1237 Comparison of Immunogenicity Between Inactivated and Live Attenuated Hepatitis a Vaccines: A Doubleblind, Randomized, Parallel-Group Clinical Trial Among Children in Xinjiang Uighur Autonomous Region, China

Liu, X.; Wushouer, Fuerhati; Gou, Aili; Kuerban, Mahemuti; Li, X.; Sun, Yu; Zhang, J.; Liu, Y.; Li, J.; Zhang, Hui

doi:10.1016/s0168-8278(13)61238-6

Cited by 5 publications

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“…Both HA-L and HA-I also produced at least 3 years of immunological persistence, because the GMC and SR values for the two vaccines remained very high, even after 3 years. The results of two previous studies showed that anti-HAV titres were higher after the booster dose of inactivated HA vaccine than after the first dose, and a twodose regimen is more effective than a one-dose regimen with HA-I [19,20]. There are other articles stating that single-dose vaccines can also provide good immune effects [3].…”

Section: Discussionmentioning

confidence: 99%

Long-term immunogenicity and immune persistence of live attenuated and inactivated hepatitis a vaccines: a report on additional observations from a phase IV study

Luo¹,

Wang²,

Kang

et al. 2019

Clinical Microbiology and Infection

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Both live attenuated (HA-L) and inactivated (HA-I) hepatitis A vaccine were licensed for routine use in China. Although phase 1, 2 and 3 clinical studies of both vaccines have been completed, further systematic evaluation of their immunogenicity and immunological persistence under phase 4 clinical studies in a wide range of conditions and involving large populations is necessary. A phase IV clinical trial (NCT02601040) was performed in 9000 participants over 18 months of age. Geometric mean concentrations (GMCs) and seroconversion rates (SRs) were compared at five time points during 3 years for 1800 individuals among them. The SRs of HA-L and HA-I were 98.08% (95% CI 95.59%e99.38%) and 99.64% (95% CI 98.93%e100.00%) respectively 28 days after administration of the first dose, and remained at 97.07% (95% CI 94.31%e98.73%) or above and 96.73% (95% CI 94.07%e98.42%) or above respectively during the following 3 years. The GMCs for both the HA-L and HA-I groups showed that both vaccines elicited high anti-HAV titres, considerably more than the threshold of protection needed against HAV infection in humans, and these titres were sustained. Hence, both HA-I and HA-L vaccines could provide an excellent long-term protective effect, and supported the routine use of both vaccines.

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Section: Discussionmentioning

confidence: 99%

Long-term immunogenicity and immune persistence of live attenuated and inactivated hepatitis a vaccines: a report on additional observations from a phase IV study

Luo¹,

Wang²,

Kang

et al. 2019

Clinical Microbiology and Infection

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“…15 Similar findings were seen in a study conducted in Xinjiang Uighur Autonomous Region of China, which showed that 12 months following 1 dose of H 2 vaccine, the average GMC was 135.8 mIU/ml, and the seropositivity rate was 92.9%. 8 Experimental studies have shown that both inactivated and live hepatitis A vaccines are able to induce a T-cell response. 16 One study showed a memory response up to 11 y with a booster dose of virosome-formulated inactivated hepatitis A vaccine.…”

Section: Discussionmentioning

confidence: 99%

“…8 Although national-level hepatitis A mortality has declined to 1.67 per 100,000 population by 2013, 11 there remain high-risk areas in China. Furthermore, none of the available hepatitis A vaccines are made available free to children over 3 y of age, including school-age children.…”

Section: Program Implicationsmentioning

confidence: 99%

Comparison of immune persistence among inactivated and live attenuated hepatitis a vaccines 2 years after a single dose

