Hepatitis B immune memory in children primed with hexavalent vaccines and given monovalent booster vaccines: an open-label, randomised, controlled, multicentre study

Zanetti, Alessandro; Romanò, Luisa; Giambi, Cristina; Pavan, Anna; Carnelli, Vito; Baitelli, Guglielmino; Malchiodi, Giancarlo; Valerio, Edgardo; Barale, Antonella; Marchisio, Maria; Montù, Domenico; Tozzi, Alberto Eugenio; D’Ancona, Fortunato

doi:10.1016/s1473-3099(10)70195-x

Cited by 55 publications

(49 citation statements)

References 23 publications

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“…These data echo those from another study of the DTaP-IPV-HB-PRP-T vaccine administered in a 6, 10, 14 week primary series schedule and including a comparison to a standalone HB vaccine (14). This adds further support to that hypothesis that if adequately primed then T and B cell memory would be expected even in the event of antibody waning to subprotective levels (21,22), meaning that a strong and adequate response would be expected even in such individuals when exposed to wild-type virus. The WHO also supports this hypothesis, stating 'the loss of detectable anti-HBs in participants who had responded to satisfactorily to a primary series does not necessarily indicate a lack of protection' (23,24).…”

Section: Discussionsupporting

confidence: 80%

A fully liquid DTaP-IPV-HB-PRP-T hexavalent vaccine for primaryand booster vaccination of healthy Turkish infants and toddlers*

Ceyhan¹,

Yıldırım²,

Tezer³

et al. 2017

Turk J Med Sci

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Background/aim: Immunogenicity and safety of a primary series of a fully liquid, hexavalent DTaP-IPV-HB-PRP-T vaccine given at 2, 3, and 4 months of age compared to licensed comparators and a DTaP-IPV-HB-PRP-T booster at 15-18 months were evaluated. Materials and methods: This was a Phase III, randomized, open-label trial. Primary series (no hepatitis B [HB] at birth) of DTaP-IPV-HB-PRP-T (N = 155) (group 1) or licensed control vaccines (DTaP-IPV//PRP-T and standalone HB: N = 155) (group 2) and DTaP-IPV-HB-PRP-T booster were administered. Noninferiority was evaluated 1 month postprimary series for anti-HB seroprotection (SP). All other analyses were descriptive. Safety was assessed from parental reports.Results: Postprimary series noninferiority of anti-HB ≥ 10 mIU/mL was demonstrated for the DTaP-IPV-HB-PRP-T vaccine (94.0%) compared to the licensed control (96.1%). Postprimary series primary SP and seroconversion (SC) rates were high and similar for both groups. Antibody persistence (prebooster) was high for each antigen and similar between groups except for HB, which was lower for DTaP-IPV-HB-PRP-T than for standalone HB. For each antigen except HB, DTaP-IPV-HB-PRP-T booster responses were high and similar in each group. Safety was good for primary and booster series and similar between groups. Conclusion:The DTaP-IPV-HB-PRP-T vaccine is immunogenic and safe when administered in a challenging primary series schedule without HB vaccination at birth.

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Section: Discussionsupporting

confidence: 80%

A fully liquid DTaP-IPV-HB-PRP-T hexavalent vaccine for primaryand booster vaccination of healthy Turkish infants and toddlers*

Ceyhan¹,

Yıldırım²,

Tezer³

et al. 2017

Turk J Med Sci

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“…However, the combined vaccine induces a lasting immune memory against hepatitis B; therefore, long term protection is likely to be similar to that observed following priming with monovalent HBV vaccines. [21][22][23][24][25] At present time, routine booster doses of hepatitis B vaccine do not seem necessary to sustain immunity in children vaccinated with hexavalent vaccines.…”

Section: Acknowledgmentsmentioning

confidence: 99%

Sero-epidemiology of hepatitis B markers in the population of Tuscany, Central Italy, 20 years after the implementation of universal vaccination

