Long-term clinical observation of the immunogenicity of inactivated hepatitis A vaccine in children

Bian, Guolin; Ma, Rui; Dong, Hongjun; Ni, Hongxia; Hu, Fang; Chen, Yao-rong; Chen, Jia-Qun; Zhou, Shaoying; Lin, Yongxin; Xu, Guozhang

doi:10.1016/j.vaccine.2010.04.096

Cited by 26 publications

(23 citation statements)

References 20 publications

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“…Thus, we predict the two-dose schedule will follow the same trend as the three-dose study and immunogenicity will persist at similar levels until at least 17 years. Two previous studies on the long-term immunogenicity of hepatitis A vaccine using the 2 dose schedule in children and adolescence have shown excellent long-term immunogenicity at 10 years [8,10]. Another study compared a two-and three-dose schedule using a combination hepatitis A and B vaccine with the same amount of antigen as in our study and demonstrated good immunogenicity at 10 years and the vaccination schedules elicit immune responses that are not statistically different [9].…”

Section: Discussionsupporting

confidence: 59%

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Duration of protection against hepatitis A for the current two-dose vaccine compared to a three-dose vaccine schedule in children

Raczniak

Thomas

Bulkow

et al. 2013

Vaccine

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Background-Hepatitis A is mostly a self-limiting disease but causes substantial economic burden. Consequently, United States Advisory Committee for Immunization Practices recommends inactivated hepatitis A vaccination for all children beginning at age 1 year and for high risk adults. The hepatitis A vaccine is highly effective but the duration of protection is unknown.Methods-We examined the proportion of children with protective hepatitis A antibody levels (anti-HAV ≥20 mIU/mL) as well as the geometric mean concentration (GMC) of anti-HAV in a cross sectional convenience sample of individuals aged 12-24 years, who had been vaccinated with a two-dose schedule in childhood, with the initial dose at least 5 years ago. We compared a HHS Public Access Author Manuscript Author ManuscriptAuthor ManuscriptAuthor Manuscript subset of data from persons vaccinated with two-doses (720 EL.U.) at age 3-6 years with a demographically similar prospective cohort that received a three-dose (360 EL.U.) schedule and have been followed for 17 years.Results-No significant differences were observed when comparing GMC between the two cohorts at 10 (P = 0.467), 12 (P = 0.496), and 14 (P = 0.175) years post-immunization. For the three-dose cohort, protective antibody levels remain for 17 years and have leveled-off over the past 7 years. Conclusion-The two-and three-dose schedules provide similar protection >14 years after vaccination, indicating a booster dose is not needed at this time. Plateauing anti-HAV GMC levels suggest protective antibody levels may persist long-term.

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Section: Discussionsupporting

confidence: 59%

“…Others have reported the long term clinical results of the two-dose vaccination schedule in other geographical areas [8][9][10], herein we compare two-dose vaccination to the three-dose vaccination which is the longest followed cohort for HAV immunization.…”

Section: Introductionmentioning

confidence: 99%

Duration of protection against hepatitis A for the current two-dose vaccine compared to a three-dose vaccine schedule in children

Raczniak

Thomas

Bulkow

et al. 2013

Vaccine

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“…Similarly, there is no consensus regarding anti-HAV seroprotective levels. We arbitrarily used the threshold of 20 IU/L as a proxy for seroprotection for anti-HAV [23][24][25] and defined a priori for all study vaccines an anamnestic response as a ≥ 4-fold rise in antibody level. For subjects with anti-HBs titers under 10 IU/L, a level above this threshold was also required to be considered as an anamnestic response.…”

Section: Discussionmentioning

confidence: 99%

“…22 Similarly, the anti-HAV GMTs in both study groups were more than 100-fold higher than the antibody titers cited in several publications as seroprotective. [23][24][25] Thus, the differences in anti-HAV and anti-HBs GMTs observed one month post-second dose of vaccine should have no clinical significance.…”

Section: Discussionmentioning

confidence: 99%

Immunogenicity of quadrivalent HPV and combined hepatitis A and B vaccine when co-administered or administered one month apart to 9–10 year-old girls according to 0–6 month schedule

