286. Hepatitis B Vaccine Compliance: Comparing 2-Dose and 3-Dose Vaccines

Bruxvoort, Katia; Slezak, Jeff; Huang, Runxin; Sy, Lina S; Towner, William; Ackerson, Bradley; Reynolds, Kristi; Qian, Lei; Carlson, Cheryl M.; Solano, Zendi; Hyer, Randall N.; Janssen, Robert S.; Jacobsen, Steven J.

doi:10.1093/ofid/ofz360.361

Cited by 5 publications

(4 citation statements)

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“…The topic of our study is of current importance, as the occurrence of AMI in recipients of HepB‐CpG vaccine and HepB‐alum vaccine is being compared in an ongoing FDA‐mandated post‐licensure study of HepB‐CpG vaccine 7 . Safety findings from the post‐licensure study may be pivotal for influencing future recommendations for adult hepatitis B vaccination, especially among individuals with DM, given the shorter two‐dose schedule of HepB‐CpG vaccine 15 . The observed lack of association of AMI with HepB‐alum vaccine receipt in this study lends support to the use of a HepB‐alum vaccine comparator in the post‐licensure study.…”

Section: Discussionmentioning

confidence: 60%

Hepatitis B vaccine and risk of acute myocardial infarction among individuals with diabetes mellitus

Wong

Bruxvoort

Slezak

et al. 2021

Pharmacoepidemiology and Drug

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Purpose A pre‐licensure clinical trial of a two‐dose cytosine phosphoguanine adjuvanted hepatitis B vaccine (HEPLISAV‐B® [Dynavax, USA]; HepB‐CpG vaccine) found an unanticipated numerical imbalance in acute myocardial infarction (AMI) compared to recipients of a three‐dose aluminum adjuvanted hepatitis B vaccine (ENGERIX‐B® [GlaxoSmithKline, Belgium]; HepB‐alum vaccine). A post‐licensure study was required to compare AMI rates among recipients of HepB‐CpG vaccine and HepB‐alum vaccine. Individuals with diabetes mellitus (DM), who are at higher risk of AMI, comprise more than half of the post‐licensure study cohort. To inform the ongoing post‐licensure study, we examined the association between AMI and receipt of HepB‐alum vaccine in individuals with DM. Methods We conducted a case–control study nested in a cohort of individuals with DM ages ≥40 years at Kaiser Permanente Southern California using electronic health records. AMI cases from 2012 to 2017 were identified by principal discharge diagnosis and matched 1:1 with randomly selected controls. The adjusted odds ratio (aOR) for receipt of ≥1 HepB‐alum vaccine dose was compared for AMI cases and controls using conditional logistic regression. We subsequently performed the same matched case–control analysis stratified by year. Results Of 8138 matched case–control pairs, 17.4% of cases and 15.0% of controls received HepB‐alum vaccine. The aOR of HepB‐alum vaccination comparing cases and controls was 0.97 (95% confidence interval 0.87–1.08). Similarly, there was no significant association between HepB‐alum vaccine and AMI in any of the study years. Conclusions HepB‐alum vaccination was not associated with AMI in individuals with DM. This finding will provide contextual insight for the ongoing post‐licensure study of HepB‐CpG vaccine.

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Section: Discussionmentioning

confidence: 60%

Hepatitis B vaccine and risk of acute myocardial infarction among individuals with diabetes mellitus

Wong

Bruxvoort

Slezak

et al. 2021

Pharmacoepidemiology and Drug

Self Cite

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“…In a recent study of 6500 HepB-CpG recipients and 7733 Engerix-B recipients, HepB-CpG recipients were 5 times more likely to complete the vaccine series compared with Engerix-B recipients (adjusted hazard ratio = 5.17; 95% CI = 3.84-6.98). 30 These findings suggest that the 2-dose series results in greater adherence to vaccine series completion compared with the traditional 3-dose HBV series, potentially contributing to the reduction in the public health burden of this vaccine-preventable disease.…”