Boccalini

Pellegrino

Tiscione

et al. 2013

Human Vaccines & Immunotherapeutics

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“…17 We, therefore, focused our study on the duration of protection after infant immunization. although quite a number of studies exist dealing with the persistence of anti-HBs after primary immunization or analyzing the response to a booster dose after anti-HBs has dropped below 10 miu/ml [18][19][20][21][22][23][24][25][26] , there is no systematic investigation assessing determinants for waning immunity.Persistence of anti-HBs ≥ 10 miu/ml and response to booster vaccination 19,21,23 may be related to vaccine dosage, [27][28][29][30] beginning of the primary vaccine regime (at birth or later in infancy), 22,28,29,[31][32][33] timing of the last vaccination of the primary series (ie, the gap time between last and preceding dose), 4,33 numbers of vaccine doses given as primary vaccine series 4 and use of plasma-derived or recombinant vaccines. 4,8,11,19,28,[31][32][33][34][35][36][37] Finally, both parameters may also be influenced by the prevalence of hepatitis B infection in the population and the HBsag carrier status of the mothers in the country.…”

mentioning

confidence: 99%

mentioning

confidence: 99%

Determinants of Long-term Protection After Hepatitis B Vaccination in Infancy

Schönberger

Riedel²,

Rückinger³

et al. 2013

Pediatric Infectious Disease Journal

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Background: the duration of protection after hepatitis B vaccination in early infancy is unclear and may be related to vaccination schedule, dosage, vaccine type and population characteristics. Factors potentially influencing waning immunity were assessed. Methods: a systematic review was performed. the main outcomes were prevalence of anti-hepatits B antibodies ≥ 10 miu/ml after primary or booster vaccination. Factors potentially influencing protection were assessed in an adjusted random-effects meta-analysis model by age for both outcomes. results of both meta-analyses were combined in a prognostic model. Results: Forty-six studies reporting on the anti-hepatits B antibodies ≥ 10 miu/ml 5 to 20 years after primary immunization and 29 on booster response were identified. the adjusted meta-analyses identified maternal carrier status (odds ratio [Or]: 2.37 [1.11; 5.08]), lower vaccine dosage than presently recommended (Or: 0.14 [0.06; 0.30]) and gap time between last and preceding dose of the primary vaccine series (Or: 0.44 [0.22; 0.86]) as determinants for persistence of anti-hepatits B antibodies ≥ 10. a lower vaccine dosage was also associated with failure to respond to booster (Or: 0.20 [0.10; 0.38]). the prognostic model predicted long-term protection of 90% [77%; 100%] at the age of 17 years for offspring of noncarrier mothers vaccinated with a presently recommended dose and vaccination schedule. Conclusions: Based on meta-analyses, predictors of waning immunity after hepatitis B vaccination in infancy could be identified. a prognostic model for long-term protection after hepatitis B vaccination in infancy was developed.Key Words: hepatitis B, infant vaccination, booster, long-term protection, determinants of protection (Pediatr Infect Dis J 2013;32: 307-313) A lthough hepatitis B vaccination is highly effective, vaccination failures leading to acute [1][2][3][4][5] and sometimes chronic infection [5][6][7][8] have been observed. although infections occurring within a short time interval after vaccination are likely to reflect primary vaccination failure 1,4 due to nonresponse, those occurring after decades are likely to reflect secondary vaccination failure due to waning immunity. anti-hepatits B antibodies [anti-HBs] ≥ 10 miu/ ml either after primary vaccination or as response to booster if the antibody concentrations have fallen below are widely accepted marker of protection after hepatitis B vaccination. 9-11 immunity against hepatitis B gives protection against infection and protection against disease. 12-14 Protection against infection is based on the presence of anti-HBs ≥ 10 miu/ml. after vaccination against hepatitis B, the proportion of individuals with anti-HBs ≥10 miu/ ml is highly dependent on the time elapsed since primary vaccination. individuals whose anti-HBs concentrations dropped below a level of 10 miu/ml are not protected any more against infection with hepatitis B virus. However, they are not at risk of hepatic disease as long as they have hepatitis B surface antigen (HBsag)-spe...

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Hepatitis B immune memory in children primed with hexavalent vaccines and given monovalent booster vaccines: an open-label, randomised, controlled, multicentre study

Cited by 55 publications

References 23 publications

A fully liquid DTaP-IPV-HB-PRP-T hexavalent vaccine for primaryand booster vaccination of healthy Turkish infants and toddlers*

A fully liquid DTaP-IPV-HB-PRP-T hexavalent vaccine for primaryand booster vaccination of healthy Turkish infants and toddlers*

Sero-epidemiology of hepatitis B markers in the population of Tuscany, Central Italy, 20 years after the implementation of universal vaccination

Determinants of Long-term Protection After Hepatitis B Vaccination in Infancy

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