MedTrace Logo

HBV Vaccination in HIV-infected Adults

NCT03212911 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2017-07-11

No results posted yet for this study

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

Interventions

BIOLOGICAL

Hepatitis B vaccine

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)

Sponsors & Collaborators

  • Chiang Mai University

    lead OTHER

Principal Investigators

  • Romanee Chaiwarith, MD · Chiang Mai University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2018-02-01
Completion
2018-07-01

Countries

  • Thailand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03212911 on ClinicalTrials.gov