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Journal Article•DOI•

Antibody persistence and immune memory in adults, 15 years after a three‐dose schedule of a combined hepatitis A and B vaccine

P. Van Damme, Geert Leroux-Roels1, P. Crasta2, Marc Messier3, Jeanne-Marie Jacquet3, K. Van Herck1 •
Ghent University1, GlaxoSmithKline Pharmaceuticals Ltd2, GlaxoSmithKline3
01 Jan 2012-Journal of Medical Virology (J Med Virol)-Vol. 84, Iss: 1, pp 11-17
TL;DR: This study confirms the long‐term immunogenicity of the three‐dose regimen of the combined hepatitis A and B vaccine, as eliciting long-term persistence of antibodies and immune memory against hepatitis Aand B for up to at least 15 years after a primary vaccination.
Abstract: A combined hepatitis A and B vaccine is available since 1996. Two separate open-label primary studies evaluated the immunogenicity and safety of this hepatitis A and B vaccine (720 EI.U of HAV and 20 µg of HBsAg) in 306 healthy subjects aged 17–43 years who received three doses of the vaccine following a 0, 1, and 6 months schedule. These subjects were followed up annually for the next 15 years to evaluate long-term persistence of anti-HAV and anti-HBs antibodies. The subjects whose antibody concentrations fell below the cut-offs between Year 11 and Year 15 (anti-HAV: <15 mIU/ml; anti-HBs: <10 mIU/ml) were offered an additional dose of the appropriate monovalent hepatitis A and/or B vaccine. In subjects who received the additional vaccine dose, a blood sample was collected 1 month after vaccination. At the Year 15 time point, all subjects in Study A and Study B were seropositive for anti-HAV antibodies and 89.3% and 92.9% of subjects in the respective studies had anti-HBs antibody concentrations ≥10 mIU/ml. Four subjects (two in each study) received an additional dose of monovalent hepatitis B vaccine and mounted anamnestic responses to vaccination. No vaccine-related serious adverse events were reported. This study confirms the long-term immunogenicity of the three-dose regimen of the combined hepatitis A and B vaccine, as eliciting long-term persistence of antibodies and immune memory against hepatitis A and B for up to at least 15 years after a primary vaccination. J. Med. Virol. 84:11–17, 2011. © 2011 Wiley Periodicals, Inc.
Citations
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Journal Article•DOI•
Medical Considerations before International Travel

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David O. Freedman1, Lin H. Chen2, Phyllis E. Kozarsky3•
University of Alabama at Birmingham1, Mount Auburn Hospital2, Harvard University3
20 Jul 2016-The New England Journal of Medicine
TL;DR: The scope of illnesses that may befall international travelers is broad and a guide to preparing for the preventable causes of illness is provided.
Abstract: The scope of illnesses that may befall international travelers is broad. A guide to preparing for the preventable causes of illness is provided. Physicians may find it useful in counseling their patients who travel internationally.

77 citations

Report•DOI•
Safety of Vaccines Used for Routine Immunization in the United States

