|
- 现金
- 62111 元
- 精华
- 26
- 帖子
- 30437
- 注册时间
- 2009-10-5
- 最后登录
- 2022-12-28
|
429
A Double-Blind Randomized Controlled Trial
of Intradermal Hepatitis B Vaccination with
Topical Imiquimod in Subjects with Occult
Hepatitis B Infection
Ivan FN Hung1,2, Danny Ka Ho Wong3,4, Wai-Kay Seto1,2,
James Fung1,5, Kwok-Yung Yuen6,7 and Man-Fung Yuen1,2,
(1)State Key Laboratory for Liver Research, the University of
Hong Kong, Hong Kong, (2)Medicine, Queen Mary Hospital,
Hong Kong, (3)State Key Laboratory for Liver Research, The
University of Hong Kong, (4)Medicine, The University of Hong
Kong, (5)Medicine, Queen Mary Hospital, (6)Microbiology,
University of Hong Kong, (7)State Key Laboratory for
Emerging Infectious Diseases, the University of Hong Kong,
Hong Kong
Background: Patients with occult hepatitis B infection (OBI)
remain at risk of hepatitis B virus reactivation when undergoing
high-risk immunosuppressive therapy. Imiquimod, a synthetic
Toll-like receptor 7 agonist, has been shown to significantly
improve hepatitis B vaccine immunogenicity in patients on renal
replacement therapy. We therefore performed a prospective
double-blind randomized controlled trial is to evaluate the
effect and safety of topical treatment with imiquimod before
intradermal hepatitis B vaccination (HBVv) in OBI patients.
Methods: We enrolled adult patients followed up in the
hepatitis specialty outpatient clinic in the Queen Mary Hospital,
Hong Kong in 2017. All recruited patients had documented
loss of HBsAg and negative anti-HBs. The HBVv used in this
study is Sci-B-Vac™. Enrolled patients were randomized into
3 groups. All patients received 3 doses HBVv regime at 0, 1
and 6 months. Group 1 received 10μg intradermal HBVv with
topical imiquimod ointment pretreatment before vaccination.
Group 2 received 10μg intradermal HBVv with topical placebo
aqueous cream pretreatment before vaccination; Group
3 received 10μg intramuscular HBVv with topical placebo
aqueous cream pretreatment. Anti-HBs titre was measured
at baseline and at 1, 6 and 12 months after the first HBVv.
The primary outcome was the seroprotection rate at 12-month
defined by the percentage of recruited subjects with anti-
HBs antibody titre ≥10 IU/L. The secondary outcome include
seroprotection rate at 1 and 6 months and the geometric mean
titre (GMT) at 1, 6 and 12 months after first HBVv. Results:
75 patients were recruited and the median age was 54 years.
25, 23 and 27 patients were randomized to group 1, 2 and 3
respectively. The seroprotection rate was significantly higher
in Group 1 at 12-month (Group 1 vs. Group 2 vs. Group 3 =
100% vs. 87% vs. 77.8%; P=0.047). There was no difference
in the seroprotection rate among the three groups at 1 and
6-month. However, the GMT anti-HBs was significantly higher
in Group 1 at 6 and 12-month, (6-month: Group 1 vs. Group 2
vs. Group 3 = 373.3 IU/L, 95% CI 177.8-783.4 IU/L vs. 169.8
IU/L, 95% CI 62.5-462.4 IU/L; vs. 76 IU/L, 95% CI 33.3-174.2
IU/L; P=0.026; (12-month: Group 1 vs. Group 2 vs. Group 3 =
3191.5 IU/L, 95% CI 1207.8-8433.3 IU/L vs. 818.5 IU/L, 95%
CI 225.9-2964.8 IU/L; vs. 58.5 IU/L, 95% CI 28.7-118.9 IU/L;
P<0.0001). Overall side effects were few and self-limiting with
no difference among the three groups. Conclusion: Topical
imiquimod before intradermal HBVv was highly effective in
OBI patients, with significantly higher seroprotection rate and
GMT at 12 months after vaccination. This vaccination strategy
could effectively prevent hepatitis B virus reactivation in OBI
patients. |
|
发表于 2018-10-20 12:57