A review of immunogenicity and tolerability of live attenuated Hepatitis A vaccine in children

Rao, Sameer; Mao, Jiang-sen; Motlekar, Salman; Zhuang, Fang-cheng; Kadhe, Ganesh

doi:10.1080/21645515.2016.1216286

Cited by 25 publications

(22 citation statements)

References 24 publications

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“…Live, attenuated HAV vaccines have been developed in China for subcutaneous (s.c.) injection in a freeze-dried form, and are also licensed in India, the Philippines, Thailand and Guatemala (Table 2). 73,75,[160][161][162] These vaccines are usually employed in a single-dose strategy and have a shelf life of 18 months. 160 In 2007, China introduced universal mass vaccination (UMV), targeting 18-month-old toddlers.…”

Section: Active Immunisation With Hepatitis a Vaccinesmentioning

confidence: 99%

Type A viral hepatitis: A summary and update on the molecular virology, epidemiology, pathogenesis and prevention

Lemon

Ott

Damme

et al. 2018

Journal of Hepatology

226

251

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Although epidemic jaundice was well known to physicians of antiquity, it is only in recent years that medical science has begun to unravel the origins of hepatitis A virus (HAV) and the unique pathobiology underlying acute hepatitis A in humans. Improvements in sanitation and the successful development of highly efficacious vaccines have markedly reduced the worldwide prevalence and incidence of this enterically-transmitted infection over the past quarter century, yet the virus persists in vulnerable populations and remains a common cause of food-borne disease outbreaks in economically-advantaged societies. Reductions in the prevalence of HAV have led to increases in the median age at which infection occurs, often resulting in more severe disease in affected persons and paradoxical increases in disease burden in some developing nations. Here, we summarize recent advances in the molecular virology of HAV, an atypical member of the Picornaviridae family, survey what is known of the pathogenesis of hepatitis A in humans and the host-pathogen interactions that typify the infection, and review medical and public health aspects of immunisation and disease prevention.

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Section: Active Immunisation With Hepatitis a Vaccinesmentioning

confidence: 99%

Type A viral hepatitis: A summary and update on the molecular virology, epidemiology, pathogenesis and prevention

Lemon

Ott

Damme

et al. 2018

Journal of Hepatology

226

251

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“…Although integrated safety analyses can be affected by methodological limitations, as described above, the incidences of systemic and injection-site AEs, and most common AEs, following HAVi were within the ranges for other licensed hepatitis A vaccines. 7,[21][22][23] Since its introduction in the US in 2006, HAVi has contributed to an all-time low for hepatitis A disease Table 5. Summary of body temperatures using brighton collaboration temperature categories by vaccination group: days 1 to 5 following any vaccination (Studies 1-5 combined).…”

Section: Discussionmentioning

confidence: 99%

Safety and immunogenicity of VAQTA® in children 12-to-23 months of age with and without administration of other US pediatric vaccines

Petrecz

Acosta

Klopfer

et al. 2018

Human Vaccines & Immunotherapeutics

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Safety and immunogenicity data from 5 clinical trials conducted in the US in children 12-to-23 months old where HAVi was administered alone or concomitantly with other pediatric vaccines (M-M-R®II, Varivax®, TRIPEDIA®, Prevnar®, ProQuad®, PedvaxHIB®, and INFANRIX®) were combined. Among 4,374 participants receiving ≥ 1 dose of HAVi, 4,222 (97%) had safety follow-up and the proportions reporting adverse events (AE) were comparable when administered alone (69.4%) or concomitantly with other pediatric vaccines (71.1%). The most common solicited injection-site AEs were pain/tenderness (Postdose 1: 25.8%; Postdose 2: 26.1%) and redness (Postdose 1: 13.6%; Postdose 2: 15.1%). The most common vaccine-related systemic AEs were fever (≥ 100.4ºF, 12.2%) and irritability (8.1%). Serious AEs (SAEs) were observed at a rate of 0.4%; 0.1% were considered vaccine-related. No deaths were reported within 14 days following a dose of HAVi. These integrated analyses also showed that protective antibody concentrations were elicited in 100% of toddlers after two doses and 92% after a single dose, regardless of whether HAVi was given concomitantly with other vaccines or alone. These results demonstrate that HAVi was well-tolerated whether given alone or concomitantly with other vaccines, with a low incidence of vaccine-related SAEs. HAVi was immunogenic in this age group regardless of whether administered with or without other pediatric vaccines and whether 1 or 2 doses were administered. HAVi did not impact the immune response to other vaccines. These data continue to support the routine use of HAVi with other pediatric vaccines in children ≥ 12 months of age.

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“…Anti-HAV antibody levels≥20 mIU/mL were defined as seroprotection. 2,4,12,13 Consent and study approval…”

Section: Clinical Trial Methodologymentioning

confidence: 99%

“…Hepatitis A is a contagious virus that could induce liver disease. [2][3][4] HAV is usually transmitted person-to-person through the fecaloral route or through the consumption of contaminated food or water. 5,6 HAV infection can induce illness with fever, nausea, abdominal pain and jaundice.…”

Section: Introductionmentioning

confidence: 99%

Immunogenicity persistence in children of hepatitis A vaccines Healive® and Havrix®: 11 years follow-up and long-term prediction

Wang

Qi²,

et al. 2020

Human Vaccines & Immunotherapeutics

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Background: Hepatitis A vaccine has been used in mass and routine public vaccination programs in China. Long-term follow-up studies are required to determine the duration of protection and the need for booster vaccinations. Methods: A prospective, randomized, open-label clinical trial was performed to compare the geometric mean concentration (GMC) and seroprotection rates of anti-Hepatitis A virus (HAV) antibodies elicited by the inactivated vaccines Healive and Havrix. 400 healthy children were randomly assigned 3:1 ratio to receive two doses of Healive or Havrix at 0 and 6 months. Persistence of anti-HAV antibodies for 5 years post immunization has been reported The current study reports new data at 11 years post immunization for the purpose of showing antibody persistence. Sensitivity analyzes were performed to assess the results. In addition, predictions for long-term antibody persistence were performed using a statistical model. Two different serological assays were used that were shown to be 98.3% concordant for detecting anit-HAV antibody. Results: GMCs were significantly higher following Healive compared to Havrix at 1, 6, 7, 66, 112 and 138 months post-vaccination. In addition, the GMCs obtained using sensitivity analysis were very similar to those obtained using the original models. Prediction analysis indicated that the duration of protection for both vaccines was at least 30 years after immunization, with a lower limit of the 95% confidence interval for GMC of greater than 20mIU/mL. Conclusions: Healive is more immunogenic than Havrix in children at 11 years post full immunization. Prediction analysis indicated at least 30 years of antibody persistence for both vaccines.

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A review of immunogenicity and tolerability of live attenuated Hepatitis A vaccine in children

Cited by 25 publications

References 24 publications

Type A viral hepatitis: A summary and update on the molecular virology, epidemiology, pathogenesis and prevention

Type A viral hepatitis: A summary and update on the molecular virology, epidemiology, pathogenesis and prevention

Safety and immunogenicity of VAQTA® in children 12-to-23 months of age with and without administration of other US pediatric vaccines

Immunogenicity persistence in children of hepatitis A vaccines Healive® and Havrix®: 11 years follow-up and long-term prediction

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