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

NCT02316444 | Completed Phase 4 DMC

• 1 other identifier: U010
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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

Conditions

HIV/AIDS and Infections

Keywords

Hepatitis B vaccine HIV infection

Outcome Measures

Primary Outcomes (1)

• Hepatitis B virus (HBV) vaccine response

  Measure Hepatitis B surface antibody (anti-HBs) levels and cell mediated immune response.

  18 months

Secondary Outcomes (1)

• Loss to follow-up (HAART naive vs. HAART exposed individuals)

  18 months

Study Arms (2)

HAART exposed

OTHER

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

Biological: Hepatitis B vaccine

HAART naive

OTHER

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

Biological: Hepatitis B vaccine

Interventions

Hepatitis B vaccine 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

Also known as: Euvax B (Sonafi)

HAART exposed; HAART naive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• Makerere University: collaborator
• Uganda Cancer Institute: collaborator

Study Sites (1)

Mulago National referral hospital

Kampala, Uganda

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Infections

Interventions

Hepatitis B Vaccines; Euvax-B

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Ponsiano Ocama, PhD

  Makerere University

  PRINCIPAL INVESTIGATOR

• Corey Casper, MD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

• Emmanuel Seremba, MMED

  HCRI-Ug, Makerere University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 12, 2014
• Study Start: November 1, 2015
• Primary Completion: April 28, 2017
• Study Completion: April 28, 2017
• Last Updated: January 25, 2019

Record last verified: 2019-01

Locations

UG (1)