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Evidence summaries

Hepatitis A Immunisation in Persons Not Previously Exposed to Hepatitis A

Hepatitis A vaccines are effective for pre-exposure prophylaxis of clinical hepatitis A in susceptible individuals. Level of evidence: "A"

The quality of evidence is downgraded by study limitations (unclear allocation concealment) and is upgraded by large magnitude of effect.

Summary

A Cochrane review [Abstract] 1 [withdrawn] included 9 RCTs with a total of 732 380 subjects to assess the clinical protective efficacy, sero-protective efficacy, and safety and harms of hepatitis A vaccination in persons not previously exposed to hepatitis A. Four trials assessed the inactivated hepatitis A vaccine (n=41 690) and 5 trials the live attenuated hepatitis A vaccine (n=690 690).

Compared to placebo, inactive control or no intervention, HAV vaccines demonstrated a significant protective effect against clinical hepatitis A, as illustrated below (Table 1). The effect was also similar when trials graded as having low risk of bias were compared to those with high risk of bias (RR 0.09; 95% CI 0.03 to 0.30 (3 trials) and RR 0.09; 95% CI 0.04 to 0.19 (6 trials), respectively).

Protective effect against clinical hepatitis A

Studies /SubgroupNumber of participants (studies)Relative effect(95% CI)
All vaccine types732 380 (9)RR 0.09(0.05 to 0.17)
Inactivated HAV vaccines41 690(3)RR 0.12(0.05 to 0.31)
Live attenuated HAV vaccines690 690(5)RR 0.07(0.03 to 0.17)
High endemicity731 343(8)RR 0.08(0.04 to 0.15)
Low endemicity1037(1)RR 0.19(0.08 to 0.42)
Single dose regimen690 707(6)RR 0.07(0.03 to 0.15)
Multiple dose regimen41 416(3)RR 0.14(0.05 to 0.37)

Clinical comments

Note

Date of latest search:

References

  • Irving GJ, Holden J, Yang R et al. Hepatitis A immunisation in persons not previously exposed to hepatitis A. Cochrane Database Syst Rev 2012;7:CD009051 [withdrawn]. [PubMed]

Primary/Secondary Keywords