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

NCT04072211 | Completed Phase 4 DMC

• 1 other identifier: 003-01-19
• Study Type: interventional
• Target: 641
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B Virus; Health Care Associated Infection

Keywords

Hepatitis B Virus; Vaccination; Health Personnel

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Demonstration of attained cell-mediated protection against Hepatitis B surface Antigen after vaccination.

  Eight Months

• Linkage of health care workers with chronic Hepatitis B virus infection to treatment and management

  One Month

• Cost and cost-effectiveness analysis of a universal Hepatitis B Virus vaccination strategy targeted at healthcare workers in Kalulushi district

  Eighteen months

Study Arms (1)

Vaccine arm

OTHER

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

Biological: Engerix-B

Interventions

Engerix-B BIOLOGICAL

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

Vaccine arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre for Infectious Disease Research in Zambia: lead
• University of Oxford: collaborator

Study Sites (1)

Kalulushi district all facilities

Kalulushi, Copperbelt, 10101, Zambia

Location

MeSH Terms

Conditions

Hepatitis B; Cross Infection

Interventions

Engerix-B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Model Details: All study participants will be screened for Hepatitis B Virus and those eligible for vaccination will receive the vaccine. Those already infected will be linked to care and those with a protective level of anti-HBs will not receive the vaccine.

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: August 28, 2019
• Study Start: November 25, 2019
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

ZA (1)