A prospective, two-armed, open-label, randomized trial was performed to compare the geometric mean titers (GMT), seroprotection (SP) and seroconversion (SC) rates found after administration of two doses of recombinant hepatitis B vaccine.
Recombinant hepatitis B vaccine 10 or 20 mug was administered IM at 0,1, and 6 months in healthy adolescents.
Volunteers who received either dose of the vaccine had similarly high seroconversion and seroprotection rates at all visits.
At Month 8, both doses of the vaccine were highly immunogenic with GMTs of 1989 mIU/mL (10 mug dose) and 7672 mIU/mL (20 mug dose) and nearly equivalent SP rates (97% and 99% in the 10 and 20 mug dose groups, respectively).
The geometric mean titers of seroconverters at Months 3,6 and 8 were significantly greater in the 20 mug group as compared to the 10 mug group (p¾0.003).
Both doses were well-tolerated, with injection site pain the most common reported adverse event.
Injection site pain was reported significantly (p=0.004) more by volunteers who received the 20 mug dose (10.7%) compared with volunteers who received the 10 mug dose (3.8%). Conclusion : Vaccination with 10 mug of recombinant hepatitis B vaccine may provide a clinically effective and economical alternative to the use of the 20 mug dose in healthy adolescents.
Mots-clés Pascal : Séroprotection, Séroconversion, Hépatite virale B, Appareil digestif pathologie, Foie pathologie, Prévention, Vaccin, Protéine recombinante, Réponse immune, Virus hépatite B, Immunogénicité, Etude longitudinale, Adolescent, Virose, Infection, Hepadnaviridae, Virus, Homme
Mots-clés Pascal anglais : Viral hepatitis B, Digestive diseases, Hepatic disease, Prevention, Vaccine, Recombinant protein, Immune response, Hepatitis B virus, Immunogenicity, Follow up study, Adolescent, Viral disease, Infection, Hepadnaviridae, Virus, Human
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 95-0179040
Code Inist : 002B30A03B. Création : 09/06/1995.