Clinical Trials

MainTitle

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

This study is ongoing, but not recruiting participants.
Sponsor
Fred Hutchinson Cancer Research Center

Collaborator
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: November 6, 2017
Last Verified: November 2017
History of Changes
Purpose

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Strategies for the Prevention of Hepatitis B Viral Infection Among HIV Infected Adults in Uganda

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

Primary Outcome Measures

  • Hepatitis B virus (HBV) vaccine response [ Time Frame: 18 months ]
    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 ]
    Compare the number of individuals lost to follow-up among the HAART naive and HAART exposed.

Enrollment: 132
Study Start Date: November 2015
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Other: 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 off protocol

Other Name: Euvax B (Sonafi)
Other: 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 off protocol

Other Name: 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 but off protocol.
Participants will be reimbursed for travel costs to and from the clinic for scheduled clinic visits.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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

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

Locations

Uganda
Mulago National referral hospital
Kampala, Uganda

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

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: November 6, 2017  

Keywords provided by Fred Hutchinson Cancer Research Center:

Hepatitis B vaccine HIV infection

Additional relevant MeSH terms:
Infection
Hepatitis
Hepatitis B
Vaccines

ClinicalTrials.gov processed this data on December 18, 2017
This information is provided by ClinicalTrials.gov.