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

January 24, 2019 updated by: Fred Hutchinson Cancer Center

Strategies for the Prevention of Hepatitis B Viral Infection Among HIV Infected Adults in Uganda

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kampala, Uganda
        • Mulago National Referral Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Euvax B (Sonafi)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatitis B virus (HBV) vaccine response
Time Frame: 18 months
Measure Hepatitis B surface antibody (anti-HBs) levels and cell mediated immune response.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

Makerere University
Uganda Cancer Institute

Investigators

  • Principal Investigator: Ponsiano Ocama, PhD, Makerere University
  • Principal Investigator: Corey Casper, MD, Fred Hutchinson Cancer Center
  • Principal Investigator: Emmanuel Seremba, MMED, HCRI-Ug, Makerere University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

April 28, 2017

Study Completion (Actual)

April 28, 2017

Study Registration Dates

First Submitted

December 10, 2014

First Submitted That Met QC Criteria

December 10, 2014

First Posted (Estimate)

December 12, 2014

Study Record Updates

Last Update Posted (Actual)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 24, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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