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Comparison of immunogenicity and persistence between inactivated hepatitis A vaccine Healive® and Havrix® among children: A 5-year follow-up study.

ABSTRACT: Inactivated vaccines for hepatitis A virus (HAV) infection are widely used in China. Mass vaccination programs drive the need for data on long-term persistence of vaccine-induced protection.A prospective, randomized, open-label clinical trial was conducted to compare geometric mean concentrations (GMCs) and seroconversion rates (SRs) of anti-HAV antibody elicited by the inactivated vaccines Healive and Havrix for 5 y post immunization, in which 400 healthy children were randomly assigned in a 3:1 ratio to receive 2 doses of Healive or Havrix at 0 and 6 month. Anti-HAV antibody concentration was detected by microparticle enzyme immunoassay (MEIA) during the study. Furthermore, an attempt was made to predict persistence of protective immunogenicity by using a suitable statistical model.The GMCs were significantly higher after vaccination with Healive than after Havrix as comparator vaccine at 1, 6, 7, 18, 30, 42, 54 and 66 month (P < 0.01) with the peak point at 7 month (3427.2 mIU/ml for Healive and 1441.9 mIU/ml for Comparator). Similarly significant differences of SRs were found between the 2 groups at 1 and 6 month (P < 0.01). Afterwards, the SRs of both groups reached 100% at 7 month and did not decline until 66 month(99.1% for Healive and 97.5% for Comparator). A linear mixed model with a change point at 18 month(Model 3) was found to be suitable to predict persistence of protective immunogenicity induced by vaccines. It was estimated that the duration of protection for Healive was at least 20 y with a lower limit of GMC 95% confidence interval (CI) no less than 20 mIU/mL.Compared with Havrix, the new preservative-free inactivated hepatitis A vaccine (Healive) in 2 doses showed better persistence of antibody concentrations for 5 y after full-course immunization among children and the persistence of protective immunogenicity was estimated for at least 20 y.

SUBMITTER: Yu C

PROVIDER: S-EPMC5084993 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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Comparison of immunogenicity and persistence between inactivated hepatitis A vaccine Healive® and Havrix® among children: A 5-year follow-up study.

Yu Chengkai C Song Yufei Y Qi Yangyang Y Li Chanjuan C Jiang Zhiwei Z Li Chen C Zhang Wei W Wang Ling L Xia Jielai J

Human vaccines & immunotherapeutics 20160706 10

<h4>Background</h4>Inactivated vaccines for hepatitis A virus (HAV) infection are widely used in China. Mass vaccination programs drive the need for data on long-term persistence of vaccine-induced protection.<h4>Methods</h4>A prospective, randomized, open-label clinical trial was conducted to compare geometric mean concentrations (GMCs) and seroconversion rates (SRs) of anti-HAV antibody elicited by the inactivated vaccines Healive and Havrix for 5 y post immunization, in which 400 healthy chil ...[more]

PMID: 27385349

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Project description:IntroductionHepatitis A virus infection is more severe in adults than children. Although vaccination can protect adults, current childhood programs cover a large population more successfully. Childhood vaccination is, therefore, a solution to protecting adults if it induces lasting immunity. Fifteen-year protection has been demonstrated in children, but longer-term data are only available for adults. We aimed to predict long term persistence of antibody in children beyond 15 years and assess if immunological mechanisms triggered by vaccination support longer-term protection.MethodsLong-term clinical studies using hepatitis A (HAV) or A/B vaccines (HAB) containing 720 or 1440 Enzyme-linked immunosorbent assay Units (EU) of hepatitis A virus antigen were identified. Duration of persistence of antibodies and possible protection was determined by descriptively comparing antibody geometric mean concentration (GMC) kinetics, as well as GMC (95% confidence interval) at 15 years post-vaccination across studies. Immunological mechanism studies describing hepatitis A vaccination were identified.ResultsOne study in children 12-15 years (2-dose HAB 720) and four in adults (2-dose HAV 1440 and 3-dose HAB 720) showed comparable GMC kinetics and per year rates of change up to 15 years. At 15 years, the GMC in children [414.7 mEU/ml (336.9; 510.5)] was in the same range as in adults [range 282.6 (217.6; 367.0) to 550.1 (416.0; 727.4)]. Based on these data, mathematical model predictions from adult studies (showing > 85% protected at 50 years) were deemed likely to also apply to children. Studies identified, both humoral and cell-mediated responses are induced following vaccination.ConclusionBased on comparable antibody data in adults and children up to 15 years, similar longer-term antibody persistence is expected in children with 2-dose inactivated hepatitis A 720 containing vaccine at least up to 50 years. Accordingly, improving routine childhood hepatitis A vaccination coverage could protect against more severe disease in adulthood. Fig. 1 Plain language summary TRIAL REGISTRATION: ClinicalTrials.gov identifiers, NCT00875485, NCT01000324, NCT01037114, NCT00289757, NCT00291876.

Project description:Highlights • Older adults with smoking history received two doses of combined NTHi-Mcat vaccine.• We evaluated antibody persistence during 4 years of follow-up after vaccination.• Immune responses against the NTHi protein antigens persisted up to 4 years.• There was no persistent immune response against the Mcat antigen.• No safety concerns were identified during the long-term follow-up period. A multicomponent vaccine has been developed to reduce the frequency of acute exacerbations of COPD associated with non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) infections, containing NTHi (PD and PE-PilA) and Mcat (UspA2) surface proteins. In a randomised, observer-blind, placebo-controlled study with two steps (NCT02547974), the investigational vaccine had good immunogenicity and no safety concerns were identified. In step 2, 90 adults aged 50–71 years with smoking history received two doses 60 days apart of one of two AS01E-adjuvanted formulations containing 10 µg of each antigen (10–10-AS01) or 10 µg NTHi antigens and 3.3 µg UspA2 (10–3-AS01), or placebo. Long-term persistence of antigen-specific humoral antibodies was assessed in 81 participants during 3 years of follow-up after the initial 14-month study (NCT03201211). Antigen-specific antibody concentrations were measured in blood samples taken every 6 months. Safety monitoring evaluated serious adverse events (SAEs) and potential immune-mediated disease (pIMD). Immune responses against NTHi antigens persisted up to 4 years post-vaccination. For PD, PE and PilA, at each follow-up time point, adjusted antibody geometric mean concentrations (GMCs) were higher (non-overlapping 95% confidence intervals [CIs]) in the vaccine groups versus placebo and versus pre-vaccination. Antibody GMC point estimates were higher with 10–3-AS01 than with 10–10-AS01. For UspA2, 95% CIs included 1 for GMC ratios of 10–10-AS01 or 10–3-AS01 to placebo at each time point. During follow-up, SAEs were reported in nine (11.1%) participants, one of which was fatal (lung cancer, 607 days after second 10–10-AS01 dose). One non-serious pIMD, trigeminal neuralgia, was reported 771 days after second 10–3-AS01 dose. The SAEs and pIMD were considered not related to vaccination. Immune responses against NTHi antigens persisted for 4 years after two-dose vaccination with the investigational NTHi-Mcat vaccine. There was no persistent response against the Mcat antigen. No safety concerns were identified during the long-term follow-up.

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Comparison of immunogenicity and persistence between inactivated hepatitis A vaccine Healive® and Havrix® among children: A 5-year follow-up study.

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Comparison of immunogenicity and persistence between inactivated hepatitis A vaccine Healive® and Havrix® among children: A 5-year follow-up study.

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