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At least 19 recordsLinked to original sources

A review of hepatitis B vaccination.

Hepatitis B is one of the most important infectious causes of acute and chronic liver disease both in the US and worldwide. In order to combat the life-threatening effects of hepatitis B infection, recombinant hepatitis B vaccines have been developed. The medical and scientific communities have generally accepted that recombinant hepatitis B vaccine - a highly purified, genetically engineered, single antigen vaccine - is a safe vaccine. Information is presented showing that hepatitis B vaccine contains yeast, aluminium, thimerosal and hepatitis B surface antigen epitopes, which may result in hepatitis B vaccine being associated with autoimmune diseases among susceptible adult vaccine recipients. There is little doubt that the benefits of this vaccine overall far outweigh its risks. Physicians and patients should evaluate the risks and benefits of hepatitis B vaccination and, together, make an informed consent decision as to whether to undergo vaccination. Individuals who experience an adverse reaction to hepatitis B vaccination should report it to the Vaccine Adverse Event Reporting System database and be advised that they may be eligible for compensation from the no-fault National Vaccine Injury Compensation Program, administered by the US Court of Claims. The authors strongly urge that additional research be conducted into the molecular basis of adverse events following hepatitis B vaccine administration, so that further recommendations may be made on how to improve their safety profiles.

Adult↗

Hepatitis B vaccine and hepatitis B markers: cost effectiveness of screening prehospital personnel.

The purpose of this study was to evaluate the cost effectiveness of screening emergency medical technicians (EMTs) and paramedical personnel prior to administering hepatitis B vaccine. Hepatitis B screening and Heptavax vaccine were offered to 259 basic EMTs and paramedics. Of the 259 individuals, 62 refused screening, and six who had already received hepatitis B vaccine were excluded from the study. The screening was not continued after the results of the first 174 tests returned negative. All 191 participants were vaccinated. No hepatitis B surface antigen carriers and only three individuals positive for hepatitis B surface antibody were found among those screened. This study corroborates the Centers for Disease Control guidelines of cost effectiveness in screening prehospital health care workers.

Allied Health Personnel↗

Protective efficacy, immunotherapeutic potential, and safety of hepatitis B vaccines.

Hepatitis B vaccines are highly effective and safe and have been incorporated into national immunization programs in over 150 countries. The major humoral immune response is to the common a determinant of the surface antigen protein of the virus. Approximately 5-10% of healthy immunocompetent subjects do not mount an antibody response (anti-HBs). Non-response is associated with different HLA-DR alleles and impaired Th cell response, among other factors such as route of injection, age, gender, body mass, and other factors. Important hepatitis B surface antigen variants have also been identified, which may have a potential impact on immunization and routine screening of blood, blood products and tissues, and organs for transplantation. Strategies for hepatitis B immunization are reviewed. Over 1,000 million doses of hepatitis B vaccine have been used with an outstanding record of safety. There is no evidence of an association between hepatitis B vaccines and the sudden infant death syndrome, chronic fatigue syndrome, and multiple sclerosis (MS). Several studies are in progress on treatment of chronic hepatitis B infection by immunization with multiple antigenic components, combination of vaccine with antiviral drugs and cytokines, T cell vaccines, DNA vaccines alone or with DNA encoded immunomodulatory cytokines, and direct genetic manipulation of antigen presenting cells.

Age Factors↗

A case report of fluctuant sensorineural hearing loss after hepatitis B vaccination.

Hepatitis B vaccine is known to induce accidents and side-effects. We report a case of unilateral fluctuant sensorineural hearing loss with tinnitus after a series of hepatitis B vaccinations. Tinnitus regressed and hearing thresholds were normalized 6 months later. The authors discuss the potential causality of hepatitis B vaccine in the occurrence of fluctuant sensorineural hearing loss and propose a physiopathological hypothesis to explain this unusual case.

Adult↗

[Efficacy of hepatitis B vaccination on hepatitis B prevention and on hepatocellular carcinoma].

