NCT04072211

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

Completed Phase 4 Last updated 20 July 2022

What this trial tests

Phase 4 trial testing Engerix-B in Hepatitis B Virus in 641 participants. Completed in 30 August 2020.

Timeline

25 November 2019

Primary endpoint
30 August 2020

30 August 2020

Quick facts

Lead sponsor	Centre for Infectious Disease Research in Zambia
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	641
Start date	25 November 2019
Primary completion	30 August 2020
Estimated completion	30 August 2020
Sites	1 location across Zambia

Drugs / interventions tested

• Engerix-B

Conditions studied

• Hepatitis B Virus — all drugs for Hepatitis B Virus →
• Health Care Associated Infection — all drugs for Health Care Associated Infection →

Sponsor

Centre for Infectious Disease Research in Zambia — full company profile →

Who can join

18 and older, any sex, with Hepatitis B Virus or Health Care Associated Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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. 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Health care workers' reactions to the newly introduced hepatitis B vaccine in Kalulushi, Zambia: Explained using the 5A taxonomy.
   Nyasa M, Chipungu J, Ngandu M, Chilambe C, et al · · 2023 · cited 1× · PMID 36880025 · DOI 10.1016/j.jvacx.2023.100274