1. Efficacy and safety of hepatitis A vaccines i
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1 1. Efficacy and safety of hepatitis A vaccines i 1a) Full dose inactivated hepatitis A vaccine Author(s): Wiersma S, Irving G, Ott J, Holden J Date: Question: Should inactivated hepatitis A vaccine vs no intervention, inactive control or placebo be used for hepatitis A? Settings: General population No of studies Design Quality assessment No of patients Effect Risk Other Inconsistency Indirectness Imprecision of considerations Inactivated hepatitis A vaccine No intervention, inactive control or placebo Relative Quality Importance (95% Absolute CI) hepatitis A (follow-up months; assessed with: clinical and laboratory criteria) 4 randomised no no serious no serious no serious very strong association 1 10/ /19906 RR 0.12 CRITICAL trials serious inconsistency indirectness imprecision (0.05%) (0.48%) (0.05 to HIGH risk of 0.31) 0% - absence of serious adverse effects (follow-up months; assessed with: clinical observation) 4 randomised no no serious no serious no serious very strong association 2 0/ / CRITICAL trials serious inconsistency indirectness imprecision (0%) (0%) HIGH risk of 0% - 1 A large effect, RR=0.12, was found. 2 Innis 1994 reported that no hospitalizations or deaths were attributed to vaccination but did not provide full breakdown of reporting according to ICH GCP 1997.
2 References Innis B, Snitbhan R, et al. Protection against hepatitis A by an inactivated vaccine.. Journal of the American Medical Association 1994;271(17): Pérez M, Herzog C. 2003;188(5): Efficacy of virosome hepatitis A vaccine in young children in Nicaragua: randomized placebo-controlled trial. The Journal of Infectious Diseases 2003;188(5): Riedemann S, Reinhardt G. Placebo-controlled efficacy study of hepatitis A vaccine in Valdivia, Chile. Vaccine 1992;10:S Werzberger A, Mensch B. A controlled trial of a formalin-inactivated hepatitis A vaccine in healthy children. New England Journal of Medicine 1992;327(7):
3 1b) Live attenuated hepatitis A vaccine Author(s): Wiersma S, Irving G, Ott J, Holden J Date: Question: Should live attenuated hepatitis A vaccine vs no intervention, inactive control or placebo be used for hepatitis A? Settings: General population No of studies Design Risk of Quality assessment No of patients Effect Other Inconsistency Indirectness Imprecision considerations Live attenuated hepatitis A vaccine No intervention, inactive control or placebo Relative Quality Importance (95% Absolute CI) hepatitis A (follow-up 1-60 months; assessed with: clinical and laboratory criteria) 13 randomised serious 1 serious 2 no serious no serious none 3 63/ / RR 0.09 CRITICAL trials indirectness imprecision (0.007%) (0.09%) (0.04 to LOW 0% 0.17) - absence of serious adverse effects (follow-up 1-60 months; assessed with: clinical observation) 13 randomised serious 4 very serious 4 serious 4 serious 5 none 0/ / CRITICAL trials (0%) (0%) 0% - VERY LOW 1 None of the studies had a low risk of when considering adequate sequence generation, allocation concealment, blinding, incomplete accounting of patients and outcome events. All studies reported on expected outcomes. 2 I squared equals 80%. 3 RR was 0.09 with over 1.6 million participants. A very large effect was found but due to downgrade factors this was not used to upgrade this study. 4 Criteria not reported using ICH GCP Insufficient evidence was reported.
4 References Gong J, Li R, Yang J. Protective efficacy of large scale immunization with a live attenuated hepatitis A vaccine (LA-1 strain. Guangxi Journal of Preventative Medicine 2000;6(5): Jiang S, Huang J, Chen J. The epidemiological Efficacy Assessment of Attenuated Live Hepatitis A Vaccine in Masses in Liuzhou.. Chinese Journal of Epidemiology 1995;16(3): Jiang W, Niu X. Observation on the efficacy of attenuated live Hepatitis A Vaccine s Vaccination Contingency.. Modern Preventative Medicine 2001;28(1): Li Y, Wu H, Xu T. Observation of Immunogenicity and Epidemiological Efficacy Assessment of Attenuated Live Hepatitis A Vaccine.. Chinese Journal of Public Health 2000;16(8): Lin F, Gu X, Wang F. Assessment on the spot of Attenuated Live Hepatitis A Vaccine s Efficacy. Acta Academiae Medicinae Suzhou 1997;17(5): Luo D, Li R, Gong J. Epidemiological efficacy of Standardized Live Attenuated Hepatitis A Vaccine(LA- 1 strain). Chinese Journal of Vaccination and Immunization 2004;10(2): Meng Z. Yao J, Zhao Y. Observation on the Immunization effects of Attenuated Live Hepatitis A Vaccine. National Medical Journal of China 2000;80(1):9-11. Wu W, Xu Zhiyi, Xia J. Assessment of Attenuated Live Hepatitis A Vaccines protective efficacy on spot.. Chinese journal of public health 1996;12(12): Xu Z, Li R, Meng Z. Immunogenicity and efficacy trials of live attenuated hepatitis A vaccines. National Medical Journal of China 1998;78(4): Xu Z, Li R, Meng Z, Zhang Y, Gong J. Immunogenicity and efficacy of two live attenuated hepatitis A vaccines (H(2) strains and LA- 1 strains). National Medical Journal of China 2002;82(10):
