Immune response for phase I clinical trial of a hepatitis B immunogenic complex therapeutic vaccine, YIC / 中华肝脏病杂志
Chinese Journal of Hepatology
;
(12): 89-92, 2006.
Article
in Chinese
| WPRIM
| ID: wpr-245742
ABSTRACT
<p><b>OBJECTIVE</b>A hepatitis B immunogenic complex therapeutic vaccine, yeast-derived recombinant HBsAg combined with human anti-HBs immunoglobulin (YIC), was evaluated for safety and immune response in phase I clinical trial.</p><p><b>METHODS</b>The subtypes IgG1, IgG2, IgG3 and IgG4 of serum anti-HBs collected from 20 immunized subjects were analyzed by ELISA. The lymphocyte proliferation assay was carried out in five subjects and was analyzed by 3H-thymidine incorporation. The assays for IFNgamma, IL-2, IL-4, IL-6, IL-10 and TNFalpha were measured using Human Cytometric Bead Array Kit with FACSCalibur.</p><p><b>RESULTS</b>The results showed that the subtypes of anti-HBs antibodies induced by 30, 60 and 90 microg YIC-immunized groups among all of the adult volunteers (20/20) were IgG1 and IgG3. The level of IgG1 was higher than that of IgG3 in each volunteer but the strength was different from each other. The rHBsAg-stimulated lymphocyte proliferation induced by three injections of 90 microg of YIC showed that the stimulation index was more than 2.0 in four out of the five individuals (4/5), ranging from 2.70 to 4.75. PHA-stimulated lymphocyte proliferation was not related to rHBsAg-stimulated lymphocyte proliferation. In the 60 microg YIC-immunized group there was no significant difference between the levels of IFNgamma, IL-2, IL-4, IL-6 and IL-10 at day 0 and day 42. At day 71, in comparison to day 0, the level of IFNgamma was higher in all eight subjects studied (P = 0.015) and the level of IL-2 was also increased in seven out of eight subjects (P = 0.002). In contrast, the levels of IL-4, IL-6, IL-10 and TNFalpha showed no significant difference in all the subjects (P-values 0.298, 0.976, 0.202 and 0.996).</p><p><b>CONCLUSION</b>Our results indicate that this hepatitis B immunogenic complex therapeutic vaccine (YIC) can induce a potent anti-HBs response.</p>
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Therapeutics
/
Recombinant Proteins
/
Immunoglobulin G
/
Vaccines, Synthetic
/
Vaccination
/
Hepatitis B Vaccines
/
Therapeutic Uses
/
Allergy and Immunology
/
Hepatitis B
/
Hepatitis B Antibodies
Limits:
Adolescent
/
Adult
/
Female
/
Humans
/
Male
Language:
Chinese
Journal:
Chinese Journal of Hepatology
Year:
2006
Type:
Article
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