- Adherence to hepatitis A and hepatitis B multi-dose vaccination schedules among adults in the United Kingdom: a retrospective cohort study. [Journal Article]
- BPBMC Public Health 2019 Apr 15; 19(1):404
- CONCLUSIONS: Adherence and series completion rates for hepatitis A and B vaccines in the UK are low. Identifying, understanding, and addressing barriers to series completion for multi-dose vaccines for adults in real-world settings are needed.
- Notes from the Field: Acute Hepatitis A Virus Infection Among Previously Vaccinated Persons with HIV Infection - Tennessee, 2018. [Journal Article]
- MMMMWR Morb Mortal Wkly Rep 2019 Apr 12; 68(14):328-329
- [The challenges of hepatitis A vaccine]. [Journal Article]
- RPRev Prat 2018; 68(3):291-292
- Changes in seroprevalence of hepatitis A after the implementation of universal childhood vaccination in Shandong Province, China: A comparison between 2006 and 2014. [Journal Article]
- IJInt J Infect Dis 2019; 82:129-134
- CONCLUSIONS: The national HepA routine immunization program has had a positive effect, leading to an increase in anti-HAV seroprevalence among children in Shandong Province, China. More attention should be paid to young adults in the province.
- Talk to Patients About: Hepatitis A. [Journal Article]
- TMTex Med 2018 May 01; 114(5):46
- Clinical experience with the inactivated hepatitis A vaccine, Avaxim 80U Pediatric. [Review]
- ERExpert Rev Vaccines 2019; 18(3):209-223
- Hepatitis A, caused by hepatitis A virus (HAV), is primarily transmitted via the fecal/oral route either through ingestion of contaminated food and water or through direct contact with an infectious …
Hepatitis A, caused by hepatitis A virus (HAV), is primarily transmitted via the fecal/oral route either through ingestion of contaminated food and water or through direct contact with an infectious person. Prevalence of hepatitis A is strongly correlated with socioeconomic factors, decreasing with increased socio-economic development, access to clean water and sanitation. Vaccination against HAV should be part of a comprehensive plan for the prevention and control of viral hepatitis, either as part of regular childhood immunization programs or with other recommended vaccines for travelers. Areas covered: We present here evidence for the immunogenicity and safety of an inactivated HAV pediatric vaccine (Avaxim® 80U Pediatric, Sanofi Pasteur), indicated for use in children aged 12 months to 15 years. Data evaluated are from trials undertaken during the clinical development of this vaccine, a systematic literature review and post-market pharmacovigilance. Expert opinion: The pediatric HAV vaccine is highly immunogenic and generates long-lasting protection against hepatitis A disease in children. The safety and immunogenicity data presented in this review suggest that the pediatric HAV vaccine is a valuable option in the prevention of HAV infection in children in many areas of the world where the disease remains a healthcare issue.
- Recommendations of the Advisory Committee on Immunization Practices for Use of Hepatitis A Vaccine for Persons Experiencing Homelessness. [Journal Article]
- MMMMWR Morb Mortal Wkly Rep 2019 Feb 15; 68(6):153-156
- Hepatitis A (HepA) vaccination is recommended routinely for children at age 12-23 months, for persons who are at increased risk for hepatitis A virus (HAV) infection, and for any person wishing to ob…
Hepatitis A (HepA) vaccination is recommended routinely for children at age 12-23 months, for persons who are at increased risk for hepatitis A virus (HAV) infection, and for any person wishing to obtain immunity. Persons at increased risk for HAV infection include international travelers to areas with high or intermediate hepatitis A endemicity, men who have sex with men, users of injection and noninjection drugs, persons with chronic liver disease, person with clotting factor disorders, persons who work with HAV-infected primates or with HAV in a research laboratory setting, and persons who anticipate close contact with an international adoptee from a country of high or interme-diate endemicity (1-3). Persons experiencing homelessness are also at higher risk for HAV infection and severe infection-associated outcomes. On October 24, 2018, the Advisory Committee on Immunization Practices (ACIP)* recommended that all persons aged 1 year and older experiencing homelessness be routinely immunized against HAV. The ACIP Hepatitis Vaccines Work Group conducted a systematic review of the evidence for administering vaccine to persons experiencing homelessness, which included a set of criteria assessing the benefits and adverse events associated with vaccination. HepA vaccines are highly immunogenic, and >95% of immunocompetent adults develop protective antibody within 4 weeks of receipt of 1 dose of the vaccine (1). HAV infections are acquired primarily by the fecal-oral route by either person-to-person transmission or via ingestion of contaminated food or water. Among persons experiencing homelessness, effective implementation of alternative strategies to prevent exposure to HAV, such as strict hand hygiene, is difficult because of living conditions among persons in this population. Integrating routine HepA vaccination into health care services for persons experiencing homelessness can reduce the size of the at-risk population over time and thereby reduce the risk for large-scale outbreaks.
