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Safety and immunogenicity of a hepatitis B vaccine formulated with a novel adjuvant system.

Abstract：

:A formulation of recombinant hepatitis B surface antigen (HBsAg) combined with a novel adjuvant system, SBAS4--a combination of aluminium salt and monophosphoryl lipid A (MPL), was assessed in 27 healthy adult volunteers with a commercial vaccine (Engerix-B) as control. After three doses (0, 1, 6 months schedule), reactogenicity profiles were similar. Local reactions were essentially mild, the most frequent being soreness at the injection site. Seroprotection was achieved after two doses in all subjects given the candidate vaccine, all Engerix-B vaccines being seroprotected after the third dose. After the second and third doses, higher anti-HBs Geometric Mean Titres (GMTs) were observed in the group which received the formulation with the novel adjuvant system, and cellular immunity, measured as HBsAg-specific lymphoproliferation was stronger than with Engerix-B. These results indicate that the new formulation is safe, well-tolerated and immunogenic and may promote more rapid protection against hepatitis B infection.

journal_name

Vaccine

journal_title

Vaccine

authors

Thoelen S,Van Damme P,Mathei C,Leroux-Roels G,Desombere I,Safary A,Vandepapeliere P,Slaoui M,Meheus A

doi

10.1016/s0264-410x(97)00254-5

subject

Has Abstract

pub_date

1998-04-01 00:00:00

pages

708-14

issue

7

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(97)00254-5

journal_volume

16

pub_type

临床试验,杂志文章,随机对照试验

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