Clinical trial NCT03212911: HBV Vaccination in HIV-infected Adults
Official title: Immunogenicity and Safety of 4- vs. 3-standard Doses HBV Vaccination in HIV-infected Adults With Isolated Anti-HBc Antibody
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B Vaccination, HIV
Keywords: HBV vaccination, HIV, isolated anti-HBc
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label, randomized controlled trial (RCT) with 1:1 allocation in parallel arms
Primary purpose: PREVENTION

Brief summary: The finding of isolated hepatitis B core antibody (isolated HBc) in absent of recent active hepatitis could cause by several scenarios, including false positive, remote infection without viremia, and occult infection with low viremia. Hepatitis B virus (HBV) vaccine booster could be a great prevention strategy for those who do not have HBV viremia. There is no standard consensus for management of this issue especially among HIV infected population. In addition, prior studies revealed that HIV-infected individuals had lower immunologic response to HBV vaccine than general population. This study intends to compare the immune response and safety of 4- versus 3-standard dose of hepatitis B virus vaccination in HIV-infected adults who has isolated HBc. The immunologic response will be evaluated after the participants receive vaccination.

Detailed description: * A randomized controlled trial to evaluate differences in immunogenicity and safety of the two hepatitis B vaccination regimens, including the percentage of responders, high-level responders, anamnestic response, geometric mean titers of anti-HBs antibody, adverse events and predictive factors associated with vaccine responsiveness
* After participant enrollment, data on baseline characteristics, time since HIV diagnosis, CD4 counts, HIV viral load, antiretroviral treatment regimen and duration will be collected, then the participants will be randomized into 2 groups to receive either 3- or 4-standard doses (20 mcg per dose) of HBV vaccination, and follow-up blood test for anti-HBs titers at multiple pre-specified time points to evaluate outcomes

Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years
* On combination antiretroviral therapy (cART)
* CD4 ≥ 200 cell/mm3 for ≥ 1 year
* HIV viral load \< 20 copies/ml for ≥ 1 year
* Isolated anti-HBc Ab (negative HBsAg, anti-HBs Ab) and negative anti-HCV at screening

Exclusion Criteria:

* Pregnancy
* Previous HBV vaccination
* Intolerance to any component of HBV vaccine
* Transaminitis in the past 3 months (≥ 5 UNL)
* Ongoing opportunistic infection (OI)
* Active malignancy, with current chemotherapy or radiotherapy
* Systemic steroid therapy (≥ 0.5 mg/kg/day) or any immunomodulating therapy in the last 6 months
* Other immunocompromised disorders (e.g. solid organ transplant)
* Asplenism
* Renal insufficiency (CrCl ≤ 30 mL/min)
* Decompensated cirrhosis (Child-Pugh C)

Primary outcomes:
measure: Immunologic response to 4 versus 3 doses of HBV vaccination in HIV-infected adults with isolated anti-HBc antibody, demonstrated by percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL ) at week 28
timeFrame: 28 weeks after the first dose of HBV vaccination
Secondary outcomes:
measure: Anamnestic response at week 4
timeFrame: 4 weeks after the first dose of HBV vaccination
measure: Percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL) at month 12
timeFrame: 12 months after the first dose of HBV vaccination
measure: Percentage of high-level responders (with anti-HBs Ab ≥ 100 mIU/mL) at week 28 and month 12
timeFrame: 28 weeks and 12 months after the first dose of HBV vaccination
measure: Intensity and frequency of vaccine adverse event (AE)
timeFrame: 1 year
measure: Geometric mean titers of anti-HBs Ab at week 28 and month 12
timeFrame: 28 weeks and 12 months after the first dose of HBV vaccination
measure: Predictive factors associated with response to vaccine (age, sex, CD4 count)
timeFrame: 1 year
Other outcomes:
Locations:
city: Muang, Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital, Department of medicine, Chiang Mai University
state: Chiang Mai
Study officials:
affiliation: Chiang Mai University
name: Romanee Chaiwarith, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Laksananun N, Praparattanapan J, Kotarathititum W, Supparatpinyo K, Chaiwarith R. Immunogenicity and safety of 4 vs. 3 standard doses of HBV vaccination in HIV-infected adults with isolated anti-HBc antibody. AIDS Res Ther. 2019 May 3;16(1):10. doi: 10.1186/s12981-019-0225-3.