Lasting immune memory against hepatitis B following challenge 10–11 years after primary vaccination with either three doses of hexavalent DTPa-HBV-IPV/Hib or monovalent hepatitis B vaccine at 3, 5 and 11–12 months of age

Avdicová, M; Crasta, Priya Diana; Hardt, Karin; Kovac, Martina

doi:10.1016/j.vaccine.2014.06.070

Cited by 31 publications

(27 citation statements)

References 22 publications

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“…A challenge dose of hepatitis B vaccine induced seroprotective titres (≥10 mIU/ml) in 94.3% of children 11 . Robust immune memory responses to hepatitis B were also observed in children 10–11 y after vaccination with DTPa-HBV-IPV/Hib at 3, 5 and 11–12 months of age, with 96.8% of children achieving an anamnestic response (4-fold increase in anti-HBs antibody concentration in initially seropositive children, or concentration ≥10mIU/ml in initially seronegative children) after the challenge dose 9 . These results compare favorably to studies of immune memory after 4 doses of HBV vaccine in infancy, administered either as DTPa-HBV-IPV/Hib or as monovalent HBV.…”

Section: Abbreviationsmentioning

confidence: 89%

Immunological persistence in 5 y olds previously vaccinated with hexavalent DTPa-HBV-IPV/Hib at 3, 5, and 11 months of age

Silfverdal

Assudani

Kuriyakose

et al. 2014

Human Vaccines & Immunotherapeutics

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The combined diphtheria-tetanus-acellular pertussis-hepatitis B-poliomyelitis/Haemophilus influenza vaccine (DTPa-HBV-IPV/Hib: Infanrix™ hexa, GlaxoSmithKline Vaccines) is used for primary vaccination of infants in a range of schedules world-wide. Antibody persistence after 4 DTPa-HBV-IPV/Hib doses in the first 2 y of life has been documented, but long-term persistence data following the 3, 5, 11–12 months (3–5–11) infant vaccination schedule, employed for example in Nordic countries, are limited. We assessed antibody persistence in 57 5-year-old children who had received either DTPa-HBV-IPV/Hib or DTPa-IPV/Hib (Infanrix™-IPV/Hib, GlaxoSmithKline Vaccines) in the 3–5–11 schedule. Among DTPa-HBV-IPV/Hib recipients, 7/12 retained seroprotective antibody concentrations for diphtheria, 10/12 for tetanus, 5/12 for hepatitis and 10/12 for Hib. Detectable antibodies were observed for 0/12 children for pertussis toxin (PT), 12/12 for filamentous haemagglutinin (FHA) and 8/12 for pertactin (PRN). Among DTPa-IPV/Hib recipients, 28/45 retained seroprotective anti-diphtheria concentrations, 34/44 for tetanus and 40/45 for Hib. Detectable antibodies were observed for 9/45 children for PT, 41/45 for FHA and 34/45 for PRN. Antibody persistence in DTPa-HBV-IPV/Hib and DTPa-IPV/Hib-vaccinees appeared similar in 5 y olds to that previously observed in children of a similar age who had received 4 prior doses of DTPa-HBV-IPV/Hib (or DTPa-IPV/Hib). As in subjects primed with 4 prior doses, we observed that antibodies markedly declined by 5 y of age, calling for the administration of a pre-school booster dose in order to ensure continued protection against pertussis.

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Section: Abbreviationsmentioning

confidence: 89%

Immunological persistence in 5 y olds previously vaccinated with hexavalent DTPa-HBV-IPV/Hib at 3, 5, and 11 months of age

Silfverdal

Assudani

Kuriyakose

et al. 2014

Human Vaccines & Immunotherapeutics

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“…The administration of an HBV challenge dose after the primary schedule, induces strong anamnestic responses and is well tolerated [28]. In Italy, for Medical School students it is necessary to assess anti-HBs titre before making stages in hospital, in order to identify subjects with levels <10 mIU/ mL.…”

Section: Discussionmentioning

confidence: 99%

Predictors of Hepatitis B Surface Antigen Titers two decades after vaccination in a cohort of students and post-graduates of the Medical School at the University of Palermo, Italy

Verso¹,

Cascio

Laddeca³

et al. 2017

Ann Agric Environ Med.

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Introduction and objective. The introduction of a vaccine against hepatitis B virus (HBV) for newborn babies in Italy in 1991, extended to 12-year-old children for the first 12 years of application, has been a major achievement in terms of the prevention of HBV infection. The objective of this study was to analyse the long-term immunogenicity and effectiveness of HBV vaccination among healthcare students with different working seniorities. Materials and method. A cross-sectional observational study of undergraduate and postgraduate students attending the Medical School of the University of Palermo was conducted from January 2014 -July 2016. HBV serum markers were performed with commercial chemiluminescence assays. Categorical variables were analyzed using the chi-square test (Mantel-Haenszel), whereas means were compared by using the Student's t test. Adjusted odds ratios (ORs) and 95% confidence intervals (CIs) were also calculated by a multivariable logistic regression, using a model constructed to examine predictors of anti-HBs titer above 10 mIU/mL, assumed as protective. Results. Of the 2,114 subjects evaluated -all vaccinated at infancy or at the age of 12 years and were HBsAg/anti-HBc negative -806 (38.1%) had an anti-HBs titre <10 IU/L. The latter were younger, more likely to be attending a healthcare profession school (i.e., nursing and midwifery), than a medical postgraduate level school, and more likely to have been vaccinated in infancy (p <0.001, 95% CI 2. adjusted OR 3.70). Conclusion. The results of the study suggest that assessment of HBV serum markers in workers potentially exposed to hospital infections is useful for identifying small numbers of unvaccinated subjects, or vaccinated subjects with low antibody titre, all of whom should be referred to a booster series of vaccinations.

