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Open Access Research article

Effectiveness of DNA-recombinant anti-hepatitis B vaccines in blood donors: a cohort study

Emil Kupek1*, Denise ER de Souza2 and Andrea Petry3

Author Affiliations

1 National Perinatal Epidemiology Unit, University of Oxford, Old Road Campus, Oxford OX3 7LF, UK

2 Department of Public Health – Postgraduate Studies Programme, Centre of Health Sciences, Universidade Federal de Santa Catarina, Campus Universitário Trindade, Florianópolis, Brazil

3 Centre for Hematology and Hemotherapy of the federal state of Santa Catarina, Av. Othon Gama d'Eça 756, Florianópolis, Brazil

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BMC Infectious Diseases 2007, 7:124  doi:10.1186/1471-2334-7-124

Published: 6 November 2007

Abstract

Background

Although various studies have demonstrated efficacy of DNA-recombinant anti-hepatitis B vaccines, their effectiveness in health care settings has not been researched adequately. This gap is particularly visible for blood donors, a group of significant importance in the reduction of transfusion-transmitted hepatitis B.

Methods

This is a double cohort study of 1411 repeat blood donors during the period 1998–2002, involving a vaccinated and an unvaccinated cohort, with matching of the two in terms of sex, age and residence. Average follow-up was 3.17 person-years. The outcome measure was infection with hepatitis B virus (HBV), defined by testing positive on serologic markers HBsAg or anti-HBC. All blood donors were from the blood bank in Joaçaba, federal state of Santa Catarina, Brazil.

Results

The cohorts did not differ significantly regarding sex, age and marital status but the vaccinated cohort had higher mean number of blood donations and higher proportion of those residing in the county capital Joaçaba. Hepatitis B incidences per 1000 person-years were zero among vaccinated and 2,33 among non-vaccinated, resulting in 100% vaccine effectiveness with 95% confidence interval from 30,1% to 100%. The number of vaccinated persons necessary to avoid one HBV infection in blood donors was estimated at 429 with 95% confidence interval from 217 to 21422.

Conclusion

The results showed very high effectiveness of DNA-recombinant anti-HBV vaccines in blood donors. Its considerable variation in this study is likely due to the limited follow-up and the influence of confounding factors normally balanced out in efficacy clinical trials.