COMPARATIVE study of TWO recombinant hepatitis B
vaccines (Euvax B and Engerix B) and their interchangeability in infants as
a primary vaccination at 0, 1 and 6 months of age
Tregnaghi M1, Ussher J1, Baudagna AM1, Calvari M1, Grana G1, Ortiz E2
1 Centro de Desarollo de
Proyectos Avanzados, Hospital Infantil Municipal de C��rdoba, C��rdoba,
Argentina
2 Aventis Pasteur, Lyon,
France
Objective: This study aimed to demonstrate the equivalence and
interchangeability of two WHO approved and recommended yeast-derived
recombinant hepatitis B vaccines, Euvax B (marketed as Hepativax in
Argentina) vs. Engerix B.
Methods: 300 infants were randomly allocated to three study
groups to receive a 3-dose primary vaccination (at 0, 1 and 6 months of
age):
group A = 3 doses of Euvax B
(Lucky Goldstart Chem. Ltd, 10 ��g dose), group B = 3 doses of Engerix B
(GlaxoSmithKline, 10 ��g dose), and group C = 1 dose of Engerix B followed
by 2 doses of Euvax B.
Reactogenicity was from
parental reports, reviewed by study medical personnel. Blood sampling
before dose 1 and after doses 2 and 3 to assay anti-hepatitis B surface
antigen (anti-HBs) by enzyme immunoassay.
Results: All 3 groups experienced equal and very low
reactogenicity rates. After the third dose, 100% of infants in each group
achieved seroprotective titres (anti-HBs ³ 10 mIU/mL). Geometric
mean concentrations were 2334, 1696 and 2105 mIU/mL in groups A, B and C,
respectively. Five months after dose 2, seroprotection rates were 95.8%,
94.6% and 90% in groups A, B and C respectively. Statistically, responses
to Euvax B, in groups A and C were identical (non-inferior) to Engerix B
(group B) in terms of seroprotection rate after the third dose.
Conclusion: Euvax B vaccine, given as a full series or as
subsequent doses, is equally immunogenic and safe as Engerix B for primary
vaccination in infants. The first two doses gave an early and significant immune response in
each group.