OBJECTIVE: To evaluate the efficacy of hepatitis B vaccination on hepatitis B prevention and on hepatocellular carcinoma. METHODS: Birth cohort study, cross-sectional seroepidemiological survey, and surveillance of hepatitis B (HBV) and hepatocellular carcinoma were used to evaluate the efficacy of hepatitis B vaccination. RESULTS: During the 14 years after hepatitis B vaccination, the HBsAg positive rates were found to be 0.7% - 2.9%, with an average of 1.5%, and the protective rates were 83.5% - 96.6%. Hepatitis B virus infection rates of children immunized with hepatitis B vaccine were 1.1% - 5.1%, with an average of 2.2% and the protective rates of 93.5% - 98.4%. 15 years after hepatitis B vaccination, the incidence of hepatitis B dropped from 3.27/10 000 to 0.17/10 000, a 94.8% decrease, in the group of 0 - 19 year-olds. CONCLUSION: The universal infant hepatitis B vaccination has proved to be effective in reducing the incidence rate of acute hepatitis B as well as the mortality of hepatocellular carcinoma.

Adolescent↗

Immune response of hospital workers to hepatitis B vaccine.

Hepatitis B vaccine (Heptavax-B vaccine, Merck Sharp and Dohme) was given by injection into the buttock of 109 healthy workers in a community hospital according to the schedule of the U.S.A. Centers for Disease Control. In only 26% of those between 41 and 65 years of age was antibody to hepatitis B surface antigen found after the full course of vaccination whereas 74% of those aged 18-40 years had detectable antibody. We did not find any significant difference between the responses of males and females in either age group. The unusually poor response may be related to injections being given into the buttock rather than the deltoid region of the arm. We, therefore, recommend that injections of hepatitis B vaccine should be given into the deltoid muscle and that vaccinees should be tested after vaccination for evidence of immunity.

Adolescent↗

Hepatitis B serological patterns of asymptomatic carriers in an endemic region and evaluation of blood plasma as a source of hepatitis B vaccine.

Hepatitis B serological studies were carried out in 251 asymptomatic carriers of HBsAg living in an endemic rural area of Cachoeiro do Itapemirim (545 km distant from Rio de Janeiro) in order to evaluate this population as a potential source of blood plasma for hepatitis B vaccine production. A pilot study on HBsAg purification from plasma was also performed to estimate antigen yield.

Adolescent↗

Subunit, recombinant and synthetic hepatitis B vaccines.

Hepatitis B surface antigen in the form of 22 nm spherical particles (and tubular forms) is excess virus coat protein. Guidelines for the preparation of the 22 nm spherical particles (and their separated polypeptides) derived from the plasma of asymptomatic human carriers, were suggested by the WHO Expert Committee on Viral Hepatitis in 1977, and the proposed requirements for the 22 nm hepatitis B particle vaccine were published by the WHO Expert Committee on Biological Standardisation in 1981 and revised in 1983. Such preparations have been tested for safety and protective efficacy and many clinical trials with the plasma-derived vaccine have demonstrated the immunogenicity, high protective efficacy and safety of the currently licensed preparations. Polypeptide vaccines, derived from the surface antigen from any source, have several advantages which include precise biochemical characterisation, exclusion of genetic material of viral origin, exclusion of host or donor-derived substances and enhanced potency. A polypeptide vaccine in micellar form has been developed in London. The applications of recombinant DNA technology permit the isolation, purification and selective amplification of almost any individual segment of DNA from practically any organism in convenient biological systems such as bacteria, yeast, or any other cell including mammalian cells. Considerable progress has been made with vaccines prepared from antigen expressed in yeast (Saccharomyces cerevisiae). Cloning of the DNA of hepatitis B virus has resulted in sequencing of nucleotides and mapping of the amino acids of antigens. Information obtained from the sequencing of the 226 amino acids of hepatitis B surface antigen has led to the development of chemically synthesised peptides corresponding to amino acid sequences predicted from the nucleotide map. Several such synthetic peptides, when linked to potent adjuvants elicit antibodies in experimental animals which react with the surface antigen. The potential of pure chemically synthetic vaccines against hepatitis B, and other infectious agents, is under intensive investigation since such vaccines should be chemically well-defined, uniform, safe and cheap to produce. Studies have been carried out recently using a chemically synthetic peptide in a linear and in a cyclical form corresponding to the amino acids sequence 139-147 of the major polypeptide I of hepatitis B surface antigen. The synthetic antigens and the native polypeptide complex p23-gp28 purified from hepatitis B surface antigen in plasma were used for the measurement of affinity of the antibody to the surface antigen (anti-HBs) in human sera.(ABSTRACT TRUNCATED AT 400 WORDS)