Zhang

et al. 2016

Human Vaccines & Immunotherapeutics

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Objective: Compare immune persistence from one dose of each of 3 different hepatitis A vaccines when given to school-age children: a domestic, live attenuated hepatitis A vaccine (H 2 vaccine); a domestic inactivated hepatitis A vaccine (Healive Ò ); and an imported, inactivated hepatitis A vaccine (Havrix Ò ),. Methods: School-age children were randomized into 1 of 4 groups to receive a single dose of a vaccine: H 2 vaccine, Healive Ò , Havrix Ò , or hepatitis B vaccine [control]. Serum samples were collected 12 and 24 months after vaccination for measurement of anti-HAV IgG using microparticle enzyme immunoassay. Seropositivity was defined as 20 mUI/ml. We compared groups on seropositivity and geometric mean concentration (GMC). Results: Seropositive rates for the H 2 , Healive Ò , Havrix Ò , and control groups were 64%, 94.4%, 73%, and 1.0%, respectively, 12-months post-vaccination; and 63%, 95.6%, 72%, and 1.0%, respectively 24-months post-vaccination. Seropositivity was greater for Healive Ò than for H 2 and Havrix Ò at 12 months (p-values < 0.001) and 24 months (p-values < 0.0001). Average GMCs for the H 2 , Healive Ò , Havrix Ò , and control groups, in mIU/ml, were 29.7, 81.0, 36.4, and 2.9, respectively at 12 months, and 30.9, 112.2, 44.3, and 2.9, respectively, at 24 months. GMCs were greater for Healive Ò than for H 2 and Havrix Ò at 12 months (p-values < 0.0001 and < 0.001, respectively) and 24 months (p-values < 0.001). No statistically significant differences in seropositivity or GMC were found within groups between 12 and 24 months. Conclusion: Immunity persisted 24 months after a single dose of inactivated hepatitis A vaccine and live attenuated hepatitis A vaccine.

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“…Two live attenuated hepatitis A vaccines, containing the H2 and LA-1 strains of virus, have been developed in China (Table 1) (Cui et al 2009;Wu et al 2012;Liu et al 2013;Xiong et al 2014;Zhang et al 2016). Only limited information is available on the attenuating mutations present in the genomes of the Chinese attenuated strains of HAV (Jiang et al 2004), but the nucleotide sequence of the H2 virus is remarkably similar to an attenuated HM175 strain vaccine candidate developed in Robert Purcell's laboratory at the U.S. National Institutes of Health (Karron et al 1988;Binn and Lemon 2010).…”

Section: Live Attenuated Vaccinesmentioning

confidence: 99%

Immunization against Hepatitis A

Shouval

2018

Cold Spring Harb Perspect Med

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Worldwide, there are multiple formaldehyde-inactivated and at least two live attenuated hepatitis A vaccines now in clinical use. The impressive immunogenicity of inactivated vaccines is reflected in rapid seroconversion rates, enabling both preexposure and postexposure prophylaxis. Universal childhood vaccination programs targeting young children have led to significant drops in the incidence of hepatitis A both in toddlers and in susceptible nonimmune adults in regions with intermediate endemicity for hepatitis A. Although the safety of inactivated vaccines is well established, further studies are needed concerning the implications of fecal virus shedding by recipients of attenuated vaccines, as well as the long-term persistence of immune memory in children receiving novel immunization schedules consisting of single doses of inactivated vaccines.

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1237 Comparison of Immunogenicity Between Inactivated and Live Attenuated Hepatitis a Vaccines: A Doubleblind, Randomized, Parallel-Group Clinical Trial Among Children in Xinjiang Uighur Autonomous Region, China

Cited by 5 publications

References 0 publications

Long-term immunogenicity and immune persistence of live attenuated and inactivated hepatitis a vaccines: a report on additional observations from a phase IV study

Long-term immunogenicity and immune persistence of live attenuated and inactivated hepatitis a vaccines: a report on additional observations from a phase IV study

Comparison of immune persistence among inactivated and live attenuated hepatitis a vaccines 2 years after a single dose

Immunization against Hepatitis A

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