Challenge with a hepatitis B vaccine in two cohorts of 4–7-year-old children primed with hexavalent vaccines: An open-label, randomised trial in Italy

Zanetti, Alessandro; Parlato, Antonino; Romanò, Luisa; Desole, Maria Giuseppina; Ferrera, Giuseppe; Giurdanella, Filippo; Zuliani, Massimo; Richard, Patrick O.; Thomas, Stéphane; Fiquet, Anne

doi:10.1016/j.vaccine.2012.06.078

Cited by 31 publications

(24 citation statements)

References 14 publications

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“…For quality assurance, individuals found to be positive for anti-HBc or HBsAg were reassessed. According to the international standards, anti-HBs level of at least 10 IU/l was considered to be protective against HBV infection [2,11]. Undetectable level was defined as anti-HBs level less than 1 IU/l and detectable level when it was 1-9 IU/l [12].…”

Section: Blood Sampling and Laboratory Analysismentioning

confidence: 99%

Hepatitis B long-term seroprotection and the response to a challenging dose among vaccinated children in Gharbeya Governorate

Sami

Salama²,

Rabah³

et al. 2013

Medical Research Journal

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Objective The aim of the study was to assess the longterm effectiveness of hepatitis B virus (HBV) vaccine and the need for a booster dose among fully vaccinated children during infancy in Gharbeya Governorate.Patients and methods A cross-sectional study was conducted using a multistage random sampling in one city and three villages in Gharbeya Governorate. Face-to-face interview with parents of 762 children was carried out. Blood samples were collected to assess HBV markers using enzyme-linked immunosorbent assay technique. Children having no HBV seroprotection received a challenging booster dose of HBV vaccine to assess their anamnestic response 3 weeks later.Results None of the participants had an evidence of chronic or breakthrough HBV infection, and the seroprotection rate was 57%. On multivariate analysis, the risk of nonseroprotection was found to be significantly higher among children aged from 5 to less than 10, 10 to less than 15, and 15 years and above compared with those aged less than 5 years [adjusted odds ratio (AOR) = 3.4, 10.2, and 18.5, respectively], among girls compared to boys (AOR = 1.5), and among those living in Kotour and Elsanta villages compared with Tanta city (AOR = 1.8). Of the 265 children with nonseroprotective levels, 91.7% developed anamnestic response after a challenging dose. Anamnestic response rate was 100% at age 1 year and decreased to 89% at age 16 years (P > 0.05).Conclusion Long-term immunity exists among children who had complete series of hepatitis B vaccination in infancy even in case of reduced or absent anti-hepatitis B over time. The developed high anamnestic response rate signifies the presence of immune memory and indicates no need for a booster dose.

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Section: Blood Sampling and Laboratory Analysismentioning

confidence: 99%

Hepatitis B long-term seroprotection and the response to a challenging dose among vaccinated children in Gharbeya Governorate

Sami

Salama²,

Rabah³

et al. 2013

Medical Research Journal

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“…16 The 1-month time interval following the challenge dose was consistent with studies of long-term immunogenicity for hepatitis B vaccines. 15,[17][18][19][20][21] The PPS analyzed for immunogenicity was representative of the 296 eligible patients from the primary study with respect to the SPR following Dose 3. 14 The results of the study demonstrated high rates of individuals with anti-HBs 10 mIU/mL pre-challenge, which increased further at 1 month following a challenge dose of HBvaxPRO Ò in individuals 50 years of age who had received primary vaccination with hepatitis B vaccine >3 years previously.…”

Section: Discussionmentioning

confidence: 99%

“…[15][16][17][18][19][20][22][23][24][25][26] The post-challenge SPRs and GMTs observed in this extension study were also comparable to or higher than those reported at the end of the primary vaccination series (Dose 3) for both groups (HBvaxPRO Ò group: 79.5% and 152.9 mIU/mL, respectively, at the end of the primary study, and 85.2% and 957.4 mIU/mL, respectively, post-challenge; Engerix B TM group : 88.3% and 437.2 mIU/mL, respectively, at the end of the primary series, and 88.3% and 1,497.6 mIU/mL, respectively, postchallenge).…”

Section: Discussionmentioning

confidence: 99%

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Persistence of immunity in healthy adults aged ≥50 years primed with a hepatitis B vaccine 3 years previously

