Italian journal of pediatrics · 2025
Comparison of safety and immunogenicity between Healive®, Havrix® and live attenuated Hepatitis A vaccines in pediatric population: a systematic review with meta-analysis.
СтатьяСистематический обзорМетаанализСравнительное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Abo Zeid Mohamed, Elrosasy Amr, Farho Mohamad Ali, Rifai Mohamed, Aboelkhier Menna M, Elkhrashy Mohamed Nabil, Zabady Ahmed Hamdy, Zaki Mohamed Samir A, Hamed Eman Mostafa, Dawood Samy A, Abuzaid Yasmine
Аннотация
BACKGROUND: Healive is an inactivated vaccine for hepatitis A virus developed in China and was found to be well-tolerated and highly immunogenic in adults and children. It is our aim this study to compare the safety and immunogenicity of Healive® with Havrix® and live attenuated vaccines in pediatric populations.
METHODS: A systematic search of PubMed, Scopus, Web of Science, and Embase databases was conducted following PRISMA guidelines. Randomized controlled trials (RCTs) comparing Healive with other vaccines were included.
RESULTS: Seven RCTs involving 3664 patients were included. Healive showed comparable efficacy to Havrix regarding seroconversion rates and GMT at one month (SMD = 0.24, 95% CI [-0.11 to 0.59]), but achieved better results at six (SMD = 0.85, 95% CI [0.57 to 1.07]) and seven months (SMD = 0.55, 95% CI [0.41 to 0.70]). When compared to live attenuated vaccines, Healive demonstrated superior GMT at one month (SMD = 0.31, 95% CI [0.07 to 0.56]) and two years (SMD = 0.36, 95% CI [0.06 to 0.67]).
CONCLUSION: Healive appears to be effective and safe for preventing hepatitis A, providing at least five years of protection. This review underscores the importance of ongoing research to optimize hepatitis A vaccination strategies, including standardized assays for antigen content, clarification of protective antibody levels, and large-scale trials in regions of intermediate endemicity.
METHODS: A systematic search of PubMed, Scopus, Web of Science, and Embase databases was conducted following PRISMA guidelines. Randomized controlled trials (RCTs) comparing Healive with other vaccines were included.
RESULTS: Seven RCTs involving 3664 patients were included. Healive showed comparable efficacy to Havrix regarding seroconversion rates and GMT at one month (SMD = 0.24, 95% CI [-0.11 to 0.59]), but achieved better results at six (SMD = 0.85, 95% CI [0.57 to 1.07]) and seven months (SMD = 0.55, 95% CI [0.41 to 0.70]). When compared to live attenuated vaccines, Healive demonstrated superior GMT at one month (SMD = 0.31, 95% CI [0.07 to 0.56]) and two years (SMD = 0.36, 95% CI [0.06 to 0.67]).
CONCLUSION: Healive appears to be effective and safe for preventing hepatitis A, providing at least five years of protection. This review underscores the importance of ongoing research to optimize hepatitis A vaccination strategies, including standardized assays for antigen content, clarification of protective antibody levels, and large-scale trials in regions of intermediate endemicity.