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Journal of Tropical Pediatrics Advance Access originally published online on March 5, 2009
Journal of Tropical Pediatrics 2009 55(5):328-331; doi:10.1093/tropej/fmp013
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© The Author [2009]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Brief Reports

Randomized Clinical Trial Comparing Hepatitis B Vaccine Administered by 0, 6 and 14 Week versus 6, 10 and 14 Week Schedule in Healthy Infants

Rashmi Ranjan Das, Joseph L. Mathew, Radha Kanta Ratho and Sourabh Dutta

Departments of Pediatrics and Virology, Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India

Correspondence: Joseph L. Mathew, Advanced Pediatrics Centre, PGIMER, Chandigarh 160012, India. Tel.: 91-172-2755357; Fax: 91-172-2744401. E-mail: <jlmathew{at}rediffmail.com>.


  Abstract

Objective: This randomized, single-blinded trial was carried out to compare the sero-efficacy of hepatitis B vaccine administered to healthy infants by either of two schedules–birth, 6, 14 weeks or 6, 10 and 14 weeks.

Methods: The 74 infants born to HbsAg-negative mothers were randomized to receive recombinant hepatitis B vaccine at 0, 6 and 14 weeks (Group A) or 6, 10 and 14 weeks (Group B). Serum anti-HBs antibody titer was measured before the first dose and 6 months after the third dose by laboratory personnel blinded to the intervention. All participants received other vaccines as per the national immunization schedule.

Results: At 6 months after the third dose sero-conversion was 100% in both groups. A total of 97.3% of subjects in Group A were sero protected (>10 mIUml–1) with geometric mean titer (GMT) of 113.78 mIUml–1 and 94.6% in Group B (GMT 107.04 mIUml–1) [p = 0.8].

Conclusion: Hepatitis B vaccination by 0, 6 and 14 weeks and 6, 10 and 14 weeks schedules are comparable in terms of sero-efficacy.

Key Words: Hepatitis B • recombinant vaccine • schedule • infant


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