Sharma

Ahlm

Østergaard

et al. 2015

Human Vaccines & Immunotherapeutics

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Hepatitis B vaccines do not generate protective immune responses in older adults as effectively as they do in children and young adults. Improved formulations of existing vaccines may have the potential to improve this. This study investigated the persistence of serum antibodies against hepatitis B surface antigens (anti-HBs) 3.1-3.5 years following primary vaccination with 3 doses of HBvaxPRO Ò or Engerix B TM in healthy adults aged 50 years who were further challenged with 1 dose of recombinant hepatitis B antigen. This was an open-label extension study. Individuals (N D 204) with a mean (standard deviation) age at enrollment of 63.7 (7.0) years receiving HBvaxPRO Ò or Engerix B TM in a randomized, double-blind primary study were challenged with 1 dose of HBvaxPRO Ò (10 mg). Anti-HBs were measured pre-and 30 days post-challenge. 45. 5% (34.8, 56.4 [95% CI]) of individuals who received HBvaxPROÒ in the per protocol set (PPS) had anti-HBs titers 10 mIU/mL pre-challenge and 85.2% (76.1, 91.9) 1-month post-challenge. In those who received Engerix B TM in the primary vaccination series, the results were 58.8% (48.6, 68.5) and 88.3% (80.5, 93.8), respectively. The challenge dose of HBvaxPRO Ò was generally well tolerated. Subjects aged 50 years receiving a challenge dose of HBvaxPRO Ò demonstrated immune memory against hepatitis B 3 years after a 3-dose primary. The safety profile of this challenge dose of HBvaxPRO Ò was consistent with the well-established safety profile of the vaccine HBvaxPRO Ò .

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“…According to international standards anti-HBs ≥10 IU/L, was considered protective against HBV infection [19]. Weak response to HBV vaccine after full vaccination dose was defined as 10-100 IU/L while strong response were at a level >100 IU/L [20].…”

mentioning

confidence: 99%

Prevalence of hepatitis B and C among some high risk groups in Egyptian children attending Benha University hospital.

Elsherbiny¹,

Abed²,

Mohammed³

et al. 2017

IJAR

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Background: Hepatitis C virus (HCV) is a global health problem especially in Egypt. Hepatitis B virus (HBV) is a major cause of chronic liver diseases especially cirrhosis and hepatocellular carcinoma. HBV incidence is markedly reduced after mass vaccination programs application. Objectives: to detect HCV and HBV seroprevalence among some high risk children with molecular confirmation of viremia by real-time PCR for seropositive cases. Materials and methods: A comparative cross sectional study was conducted on 5 groups of Egyptian children attending Benha University Hospital (diabetes mellitus, thalassemia, hemodialysis, previously exposed to surgery and healthy children). All children were subjected to full history taking, physical examination and laboratory investigations including HCV antibodies by 4 th generation ELISA, HBsAg, HBsAb using ELISA, liver function tests and CBC, HCV and HBV viremia detection by real-time PCR for ELISA positive subjects. Results: HCV seropositivity was detected in 5%, 15%, 30%, 50% and 10% for healthy, diabetic, thalassemia, hemodialysis and previously exposed to surgery, respectively. As regard HBV, only a hemodialysis case was positive for both HBsAg and HBV-DNA. Low social class, blood transfusion, frequent intravenous injection, previous surgery and previous hospitalization are major risk factors for HCV transmission. Conclusion:The study revealed high HCV seropositivity prevalence among the studied high risk groups. PCR should be done for all HCV seropositive cases to confirm the presence of viremia.

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Challenge with a hepatitis B vaccine in two cohorts of 4–7-year-old children primed with hexavalent vaccines: An open-label, randomised trial in Italy

Cited by 31 publications

References 14 publications

Hepatitis B long-term seroprotection and the response to a challenging dose among vaccinated children in Gharbeya Governorate

Hepatitis B long-term seroprotection and the response to a challenging dose among vaccinated children in Gharbeya Governorate

Persistence of immunity in healthy adults aged ≥50 years primed with a hepatitis B vaccine 3 years previously

Prevalence of hepatitis B and C among some high risk groups in Egyptian children attending Benha University hospital.

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