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“…Among those children with anti-HBs levels <10 mIU/ml at the time of the challenge dose, 93.8% in the DTPa-HBV-IPV/Hib group and 97.3% in the DTPa-IPV/Hib + HBV group had post-challenge concentrations ≥10 mIU/ml. The percentage of participants with anti-HBs antibody concentrations ≥100 mIU/ml increased from 14.7% to 93.6% in the DTPa-HBV-IPV/Hib group, and from 19.1% to 94.4% in the DTPa-IPV/Hib + HBV group, and GMTs increased by at least 187-fold in each group [16], indicating that both vaccine schedules induced strong immune memory responses to HBV after a two-dose priming and booster regimen. These results are consistent with studies of antibody persistence and immune memory in children 7-8 years and 12-13 years of age who were immunized with HBV (Engerix B) in routine clinical practice [38].…”

Section: Immunogenicitymentioning

confidence: 94%

“…Here, we summarize immunogenicity one month after completion of the primary vaccination course in 10 studies with immunogenicity data and safety data from all 11 trials. Of 11 studies identified, 8 were conducted during the clinical development of GSK's hexavalent DTPa-HBV-IPV/Hib vaccine and evaluated DTPa-HBV-IPV/Hib compared to two separate injections of a pentavalent vaccine (either DTPa-IPV/ Hib or DTPa-HBV-IPV) co-administered with a single valent component vaccine (either HBV or Hib vaccine, respectively) ( Table 1) [12][13][14][15][16][17][18][19][20][21][22][23][24][25]. These studies assessed two-dose or threedose primary vaccination schedules in healthy infants.…”

Section: Clinical Trials Supporting Interchangeability and Mixed Schementioning

confidence: 99%

“…Children enrolled in study 4 participated at a follow-up visit 10-11 years after primary and booster vaccination at 3, 5, and 11 months of age to assess long-term persistence of anti-HBs antibodies and the response to an HBV challenge dose [16]. In 11-12-year-olds, 48.4% of the hexavalent DTPa-HBV-IPV/Hib vaccine recipients and 58.4% of the pentavalent DTPa-IPV/ Hib + HBV recipients had persisting anti-HBs concentrations ≥10 mIU/ml.…”

Section: Immunogenicitymentioning

confidence: 99%

See 1 more Smart Citation

Hexavalent vaccines: increasing options for policy-makers and providers. A review of the data supporting interchangeability (substitution with vaccines containing fewer antigens) and mixed schedules from the same manufacturer

Dolhain

Janssens

Mesaros

et al. 2018

Expert Review of Vaccines

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Combination vaccines improve vaccine uptake and open the infant immunization space for additional vaccines. Hexavalent vaccines have been marketed since 2000. Infanrix hexa (combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b conjugate vaccine, DTPa-HBV-IPV/Hib, GSK) is longest on the market, providing 16 years post-marketing experience. Each DTPa-HBV-IPV/Hib vaccine component is licensed alone and/or in smaller combination vaccines. Programmatic considerations sometimes require an interchange between vaccines due to unavailability, program change or mixed schedules (when the number of required antigens differs across scheduled primary vaccination visits). Areas covered: Immunogenicity and safety data from 11 GSK-sponsored clinical trials support the interchangeability of DTPa-HBV-IPV/Hib within the same vaccines family, and use of DTPa-HBV-IPV/Hib in mixed primary vaccination schedules. Expert commentary: Data show acceptability of interchange of DTPa-HBV-IPV/Hib with other products within the same vaccines family and its use in mixed immunization schedules. This aligns with WHO recommendations that vaccines of the same family from the same manufacturer be used to complete the infant vaccination schedule. Interchangeability and suitability for use in mixed schedules is of interest for policy-makers/providers in the framework of vaccination recommendations as it provides flexibility. Given the complexity of larger combination vaccines, interchangeability or sequential use needs careful assessment.

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Lasting immune memory against hepatitis B following challenge 10–11 years after primary vaccination with either three doses of hexavalent DTPa-HBV-IPV/Hib or monovalent hepatitis B vaccine at 3, 5 and 11–12 months of age

Cited by 31 publications

References 22 publications

Immunological persistence in 5 y olds previously vaccinated with hexavalent DTPa-HBV-IPV/Hib at 3, 5, and 11 months of age

Immunological persistence in 5 y olds previously vaccinated with hexavalent DTPa-HBV-IPV/Hib at 3, 5, and 11 months of age

Predictors of Hepatitis B Surface Antigen Titers two decades after vaccination in a cohort of students and post-graduates of the Medical School at the University of Palermo, Italy

Hexavalent vaccines: increasing options for policy-makers and providers. A review of the data supporting interchangeability (substitution with vaccines containing fewer antigens) and mixed schedules from the same manufacturer

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