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Margaret Maglione, Courtney A. Gidengil, Lopamudra Das, Laura Raaen, Alexandria Smith, Ramya Chari, Sydne J Newberry, Susanne Hempel, Roberta M. Shanman, Tanja Perry, Matthew Bidwell Goetz 
01 Jul 2014
TL;DR: Evidence was insufficient to make conclusions regarding whether several routinely recommended vaccines are associated with serious conditions such as multiple sclerosis, transverse myelitis, and acute disseminated encephalomyelitis; however, important factors must be taken into account when determining whether studies are warranted.
Abstract: Objectives To conduct a systematic review of the literature on the safety of vaccines recommended for routine immunization of children, adolescents, and adults in the United States as of 2011. Data sources We included placebo-controlled clinical trials and cohort studies comparing vaccinated and unvaccinated patients. We also included the following types of post-licensure analyses: case-control studies, self-controlled case series, and multivariate risk factor analyses. We conducted an electronic search of PubMed from inception through August 2013, and reviewed Advisory Committee for Immunization Practices statements, vaccine package inserts, and previously published reviews to identify studies. Scientific Information Packets were requested from vaccine manufacturers. Review methods We reviewed the methodology of the 2011 Institute of Medicine (IOM) consensus report "Adverse Effects of Vaccines: Evidence and Causality" and accepted their findings. We augmented their work with new studies and additional vaccines. For studies not included in the IOM report, we abstracted data on the presence or absence of adverse health outcomes, characteristics of patients, study design, and vaccine description, including brand, potency, dosage, timing, and formulation, where available. We excluded formulations not used in the United States. The McHarm instrument was used to evaluate the quality of adverse events collection and reporting in each study. We were unable to pool results; we rated the overall strength of evidence (SOE) as high, moderate, low, or insufficient by using guidance suggested by the Agency for Healthcare Research and Quality for its Effective Health Care Program. Results A total of 20,478 titles were identified; after title, abstract, and full-text review, 166 studies were accepted for abstraction. The vast majority of studies either did not investigate or could not identify risk factors for adverse events (AEs) associated with vaccination. Similarly, the severity of AEs was inconsistently reported, as was information that would make independent severity determination possible. SOE was high for the following associations in nonpregnant adults: seasonal influenza vaccine and arthralgia, myalgia, malaise, fever, pain at injection site; 2009 monovalent H1N1 vaccine and Guillain-Barre syndrome (GBS); and a lack of association between influenza and pneumococcal vaccines and cardiovascular events in the elderly. Risk of GBS was estimated at 1.6 excess cases per million persons vaccinated. SOE was high for the following associations in children and adolescents: measles, mumps, rubella (MMR) vaccine and febrile seizures in children under age 5; lack of association between MMR vaccine and autism spectrum disorders; and varicella vaccine and disseminated Oka strain varicella zoster virus with associated complications (i.e., meningitis, encephalitis) in individuals with demonstrated immunodeficiencies. There is moderate SOE that vaccines against rotavirus are associated with intussusception in children; risk was estimated as 1 to 5 cases per 100,000 vaccine doses, depending on brand. Moderate-strength evidence exists regarding human papillomavirus vaccine and a lack of association with onset of juvenile rheumatoid arthritis, type 1 diabetes, and GBS. Moderate-strength evidence shows no association between inactivated influenza vaccine and serious AEs in pregnant women.Evidence was insufficient to make conclusions regarding whether several routinely recommended vaccines are associated with serious conditions such as multiple sclerosis, transverse myelitis, and acute disseminated encephalomyelitis. Conclusions There is evidence that some vaccines are associated with serious adverse events; however, these events are extremely rare and must be weighed against the protective benefits that vaccines provide. Careful consideration should be given to the investigation of research gaps, including patient risk factors that may be associated with AEs; however, important factors must be taken into account when determining whether studies are warranted, including the severity and frequency of the AE being studied and the challenges of conducting sufficiently powered studies when investigating rare events.

37 citations

Journal Article•DOI•
Persistence of antibodies 20 y after vaccination with a combined hepatitis A and B vaccine.

