NCT02732054

Brief Summary

This study aimed to evaluate the efficacy of different hepatitis B vaccination regimens in HIV-infected adults with low CD4 cell count in northern Thailand.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 8, 2016

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

11 months

First QC Date

March 31, 2016

Last Update Submit

April 17, 2017

Conditions

Hepatitis B

Keywords

HBV vaccination, immunity

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants with protective immunity against HBV

    comparison of proportion of participants who had protective immunity (anti-HBS titer \>=10 mIU/ml) against HBV between HIV group 2 v.s. HIV group 1

    1 month after vaccination

Secondary Outcomes (2)

  • The geometric means of anti-HBs titers

    1 month after vaccination

  • Proportion of participants with high level of immune response against HBV

    1 month after vaccination

Study Arms (2)

HIV-Group 1

ACTIVE COMPARATOR

Receiving three intramuscular injections of 20 µg of recombinant hepatitis B vaccine \[(CIGB) La Habana, Cuba\] at months 0, 1, and 6

Biological: Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]

HIV-Group 2

EXPERIMENTAL

Receiving four intramuscular injections of 20 µg of recombinant hepatitis B vaccine \[(CIGB) La Habana, Cuba\] at months 0, 1, 2, and 6

Biological: Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]

Interventions

Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]BIOLOGICAL

Different HBV vaccine regimen in each group

HIV-Group 1HIV-Group 2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • HIV-infection
  • ≥18 years old
  • Received combination antiretroviral therapy for at least 1 year
  • Had a CD4+ cell count \< 200 cells/mm3 for at least 1 year
  • Undetectable plasma HIV-1 RNA for at least 1 year
  • Negative for hepatitis B surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc),
  • Had no history of previous HBV vaccine
  • Negative for antibody to hepatitis C virus (anti-HCV)
  • No active opportunistic infections (at the time of screening)
  • Willing to sign an informed consent
  • Able to return for follow-up.

You may not qualify if:

  • Pregnancy or lactation
  • History of hypersensitivity to any component of the vaccine
  • Active malignancy receiving chemotherapy or radiation, or other immunocompromised conditions besides HIV (e.g., solid organ transplant), received immunosuppressive (e.g., corticosteroid ≥ 0.5 mg/kg/day) or immunomodulating treatment in the last six months before screening visit
  • Renal insufficiency (creatinine clearance \<30 mL/min)
  • Decompensated cirrhosis (Child-Pugh class C)

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, 50200, Thailand

Location

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

    Thailand Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University Muang, Chiang Mai Thailand

    PRINCIPAL INVESTIGATOR

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

March 31, 2016

First Posted

April 8, 2016

Study Start

March 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

April 19, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)