Observational Study
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Hepatol. Oct 8, 2015; 7(22): 2418-2426
Published online Oct 8, 2015. doi: 10.4254/wjh.v7.i22.2418
Effectiveness of hepatitis B virus vaccination program in Egypt: Multicenter national project
Iman I Salama, Samia M Sami, Zeinab Nabil Ahmed Said, Manal H El-Sayed, Lobna A El Etreby, Thanaa M Rabah, Dalia M Elmosalami, Amany T Abdel Hamid, Somaia I Salama, Aida M Abdel Mohsen, Hanaa M Emam, Safaa M Elserougy, Amal I Hassanain, Naglaa F Abd Alhalim, Fatma A Shaaban, Samia A Hemeda, Nihad A Ibrahim, Ammal M Metwally
Iman I Salama, Lobna A El Etreby, Thanaa M Rabah, Dalia M Elmosalami, Amany T Abdel Hamid, Somaia I Salama, Aida M Abdel Mohsen, Samia A Hemeda, Nihad A Ibrahim, Ammal M Metwally, Community Medicine Research Department, National Research Center, Cairo 12311, Egypt
Samia M Sami, Amal I Hassanain, Fatma A Shaaban, Child Health Department, National Research Center, Cairo 12311, Egypt
Zeinab Nabil Ahmed Said, Naglaa F Abd Alhalim, Micro-biology and Immunology Department, Faculty of Medicine (for girls), Al-Azhar University, Cairo 11754, Egypt
Manal H El-Sayed, Pediatrics Department, Faculty of Medicine, Ain-Shams University, Cairo 11566, Egypt
Hanaa M Emam, Dermatology and Venereology Department, National Research Center, Cairo 12311, Egypt
Safaa M Elserougy, Environmental and Occupational Medicine Department, National Research Center, Cairo 12311, Egypt
Author contributions: All the authors contributed to this work.
Institutional review board statement: The study was reviewed and approved by the ethical committees of Ministry of Health (MOH), National Research Center and Ministry of Education- Egypt in accordance with the Helsinki Declaration.
Informed consent statement: All the legal guardians of the study participants were provided informed written consent prior to study enrollment. In addition, children aged above 10 years were enrolled after getting their verbal assent.
Conflict-of-interest statement: The authors declare no conflict of interest.
Data sharing statement: Statistical code and dataset are available from the first author at salamaiman@yahoo.com. Consent for data sharing was not obtained from participants but the presented data are anonymized and risk of identification is nil. No additional data are available.
Corresponding author: Zeinab Nabil Ahmed Said, Professor in Microbiology and Immunology Department, Faculty of Medicine (for girls), Al-Azhar University, Yousef Abbas Str, Nasr City, Cairo 11754, Egypt. znabil58@yahoo.com
Received: April 26, 2015
Peer-review started: April 28, 2015
First decision: June 3, 2015
Revised: August 4, 2015
Accepted: September 10, 2015
Article in press: September 16, 2015
Published online: October 8, 2015
Processing time: 159 Days and 15.7 Hours
Abstract
AIM

To assess the effectiveness of hepatitis B virus (HBV) vaccination program among fully vaccinated children.

METHODS

A national community based cross-sectional study was carried out in 6 governorates representing Egypt. A total of 3600 children aged from 9 mo to 16 years who were fully vaccinated with HBV vaccine during infancy were recruited. Face to face interviews were carried out and sera were evaluated for hepatitis B surface antigen (HBsAg), anti-HBV core antibodies (total) and quantitative detection of hepatitis B surface antibody using enzyme linked immunoassays techniques. Samples positive to HBsAg/anti-HBV core antibodies were subjected to quantitative HBV-DNA detection by real time polymerase chain reaction with 3.8 IU/L detection limit.

RESULTS

Sero-protection was detected among 2059 children (57.2%) with geometric mean titers 75.4 ± 3.6 IU/L compared to 3.1 ± 2.1 IU/L among non-seroprotected children. Multivariate logistic analysis revealed that older age and female gender were the significant predicting variables for having non sero-protective level, with adjusted odds ratio 3.3, 9.1 and 14.2 among children aged 5 to < 10, 10 to < 15 and ≥ 15 years respectively compared to those < 5 years and 1.1 among girls compared to boys with P < 0.01. HBsAg was positive in 0.11% and breakthrough infection was 0.36% and 0.39% depending on positivity of anti-HBc and DNA detection respectively. The prevalence of HBV infection was significantly higher among children aged ≥ 7 years (0.59%) compared to 0.07% among younger children with odds ratio equal to 8.4 (95%CI: 1.1-64.2) and P < 0.01.The prevalence was higher among girls (0.48%) than boys (0.29%) with P > 0.05.

CONCLUSION

The Egyptian compulsory HBV vaccination program provides adequate protection. Occult HBV infection exists among apparently healthy vaccinated children. Adherence to infection control measures is mandatory.

Keywords: Hepatitis B virus; Immunization; Sero-protection; Breakthrough infection; Children

Core Tip: To assess the effectiveness of hepatitis B virus (HBV) vaccination program, a national community based survey was carried out in six governorates representing Egypt on 3600 children aged 9 mo to 16 years (received 3 doses HBV vaccine during infancy). Anti-hepatitis B surface (anti-HBs) titer, anti-HBc and HBs antigen were assessed. HBV DNA detection was done for suspected cases. Prevalence of HBV sero-protection, breakthrough HBV infection, and chronic carrier were 57.2% 0.39% and 0.11% respectively. Multivariate analysis revealed that older age and girls were the significant predictor variables for non sero-protection. Despite waning of anti-HBs over time, HBV vaccination program is effective in Egypt.