Strategies for the Prevention of Hepatitis B Among HIV Infected Patients in Uganda
Primary Purpose
HIV/AIDS and Infections
Status
Completed
Phase
Phase 4
Locations
Uganda
Study Type
Interventional
Intervention
Hepatitis B vaccine
Sponsored by
About this trial
This is an interventional prevention trial for HIV/AIDS and Infections focused on measuring Hepatitis B vaccine HIV infection
Eligibility Criteria
Inclusion Criteria:
- Hepatitis B core antibody (anti-HBc) and anti-HBs negative
- Age ≥18 years
- 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%.
- Ambulatory
- Intention to attend the Mulago HIV/AIDS clinic for the 18 months
- Able and willing to comply with study protocol including providing informed consent
Exclusion Criteria:
- History of hypersensitivity to vaccines or intolerance to any of the HBV vaccine components
- Previously-confirmed diagnosis of decompensated liver disease or HCC
- Serological evidence of prior receipt of the HBV vaccine (anti-HBS positive, anti-HBc negative) or documented (clinical) evidence of having been vaccinated.
- Known history of HBV infection (HBsAg and/or anti-HBc positive).
- Inability to follow study procedures
- If a participant chooses not to consent to the review of his or her medical records
Sites / Locations
- Mulago National referral hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
HAART exposed
HAART naive
Arm Description
Participants in both arms will receive the Hepatitis B vaccine as summarized in the study description
Participants in both arms will receive the Hepatitis B vaccine as summarized in the study description
Outcomes
Primary Outcome Measures
Hepatitis B virus (HBV) vaccine response
Measure Hepatitis B surface antibody (anti-HBs) levels and cell mediated immune response.
Secondary Outcome Measures
Loss to follow-up (HAART naive vs. HAART exposed individuals)
Compare the number of individuals lost to follow-up among the HAART naive and HAART exposed.
Full Information
NCT ID
NCT02316444
First Posted
December 10, 2014
Last Updated
January 24, 2019
Sponsor
Fred Hutchinson Cancer Center
Collaborators
Makerere University, Uganda Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT02316444
Brief Title
Strategies for the Prevention of Hepatitis B Among HIV Infected Patients in Uganda
Official Title
Strategies for the Prevention of Hepatitis B Viral Infection Among HIV Infected Adults in Uganda
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
April 28, 2017 (Actual)
Study Completion Date
April 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
Makerere University, Uganda Cancer Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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:
The role of CD4-cell count and HIV viral loads on the HBV vaccine response.
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.
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:
Those who have received less than 3 months treatment, or no treatment, with highly active antiretroviral drugs (HAART naive).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS and Infections
Keywords
Hepatitis B vaccine HIV infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HAART exposed
Arm Type
Other
Arm Description
Participants in both arms will receive the Hepatitis B vaccine as summarized in the study description
Arm Title
HAART naive
Arm Type
Other
Arm Description
Participants in both arms will receive the Hepatitis B vaccine as summarized in the study description
Intervention Type
Biological
Intervention Name(s)
Hepatitis B vaccine
Other Intervention Name(s)
Euvax B (Sonafi)
Intervention Description
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
Primary Outcome Measure Information:
Title
Hepatitis B virus (HBV) vaccine response
Description
Measure Hepatitis B surface antibody (anti-HBs) levels and cell mediated immune response.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Loss to follow-up (HAART naive vs. HAART exposed individuals)
Description
Compare the number of individuals lost to follow-up among the HAART naive and HAART exposed.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hepatitis B core antibody (anti-HBc) and anti-HBs negative
Age ≥18 years
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%.
Ambulatory
Intention to attend the Mulago HIV/AIDS clinic for the 18 months
Able and willing to comply with study protocol including providing informed consent
Exclusion Criteria:
History of hypersensitivity to vaccines or intolerance to any of the HBV vaccine components
Previously-confirmed diagnosis of decompensated liver disease or HCC
Serological evidence of prior receipt of the HBV vaccine (anti-HBS positive, anti-HBc negative) or documented (clinical) evidence of having been vaccinated.
Known history of HBV infection (HBsAg and/or anti-HBc positive).
Inability to follow study procedures
If a participant chooses not to consent to the review of his or her medical records
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ponsiano Ocama, PhD
Organizational Affiliation
Makerere University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Corey Casper, MD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emmanuel Seremba, MMED
Organizational Affiliation
HCRI-Ug, Makerere University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mulago National referral hospital
City
Kampala
Country
Uganda
12. IPD Sharing Statement
Learn more about this trial
Strategies for the Prevention of Hepatitis B Among HIV Infected Patients in Uganda
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