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

Hepatitis B Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04072211
• Other study ID #: 003-01-19
• Status: Completed
• Phase: Phase 4
• Start date: November 25, 2019
• Est. completion date: August 30, 2020

Study information

• Verified date: July 2022
• Source: Centre for Infectious Disease Research in Zambia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 641
• Est. completion date: August 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cross Infection
• Health Care Associated Infection
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Virus

Intervention

Biological:
• Engerix-B
Hepatitis B vaccine administered through intramuscular injection at 0, 1, and 6 months

Locations

Country	Name	City	State
Zambia	Kalulushi district all facilities	Kalulushi	Copperbelt

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Infectious Disease Research in Zambia	University of Oxford

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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