and protection against hepatitis B virus. Disclosures All authors: No reported disclosures.


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