A comparison of two commercial recombinant vaccines for hepatitis B in adolescents.
The immunogenicity and reactogenicity profiles of three doses each of Engerix-B(R) (10 microg hepatitis B surface antigen) and Recombivax(R) (5 microg hepatitis B surface antigen), given on a 0, 1, 6 month schedule to healthy adolescents were compared in a single-blind, randomized clinical trial. One month following the third dose, seroprotection rates after Engerix-B and Recombivax were similar (99 and 98%, respectively). The geometric mean titre (GMT) was statistically significantly higher following vaccination with Engerix-B (3961 vs. 1001 mIU/ml; P=0.0001, Fisher's exact test). Most of the symptoms reported were mild or moderate in intensity and transient. There were no vaccine-related serious adverse events.
Leroux-Roels
G
G
Centre for Vaccinology, University of Ghent-University Hospital, De Pintelaan 185, 9000, Ghent, Belgium.
Abraham
B
B
Fourneau
M
M
De Clercq
N
N
Safary
A
A
D000293:Adolescent; D002648:Child; D005260:Female; D006510:Hepatitis B Antibodies / Q000097:blood; D017325:Hepatitis B Vaccines / Q000009:adverse effects / Q000276:immunology / Q000494:pharmacology*; D006801:Humans; D007115:Immunization Schedule; D008297:Male; D012449:Safety; D016037:Single-Blind Method; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology / Q000494:pharmacology*
C075654:Engerix-B; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; C075655:Recombivax HB; D014614:Vaccines, Synthetic