Gîlca

Sauvageau

Boulianne

et al. 2014

Human Vaccines & Immunotherapeutics

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IntroductionThe approved schedules for human papilloma virus (HPV) vaccines (qHPV (Gardasil®) and bHPV (Cervarix®)) include three doses administered at 0, 1-2 and 6 m. The first two doses given within a relatively short period of time are expected to prime the immune system and the third is expected to confer long-lasting immunity.1 When given according to this schedule to 16-45 y old females, HPV vaccines have been shown to be highly immunogenic and protect against persistent infection, anogenital warts and precancerous abnormalities.2-10 Post-licensure trials with bHPV showed that > 98% of 15-25 y old females developed antibodies to HPV 16 and HPV 18 which remain detectable up to 76 mo after a single vaccine dose.3 In addition, a significant increase in antibody titers resulted from a second dose of vaccine and high clinical efficacy was demonstrated in individuals who received less than three vaccine doses. [4][5][6] Finally, in preadolescents and adolescents, both HPV and combined HAV/HBV vaccines Background. No immunogenicity data has been reported after a single dose of the quadrivalent HPV vaccine (qHPVGardasil®) and no data are available on co-administration of this vaccine with the HAV/HBV vaccine (Twinrix-Junior®). Two pre-licensure studies reported similar anti-HPV but lower anti-HBs titers when co-administering HPV and HBV vaccines.Objectives. To assess the immunogenicity of the qHPV and HAV/HBV vaccine when co-administered (Group-co-adm) or given one month apart (Group-sep) and to measure the persistence of HPV antibodies three years post-second dose of qHPV vaccine in both study groups.Methods. 416 9-10 year-old girls were enrolled. Vaccination schedule was 0-6 months. Anti-HAV and anti-HBs were measured in all subjects 6 months post-first dose and 1 month post-second dose. Anti-HPV were measured 6 months post-first dose in Group-co-adm and in all subjects 1 and 36 months post-second dose.Results. six months post-first dose: 100% of subjects had detectable anti-HAV and 56% and 73% had detectable antiHBs in Group-co-Adm and Group-sep, respectively. In Group-co-adm 94, 100, 99 and 96% had detectable antibodies to HPV 6, 11, 16 and 18, respectively. One month post-second dose of qHPV and HAV/HBV vaccine, in both study groups 99.5-100% of subjects had an anti-HAV titer ≥ 20IU/L, 97.5-97.6% an anti-HBs level ≥ 10IU/L, and 100% had an anti-HPV titer ≥ 3LU. Thirty-six months post-second dose of qHPV all but four subjects (99%) had antibodies to HPV18 and 100% had antibodies to HPV6, 11 and 16. The great majority (97-100%) had an anti-HPV titer ≥ 3 LU. Post-second dose administration of qHPV and HAV/HBV, no meaningful difference was observed in the immune response in the two study groups to any component of vaccines.conclusions. The results indicate that qHPV and HAV/HBV can be given during the same vaccination session. Two doses of of qHPV and HAV/HBV vaccines induce a strong immune response. Three years post-second dose of qHPV, the great majority of subjects had antibodies to HPV types included in the v...

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“…However, we do not know how far the immunity induced by immunization persists, though several studies reported recently that the vaccine induced immunity last as long as vaccines have been available [19][20][21][22]. Therefore, the heterogeneous endemicity over the country [17,18] raised a serious concern of HAV infection, that is, if immunity induced by vaccination decreases when immunized children become adults, the disease burden from hepatitis A will paradoxically increase, because relatively high levels of circulating hepatitis A virus persist.…”

Section: Discussionmentioning

confidence: 99%

Waning of anti-HAV immunity in Shijiazhuang prefecture, Hebei province, China: A comparison of seroprevalence between 1992 and 2011

Chen

Zhang²,

Zhao

et al. 2014

Vaccine

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Long-term clinical observation of the immunogenicity of inactivated hepatitis A vaccine in children

Cited by 26 publications

References 20 publications

Duration of protection against hepatitis A for the current two-dose vaccine compared to a three-dose vaccine schedule in children

Duration of protection against hepatitis A for the current two-dose vaccine compared to a three-dose vaccine schedule in children

Immunogenicity of quadrivalent HPV and combined hepatitis A and B vaccine when co-administered or administered one month apart to 9–10 year-old girls according to 0–6 month schedule

Waning of anti-HAV immunity in Shijiazhuang prefecture, Hebei province, China: A comparison of seroprevalence between 1992 and 2011

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