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HBV Vaccination in HIV-infected Adults

Primary Purpose

Hepatitis B Vaccination, HIV

Status

Unknown status

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Hepatitis B vaccine

About this trial

This is an interventional prevention trial for Hepatitis B Vaccination, HIV focused on measuring HBV vaccination, HIV, isolated anti-HBc

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Maharaj Nakorn Chiang Mai Hospital, Department of medicine, Chiang Mai UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

3-standard dose HBV vaccination group

4-standard dose HBV vaccination group

Arm Description

participants will receive 3 standard doses of HBV vaccination at 0, 1, 6 months

participants will receive 4 standard doses of HBV vaccination at 0, 1, 2, 6 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Anamnestic response at week 4

Percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL) at month 12

Percentage of high-level responders (with anti-HBs Ab ≥ 100 mIU/mL) at week 28 and month 12

Intensity and frequency of vaccine adverse event (AE)

Geometric mean titers of anti-HBs Ab at week 28 and month 12

Predictive factors associated with response to vaccine (age, sex, CD4 count)

Full Information

NCT ID

NCT03212911

First Posted

July 6, 2017

Last Updated

July 6, 2017

Sponsor

Chiang Mai University

1. Study Identification

Unique Protocol Identification Number

NCT03212911

Brief Title

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

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2017 (Actual)

Primary Completion Date

February 1, 2018 (Anticipated)

Study Completion Date

July 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chiang Mai University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B Vaccination, HIV

Keywords

HBV vaccination, HIV, isolated anti-HBc

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Open-label, randomized controlled trial (RCT) with 1:1 allocation in parallel arms

Masking

None (Open Label)

Masking Description

No masking

Allocation

Randomized

Enrollment

96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

3-standard dose HBV vaccination group

Arm Type

Active Comparator

Arm Description

participants will receive 3 standard doses of HBV vaccination at 0, 1, 6 months

Arm Title

4-standard dose HBV vaccination group

Arm Type

Active Comparator

Arm Description

participants will receive 4 standard doses of HBV vaccination at 0, 1, 2, 6 months

Intervention Type

Biological

Intervention Name(s)

Hepatitis B vaccine

Intervention Description

Hepatitis B vaccine (20 mcg/ml) 1 ml intramuscular injection in 3 (at 0, 1, 6 months) or 4 doses (0, 1, 2, 6 months)

Primary Outcome Measure Information:

Title

Description

Time Frame

28 weeks after the first dose of HBV vaccination

Secondary Outcome Measure Information:

Title

Anamnestic response at week 4

Description

Anamnestic response at week 4

Time Frame

4 weeks after the first dose of HBV vaccination

Title

Percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL) at month 12

Description

Percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL) at month 12

Time Frame

12 months after the first dose of HBV vaccination

Title

Percentage of high-level responders (with anti-HBs Ab ≥ 100 mIU/mL) at week 28 and month 12

Description

Percentage of high-level responders (with anti-HBs Ab ≥ 100 mIU/mL) at week 28 and month 12

Time Frame

28 weeks and 12 months after the first dose of HBV vaccination

Title

Intensity and frequency of vaccine adverse event (AE)

Description

Intensity and frequency of vaccine adverse event (AE)

Time Frame

1 year

Title

Geometric mean titers of anti-HBs Ab at week 28 and month 12

Description

Geometric mean titers of anti-HBs Ab at week 28 and month 12

Time Frame

28 weeks and 12 months after the first dose of HBV vaccination

Title

Predictive factors associated with response to vaccine (age, sex, CD4 count)

Description

Predictive factors associated with response to vaccine (age, sex, CD4 count)

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Romanee Chaiwarith, MD

Phone

+66-5393-6457

rchaiwar@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Quanhathai Kaewpoowat, MD

Phone

+66-5393-6457

quanhathai@rihes.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Romanee Chaiwarith, MD

Organizational Affiliation

Chiang Mai University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maharaj Nakorn Chiang Mai Hospital, Department of medicine, Chiang Mai University

City

Muang, Chiang Mai

State/Province

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Romanee Chaiwarith, MD

Phone

+66-5393-6457

rchaiwar@gmail.com

First Name & Middle Initial & Last Name & Degree

Quanhathai Kaewpoowat, MD

Phone

+66-5393-6457

quanhathai@rihes.org

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31053142

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.

Results Reference

derived

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HBV Vaccination in HIV-infected Adults

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