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440
HBV Vaccination Can Accelerate HBsAg
Seroconversion in Chronic Hepatitis B Patients
Who Loss HBsAg: A Randomized Controlled
Trial - Preliminary Analysis
Tawesak Tanwandee and Suppawat Jiraphairot, Internal
Medicine, Mahidol University
Background: Most of chronic hepatitis B (CHB) patients
carry HBsAg life-long even with current treatment. Moreover,
those who clear HBsAg, many still do not have Anti-HBs
presence, some patients even have HBsAg reappearance
during follow up. It would be helpful if we can induce sustained
HBsAg seroconversion. HBV vaccine contain both HBsAg
and immunoadjuvant which can help induction of antibody
response. This study was aimed to determine whether
HBV vaccination can induce HBsAg seroconversion and to
determine whether Anti-HBs is sustained. Methods: This
is a prospective randomized control trial involved 79 CHB
patients who loss HBsAg at least twice, 3 months (M) apart
without Anti-HBs at Hepatitis clinic, Siriraj Hospital. Patients
who previously exposed to interferon was excluded and we
also included 16 healthy volunteers who did not exposed to
hepatitis B to determine the efficacy of HBV vaccine. The
subjects were randomly assigned 1:1 ratio to receive either
3 standard doses of HBV vaccine or no intervention. HBV
DNA, HBsAg, Anti-HBs as well as liver function tests was
measured at baseline, M7 (1M after vaccine completion)
and M12. HBV vaccine used in the study was recombinant
hepatitis B vaccine 20 microgram at M0, 1, 6. The primary
end-point was presence of Anti-HBs (≥10 IU/mL) at M7 of
the study with secondary endpoint to measure Anti-HBs at
M12 and identify factors that may associate with vaccine
response and side effect of vaccination. Results: Of the 79
CHB patients, baseline characteristic as shown in Table1.
There were 45 patients who had completed M7 (on May,
22th2018), of which, 20 patients in vaccination group and
there was no significant different of baseline characteristic as
compared with the whole groups. At M7, vaccine response in
healthy volunteers was 15/16(93%), whereas, in CHB, Anti-
HBs was present 12/20(60%) and 2/25(8%) in vaccine and
no intervention group, respectively, (p< 0.001). There was
no HBsAg reappearance in both groups and there was no
serious side effect. Conclusion: In CHB patient who have
lost HBsAg, standard dose HBV vaccination can accelerate
HBsAg seroconversion as compared with no intervention.
This can secure safe discontinuation of nucleoside analogues
in CHB patients. To our knowledge, this is the first randomized
controlled trial to demonstrate usefulness of HBV vaccination.
However, we need the data of all patients which will be
completed M7 by November, 2018 and M12 by early 2019.
HBV vaccination was safe. |
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发表于 2018-10-21 16:43