Adverse Effects of Vaccines Evidence and Causality (2012) / Chapter Skim
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8 Hepatitis B Vaccine
8 Hepatitis B Vaccine
Pages 435-504
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From page 435... ...
. Extrahepatic manifestations of hepatitis B can include arthritis, urticaria, vasculitis, and glomerulonephritis (Mast and Ward, 2008)
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, DNA recombinant vaccines replaced plasma-derived vaccines in the United States (Mast and Ward, 2008)
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. In unvaccinated adolescents and adults, the CDC recommends three doses of the vaccine with the first and second dose 1 month apart and the third dose 6 months after the initial dose (CDC, 1991)
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Weight of Mechanistic Evidence The committee assesses the mechanistic evidence regarding an as sociation between hepatitis B vaccine and encephalitis or encepha lopathy as lacking. Causality Conclusion Conclusion 8.1: The evidence is inadequate to accept or reject a causal relationship between hepatitis B vaccine and encephalitis.
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The publications did not provide evidence beyond temporality, some too long or too short based on the possible mechanisms involved (Battaglia and Valiani, 1992; de Carvalho and Shoenfeld, 2008; Hartman, 1990; Kaygusuz et al., 2002; Planchamp et al., 2009; Yang et al., 2006)
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Mechanistic Evidence The committee identified eight publications describing the development of ADEM after the administration of hepatitis B vaccine. Six publications did not report evidence of causality beyond a temporal relationship between vaccination and the development of ADEM (Brinar and Poser, 2008; Cabrera-Gomez et al., 2002; Geier and Geier, 2004; Herroelen et al., 1991; Rogalewski et al., 2007; Voigt et al., 2001)
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An MRI after the third dose showed high signal lesions T2-weighted images involving arcuate fibers of both hemispheres, periventricular and subcortical white matter, corpus callosum and cerebellar white matter, and cortex. Weight of Mechanistic Evidence The two publications described above, when considered together, presented clinical evidence suggestive but not sufficient for the committee to conclude the vaccine may be a contributing cause of ADEM after vaccination against hepatitis B
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Six publications did not provide evidence beyond temporality, some too long or too short based on the possible mechanisms involved (Fonseca et al., 2003; Iniguez et al., 2000; Karaali-Savrun et al., 2001; Mahassin et al., 1993; Renard et al., 1999; Senejoux et al., 1996)
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Autoantibodies, T cells, and molecular mimicry may contribute to the symptoms of transverse myelitis; however, the publications did not provide evidence linking these mechanisms to hepatitis B vaccine. The committee assesses the mechanistic evidence regarding an as sociation between hepatitis B vaccine and transverse myelitis as weak based on one case.
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Mechanistic Evidence The committee identified six publications reporting optic neuritis after the administration of hepatitis B vaccine. The publications did not provide evidence beyond temporality (Albitar et al., 1997; Erguven et al., 2009;
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c DeStefano Date of optic Three Case 108 OR for optic neuritis None Serious Ages < 18, 18–40, et al. neuritis onset HMOs control patients onset any time after described > 40 years (2003)
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Autoantibodies, T cells, immune complexes, and molecular mimicry may contribute to the symptoms of optic neuritis; however, the publications did not provide evidence linking these mechanisms to hepatitis B vaccine. The committee assesses the mechanistic evidence regarding an as sociation between hepatitis B vaccine and optic neuritis as lacking.
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Causality Conclusion Conclusion 8.7: The evidence is inadequate to accept or reject a causal relationship between hepatitis B vaccine and NMO. MULTIPLE SCLEROSIS ONSET IN ADULTS Epidemiologic Evidence The committee reviewed eight studies to evaluate the risk of onset (date of first symptom)
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This case-control study evaluated the association between hepatitis B vaccination and MS or optic neuritis onset using data from three HMOs participating in the VSD. The MS analysis included 332 cases and 722 controls.
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The immunization status was obtained during telephone interviews, during which participants referred to their vaccination records. The analysis included 192 cases with definite or probable MS.
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Mechanistic Evidence The committee identified one publication reporting the onset of MS in an adult after administration of a hepatitis B vaccine. The publication did not provide evidence beyond temporality (Rogalewski et al., 2007)
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TABLE 8-2 Studies Included in the Weight of Epidemiologic Evidence for Hepatitis B Vaccine and MS Onset in Adults Operationally Primary Effect Size Heterogeneous Limitations Defined Study Defined Study Study Sample Estimatea (95% CI or Subgroups at (Negligible Citation Outcome Setting Population Design Size p value) Higher Riskb or Serious)
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in medical with MS hepatitis B vaccination: Cases had MS records 3.1 (95% CI, 1.5–6.3) diagnoses in 1,604 medical records controls from 1993 through 2000
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compared with the risk/effect estimate reported for the primary group/definition. c Studies designated as serious had more methodological limitations than those designated as negligible.
