Hepatitis B VirusPhase 4NCT04072211
Demonstration Project on Health Care Worker Protection Against Hepatitis B in Kalulushi District
A Phase 4 study testing Engerix-B in people with Hepatitis B Virus and Health Care Associated Infection, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B Virus, Health Care Associated Infection
- What is being tested?
- Engerix-B
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 641 participants
- Where
- 1 siteZambia
- Study dates
- 25 Nov 2019to 30 Aug 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥18 years
- Willing to consent and meet project requirements for training and follow-up.
Who cannot join
- Kidney disease or renal failure
- Pregnant
- History or current neurological condition
- Express refusal to consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Engerix-B
- Keywords
- Hepatitis B Virus, Vaccination, Health Personnel
- Medical subject headings
- Hepatitis B, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engerix-BBiological
Hepatitis B vaccine administered through intramuscular injection at 0, 1, and 6 months
| Study group | Role | What they receive |
|---|---|---|
| Vaccine arm | Other | Engerix-B vaccine will be administered. This arm will include all those at risk of hepatitis B virus infection Receives: Biological: Engerix-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Eight Months
Secondary outcomes (3)
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.
Measured: 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
Measured: 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.
Measured: Eighteen months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start25 Nov 2019
- Primary completion30 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 641 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Infectious Disease Research in Zambia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072211
- Sponsor's protocol ID
- 003-01-19 Kalulushi Hepatitis
- Status last verified
- Aug 2026
- First submitted
- 22 May 2019
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration Project on Health Care Worker Protection Against Hepatitis B in Kalulushi District
- ClinicalTrials.gov ID
- NCT04072211
- Acronym / sponsor ID
- 003-01-19 Kalulushi Hepatitis
- Keywords
- Hepatitis B Virus, Vaccination, Health Personnel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 641 participants (actual)
- Lead sponsor
- Centre for Infectious Disease Research in ZambiaUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Vaccine arm | Other | Biological: Engerix-BEngerix-B vaccine will be administered. This arm will include all those at risk of hepatitis B virus infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged ≥18 years
- Willing to consent and meet project requirements for training and follow-up.
Key exclusion criteria (4 listed)
- Kidney disease or renal failure
- Pregnant
- History or current neurological condition
- Express refusal to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Engerix-BHepatitis B vaccine administered through intramuscular injection at 0, 1, and 6 months | Biological | Vaccine arm |
Primary outcome
Demonstrate attainment of protective Hepatitis B surface antibody (anti-HBs) levels in their serum
Time frame: Eight Months
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.
3 secondary outcomes
Demonstration of attained cell-mediated protection against Hepatitis B surface Antigen after vaccination.
Time frame: Eight Months
Linkage of health care workers with chronic Hepatitis B virus infection to treatment and management
Time frame: One Month
Cost and cost-effectiveness analysis of a universal Hepatitis B Virus vaccination strategy targeted at healthcare workers in Kalulushi district
Time frame: Eighteen months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Engerix-B in people with Hepatitis B Virus and Health Care Associated Infection, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate attainment of protective Hepatitis B surface antibody (anti-HBs) levels in their serum (time frame: Eight Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.