5 Yuan Q, Luo S, Wu X. Observations on the Immunization effects of Attenuated Live Hepatitis A Vaccine. National Medical Journal of China 1995;80(1):9-11. Zhang S, Ma J, Han C. Primary research on Efficacy of Attenuated Live Hepatitis A Vaccine. Chinese Journal of Epidemiology 1994;13(6): Zhang Y, Liu X, Ma J. A field evaluation of the epidemiological efficacy of an attenuated live hepatitis A vaccine (H2 strain). Chinese Journal of Preventative Medicine 2001;35(6):
6 1c) Single dose inactivated hepatitis A vaccine Author(s): Wiersma S, Irving G, Ott J, Holden J Date: Question: Should single dose inactivated hepatitis A vaccine versus no intervention, inactive control or placebo be used for hepatitis A? Setting: General population Quality assessment No of patients Effect Single dose No of Risk Other Design Inconsistency Indirectness Imprecision inactivated studies of considerations hepatitis A 1 hepatitis A (follow-up mean 15 months; assessed with: clinical and laboratory criteria) 1 randomised no no serious no serious no serious very strong 0/136 trials serious inconsistency indirectness imprecision association (0%) risk of 1 Virosomal inactivated hepatitis A vaccine. No intervention, inactive control or placebo 17/136 (12.5%) 0% Relative Quality Importance (95% Absolute CI) RR 0.03 (0 to 0.47) - HIGH CRITICAL Reference Perez M, Herzog Z. Efficacy of virosome hepatitis A vaccine in young children in Nicaragua: randomized placebo-controlled trial. Int J Infect Diseases 2003; 188:
7 1d) Single dose live attenuated hepatitis A vaccine Author(s): Wiersma S, Irving G, Ott J, Holden J Date: Question: Should single dose live attenuated hepatitis A vaccine vs no intervention, inactive control or placebo be used for hepatitis A? Settings: General population No of studies Design Risk of Quality assessment No of patients Effect Other Inconsistency Indirectness Imprecision considerations Single dose live attenuated hepatitis A vaccine No intervention, inactive control or placebo Relative Quality Importance (95% Absolute CI) hepatitis A (follow-up 1-60 months; assessed with: clinical and laboratory criteria) 13 randomised serious 1 serious 2 no serious no serious none 3 63/ / RR 0.09 trials indirectness imprecision (0.007%) (0.09%) (0.04 to LOW 0% 0.17) - 1 None of the studies had a low risk of when considering adaquate sequence generation, allocation concealment, blinding, incomplete accounting of patients and outcome events. All studies reported on expected outcomes. 2 I squared equals 80%. 3 RR was 0.09 with over 1.6 million participants. CRITICAL References Gong J, Li R, Yang J. Protective efficacy of large scale immunization with a live attenuated hepatitis A vaccine (LA-1 strain. Guangxi Journal of Preventative Medicine 2000;6(5): Jiang S, Huang J, Chen J. The epidemiological Efficacy Assessment of Attenuated Live Hepatitis A Vaccine in Masses in Liuzhou.. Chinese Journal of Epidemiology 1995;16(3):
8 Jiang W, Niu X. Observation on the efficacy of attenuated live Hepatitis A Vaccine s Vaccination Contingency.. Modern Preventative Medicine 2001;28(1): Li Y, Wu H, Xu T. Observation of Immunogenicity and Epidemiological Efficacy Assessment of Attenuated Live Hepatitis A Vaccine.. Chinese Journal of Public Health 2000;16(8): Lin F, Gu X, Wang F. Assessment on the spot of Attenuated Live Hepatitis A Vaccine s Efficacy. Acta Academiae Medicinae Suzhou 1997;17(5): Luo D, Li R, Gong J. Epidemiological efficacy of Standardized Live Attenuated Hepatitis A Vaccine(LA- 1 strain). Chinese Journal of Vaccination and Immunization 2004;10(2): Meng Z. Yao J, Zhao Y. Observation on the Immunization effects of Attenuated Live Hepatitis A Vaccine. National Medical Journal of China 2000;80(1):9-11. Wu W, Xu Zhiyi, Xia J. Assessment of Attenuated Live Hepatitis A Vaccines protective efficacy on spot.. Chinese journal of public health 1996;12(12): Xu Z, Li R, Meng Z. Immunogenicity and efficacy trials of live attenuated hepatitis A vaccines. National Medical Journal of China 1998;78(4): Xu Z, Li R, Meng Z, Zhang Y, Gong J. Immunogenicity and efficacy of two live attenuated hepatitis A vaccines (H(2) strains and LA- 1 strains). National Medical Journal of China 2002;82(10): Yuan Q, Luo S, Wu X. Observations on the Immunization effects of Attenuated Live Hepatitis A Vaccine. National Medical Journal of China 1995;80(1):9-11. Zhang S, Ma J, Han C. Primary research on Efficacy of Attenuated Live Hepatitis A Vaccine. Chinese Journal of Epidemiology 1994;13(6):
9 Zhang Y, Liu X, Ma J. A field evaluation of the epidemiological efficacy of an attenuated live hepatitis A vaccine (H2 strain). Chinese Journal of Preventative Medicine 2001;35(6): i All four GRADE tables on hepatitis A vaccine safety and efficacy were prepared on the bases of a recently conducted Cochrane Review. References to individual studies are included at the end of each table. Irving GJ, Yang R, Holden J, Pope D. Hepatitis A immunisation in persons not previously exposed to hepatitis A (Review). Cochrane Database of Systematic Reviews 2011, Issue 3. Art. No.: CD DOI: / CD
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