NCT03219203

Brief Summary

This study aims to evaluate the immunologic response to the two hepatitis B virus (HBV) vaccination booster strategies in previously vaccinated HIV-infected adults at Maharaj Nakorn Chiang Mai Hospital.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 17, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

July 17, 2017

Status Verified

July 1, 2017

Enrollment Period

1 year

First QC Date

July 6, 2017

Last Update Submit

July 13, 2017

Conditions

Hepatitis B

Keywords

HBV vaccinationimmunity

Outcome Measures

Primary Outcomes (1)

  • Immunologic response to single dose versus 3-dose series of HBV vaccination in HIV-infected adults

    Immunologic response to single versus 3-dose series of HBV vaccination in HIV-infected adults, 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 (3)

  • 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]

  • Intensity and frequency of vaccine adverse event (AE)

    1 year

Study Arms (2)

Arm A: Single dose hepatitis B vaccine

EXPERIMENTAL

Single dose of hepatitis B vaccine group will receive a 20 µg recombinant HBV vaccine intramuscular at entry

Biological: Hepatitis B vaccine

Arm B: 3-dose series of hepatitis B vaccine

ACTIVE COMPARATOR

3-dose series of hepatitis B vaccine group will receive a 20 µg recombinant HBV vaccine intramuscular at month 0, 1, and 6

Biological: Hepatitis B vaccine

Interventions

Hepatitis B vaccineBIOLOGICAL

Hepatitis B vaccine (20 µg/ml) 1 ml intramuscular injection in single (at 0 month) or 3-dose series (at 0, 1, 6 months)

Arm A: Single dose hepatitis B vaccineArm B: 3-dose series of hepatitis B vaccine

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Document of HIV infection
  • Thai nationality
  • Age ≥18 years old
  • Born after 1 January 1992
  • Has been taking antiretroviral drugs for HIV treatment
  • CD4 ≥200 cell/mm3 and VL \<50 copies/mL for at least 6 months before enrollment
  • Negative for any HBV and HCV serological markers
  • Willing to sign informed consent
  • Able to follow up

You may not qualify if:

  • Active opportunistic infection
  • Pregnancy or breast feeding
  • History of previous hepatitis B vaccine booster
  • History of hypersensitivity to any component of vaccine
  • Malignancy which received chemotherapy or radiation
  • Immunocompromised condition such as solid-organ transplantation, chemotherapy in the last 6 months
  • On Immunosuppressive treatment, immunomodulating treatment or general corticotherapy (equal or above 0.5 mg per kg per day )
  • Renal failure (creatinine clearance \<30 mL/min)
  • Transaminitis in the past 3 months (≥ 5 UNL)
  • Decompensated cirrhosis (child-Pugh class C)
  • Unable or not willing to return for follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Muang, Chiang Mai, Chiang Mai, 50200, Thailand

RECRUITING

MeSH Terms

Conditions

Hepatitis B

Interventions

Hepatitis B Vaccines

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Romanee Chaiwarith, MD

    Chiang Mai University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Romanee Chaiwarith, MD

CONTACT

+66-5393-6457rchaiwar@gmail.com

Quanhathai Kaewpoowat, MD

CONTACT

+66-5393-6457quanhathai@rihes.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 6, 2017

First Posted

July 17, 2017

Study Start

July 1, 2017

Primary Completion

July 1, 2018

Study Completion

October 1, 2018

Last Updated

July 17, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)