Safety and immune response to a challenge dose of hepatitis B vaccine in healthy children primed 10 years earlier with hexavalent vaccines in a 3, 5, 11-month schedule: An open-label, controlled, multicentre trial in Italy

Zanetti, Alessandro; Desole, Maria Giuseppina; Romanò, Luisa; D’Alessandro, Antonio; Conversano, Michele; Ferrera, Giuseppe; Panico, Maria Grazia; Tomasi, Alberto; Zoppi, G; Zuliani, Massimo; Thomas, Stéphane; Soubeyrand, B.; Eymin, Cécile; Lockhart, Stephen

doi:10.1016/j.vaccine.2017.05.047

Cited by 11 publications

(9 citation statements)

References 21 publications

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“…With effective infant HBV vaccination programmes, HBV infection and carrier rates of children have declined dramatically in China, whereas the cumulative HBsAg(+) rate in children born to HBsAg(+) mothers has reached about 15% even with passive‐active immunization . It has been well accepted that maternal HBsAg‐positive status is an independent risk factor for vaccination failure in children . In the current study, the no/weak response to vaccination was 4.1%, which is similar to previous studies, and there was no significant difference between the antiviral treatment group and untreated group.…”

Section: Discussionsupporting

confidence: 87%

Efficacy and safety of telbivudine and tenofovir disoproxil fumarate in preventing hepatitis B vertical transmission: A real‐life practice

Liu

Wang

et al. 2019

Journal of Viral Hepatitis

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Mother‐to‐child transmission (MTCT) is a major obstacle in the elimination of hepatitis B virus (HBV) infection. Telbivudine (LdT) and tenofovir disoproxil fumarate (TDF) are the two most common antiviral medicines for preventing MTCT. However, the efficacy and safety of LdT and TDF in preventing HBV vertical transmission during the second to third trimester have not been compared rigorously. Therefore, we carried out a prospective multicentre cohort study of chronic hepatitis B in mothers with HBV DNA > 106 IU/mL, receiving LdT or TDF during the second to third trimester. Among the 893 mothers enrolled, 857 (LdT/TDF/untreated group (NTx) = 396/325/136) completed consecutive follow‐up with 854 infants (LdT/TDF/NTx = 395/323/136). LdT and TDF treatment resulted in a similar decrease of HBV DNA in mothers at delivery. Multivariate analysis indicated that only HBsAg titre at the baseline correlated with viral DNA decrease (P = 0.015). With intention‐to‐treat analysis, MTCT rates in the LdT, TDF and NTx group were 4.41%, 2.42% and 22.08%, respectively. An increasing vertical transmission rate was found to be closely associated with higher HBsAg titre, 5.32% and 17.65% infection rate was estimated in infants born to mothers with HBsAg > 4 and >5 log10 IU/mL, respectively. No serious side effects were reported in either mothers or infants. LdT and TDF treatments were well tolerated and showed comparable efficacy in reducing MTCT. Higher risk of MTCT was shown in pregnant women with HBsAg > 4 log10IU/mL.

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Section: Discussionsupporting

confidence: 87%

Efficacy and safety of telbivudine and tenofovir disoproxil fumarate in preventing hepatitis B vertical transmission: A real‐life practice

Liu

Wang

et al. 2019

Journal of Viral Hepatitis

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“…Likewise, Zanetti et al 24,25 report an anamnestic response in more than 95% of subjects, but in this case, individuals with anti-HBs titer <10 mIU/mL are predominantly those vaccinated in infancy (36%) rather than those vaccinated at adolescent age (11%). The higher proportion of subjects who tested negative among those vaccinated as infants in some studies compared to others might partly be explained by a higher proportion of individuals immunized with the Hexavac hexavalent vaccine, which was withdrawn in 2005 due to a progressive decrease of potency of the hepatitis B component.…”

