HBV Vaccination in HIV-infected Adults

NCT03212911 | Unknown Phase 4

• 1 other identifier: 04565
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B Vaccination, HIV

Keywords

HBV vaccination, HIV, isolated anti-HBc

Outcome Measures

Primary Outcomes (1)

• 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

  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

  28 weeks after the first dose of HBV vaccination

Secondary Outcomes (6)

• Anamnestic response at week 4

  4 weeks after the first dose of HBV vaccination

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

  12 months after the first dose of HBV vaccination

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

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

• Intensity and frequency of vaccine adverse event (AE)

  1 year

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

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

Study Arms (2)

3-standard dose HBV vaccination group

ACTIVE COMPARATOR

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

Biological: Hepatitis B vaccine

4-standard dose HBV vaccination group

ACTIVE COMPARATOR

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

Biological: Hepatitis B vaccine

Interventions

Hepatitis B vaccine BIOLOGICAL

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)

3-standard dose HBV vaccination group; 4-standard dose HBV vaccination group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

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

Muang, Chiang Mai, Chiang Mai, 50200, Thailand

RECRUITING

Related Publications (1)

• 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.

  PMID: 31053142 DERIVED

MeSH Terms

Interventions

Hepatitis B Vaccines

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Romanee Chaiwarith, MD

  Chiang Mai University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Romanee Chaiwarith, MD

CONTACT

+66-5393-6457; rchaiwar@gmail.com

Quanhathai Kaewpoowat, MD

CONTACT

+66-5393-6457; quanhathai@rihes.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 11, 2017
• Study Start: July 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 11, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)