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The date of first symptom of MS was obtained from the medical record, and telephone calls and written questionnaires were used to gather more data on the description of symptoms. The immunization status was obtained from vaccination certificates, and telephone interviews were used for 30 controls that did not provide certificates.
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Autoantibodies, T cells, and molecular mimicry may contribute to the symptoms of MS; however, the publication did not provide evidence linking these mechanisms to hepatitis B vaccine. The committee assesses the mechanistic evidence regarding an as sociation between hepatitis B vaccine and onset of MS in children as lacking.
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Weight of Mechanistic Evidence The symptoms described in the publication referenced above are consistent with those leading to a relapse of MS. Autoantibodies, T cells, and molecular mimicry may contribute to the symptoms of MS; however, the publication did not provide evidence linking these mechanisms to hepatitis B vaccine.
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Weight of Epidemiologic Evidence The committee has limited confidence in the epidemiologic evi dence, based on one study that lacked validity and precision to assess an association between hepatitis B vaccine and relapse of MS in children. Mechanistic Evidence The committee did not identify literature reporting clinical, diagnostic, or experimental evidence of relapse of MS in children after the administration of hepatitis B vaccine.
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This case-control study evaluated the association between hepatitis B vaccination and MS or optic neuritis onset using data from three HMOs participating in the VSD. The first demyelinating event analysis included 440 cases (documented diagnosis of MS or optic neuritis)
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received hepatitis B vaccine within the 18-week risk period, which suggested that possible confounders related to the decision to vaccinate were present. Although the authors considered three exposure times -- 6, 12, and 18 weeks after vaccination -- only the odds ratio for optic neuritis diagnosis within 18 weeks of hepatitis B vaccination was given (OR, 1.02; 95% CI, 0.68–1.54)
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Mechanistic Evidence The committee identified 15 publications reporting the development of a first demyelinating event (with or without relapse) in adults after the administration of hepatitis B vaccine.
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disease onset participating demyelinating disease onset any Cases had optic from medical in the VSD disease time after hepatitis neuritis or MS records or B vaccination: diagnosed by a 950 controls telephone 0.9 (95% CI, physician from interviews 0.6–1.5) 1995 through of patients 1999 with optic neuritis or MS diagnosis Payne Date of first Defense U.S.
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RR of first demyelinating event indefinitely (maximum of 2.29 years) after hepatitis B vaccination: 1.35 (95% CI, 0.61–3.01)
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Brain MRIs revealed new white matter disease after the first and third doses of vaccine. Weight of Mechanistic Evidence The two publications described above, when considered together, presented clinical evidence suggestive but not sufficient for the committee to conclude the vaccine may be a contributing cause of a first demyelinating event in adults after vaccination against hepatitis B
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was limited to diagnoses of ADEM and countered the null assessment of the epidemiologic evidence. The uncertainties in the epidemiologic evidence combined with the uncertainties in the mechanistic evidence impacted the committee's final interpretation as applied to the causality conclusion.
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Weight of Mechanistic Evidence The symptoms described in the publications referenced above are consistent with those leading to the diagnoses reported in the publications. Autoantibodies, T cells, and molecular mimicry may contribute to the symptoms reported in the publications; however, the publications did not provide evidence linking these mechanisms to hepatitis B vaccine.
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Autoantibodies, complement activation, immune complexes, T cells, and molecular mimicry may contribute to the symptoms of GBS; however, the publications did not provide evidence linking these mechanisms to hepatitis B vaccine. The committee assesses the mechanistic evidence regarding an as sociation between hepatitis B vaccine and GBS as lacking.
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Weight of Mechanistic Evidence The symptoms described in the publication referenced above are consistent with those leading to a diagnosis of CIDP. Autoantibodies, T cells, and molecular mimicry may contribute to the symptoms of CIDP; however, the publication did not provide evidence linking these mechanisms to hepatitis B vaccine.
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Weight of Epidemiologic Evidence The epidemiologic evidence is insufficient or absent to assess an association between hepatitis B vaccine and anaphylaxis. Mechanistic Evidence The committee identified two publications reporting anaphylaxis after the administration of hepatitis B vaccine.