Amino Acid Sequence↗

Breakthrough infections and identification of a viral variant in Gambian children immunized with hepatitis B vaccine.

Hepatitis B (HB) breakthrough infections, identified by the presence of HB core (c) antibody, were found in 32 of 358 Gambian children vaccinated with plasma-derived HB vaccine. Over 2 years, 15 of these children lost their HBc antibodies. These children had significantly higher HB surface antibody levels before infection than those who retained HBc antibodies. One child, who responded well to the vaccine, had HB viral DNA detected in the presence of HBs antibodies. The S gene sequence of this DNA showed nucleotide changes that resulted in an amino acid substitution at residue 141 (lysine to glutamic acid) of the surface antigen. This finding suggests the child was infected with a variant virus that was not neutralized by antibodies resulting from HB vaccination.

Child↗

Enhancing effects of oral adjuvants on anti-HBs responses induced by hepatitis B vaccine.

Hepatitis B (HB) vaccine is very promising for the prevention of HB infection. There exist, however, some non-responders to current vaccination trials. In this study, taurine, parotin and lithium were selected as adjuvants which can be administered orally. The mechanisms of these three materials as adjuvants and their effects on HB vaccine were investigated in mice. For instance, taurine induced polyclonal antibody production and exhibited adjuvant activity. Although taurine did not have any activity on the proliferation of thymocytes nor stimulate IL-2 production, taurine did induce IL-1 production by macrophages. It was considered that taurine-induced IL-1 would play an essential role in the proliferation and differentiation of B cells. Parotin also induced polyclonal antibody production and exhibited adjuvant activity. These effects of parotin were not affected even if macrophages or T cells were depleted, and parotin itself had an IL-1-like activity. Therefore, it was considered that parotin acted directly on B cells by its IL-1-like activity and mitogenic activity, resulting in the proliferation and differentiation of B cells. Lithium induced neither polyclonal antibody production, nor IL-1 or IL-2 production. However, when given with an antigen, lithium activated the humoral immune system, resulting in the augmentation of antibody production. Oral administration of taurine, parotin and lithium were capable of restoring antibody responses to HB surface antigen (HBsAg) in HBsAg-nonresponder mice. Furthermore, taurine, parotin and lithium enhanced the adjuvant effects of aluminium contained in the present HB vaccine. These observations indicate that use of these oral adjuvants may open new perspectives in the field of human HB vaccination.

Adjuvants, Immunologic↗

Administration of combined diphtheria and tetanus toxoids and pertussis vaccine, hepatitis B vaccine, and Haemophilus influenzae type b (Hib) vaccine to infants and response to a booster dose of Hib conjugate vaccine.

