Evaluation of the Protection Provided by Hepatitis B Vaccination in India
In India, Hepatitis B vaccination is recommended at 6 wk except for hospital-deliveries. The authors examined protection afforded by the birth dose.
A case-control study was done. HBsAg and HBcAb were tested in 2671 children, 1 to 5 y and HBsAb was evaluated in a subset of 1413 children. Vaccination history was recorded. Cases were HBsAg carriers. In another analysis, children who got infected (HBsAg and/or HBcAb positive) were considered as cases. Exposed were the unvaccinated. In another analysis, exposed were those vaccinated without the birth dose.
The odds ratio (OR) for HBsAg positivity with birth vaccination was 0.35 (95% CI 0.19–0.66); while with vaccination at 6 wk was 0.29 (95%CI 0.14–0.61), both compared to unvaccinated. Birth vaccination has no added protection when compared to the unvaccinated. Unvaccinated children in index study had HBsAg positivity of 4.38%. The number needed to treat (NNT) to prevent one case of HBsAg positivity was 32.6 (95% CI, 20.9 to 73.6). The odds of getting HBV infection was 0.42 (CI 0.25–0.68) with birth dose and 0.49 (CI 0.30–0.82) without the birth dose compared to the unvaccinated. Protective antibody (HBsAb) was present in about 70% of the vaccinated. In the unimmunised, in the first 2 y HBsAb protection was present in 40%. The odds ratio (OR) for HBsAb in the fully vaccinated between 4 and 5 y was 1.4 (95%CI 0.9–2.18) compared to the unvaccinated.
The present study lends support to the pragmatic approach of the Government to vaccinate babies born at home starting at 6 wk.
KeywordsImmunization Passive immunity Hepatitis B surface antigen Hepatitis B core antigen Antibody to hepatitis B surface antigen Antibody to hepatitis B core antigen
This multicenter study was conceived by JP and designed originally by JP, PN, AP KA and VS. AP developed the computer architecture for data monitoring and VS helped with the statistical analysis. PN was responsible for study in Surat; DN, VT, PT, JP were responsible for study in Delhi centres; SKS and US for UP; RS for Uttarakhand. VL and NK were responsible for testing and interpretation of the test data.
The first draft was written by PN and it was finalised with critical inputs from each of the authors. AP was responsible for the write up on the computer programme used and he overlooks the data availability and will ensure it is available openly with no conditions attached.
Each author has seen the final draft, takes responsibility for its contents and signed the copyright transfer forms. JP will be the guarantor for the study report.
Compliance with Ethical Standards
Conflict of Interest
Source of Funding
Indian Council of Medical Research, Delhi.
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