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The committee assesses the mechanistic evidence regarding an association between hepatitis B vaccine and anaphylaxis in yeast sensitive individuals as strong based on ten cases presenting tempo rality and clinical symptoms consistent with anaphylaxis. Causality Conclusion Conclusion 8.17: The evidence convincingly supports a causal relationship between hepatitis B vaccine and anaphylaxis in yeast sensitive individuals.
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The publication reported a temporal association and recurrence of symptoms after vaccine rechallenge. Autoantibodies, T cells, complement activation, and immune complexes may contribute to the symptoms of erythema nodosum; however, the publications did not provide evidence linking these mechanisms to hepatitis B vaccine.
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was not considered in the weight of epidemiologic evidence because it provided data from a passive surveillance system and lacked an unvaccinated comparison population. The one remaining controlled study (Cooper et al., 2002)
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Mechanistic Evidence The committee identified 13 publications reporting the onset or exacerbation of SLE after the administration of hepatitis B vaccine. Twelve publications did not provide evidence beyond temporality, some too long or too short based on the possible mechanisms involved (Agmon-Levin et al., 2009; Delbrel et al., 1998; Finielz et al., 1998; Geier and Geier, 2005; Grezard et al., 1996; Guiserix, 1996; Maillefert et al., 1999, 2000; Mamoux and Dumont, 1994; Santoro et al., 2007; Senecal et al., 1999; Tudela et al., 1992)
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Nine publications did not provide evidence beyond temporality, some too long or too short based on the possible mechanisms involved (Allen et al., 1993; Bellut et al., 2001; Beretta et al., 2001; Cockwell et al., 1990; Jacobi et al., 2005;
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These publications did not contribute to the weight of mechanistic evidence. Described below are eight publications reporting clinical, diagnostic, or experimental evidence that contributed to the weight of mechanistic evidence.
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The first two cases did not provide evidence beyond a temporal relationship between vaccination and development of symptoms. These cases did not contribute to the weight of mechanistic evidence.
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In addition, the eight publications described above, when considered together, presented clinical evidence suggestive but not sufficient for the committee to conclude the vaccine may be a contributing cause of vasculitis after vaccination against hepatitis B The evidence contributing to the weight of mechanistic evidence includes the latency of several days to 4 weeks between vaccination and development of symptoms, the resolution of symptoms after vaccination, positive tests for circulating immune complexes or cryoglobulins, and recurrence or exacerbation of symptoms after revaccination against hepatitis B in two publications.
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Mechanistic Evidence The committee identified nine publications of onset or exacerbation of PAN after administration of a hepatitis B vaccine. Five publications did not provide evidence beyond temporality (de Carvalho et al., 2008; Kerleau et al., 1997; Le Goff et al., 1988, 1991; Saadoun et al., 2001)
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. Furthermore, circulating immune complexes containing hepatitis B surface antigen (HBsAg)
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In addition, autoantibodies, T cells, and complement activation may contribute to the symptoms of vasculitis; however, the publications did not provide evidence linking these mechanisms to hepatitis B vaccine. The committee assesses the mechanistic evidence regarding an as sociation between hepatitis B vaccine and onset or exacerbation of PAN as weak based on knowledge about the natural infection and three cases.
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Aherne and Collins (1995) did not provide evidence beyond temporality in the two cases and did not contribute to the weight of mechanistic evidence.
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. Described below are two publications reporting clinical, diagnostic, or experimental evidence that contributed to the weight of mechanistic evidence.
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In addition, molecular mimicry may contribute to the symptoms of reactive arthritis; however, the publications did not provide evidence linking this mechanism to hepatitis B vaccine. The committee assesses the mechanistic evidence regarding an as sociation between hepatitis B vaccine and onset or exacerbation of reactive arthritis as weak based on four cases.
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did not provide evidence beyond temporality and did not contribute to the weight of mechanistic evidence. Described below are seven publications reporting clinical, diagnostic, or experimental evidence that contributed to the weight of mechanistic evidence.
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Weight of Mechanistic Evidence Extrahepatic manifestations, including the development of arthralgia and polyarthritis, develop in 10–20 percent of patients with acute hepatitis and are thought to be mediated by circulating immune complexes (Koziel and Thio, 2010)
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In addition to immune complexes and molecular mimicry, autoantibodies, T cells, and complement activation may contribute to the symptoms of rheumatoid arthritis; however, the publications did not provide evidence linking these mechanisms to hepatitis B vaccine. The committee assesses the mechanistic evidence regarding an as sociation between hepatitis B vaccine and onset or exacerbation of rheumatoid arthritis as weak based on knowledge about the natural infection and 19 cases.
