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Evidence summaries

Hepatitis B Immunisation in Persons Not Previously Exposed to Hepatitis B or with Unknown Exposure Status

Because of poor quality of available studies, there is insufficient evidence on the effectiveness of hepatitis B vaccination on the risk of hepatitis B in children or grown-ups who have not been previously exposed to hepatitis B infection or whose exposure status is not known. According to analysis restricted to participants available for follow-up, vaccination might possibly be effective. Level of evidence: "D"

A Cochrane review [Abstract] 1 included 12 studies. Hepatitis B vaccine did not show a clear effect on the risk of developing HBsAg (RR 0.96, 95% CI 0.89 to 1.03; 4 studies, n=1230) and anti-HBc (RR 0.81, 95% CI 0.61 to 1.07; 4 studies, n=1230, random-effects) when data were analysed using intention-to-treat analysis assuming an unfavourable event for missing data. Analysis based on data of available participants showed reduced risk of developing HBsAg (RR 0.12, 95% CI 0.03 to 0.44; 4 studies, n=576) and anti-HBc (RR 0.36, 95% CI 0.17 to 0.76; 4 studies, n=576, random-effects). Intention-to-treat analysis assuming favourable outcome for missing data showed similar reduction in risk. Hepatitis B vaccination had an unclear effect on the risk of lacking protective antibody levels (RR 0.57, 95% CI 0.26 to 1.27; 3 studies, n=1210, random-effects). Development of adverse events was sparsely reported.

Comment: The quality of evidence is downgraded by study quality (unclear allocation concealment and blinding, and more than 20% loss to follow up) and by inconsistency (heterogeneity in interventions and outcomes).

    References

    • Mathew JL, El Dib R, Mathew PJ et al. Hepatitis B immunisation in persons not previously exposed to hepatitis B or with unknown exposure status. Cochrane Database Syst Rev 2008;(3):CD006481. [PubMed].

Primary/Secondary Keywords