We compared antibody levels following separate but simultaneous administration of diphtheria and tetanus toxoids with acellular pertussis vaccine (DTaP) containing pertussis toxoid, filamentous hemagglutinin, and pertactin (PRN); hepatitis B vaccine; and Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate; PRP) vaccine conjugated to tetanus toxoid (PRP-T) with those following administration of a combination of a DTaP-hepatitis B vaccine-PRP-T to infants at 2, 4, and 6 months of age. The antibody response to a booster dose of PRP conjugate vaccine (CRM197-OS) in infants with low (< 1 microgram/mL) or undetectable (< 0.10 microgram/mL) postpriming levels of antibody to PRP was also studied. Antibody levels were quantitated before and after dose 3 by enzyme-linked immunosorbent assay, radioimmunoassay, or neutralization assay. Seroresponse rates were not different between the two vaccine groups except for rates of response to PRP. There was a trend that levels of antibody to all the antigens included in the combination vaccine were lower than those of antibody to antigens in separate vaccines; for levels of antibody to diphtheria toxoid (P = .001), PRN (P < .0001), and PRP (P < .0001), the differences were significant. Despite low or undetectable postpriming levels of antibody to PRP, high-titered (geometric mean concentration, 9.02 micrograms/mL; range, 1.0-81.5 micrograms/mL), immunoglobulin G-predominant antibody to PRP was produced following a booster dose of CRM197-OS, a finding consistent with a memory response.

Diphtheria-Tetanus-Pertussis Vaccine↗

Hepatitis B vaccine.

Hepatitis B virus (HBV) infection is a health problem that affects numerous infants and children in the United States. Approximately 4000 to 6000 new infections occur each year in children and adolescents; most often they become infected without obvious clinical manifestations. Some persons become chronically infected, and this asymptomatic chronically infected population serves as a reservoir for HBV. Immunization of all newborn infants and adolescents for HBV is a vital step toward eradicating HBV from the general population. Pediatric nurse practitioners are in a strategic position to provide education and the carry out immunization efforts that will dramatically decrease the morbidity associated with HBV.

Adolescent↗

Comparison of a triple antigen and a single antigen recombinant vaccine for adult hepatitis B vaccination.

Hepatitis B and its sequelae are a major public health problem. Vaccines have been available for almost 20 years; however the disease still remains a global problem. Many factors contribute to the failure to control hepatitis B, including the limited nature of the vaccination programs implemented initially. Only relatively recently has mass childhood vaccination begun to be implemented and vaccination of high-risk groups, other than healthcare workers, is still not general policy. Additional factors contributing to continued persistence of hepatitis B in the developed world are that the present vaccines are not fully used by those recommended to be vaccinated and even when vaccination is carried out appropriately, there remain some who fail to achieve adequate protection. Clearly, the protection of at-risk groups who have inadequate response to current vaccines, and those who are unwilling or unable to comply with protracted multi-dose vaccine regimens, could be improved if there were a more potent vaccine and/or a shorter vaccination regimen available. Adults who had never been vaccinated against hepatitis B were randomised to receive a vaccination course of either a present single antigen (S) vaccine (Recombivax-HB) or a novel triple antigen (S, pre-S1, and pre-S2) recombinant vaccine (Hepacare Medeva Pharma plc). Doses were given at baseline and 1 month and 6 months later. Hepatitis B surface antibody (anti-HBs) levels were measured at 2, 4, 6, and 7 months after beginning vaccination. The primary efficacy parameter was the degree of protection, measured as the percentage of subjects with anti-HBs titres > or = 10 IU/L, 6 or 7 months (26 +/- 2 weeks) after beginning vaccination. A total of 303 adult subjects entered the study and were vaccinated. Of these, 11 failed to complete the study (4 on Hepacare and 7 on Recombivax-HB); however all but 2 (1 to receive the triple antigen vaccine and 1 to receive Recombivax-HB) were included in the intent-to-treat population for efficacy evaluation. Treatment randomisation was stratified at entry based on age (above and below 40 years old) and gender. The standard three-dose/6-month vaccination regimen of the single antigen vaccine protected 83% of subjects by 7 months after starting vaccination whereas the triple antigen vaccine as a two-dose/1-month regimen protected 88% within 6 months and as a three-dose/6-month regimen protected 97% by 7 months after starting vaccination. Thus the protection rate provided by the shortened (0, 1) regimen of the novel vaccine was "essentially equivalent" (i.e., not statistically inferior) to that provided by the full (0, 1, and 6) regimen of today's vaccine (88% vs. 81%, P < 0.001), and the protection rate provided by a three-dose/6-month (0, 1, and 6) regimen of the new vaccine was significantly superior to that provided by present vaccines (97% vs. 83% P < 0.001). The percentage of subjects protected increases with time after beginning vaccination and at all time points up to and including 6 months was significantly greater with the two-dose regimen of the triple antigen vaccine than with the single antigen vaccine regimen. In adults at risk for a reduced response to hepatitis B vaccination [i.e., older adults (>/=40), the obese, males, and smokers], the triple antigen vaccine produced a significantly greater percentage of protected subjects (P < 0.001) and higher geometric mean titre (P < 0.001). Indeed as a three-dose/6 month regimen, the triple antigen vaccine raised the level of protection in these vulnerable subgroups to that seen when a single antigen vaccine is used in the optimal younger adult group. Both vaccines were well tolerated and had similar safety profiles. The most frequently (> or = 10%) reported adverse events with the use of either vaccine were pain at the site of injection (38% vs. 41% vs. 20% for the two-dose Hepacare regimen, the three-dose Hepacare regimen, and the three-dose Recombivax-HB regimen, respectively), infections at the site of injection (1% vs. 14% vs. 9%), headache (9% vs. 13% vs. 11%), and nausea (7% vs. 11% vs. 3%). It is concluded that in healthy normal adults, a triple antigen hepatitis B vaccine that contained S and pre-S antigens produced an enhanced immunological response. This was exemplified by the novel vaccine's ability to overcome factors such as advancing age (> or = 40 years), obesity, and smoking, each of which is known to reduce the potential for protection with present recombinant S only vaccines. A two-dose/1-month (0 and 1) regimen of this triple antigen vaccine was as effective as the standard three-dose/6 month (0, 1, and 6) regimen of present single antigen vaccines. (c) 2001 Wiley-Liss, Inc.

