Randomized clinical trial comparing hepatitis B vaccine administered by 0, 6 and 14 week versus 6, 10 and 14 week schedule in healthy infants.
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].


CONCLUSIONS
Hepatitis B vaccination by 0, 6 and 14 weeks and 6, 10 and 14 weeks schedules are comparable in terms of sero-efficacy.
Das
Rashmi Ranjan
RR
Departments of Pediatrics and Virology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Mathew
Joseph L
JL
Ratho
Radha Kanta
RK
Dutta
Sourabh
S
D005260:Female; D017408:Guidelines as Topic; D006509:Hepatitis B / Q000517:prevention & control*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000276:immunology; D006801:Humans; D007115:Immunization Schedule; D007194:India; D007223:Infant; D018709:Statistics, Nonparametric; D013997:Time Factors; D016896:Treatment Outcome; D014614:Vaccines, Synthetic / Q000008:administration & dosage* / Q000276:immunology
D017325:Hepatitis B Vaccines; D014614:Vaccines, Synthetic