Section: Relevance To Patient Care and Clinical Practicementioning

confidence: 87%

Heplisav-B: A Hepatitis B Vaccine With a Novel Adjuvant

Champion

2020

Ann Pharmacother

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Objective: To review the immunogenicity and safety of a hepatitis B vaccine containing the cytosine phosphoguanosine (CpG) 1018 adjuvant (HepB-CpG). Data Sources: Literature searches were performed using PubMed and Scopus with the search terms hepatitis B vaccine, HepB-CpG, CpG 1018, 1018-ISS, HBsAg-1018, HBV-ISS, and Heplisav. Other sources included the Centers for Disease Control, the Food and Drug Administration, the Advisory Committee on Immunization Practices (ACIP), and prescribing information. Study Selection and Data Extraction: Search limits included randomized controlled trial in humans and published in English from January 2003 to August 2020. Studies using the final formulation and dosing schedule were reviewed. Data Synthesis: Studies demonstrated that 2 doses of HepB-CpG induced significantly higher seroprotective responses with a faster onset in adults, including those in hyporesponsive populations, compared with 3 doses of alum-adjuvanted Engerix-B. Although the safety profile was comparable to that of Engerix-B, one study observed higher rates of acute myocardial infarction, herpes zoster, and death with HepB-CpG. Relevance to Patient Care and Clinical Practice: ACIP recommends use of HepB-CpG as an option to prevent hepatitis B virus infection in adults ≥18 years old. Higher immune responses after 2 doses make it a promising option, especially in those with risk factors for hyporesponsiveness or at risk for poor adherence to vaccine series completion. Additional data are needed regarding the vaccine’s safety in the general population and the persistence of its antibody response. Conclusion: HepB-CpG has been shown to be as immunogenic as Engerix-B; however, long-term safety and persistence of immune memory has yet to be established.

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“…A prior meta‐analysis showed that financial incentives, followed by accelerated vaccine schedules had the highest efficacy in helping the PWID to complete the scheduled 3‐dose vaccination series 57 . The newly available and equally efficacious Heplisav‐B vaccine which requires only two doses over only 1 month (vs 3 doses over 6 months) should be considered in this population to improve compliance and adherence 58 …”

Section: Gaps In Hbv Vaccination and Preventionmentioning

confidence: 99%

Review article: current gaps and opportunities in HBV prevention, testing and linkage to care in the United States—a call for action

Yeo

Nguyen

2020

Aliment Pharmacol Ther

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SummaryBackgroundThe World Health Organization (WHO) has set an elimination goal for hepatitis B virus (HBV) by 2030, so a comprehensive review of current HBV testing and care gaps are needed to help formulate solutions and opportunities for action.AimsTo summarise current gaps and barriers, and to propose solutions for HBV prevention, testing and linkage to care in the United StatesMethodsRelevant guidelines and studies were reviewed including a systematic review of HCC surveillance adherence.ResultsA total of 64.5 million (95% CI, 61.3‐67.5) high‐risk US adults had no evidence of HBV immunity. Only 18.6% (95% CI, 13.5‐29.9) of privately insured patients with HBV infection have been diagnosed. Among those with known HBV infection, linkage to care rate (33.3%‐57%) was poor and the adherence to guidelines regarding anti‐viral therapy (30.66% [95% CI, 30.28‐31.03]) and HCC surveillance (8%‐87%, from a systematic review) were poor with even more concerning data for care and treatment retention. The causes are complex and include lack of access to medical care, lack of physician knowledge, lack of patient health literacy and awareness, linguistic and cultural barriers and fear of stigma.ConclusionsA ‘scale‐up’ effort is needed to optimise the care continuum to achieve the WHO 2030 targets. As targeted screening policy has leftover 80% of patients undiagnosed, we advocate for universal screening which can help to remove barriers regarding stigma. More active and system level interventions are also needed to improve linkage to care for patients with HBV infection.

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286. Hepatitis B Vaccine Compliance: Comparing 2-Dose and 3-Dose Vaccines

Cited by 5 publications

References 0 publications

Hepatitis B vaccine and risk of acute myocardial infarction among individuals with diabetes mellitus

Hepatitis B vaccine and risk of acute myocardial infarction among individuals with diabetes mellitus

Heplisav-B: A Hepatitis B Vaccine With a Novel Adjuvant

Review article: current gaps and opportunities in HBV prevention, testing and linkage to care in the United States—a call for action

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