Trial record 8 of 512 for:    hepatitis b | Open Studies

Strategies for the Prevention of Hepatitis B Among HIV Infected Patients in Uganda

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Fred Hutchinson Cancer Research Center
Sponsor:
Collaborators:
Makerere University
Uganda Cancer Institute
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT02316444
First received: December 10, 2014
Last updated: May 31, 2016
Last verified: May 2016
  Purpose

The aim of this study is to compare the effectiveness of two vaccination strategies against Hepatitis B virus (HBV) in subjects already infected with human immunodeficiency virus (HIV).

Researchers plan to determine the optimal vaccination strategy for achieving protective immunity to HBV infection in HIV-infected adults attending Mulago Hospital's HIV care clinic.

Primary objectives are to assess:

  1. The role of CD4-cell count and HIV viral loads on the HBV vaccine response.
  2. The role of highly active antiretroviral therapy (HAART) on the HBV vaccine response.

The secondary objective is to evaluate whether lack of HAART is associated with high rates of loss to follow-up.


Condition Intervention Phase
HIV/AIDS and Infections
Biological: Hepatitis B vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Strategies for the Prevention of Hepatitis B Viral Infection Among HIV Infected Adults in Uganda

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Hepatitis B virus (HBV) vaccine response [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Measure Hepatitis B surface antibody (anti-HBs) levels.


Secondary Outcome Measures:
  • Loss to follow-up (HAART naive vs. HAART exposed individuals) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Compare the number of individuals lost to follow-up among the HAART naive and HAART exposed.


Estimated Enrollment: 132
Study Start Date: November 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
HAART exposed
Participants in both arms will receive the Hepatitis B vaccine as summarized in the study description
Biological: Hepatitis B vaccine
An eligible participant will receive 3 doses of hepatitis B vaccine ( 20mcg in the deltoid intramuscular). Then their immune response will be assessed. Non responders will receive 3 additional vaccine doses then their response will be re-assessed.
Other Name: Engerix (GSK) or Euvax B (Sonafi)
HAART naive
Participants in both arms will receive the Hepatitis B vaccine as summarized in the study description
Biological: Hepatitis B vaccine
An eligible participant will receive 3 doses of hepatitis B vaccine ( 20mcg in the deltoid intramuscular). Then their immune response will be assessed. Non responders will receive 3 additional vaccine doses then their response will be re-assessed.
Other Name: Engerix (GSK) or Euvax B (Sonafi)

Detailed Description:

This is an interventional study in which researchers will recruit HIV positive individuals who do not have hepatitis B (HBV negative) in order to assess the effectiveness of a hepatitis B vaccine in 2 subgroups:

  1. Those who have received less than 3 months treatment, or no treatment, with highly active antiretroviral drugs (HAART naive).
  2. Those who have received at least 3 months of treatment with highly active antiretroviral drugs (HAART exposed).

All study participants will receive vaccination against HBV.

There will be 6-12 clinic visits depending on 1) whether or not the participant responds to the standard 3-dose vaccination protocol and 2) whether he or she suffers a clinical condition or vaccine related adverse event that would call for postponement of the next vaccine dose.

The first visit will be to determine if the participant is eligible for the study. If eligible, the participant will receive one dose of vaccine at each of the following three visits. The fifth visit will be to collect blood to determine whether the participant has responded to the 3-dose vaccination protocol. The sixth visit will be to discuss the outcome of the vaccination with the participant. Participants who respond favorably to the 3-dose vaccine protocol will exit the study at this point. However, if a participant fails to respond to the initial 3-dose vaccine protocol, he or she may restart the regimen and receive another 3 doses of vaccine following the same schedule as before.

Participants will be reimbursed for travel costs to and from the clinic for scheduled clinic visits.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Hepatitis B core antibody (anti-HBc) and anti-HBs negative
  2. Age ≥18 years
  3. HIV infected persons (HAART naïve and HAART exposed). HAART enrollees will be considered to be HAART exposed if they have been taking these medications for at least 3 months. Participants that have never been on HAART and those that have been on HAART for <3months will be considered to be HAART naïve. HAART exposed enrollees will have an adherence of at least 95%.
  4. Ambulatory
  5. Intention to attend the Mulago HIV/AIDS clinic for the 18 months
  6. Able and willing to comply with study protocol including providing informed consent

Exclusion Criteria:

  1. History of hypersensitivity to vaccines or intolerance to any of the HBV vaccine components
  2. Previously-confirmed diagnosis of decompensated liver disease or HCC
  3. Serological evidence of prior receipt of the HBV vaccine (anti-HBS positive, anti-HBc negative) or documented (clinical) evidence of having been vaccinated.
  4. Known history of HBV infection (HBsAg and/or anti-HBc positive).
  5. Inability to follow study procedures
  6. If a participant chooses not to consent to the review of his or her medical records
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02316444

Contacts
Contact: Janet Quade 206 667-2849 jquade@fhcrc.org
Contact: Noreen Muwanguzi +256772785101 nmuwangu@fhcrc.org

Locations
Uganda
Mulago National referral hospital Recruiting
Kampala, Uganda
Contact: Emmanuel Seremba, MBchB, Mmed    +256 782838435    eseremba@fredhutch.org   
Contact: Ponsiano Ocama, MBchB,Mmed,PhD    +256772421190    ponsiano.ocama@gmail.com   
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Makerere University
Uganda Cancer Institute
Investigators
Principal Investigator: Ponsiano Ocama, PhD Makerere University
Principal Investigator: Corey Casper, MD Fred Hutchinson Cancer Research Center
Principal Investigator: Emmanuel Seremba, MMED HCRI-Ug, Makerere University
  More Information

Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT02316444     History of Changes
Other Study ID Numbers: U010 
Study First Received: December 10, 2014
Last Updated: May 31, 2016
Health Authority: Uganda: National Drug Authority
Uganda: National Council for Science and Technology
Uganda: Research Ethics Committee

Keywords provided by Fred Hutchinson Cancer Research Center:
Hepatitis B vaccine HIV infection

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Hepatitis, Viral, Human
Infection
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 29, 2016