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CSU 6/2011: TWO ON HEP B

Tuesday, 4th of January 2011

CSU 6/2010: TWO ON HEP B  

1) HEPATITIS B IMMUNE MEMORY 

Below, the abstract of work by an Italian research group, contributing to the debate whether hep B boosters are required. ‘5 years after immunisation with hexavalent vaccines, immunological memory seems to persist in children with anti-HBs concentrations lower than 10 mIU/mL, suggesting that booster doses are not needed. Additional follow-up is needed.’ 

Full text, to subscribers, is available online at http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(10)70195-X/fulltext 

 

outline goes here

The Lancet Infectious Diseases, Volume 10, Issue 11, Pages 755 - 761, November 2010

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

Original Text

Prof Alessandro Remo Zanetti PhD a , Luisa Romanò PhD a, Cristina Giambi PhD b, Anna Pavan MD c, Vito Carnelli MD d, Guglielmino Baitelli MD e, Giancarlo Malchiodi MD f, Edgardo Valerio MD g, Antonella Barale BSc h, Maria Anna Marchisio MD i, Domenico Montù MD j, Alberto Eugenio Tozzi MD k, Fortunato D'Ancona MD b, for the study group‡

Summary

Background

In 2000, hexavac and infanrix hexa were licensed in Europe for primary immunisation of children against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive infections caused by Haemophilus influenzae b. In 2005, hexavac was suspended because of concerns about the long-term immunogenicity of its hepatitis B component. We aimed to assess the duration of immunity and need for booster injections in children primed with these vaccines.

Methods

In an open-label, randomised, controlled, multicentre study in six local health units and at the Bambino Gesù Paediatric Research Hospital in Italy, antibody concentrations were measured 5 years after immunisation of infants with hexavac or infanrix hexa. Children with concentrations of antibodies to hepatitis B surface antigen (anti-HBs) lower than 10 mIU/mL were randomly assigned by simple randomisation to receive a booster of HBVaxPro or engerix B monovalent hepatitis B vaccine and tested 2 weeks later. Primary endpoints were the proportion of children with anti-HBs concentrations of at least 10 mIU/mL, geometric mean concentrations (GMCs) of antibody 5 years after vaccination, and the proportion of children with anti-HBs concentrations lower than 10 mIU/mL who had anamnestic response to booster. The study is registered with Agenzia Italiana del Farmaco, code FARM67NFPN.

Findings

1543 children were enrolled, 833 had received hexavac and 710 infanrix hexa. 831 children who received hexavac and 709 who received infanrix hexa were included in the analysis. 319 children who received hexavac (38·4%, 95% CI 35·1—41·7) had anti-HBs concentrations of at least 10 mIU/mL compared with 590 who received infanrix hexa (83·2%, 80·5—86·0; p<0·0001). GMCs before booster were 4·5 mIU/mL in the hexavac group compared with 61·3 mIU/mL in the infanrix hexa group (p<0·0001). After booster 409 (92·1%, 89·6—94·6) of 444 children primed with hexavac and 99 (94·3%, 89·8—98·7) of 105 primed with infanrix hexa had anti-HBs concentrations of at least 10 mIU/mL (p=0·4); GMCs were 448·7 mIU/mL and 484·9 mIU/mL (p=0·6). The two booster vaccine groups did not differ in number of side-effects; no serious adverse events were reported.

Interpretation

5 years after immunisation with hexavalent vaccines, immunological memory seems to persist in children with anti-HBs concentrations lower than 10 mIU/mL, suggesting that booster doses are not needed. Additional follow-up is needed.

Funding

Agenzia Italiana del Farmaco.

2) BOOSTER DOSE VACCINATION FOR PREVENTING HEP B

 

Conclusion from this Cochrane Review: We don’t know enough.

 

[Intervention Review]
Booster dose vaccination for preventing hepatitis B

Jalal Poorolajal¹, Mahmood Mahmoodi², AliAkbar Haghdoost³, Reza Majdzadeh², Siavosh Nasseri-Moghaddam⁴, Leila Ghalichi², Akbar Fotouhi<sup>2

1</sup>Department of Epidemiology and Biostatistics, Research Centre for Health Sciences, Faculty of Health, Hamadan University of Medical Sciences (UMSHA), Hamadan, Iran. ²Department of Epidemiology and Biostatistics, Tehran University of Medical Science (TUMS), Tehran, Iran. ³Community Medicine Department and Physiology Research Center, Kerman University of Medical Sciences, Kerman, Iran. ⁴Digestive Disease Research Centre, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran

Contact address: Jalal Poorolajal, Department of Epidemiology and Biostatistics, Research Centre for Health Sciences, Faculty of Health, Hamadan University of Medical Sciences (UMSHA), Shahid Fahmideh Avenue, Hamadan, Hamadan, 6517838695, Iran. poorolajal@umsha.ac.ir. poorolajal@yahoo.com.

Editorial group: Cochrane Hepato-Biliary Group.
Publication status and date: New, published in Issue 11, 2010.
Review content assessed as up-to-date: 24 July 2010.

Citation: Poorolajal J, Mahmoodi M, Haghdoost A, Majdzadeh R, Nasseri-Moghaddam S, Ghalichi L, Fotouhi A. Booster dose vaccination for preventing hepatitis B. Cochrane Database of Systematic Reviews 2010, Issue 11. Art. No.: CD008256. DOI: 10.1002/14651858.CD008256.pub2.

Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Abstract

Background

Antibodies against hepatitis B surface antigen (HBs) wane over time after vaccination for hepatitis B (HB); hence, the duration of protection provided by the vaccine is still unknown but may be evaluated indirectly by measuring the anamnestic immune response to booster doses of vaccine.

Objectives

To assess the benefits and harms of booster dose hepatitis B vaccination for preventing HB infection.

Search strategy

We searched The Cochrane Hepato-biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 4, 2010) in The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded, conference databases, and reference lists of articles to May 2010. We also contacted authors of articles and manufacturers.

Selection criteria

Randomised clinical trials addressing anamnestic immune response to booster of HB vaccine five years or more after primary vaccination in apparently healthy participants, vaccinated in a 3-dose or 4-dose schedules of HB vaccine without receiving additional dose or immunoglobulin.

Data collection and analysis

Two authors made the decisions if the identified publications on studies met the inclusion criteria or not. Primary outcome measures included the proportion with anamnestic immune response in non-protected participants and signs of hepatitis B virus infection. Secondary outcomes were the proportion with local and systemic adverse event events developed following booster dose injection. Weighted proportion were planned to be reported with 95% confidence intervals.

Main results

There were no eligible randomised clinical trials fulfilling the inclusion criteria of this review.

Authors' conclusions

We were unable to identify randomised clinical trials on the topic. We need randomised clinical trials to formulate future booster policies for preventing hepatitis B infection.

 

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