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Pierre Van Damme1, Geert Leroux-Roels2, P.V. Suryakiran, Nicolas Folschweiller, Olivier Van Der Meeren •
University of Antwerp1, Ghent University Hospital2
10 Mar 2017-Human Vaccines & Immunotherapeutics
TL;DR: Immunogenicity data confirm that primary immunization with 3-doses of HAB induces persisting anti-HAV and anti-HBs specific antibodies in most adults for up to 20 y; mathematical modeling predicts even longer-term protection.
Abstract: Vaccination is the most effective and well-tolerated method of conferring long-term protection against hepatitis A and B viruses (HAV; HBV). Long-term studies are required to characterize the duration of protection and need for boosters. Following primary immunization of 150 and 157 healthy adults with 3-doses of combined hepatitis A/hepatitis B vaccine (HAB; Twinrix™, GSK Vaccines, Belgium) at 0-1-6 months in 2 separate studies, we measured vaccine-induced antibody persistence against HAV and HBV annually for 20 y (Study A: NCT01000324; Study B: NCT01037114). Subjects with circulating anti-HAV antibodies < 15 mIU/mL or with anti-hepatitis B surface antigen < 10 mIU/mL were offered an additional monovalent hepatitis A and/or B vaccine dose (Havrix™/Engerix™-B, GSK Vaccines, Belgium). Applying the immunogenicity results from these studies, mathematical modeling predicted long-term persistence. After 20 y, 18 and 25 subjects in studies A and B, respectively, comprised the long-term according-to-prot...

34 citations

Cites background or methods or result from "Antibody persistence and immune mem..."

  • ...Such a trend was also commented upon at Year 15, when the differences were attributed to likely inconsistencies in the study cohorts and natural variations in GMC.22 The first observations from these clinical trials had suggested that protection would last 5–10 y.16,18,19 However, by applying these data for hepatitis A vaccine in mathematical models, it was estimated that anti-HAV antibody titers after a complete primary course would persist for 25 y in 95% of vacinees.23 Our current data, using the HAB vaccine, collected up to 20 y after vaccination, confirm that most subjects still present circulating antibodies at Year 20....

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  • ...Such a trend was also commented upon at Year 15, when the differences were attributed to likely inconsistencies in the study cohorts and natural variations in GMC.(22)...

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  • ...Over the course of the 20 y follow-up, several assay changes were required and details of the assays used until Year 15 are described by Van Damme et al (2012).22 From Years 16 to 20, anti-HAV antibodies were assessed using a commercially available enzyme-linked immunoassay (EnzygnostTM , Siemens…...

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  • ...Over the course of the 20 y follow-up, several assay changes were required and details of the assays used until Year 15 are described by Van Damme et al (2012).22 From Years 16 to 20, anti-HAV antibodies were assessed using a commercially available enzyme-linked immunoassay (EnzygnostTM , Siemens Healthcare, Germany; seropositivity cut-off: 15 mIU/mL)....

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  • ...We observed a steep fall in both anti-HAV and antiHBs antibodies up to Month 12 in both studies, followed by an apparent stabilization until Year 15.(22) Our current results confirm that the vast majority of subjects still present circulating antibodies after 20 y, and suggest that the shallow decrease in GMC is maintained [anti-HAV antibody GMCs: 229....

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Journal Article•DOI•
New challenges in viral hepatitis

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David L. Thomas1, Fabien Zoulim2•
Johns Hopkins University1, University of Lyon2
01 May 2012-Gut
TL;DR: This supplement to Gut looks forward to the next generation of challenges in the field of viral hepatitis, and this introductory article highlights several key issues.
Abstract: Over the past few decades there has been remarkable progress in viral hepatitis. Beginning with discovery of the viral agents, we now have reliable methods to diagnose and monitor all hepatitis virus infections, as well significant advances in treatment and prevention. Nonetheless, important challenges remain. This supplement to Gut looks forward to the next generation of challenges in the field of viral hepatitis, and this introductory article highlights several key issues.

31 citations

Cites background from "Antibody persistence and immune mem..."

  • ...In addition, a recent study of 306 persons vaccinated in 1996 with three doses of the combined HAV and HBV vaccine demonstrated that all had anti-HAV titres >15 mIU/ml 15 years later.(14) Thus, given the safety and durability of HAV vaccination, clearly the major future challenge is coupling vaccination with other methods of preventing HAV infection to eliminate HAV from humans....

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Journal Article•DOI•
Prevalence of Hepatitis B Vaccination Coverage and Serologic Evidence of Immunity Among US-Born Children and Adolescents From 1999 to 2016.