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These publications contributed to the weight of mechanistic evidence and are described below. Bracci and Zoppini (1997)
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The four publications described above, when considered together, did not present evidence sufficient for the committee to conclude the vaccine may be a contributing cause of juvenile idiopathic arthritis after vaccination against hepatitis B Bracci and Zoppini (1997)
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Autoantibodies, T cells, complement activation, and bystander activation may contribute to the symptoms of juvenile idiopathic arthritis; however, the publications did not provide evidence linking these mechanisms to hepatitis B vaccine. The committee assesses the mechanistic evidence regarding an as sociation between hepatitis B vaccine and onset or exacerbation of juvenile idiopathic arthritis as weak based on knowledge about the natural infection and eight cases.
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Weight of Mechanistic Evidence Autoantibodies, T cells, complement activation, and molecular mimicry may contribute to the symptoms of type 1 diabetes; however, the publication did not provide evidence linking these mechanisms to hepatitis B vaccine. The committee assesses the mechanistic evidence regarding an asso ciation between hepatitis B vaccine and type 1 diabetes as lacking.
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Mechanistic Evidence The committee did not identify literature reporting clinical, diagnostic, or experimental evidence of fibromyalgia after administration of a hepatitis B vaccine. Weight of Mechanistic Evidence The committee assesses the mechanistic evidence regarding an as sociation between hepatitis B vaccine and fibromyalgia as lacking.
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TABLE 8-4 Summary of Epidemiologic Assessments, Mechanistic Assessments, and Causality Conclusions for Hepatitis B Vaccine Studies Cases Contributing to Contributing to Epidemiologic the Epidemiologic Mechanistic the Mechanistic Causality Vaccine Adverse Event Assessment Assessment Assessment Assessment Conclusion Hepatitis B Encephalitis Insufficient None Lacking None Inadequate Hepatitis B Encephalopathy Insufficient None Lacking None Inadequate Hepatitis B Seizures Limited 1 Lacking None Inadequate Hepatitis B Acute Disseminated Encephalomyelitis Insufficient None Low- 2 Inadequate Intermediate Hepatitis B Transverse Myelitis Insufficient None Weak 1 Inadequate Hepatitis B Optic Neuritis* Limited 2 Lacking None Inadequate Hepatitis B Neuromyelitis Optica Insufficient None Lacking None Inadequate Hepatitis B Multiple Sclerosis Onset in Adults Limited 4 Lacking None Inadequate Hepatitis B Multiple Sclerosis Onset in Children Limited 1 Lacking None Inadequate Hepatitis B Multiple Sclerosis Relapse in Adults Limited 1 Lacking None Inadequate Hepatitis B Multiple Sclerosis Relapse in Children Limited 1 Lacking None Inadequate Hepatitis B First Demyelinating Event in Adults Moderate 3 Low- 2 Inadequate (null)
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Insufficient None (exacerbation) Hepatitis B Onset or Exacerbation of Vasculitis Insufficient None Low- 12 Inadequate Intermediate Hepatitis B Onset or Exacerbation Polyarteritis Nodosa Insufficient None Weak 3 Inadequate Hepatitis B Onset or Exacerbation of Psoriatic Arthritis Insufficient None Lacking None Inadequate
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Hepatitis B Onset or Exacerbation of Juvenile Insufficient None Weak 8 Inadequate Idiopathic Arthritis Hepatitis B Type 1 Diabetes Moderate 1 Lacking None Inadequate (null) Hepatitis B Fibromyalgia Insufficient None Lacking None Inadequate *
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2001. Safety data on meningococcal poly saccharide vaccine from the Vaccine Adverse Event Reporting System.
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2006. A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States -- recommendations of the Advisory Committee on Immunization Practices (ACIP)
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2006. Vaccination of yeast sensitive individuals: Review of safety data in the US Vaccine Adverse Event Reporting System (VAERS)
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2004. A case-series of adverse events, positive re-challenge of symptoms, and events in identical twins following hepatitis B vaccination: Analysis of the Vaccine Adverse Event Reporting System (VAERS)
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1996. Systemic lupus erythematosus following hepatitis B vaccine.
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1993. Acute myelitis following hepatitis B vaccination [in French]
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1996. Recombinant hepatitis B vaccination of neonates and infants: Emerging safety data from the Vaccine Adverse Event Reporting System.
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2009. Guillain-Barré syndrome after vaccination in United States: Data from the Centers for Disease Control and Prevention/ Food and Drug Administration Vaccine Adverse Event Reporting System (1990-2005)
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1998. Immunoglobulin- and hepatitis B surface antigen-specific circulating immune complexes in chronic hepatitis B virus infection.
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2001. Large artery vasculitis following recombinant hepatitis B vaccination: 2 cases.
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