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

NCT ID: NCT02316444

Last Updated: 2019-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-04-28

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:

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.

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.

Conditions

HIV/AIDS and Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

HAART exposed

Participants in both arms will receive the Hepatitis B vaccine as summarized in the study description

Group Type: OTHER

Hepatitis B vaccine

Intervention Type: BIOLOGICAL

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

HAART naive

Participants in both arms will receive the Hepatitis B vaccine as summarized in the study description

Group Type: OTHER

Hepatitis B vaccine

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Euvax B (Sonafi)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Makerere University

OTHER

Sponsor Role: collaborator

Uganda Cancer Institute

OTHER

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ponsiano Ocama, PhD

Role: PRINCIPAL_INVESTIGATOR

Makerere University

Corey Casper, MD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Emmanuel Seremba, MMED

Role: PRINCIPAL_INVESTIGATOR

HCRI-Ug, Makerere University

Locations

Mulago National referral hospital

Kampala, , Uganda

Countries

Uganda

Other Identifiers

U010

Identifier Type: -

Identifier Source: org_study_id