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Michael H. Le1, Yee Hui Yeo1, Samuel So1, E.J. Gane2, Ramsey Cheung1, Ramsey Cheung3, Mindie H. Nguyen1 •
Stanford University1, University of Auckland2, Veterans Health Administration3
02 Nov 2020
TL;DR: This cross-sectional study used NHANES data from 1999 to 2016 to assess the trends in self-reported hepatitis B vaccination coverage and serologic evidence of immunity among children and adolescents in the US.
Abstract: Importance The World Health Assembly has called for the elimination of hepatitis B and C by 2030. As hepatitis B has no cure, the US strategy to eliminate hepatitis B has focused on prevention through vaccination. However, there are limited data on the trend in vaccine-associated immunity since the US implementation of universal infant hepatitis B vaccination. Objective To compare self-reported hepatitis B vaccination coverage among children and adolescents with serologic evidence of immunity and infection in the US from 1999 to 2016. Design, Setting, and Participants This population-based cross-sectional study used data from the National Health and Nutrition Examination Survey (NHANES) from 1999 to 2016. US-born persons aged 2 to 18 years without missing hepatitis B serologic test results and with reported vaccination history were included. Data were analyzed from September 2017 to June 2018. Main Outcomes and Measures The proportion of participants who reported complete vaccination for hepatitis B and who had positive serologic test results indicating immunity. Results Of 21 873 children and adolescents, 51.2%% were male, and the mean (SD) age was 10.6 (4.6) years. The survey reported that hepatitis B vaccination coverage increased significantly from 1999 to 2016 (from 62.6% [95% CI, 58.6%-66.4%] to 86.3% [95% CI, 82.9%-89.2%]; P < .001). Vaccine-associated immunity also increased from 1999 to 2016 among children aged 2 to 5 years (from 60.7% [95% CI, 48.8%-71.4%] to 65.2% [95% CI, 57.4%-72.3%]; P = .001) but decreased among children aged 6 to 10 years (from 64.6% [95% CI, 57.7%-70.9%] to 46.5% [95% CI, 39.1%-54.0%]; P < .001), adolescents aged 11 to 13 years (from 68.8% [95% CI, 58.1%-77.8%] to 26.2% [95% CI, 18.6%-35.5%]; P < .001), and adolescents aged 14 to 18 years (from 68.5% [95% CI, 62.9%-73.6%] to 15.6% [95% CI, 12.2%-19.8%]; P < .001). By birth year, serologic evidence of vaccine-associated immunity significantly decreased in the 1994-2003 NHANES birth cohort but not among those born between 1988 and 1993. Non-US-born children and adolescents did not show the same decreasing trend in immunity. Conclusions and Relevance In this cross-sectional study, decreasing hepatitis B immunity was observed among US-born children and adolescents in the 1994-2003 NHANES birth cohort despite increasing rates of hepatitis B vaccination coverage. These findings suggest a possible need for surveillance and a booster vaccine dose for hepatitis B as those without serologic evidence of immunity become young adults and may engage in behaviors associated with an increased risk for infection.

25 citations

References
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Journal Article•DOI•
Hepatitis A virus seroprevalence by age and world region, 1990 and 2005.

[...]

Kathryn H. Jacobsen1, Steven T. Wiersma2•
George Mason University1, World Health Organization2
24 Sep 2010-Vaccine
TL;DR: Anti-HAV prevalence estimates in this analysis suggest that middle-income regions in Asia, Latin America, Eastern Europe, and the Middle East currently have an intermediate or low level of endemicity.

488 citations

of Young Adults.

[...]

E Rodney
01 Jan 1998

465 citations

"Antibody persistence and immune mem..." refers background in this paper

  • ...2011 WILEY PERIODICALS, INC. Wielen et al., 2000; Burgess and Rodger, 2001; Van Damme et al., 2001]....

