Demonstration Project on Health Care Worker Protection Against Hepatitis B in Kalulushi District

Hepatitis B virus (HBV) has infected over one third of the world's population; of these about 350 million go on to be chronic carriers. Infection with HBV can be self-limiting depending on age and immunity status of the infected person. Acute infection with HBV is cleared within six months of initial infection while chronic infection can last longer than six months. HBV can be transmitted perinatally, sexually, horizontally, through direct contact with infectious body fluids or blood, being pricked with an infected needle and injury from instruments contaminated with infectious body fluid or blood. Certain population groups are at higher risk of infection with HBV. Among these populations is that of health care workers (HCWs). In this population, HBV infection can occur through occupational exposure. In fact, the hepatitis B virus is more contagious than human immunodeficiency virus (HIV) during a needle stick injury (30% versus 0.5%). It is therefore imperative that HCWs are highly knowledgeable about HBV and how they can prevent transmission. Protection from HBV infection can be achieved by means of vaccination after which the HBV vaccine has been shown to be 90-100% effective.

Study Overview

• Status: Completed
• Conditions: Hepatitis B Virus; Health Care Associated Infection
• Intervention / Treatment: Biological: Engerix-B

Detailed Description

Hepatitis B virus (HBV) has infected over one third of the world's population; of these about 350 million go on to be chronic carriers. In adults, infection with HBV can be self-limiting in up to 95% of those infected and the most common route of infection is sexual transmission. HBV can also be transmitted perinatally, horizontally, through direct contact with infectious body fluids or blood, being pricked with an infected needle and injury from instruments contaminated with infectious body fluid or blood.

Certain population groups are at higher risk of infection with HBV. Among these populations is that of health care workers (HCW). In this population, HBV infection can occur through occupational exposure. It is therefore imperative that HCWs are highly knowledgeable about HBV and how they can prevent transmission.Protection from HBV infection can be achieved by means of vaccination after which the HBV vaccine has been shown to be 90-100% effective.

Despite availability of these vaccines, studies have shown low rates of vaccination against HBV amongst HCW in different countries. However, in countries where there is a deliberate policy to vaccinate HCW, the rates of HBV vaccination are over 90%. In Zambia, this rate has been reported to be as low as 19.3%.

This project will demonstrate an approach to reduce HCW risk of HBV through increasing knowledge and awareness of HBV among HCWs, providing vaccination to HCWs and linking those already carrying HBV infection to care and treatment. The study will also investigate the cost of vaccinating HCWs against HBV and evaluate feasibility, acceptability and implementation factors to inform possible scale-up of this approach throughout Zambia.

• Study Type: Interventional
• Enrollment (Actual): 641
• Phase: Phase 4

Contacts and Locations

Study Locations

• Zambia
  • Copperbelt
    • Kalulushi, Copperbelt, Zambia, 10101
      • Kalulushi district all facilities

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged ≥18 years
• Willing to consent and meet project requirements for training and follow-up.

Exclusion Criteria:

• Kidney disease or renal failure
• Pregnant
• History or current neurological condition
• Express refusal to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Vaccine arm; Engerix-B vaccine will be administered. This arm will include all those at risk of hepatitis B virus infection	Biological: Engerix-B; Hepatitis B vaccine administered through intramuscular injection at 0, 1, and 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demonstrate attainment of protective Hepatitis B surface antibody (anti-HBs) levels in their serum	anti-HBs will be measured at enrollment before any vaccine is administered, at one months post first, before administering the third dose, and one month post last vaccine doses.	Eight Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demonstration of attained cell-mediated protection against Hepatitis B surface Antigen after vaccination.	2.0×106 cells/mL will be stimulated with artificial Hepatitis B surface Antigen antigen and characterised into naïve B and T cells, effector B and T cells and memory B and T cells. This will be done by targeting specific cell surface markers using fluorochrome labelled antibodies such as anti-CD4+-ECD, CD8+-PeCy7, CD3-APC-H7, CD45RA-FITC, CD45RO-PCy7, FoxP3+-PE, CD27-PCy5, CCR7-FITC, CD20-APC, CD40-FITC, CD78-FITC, CD30-PE, CD38-PerCP-Cy5.5, CD19-PE-Cy7 and IgM-FITC. Before the cells are labelled, they will be stained and blocked using FcR blocking reagents.	Eight Months
Linkage of health care workers with chronic Hepatitis B virus infection to treatment and management	Health care workers who are Hepatitis B surface Antigen positive linked to routine care	One Month
Cost and cost-effectiveness analysis of a universal Hepatitis B Virus vaccination strategy targeted at healthcare workers in Kalulushi district	The descriptive costing study will estimate the costs of a vaccination program. Assuming a bottom-up, ingredients-based approach, costs will be collected in local currency units and converted to United States Dollar (US$) using the midpoint exchange rate at the time of implementing the study. The cost-effectiveness analysis will be carried out from societal and payer's perspective.	Eighteen months

Collaborators and Investigators

• Sponsor: Centre for Infectious Disease Research in Zambia
• Collaborators: University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2019
• Primary Completion (Actual): August 30, 2020
• Study Completion (Actual): August 30, 2020

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Vaccination; Hepatitis B Virus; Health Personnel
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Iatrogenic Disease; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Cross Infection
• Other Study ID Numbers: 003-01-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No