Section: Discussionmentioning

confidence: 90%

High chance to overcome the non-responder status to hepatitis B vaccine after a further full vaccination course: results from the extended study on healthcare students and workers in Florence, Italy

Grazzini

Arcangeli

Mucci

et al. 2019

Human Vaccines & Immunotherapeutics

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“…A number of studies have shown that T-cell and B-cell memory against HBV can persist in individuals previously vaccinated with HBs-containing combination vaccines decades after the primary vaccination series with no regular booster vaccination 30-33 and that this persistent memory can be observed even in the absence of detectable anti-HBs antibodies. 34 , 35 This observation has even been reported for a previously licensed fully liquid DTaP-IPV-HB-PRP∼T vaccine (Hexavac™) that has been shown to induce lasting immune memory 36-38 despite having initially presented with sub-optimal early anti-HBs responses. 39 , 40…”

Section: Introductionmentioning

confidence: 70%

Persistence of hepatitis B immune memory until 9–10 years of age following hepatitis B vaccination at birth and DTaP-IPV-HB-PRP∼T vaccination at 2, 4 and 6 months

Kosalaraksa

Chokephaibulkit

Benjaponpitak

et al. 2018

Human Vaccines & Immunotherapeutics

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Objective: To evaluate the long-term persistence of anti-hepatitis B surface (HBs) antibodies and the response to a HB challenge re-vaccination in children who had received a primary series of DTaP-IPV-HB-PRP∼T (Hexaxim™) or DTaP-IPV-HB/PRP∼T (Infanrix hexa™).Methods: Two cohorts of participants who had previously received HB vaccine at birth followed by either DTaP-IPV-HB-PRP∼T or DTaP-IPV-HB/PRP∼T co-administered with PCV7 at 2, 4, 6 months of age in a randomized, Phase III, observer-blind study in Thailand, were followed up for anti-HBs antibodies (geometric mean concentrations [GMCs] and seroprotection [SP] rate [% of participants with a titer ≥10 mIU/mL]) at 12–18 months of age and 9–10 years of age. A monovalent HB challenge re-vaccination was administered at 9–10 years of age and the anamnestic response was evaluated.Results: Anti-HBs GMCs and SP rates in the DTaP-IPV-HB-PRP∼T and DTaP-IPV-HB/PRP∼T groups were high and similar post-primary vaccination series (2477 mIU/mL and 99.5% and 2442 mIU/mL and 99.5%, respectively) and declined to a similar extent in each group at 12–18 months (154.5 mIU/mL and 90.8% and 162.3 mIU/mL and 96.5%, respectively). Antibody levels further declined at 9–10 years of age (13.3 mIU/mL and 49.3% and 8.0 mIU/mL and 42.9%) and a strong anamnestic response occurred in each group post-HB challenge re-vaccination (92.8% and 98.7%, respectively).Conclusion: The kinetics of long-term anti-HBs antibody persistence were similar following a primary series of DTaP-IPV-HB-PRP∼T or DTaP-IPV-HB/PRP∼T. The response to a subsequent HB challenge re-vaccination was strong and similar in each group, demonstrating persisting immune memory.

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Safety and immune response to a challenge dose of hepatitis B vaccine in healthy children primed 10 years earlier with hexavalent vaccines in a 3, 5, 11-month schedule: An open-label, controlled, multicentre trial in Italy

Cited by 11 publications

References 21 publications

Efficacy and safety of telbivudine and tenofovir disoproxil fumarate in preventing hepatitis B vertical transmission: A real‐life practice

Efficacy and safety of telbivudine and tenofovir disoproxil fumarate in preventing hepatitis B vertical transmission: A real‐life practice

High chance to overcome the non-responder status to hepatitis B vaccine after a further full vaccination course: results from the extended study on healthcare students and workers in Florence, Italy

Persistence of hepatitis B immune memory until 9–10 years of age following hepatitis B vaccination at birth and DTaP-IPV-HB-PRP∼T vaccination at 2, 4 and 6 months

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