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Journal Article•DOI•
Hepatitis A booster vaccination: is there a need?

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Pierre Van Damme1, J. E. Banatvala, O Fay, S Iwarson, Brian J. McMahon, K. van Herck, Daniel Shouval, Paolo Bonanni, Bradley A. Connor, G Cooksley, Geert Leroux-Roels, F Von Sonnenburg •
University of Antwerp1
27 Sep 2003-The Lancet
TL;DR: There is no evidence to lend support to HAV booster vaccination after a full primary vaccination course in a healthy individual, and further investigations are needed before deciding if boosters can be omitted in special patient-groups.

223 citations

"Antibody persistence and immune mem..." refers background in this paper

  • ...Active immunization is a well-established, safe and effective method of conferring long-term protection against hepatitis A and B infections in susceptible persons [Van Herck et al., 1999, 2007; Van Der Grant sponsor: GlaxoSmithKline Biologicals....

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  • ...The pattern of decline in the anti-HAV and antiHBs antibody GMCs over time in this study was comparable to that observed in previous studies with the hepatitis A and B vaccine—a rapid decline in the first year followed by a more gradual decrease over the subsequent years [Van Damme et al., 2001; Van Herck et al., 2007]; this has also been observed for monovalent hepatitis A and B vaccines [Duval et al., 2005; Rendi-Wagner et al., 2007]....

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  • ...…to be correlated to loss of long-term protection and immune memory against hepatitis A and B disease, as shown for monovalent vaccines [Banatvala et al., 2000; Van Damme et al., 2003; Gabbuti et al., 2007] and the same principle is expected to hold true for this combined hepatitis A and B vaccine....

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  • ...*Correspondence to: P. Van Damme, MD, PhD, Professor, Faculty of Medicine, Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute (WHO Collaborating Centre), University of Antwerp, Campus Drie Eiken (room R2....

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  • ...No vaccine-related SAEs were reported at the Year 15 time point since the previous publication [Van Herck et al., 2007]....

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Journal Article•DOI•
Lifelong protection against hepatitis B: the role of vaccine immunogenicity in immune memory.

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J. E. Banatvala1, Pierre Van Damme2, Stephan Oehen3•
John Radcliffe Hospital1, University of Antwerp2, University of Zurich3
22 Nov 2000-Vaccine
TL;DR: New knowledge is presented that allows a better understanding of the mechanisms of long-term protection following hepatitis B vaccination and the use of highly immunogenic HB vaccines in order to provide long-lasting protection against HB disease.

202 citations

"Antibody persistence and immune mem..." refers background in this paper

  • ...…considered to be correlated to loss of long-term protection and immune memory against hepatitis A and B disease, as shown for monovalent vaccines [Banatvala et al., 2000; Van Damme et al., 2003; Gabbuti et al., 2007] and the same principle is expected to hold true for this combined hepatitis A…...

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Journal Article•DOI•
The first combined vaccine against hepatitis A and B: an overview.

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S. Thoelen, P. Van Damme1, A Leentvaar-Kuypers, Geert Leroux-Roels, M Bruguera, P. C. Frei2, V Bakasenas, Assad Safary •
University of Antwerp1, University Hospital of Lausanne2
01 Jan 1999-Vaccine
TL;DR: The combined hepatitis A and B vaccine Twinrix proves to be consistently safe, well tolerated and highly immunogenic and compares well with serological responses reached with monovalent vaccines.

112 citations

"Antibody persistence and immune mem..." refers result in this paper

  • ...Similar observations indicating a negative correlation between universal mass immunization against hepatitis A and HAV-associated morbidity have been reported in other countries [Andre, 2006; Torner et al., 2011]....

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Trending Questions (1)
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This study confirms the long‐term immunogenicity of the three‐dose regimen of the combined hepatitis A and B vaccine, as eliciting long‐term persistence of antibodies and immune memory against hepatitis A and B for up to at least 15 years after a primary vaccination.

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