High seroprotection rate induced by low doses of a recombinant hepatitis B vaccine in healthy Iranian neonates

http://www.elsevier.nl/gej-ng/10/42/35/40/47/52/abstract.html

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Vaccine, Vol. 19 (31) (2001) pp. 4544 - 4548
© 2001 Elsevier Science Ltd. All rights reserved.
PII: S0264-410X(01)00183-9

High seroprotection rate induced by low doses of a recombinant hepatitis B vaccine in healthy Iranian neonates

F. Shokri * and A. Jafarzadeh

Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, PO Box 6446-14155, Iran

Received 14 February 2001; received in revised form 2 May 2001; accepted 8 May 2001

Abstract

Low-dose vaccination has been proposed as a cost-saving strategy to implement mass vaccination of neonates with hepatitis B (HB) vaccine, world-wide, particularly in developing countries. The effectiveness of low vaccine doses, however, needs to be evaluated and verified in newborns from different ethnic backgrounds. In this study, a recombinant HB vaccine (Heberbiovac) was administered in three different doses, including the standard 10 µg together with 5 and 2.5 µg to three groups of healthy Iranian neonates. Each group, consisting of 230-260 subjects, received triple doses of vaccine given i.m. at 0, 1.5 and 9 month intervals. Serum samples were collected 2-4 weeks after completion of vaccination, and anti-HBs antibody was quantitated by a sandwich ELISA. Seroprotection (anti-HBs>10 IU/L) was detected in 92, 97.4 and 96.1% of 2.5, 5 and 10 µg vaccine dose recipients, with geometric mean titer (GMT) of 4502, 5824 and 6104 IU/L, respectively. No significant differences were observed in seroprotection rate and GMT between the 10 and 5 µg dose recipients. Both parameters, however, were significantly lower in neonates vaccinated with a 2.5 µg vaccine dose (P<0.05 and P<0.001, respectively).

These findings indicate induction of a strong protective immune response in healthy Iranian neonates by a low dose (5 µg) of the recombinant HB vaccine.

Keywords: Anti-HBs antibody; Hepatitis B vaccine; Neonates; Seroprotection; Vaccination

^*Corresponding author. Tel.: +98-21-6462268; fax: +98-21-6462267

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