Adolescent↗

The delivery of hepatitis B vaccine.

Hepatitis B is a serious preventable infection that is common in men who have sex with men. Historically, uptake of the vaccine has been poor in this group. Leigh Chislett describes how the introduction of a nurse-led service significantly increased uptake of the vaccine at a London clinic.

Ambulatory Care↗

A pilot study on universal immunization of newborn infants in an area of hepatitis B virus and primary hepatocellular carcinoma prevalence with a low dose of hepatitis B vaccine.

Hepatitis B virus (HBV) had been considered as the main causative factor of primary hepatocellular carcinoma and universal immunization of newborns was recommended as the major approach to control hepatitis and hepatoma in areas of prevalence. As the initial phase of the first vaccination program for such a purpose, a pilot study was done from September 1983 to May 1984 in a high incidence rural area of China. In an area of 214,343 inhabitants, 1,703 newborns (99% of all births) were vaccinated. Ninety-seven percent of all vaccinees were followed up at 1 year. The vaccine used was Hep-B Vax, given intramuscularly at 0, 1, and 6 months after birth. Four immunization regimes were used: 5-micrograms or 2.5-micrograms doses with or without hepatitis B immune globulin (HBIG) added in the case of carriers children. These groups were defined by drawing lots at community level. A matched control was selected on a voluntary basis. Each group consisted of 400 infants. Vaccination was proven to be very safe and well accepted by the public. The prevalence of HBV infection in the area was further demonstrated by the high HBsAg-positive rate measured: 14.2% of the 1,180 mothers (3.9% were also e-antigen positive), 7.6% and 10.1% of the unvaccinated children at 6.5 months and 1 year of age, respectively. It was shown that vaccination with a 5-micrograms or 2.5-micrograms dose significantly lowered the HBsAg positives to a level close to 1.5% versus 10% in the control group at 1 year. An 85% protection was thus achieved. A 5-micrograms dose plus HBIG did not show additional benefit. A 2.5-micrograms dose plus HBIG gave less protection, and anti-HB levels were also significantly lower than in other groups. Among the 12 failures found in the 5-micrograms and 2.5-micrograms groups, 11 were born to HBsAg-positive mothers, nine of whom also had e-antigen. Available data showed that 29% of children born by e-antigen-positive and 2.7% of children born by e-antigen-negative carriers had the risk of becoming carriers during the first year of life following vaccination. The present study demonstrated the feasibility and rationale of conducting universal immunization of newborns in endemic rural area for controlling hepatitis and hepatoma. The significance of the possible use of the vaccination at lower dose had also been stressed.

