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

NCT ID: NCT04072211

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 641 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-25
• Study Completion Date: 2020-08-30

Brief 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.

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.

Conditions

Hepatitis B Virus; Health Care Associated Infection

Study Design

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

Study Groups

Vaccine arm

Engerix-B vaccine will be administered. This arm will include all those at risk of hepatitis B virus infection

Group Type: OTHER

Engerix-B

Intervention Type: BIOLOGICAL

Hepatitis B vaccine administered through intramuscular injection at 0, 1, and 6 months

Interventions

Engerix-B

Hepatitis B vaccine administered through intramuscular injection at 0, 1, and 6 months

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oxford

OTHER

Sponsor Role: collaborator

Centre for Infectious Disease Research in Zambia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kalulushi district all facilities

Kalulushi, Copperbelt, Zambia

Countries

Zambia

Other Identifiers

003-01-19

Identifier Type: -

Identifier Source: org_study_id