- Immunogenicity and side-effects of the inactivated hepatitis A vaccine in periodic fever, aphthous stomatitis, pharyngitis, and adenitis patients. [Journal Article]
- PIPediatr Int 2019; 61(1):104-106
- The aim of this study was to compare the immunogenicity and side-effects of hepatitis A virus (HAV) vaccination between periodic fever, aphthous stomatitis, pharyngitis, and adenitis (PFAPA) patients…
The aim of this study was to compare the immunogenicity and side-effects of hepatitis A virus (HAV) vaccination between periodic fever, aphthous stomatitis, pharyngitis, and adenitis (PFAPA) patients and healthy controls who have not been previously exposed to HAV. A prospective observational study was carried out of 28 PFAPA patients and 76 controls who received two doses of the vaccine. Immunogenicity was expressed as seroconversion and seroprotection rates; mean HAV-immunoglobulin G concentration was measured at 0, 1, 7 and 18 months. Side-effects were defined as incidence of adverse events and the effect of vaccination on PFAPA symptoms. All participants were seronegative and seroconverted at 1 month. One month after primary vaccination, 92.9% of PFAPA patients and 77.6% of the controls attained seroprotection, while the rates increased to 100% and 96.1%, respectively, 1 month after the second dose. Seroprotection rates remained adequate 1 year after completion of vaccination. In conclusion, two doses of the inactivated HAV vaccine are well-tolerated and effective in children with PFAPA.
- Comparison of the immunogenicity and safety of 3 inactivated hepatitis A vaccines in Korean children aged 12 to 18 months: An open-label, randomized, prospective, multicenter study. [Randomized Controlled Trial]
- MMedicine (Baltimore) 2019; 98(6):e14364
- Several approved inactivated hepatitis A (HA) vaccines are available in Korea. These have been shown to be immunogenic and safe in European children; however, their immunogenicity and safety have not…
Several approved inactivated hepatitis A (HA) vaccines are available in Korea. These have been shown to be immunogenic and safe in European children; however, their immunogenicity and safety have not been investigated among Korean children. We aimed to compare the immunogenicity and safety of the most commonly used HA vaccines in ethnic Korean children aged 12 to 18 months.In this open-label, randomized, prospective, multicenter study, 108 children were enrolled and randomized to receive a pediatric form of Avaxim, Epaxal, or Havrix. The 2nd dose was administered after an interval of 6 months. Anti-HA virus (HAV) immunoglobulin (Ig) G was measured to assess geometric mean concentrations (GMCs) and seropositvity rates (≥20 mIU/mL anti-HAV IgG). To assess safety, local solicited adverse events (AEs), systemic solicited AEs, unsolicited AEs, and serious AEs (SAEs) were graded.Among the 108 participants enrolled, 37, 34, and 37 received Avaxim, Epaxal, and Havrix, respectively. After administration of 2 doses, the seropositivity rates in the Avaxim, Epaxal, and Havrix groups were all 100% (95% confidence intervals [CIs]: 99.0-100, 98.9-100, and 99.0-100, respectively; P < .001). The anti-HAV GMCs in the Avaxim, Epaxal, and Havrix groups were 5868.4 (95% CI: 4237.2-8126.6), 1962.1 (95% CI: 1298.0-2965.9), and 2232.9 mIU/mL (95% CI: 1428.4-3490.4), respectively, after administration of 2 doses (P < .001). There were no significant differences in the proportions of participants reporting local solicited AEs, systemic solicited AEs, unsolicited AEs, and SAEs among the 3 vaccine groups after the 1st and 2nd doses. All local solicited and unsolicited AEs were grade 1 or 2. Grade 3 systemic solicited AE occurred in 5.4% and 2.9% of the participants in the Havrix group after the 1st and 2nd doses, respectively. SAEs after the 1st and 2nd doses were reported in 2 participants and 1 participant, respectively, but none was assessed as being related to vaccination.The results indicate that these vaccines were safe and immunogenic in ethnic Korean children. The results have contributed to the establishing of an HA vaccination policy in Korea and will be informative to countries that plan to initiate vaccination programs against HAV.
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- Establishment of an erythropoietin CRS with stable measurable dimer content for SEC system suitability qualification [Journal Article]
- PBPharmeur Bio Sci Notes 2019; 2019:11-26
- The European Pharmacopoeia (Ph. Eur.) monograph 1316 'Erythropoietin concentrated solution' prescribes that the dimer content of therapeutic erythropoietin (EPO) preparations must not exceed 2% as de…
The European Pharmacopoeia (Ph. Eur.) monograph 1316 'Erythropoietin concentrated solution' prescribes that the dimer content of therapeutic erythropoietin (EPO) preparations must not exceed 2% as determined by Size-Exclusion Chromatography (SEC). This report describes the evaluation of a candidate Chemical Reference Substance (cCRS) to serve as system suitability reference material for the qualification of SEC systems used to assess dimer and oligomer content in EPO solutions. The study organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM) was performed with the participation of six European laboratories which tested the candidate material and the EPO for physicochemical tests CRS batch 1. The candidate material was shown to be a suitable reference material for the determination of the resolving capability of the SEC system for separation of dimer and higher oligomers from monomeric EPO. The cCRS was adopted by the Ph. Eur. Commission as Erythropoietin for SEC system suitability CRS batch 1 following consideration of the report. The importance of the resolving capability of the SEC system, as defined by the peak ratios or the peak-to-valley resolution, together with the asymmetry of the peaks eluted, and the linear response of the UV detector were all seen as critical parameters. Therefore, the monograph Erythropoietin concentrated solution (1316) was revised concomitantly to take account of the CRS and to set acceptance criteria for these critical parameters..