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Reappraisal of the Immunogenicity and Safety of Three Hepatitis A Vaccines in Adolescents.

ABSTRACT: Although the overall incidence of hepatitis A in Korea has been decreasing, adolescents remain highly vulnerable to its outbreaks. This study was conducted to compare the immunogenicity and safety of three hepatitis A vaccines in Korean adolescents. Healthy anti-hepatitis A virus seronegative subjects aged 13 to 19 yr were randomized in three equal groups to receive two doses of Avaxim™, Epaxal®, or Havrix®, 6 to 12 months apart. Seroconversion rates one month after the first dose were 98%, 95%, and 93% for Avaxim™, Epaxal®, and Havrix®, respectively. Seroconversion rates reached 100% for all vaccine groups one month after the second dose. Anti-HAV geometric mean concentrations (GMCs) were 7,207.7 mIU/mL (95% CI, 6023.1-8684.7), 1,750.5 mIU/mL (95% CI, 1362.9-2248.3), and 1,953.5 mIU/mL (95% CI, 1459.4-2614.7) after two doses of Avaxim™, Epaxal®, and Havrix® respectively. Avaxim™ was significantly more immunogenic than Epaxal® and Havrix®, whereas there were no significant differences in antibody responses between Epaxal® and Havrix®. Local and systemic solicited adverse events (AEs) were mostly of mild-to-moderate intensity and resolved within 5 days. No serious AEs were reported. In conclusion, all three vaccines are highly immunogenic and well-tolerated in Korean adolescents. (Clinical Trial Registry NCT00483470).

SUBMITTER: Yoon SH

PROVIDER: S-EPMC4712583 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature

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Reappraisal of the Immunogenicity and Safety of Three Hepatitis A Vaccines in Adolescents.

Yoon Seo Hee SH Kim Han Wool HW Ahn Jong Gyun JG Kim In Tae IT Kim Jong-Hyun JH Kong Kyoung Ae KA Kim Kyung-Hyo KH

Journal of Korean medical science 20151224 1

Although the overall incidence of hepatitis A in Korea has been decreasing, adolescents remain highly vulnerable to its outbreaks. This study was conducted to compare the immunogenicity and safety of three hepatitis A vaccines in Korean adolescents. Healthy anti-hepatitis A virus seronegative subjects aged 13 to 19 yr were randomized in three equal groups to receive two doses of Avaxim™, Epaxal®, or Havrix®, 6 to 12 months apart. Seroconversion rates one month after the first dose were 98%, 95%, ...[more]

PMID: 26770041

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Project description:To identify the safety, immunogenicity, and protective efficacy of COVID-19 vaccines in children and adolescents. We conducted a systematic review of published studies and ongoing clinical studies related to the safety, immunogenicity, and efficacy of COVID-19 vaccine in children or adolescents (aged < 18 years). Databases including PubMed, Web of Science, WHO COVID-19 database, and China National Knowledge Infrastructure (CNKI) were searched on 23 July 2021. International Clinical Trials Registry Platform (ICTRP) was also searched to identify ongoing studies. Eight published studies with a total of 2852 children and adolescents and 28 ongoing clinical studies were included. Of the eight published studies, two were RCTs, two case series, and four case reports. The investigated COVID-19 vaccines had good safety profiles in children and adolescents. Injection site pain, fatigue, headache, and chest pain were the most common adverse events. A limited number of cases of myocarditis and pericarditis were reported. The RCTs showed that the immune response to BNT162b2 in adolescents aged 12-15 years was non-inferior to that in young people aged 16-25 years, while with 3 μg CoronaVac injection the immune response was stronger than with 1.5 μg. The efficacy of BNT162b2 was 100% (95% CI: 75.3 to 100), based on one RCT. Of the 28 ongoing clinical studies, twenty-three were interventional studies. The interventional studies were being conducted in fifteen countries, among them, China (10, 43.5%) and United States(9, 39.1%) had the highest number of ongoing trials. BNT162b2 was the most commonly studied vaccine in the ongoing trials. Two COVID-19 vaccines have potential protective effects in children and adolescents, but awareness is needed to monitor possible adverse effects after injection. Clinical studies of the COVID-19 vaccination in children and adolescents with longer follow-up time, larger sample size, and a greater variety of vaccines are still urgently needed.

Project description:BackgroundAs the epidemic progresses, universal vaccination against COVID-19 has been the trend, but there are still some doubts about the efficacy and safety of COVID-19 vaccines in adolescents, children, and even infants.PurposeTo evaluate the safety, immunogenicity, and efficacy of COVID-19 vaccines in the population aged 0-17 years.MethodA comprehensive search for relevant randomized controlled trials (RCTs) was conducted in PubMed, Embase, and the Cochrane Library from inception to November 9, 2021. All data were pooled by RevMan 5.3 statistical software, with risk ratio (RR) and its 95% confidence interval as the effect measure. This study protocol was registered on PROSPERO (CRD42021290205).ResultsThere was a total of six randomized controlled trials included in this systematic review and meta-analysis, enrolling participants in the age range of 3-17 years, and containing three types of COVID-19 vaccines. Compared with mRNA vaccines and adenovirus vector vaccines, inactivated vaccines have a more satisfactory safety profile, both after initial (RR 1.40, 95% CI 1.04-1.90, P = 0.03) and booster (RR 1.84, 95% CI 1.20-2.81, P = 0.005) vaccination. The risk of adverse reactions was significantly increased after the first and second doses, but there was no significant difference between the first two doses (RR 1.00, 95%CI 0.99-1.02, P = 0.60). Nevertheless, the two-dose regimen is obviously superior to the single-dose schedule for immunogenicity and efficacy. After booster vaccination, both neutralizing antibodies (RR 144.80, 95%CI 44.97-466.24, P < 0.00001) and RBD-binding antibodies (RR 101.50, 95%CI 6.44-1,600.76, P = 0.001) reach optimal levels, but the cellular immune response seemed not to be further enhanced. In addition, compared with younger children, older children and adolescents were at significantly increased risk of adverse reactions after vaccination, with either mRNA or inactivated vaccines, accompanied by a stronger immune response.ConclusionThe available evidence suggests that the safety, immunogenicity and efficacy of COVID-19 vaccines are acceptable in people aged 3-17 years. However, there is an urgent need for additional multicenter, large-sample studies, especially in younger children under 3 years of age and even in infants, with long-term follow-up data.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021290205, identifier: CRD42021290205.

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Reappraisal of the Immunogenicity and Safety of Three Hepatitis A Vaccines in Adolescents.

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Reappraisal of the Immunogenicity and Safety of Three Hepatitis A Vaccines in Adolescents.

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