Adult↗

Randomized, comparative trial of 20 micrograms vs 40 micrograms Engerix B vaccine in hepatitis B vaccine non-responders.

Fifty-two adults who had previously received 4 x 20 micrograms doses of hepatitis B [Engerix-B] vaccine (appropriately administered into the deltoid muscle) and who had failed to develop detectable anti-HBs were randomized to receive a fifth dose of Engerix-B (either 20 micrograms or 40 micrograms) intramuscularly (deltoid). The participants were blinded as to the contents of the syringe. Anti-HBs was tested (by EIA) 3 months after the injection. Anti-HBs results from 45 non-responders were evaluable. Seven vaccinees were excluded; four of these on the basis of failure to have follow-up blood collected and three who were found to be anti-HBc positive (one HBsAg positive). Twelve of 22 (54.5%) of those receiving 20 micrograms of HB vaccine developed anti-HBs, whereas 10 of 23 (43.5%) who received 40 micrograms developed anti-HBs, showing no significant difference between the regimens. The mean geometric titres were 93 +/- 50 and 86 +/- 51 IU l-1, respectively. Vaccinee groups were well matched for age, sex and body mass index and the interval between injection and bleeding. Side-effects in those receiving the double (40 micrograms) dose were no different from those receiving the normal (20 micrograms) adult dose. On the basis of this study, a fifth dose of vaccine in non-responsive vaccinees is recommended. No significant advantage of 40 micrograms over 20 micrograms of vaccine was observed. Whilst smoking and obesity were common in this cohort of non-responders and probably contributed to the individuals primary non-responsive state, these factors had no unfavourable effect on response to a fifth dose of vaccine.

Adolescent↗

Humoral and cellular immune responses to hepatitis B vaccination in hepatitis B surface antigen-carrier children who cleared serum-hepatitis B surface antigen.

The immune responses to hepatitis B vaccine were studied in 11 hepatitis B surface antigen (HBsAg) carrier children who had cleared HBsAg but failed to develop hepatitis B surface antigen antibodies (anti-HBs) in sera (group 1), 5 HBsAg carrier children who had cleared HBsAg and developed detectable anti-HBs in sera (group 2), and 5 healthy subjects seronegative for all hepatitis B virus (HBV) markers (group 3). After receiving three doses of HB vaccine, group 1 subjects failed to develop detectable anti-HBs. Subsequently, each subject of the three groups was given one dose of the same vaccine for a cellular immunity study, and a measurable proliferation of peripheral blood mononuclear cells (PBMC) to HBsAg was detected in 1 of 8 (12.5%), 0 of 5, and 4 of 5 (80%) of the cases in each group, respectively, after vaccination. The removal of CD8+ cells enhanced the HBsAg blastogenic response in group 3 but did not reverse the unresponsiveness in group 1 and group 2 subjects. The addition of interleukin (IL)-2 in culture reversed unresponsiveness in all cases except one case in group 1. Compared with before vaccination, PBMC from group 2 subjects produced significantly less interferon gamma (IFN-gamma) and more IL-4 in response to HBsAg after vaccination, a cytokine response not observed in group 1 subjects. HLA typing indicated that 3 of 10 patients in group 1 (30%) and 1 of 5 patients in group 2 (20%) had HLA-DRw14-DRw52, a marker previously linked to low anti-HBs response to hepatitis B vaccine in Taiwan. We conclude that the underlying causes of poor anti-HBs response in group 1 subjects are multifactorial, including specific failure of antigen presentation or T-cell activation, or the lack of T helper (Th)2 cell-like response to HBsAg. HLA-DRw14-DRw52 does not confer absolute nonresponsiveness to HBsAg. These patients are not benefited by hepatitis B immunization.

Adolescent↗