HIV/AIDS and InfectionsPhase 4NCT02316444
Strategies for the Prevention of Hepatitis B Among HIV Infected Patients in Uganda
A Phase 4 study testing Hepatitis B vaccine in people with HIV/AIDS and Infections, run by Fred Hutchinson Cancer Center at 1 site in Uganda.
Trial summary
The aim of this study is to compare the effectiveness of two vaccination strategies against Hepatitis B virus (HBV) in subjects already infected with human immunodeficiency virus (HIV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS and Infections
- What is being tested?
- Hepatitis B vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUganda
- Study dates
- Nov 2015to 28 Apr 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hepatitis B core antibody (anti-HBc) and anti-HBs negative
- Age ≥18 years
- HIV infected persons (HAART naïve and HAART exposed). HAART enrollees will be considered to be HAART exposed if they have been taking these medications for at least 3 months. Participants that have never been on HAART and those that have been on HAART for <3months will be considered to be HAART naïve. HAART exposed enrollees will have an adherence of at least 95%.
- Ambulatory
- Intention to attend the Mulago HIV/AIDS clinic for the 18 months
- Able and willing to comply with study protocol including providing informed consent
Who cannot join
- History of hypersensitivity to vaccines or intolerance to any of the HBV vaccine components
- Previously-confirmed diagnosis of decompensated liver disease or HCC
- Serological evidence of prior receipt of the HBV vaccine (anti-HBS positive, anti-HBc negative) or documented (clinical) evidence of having been vaccinated.
- Known history of HBV infection (HBsAg and/or anti-HBc positive).
- Inability to follow study procedures
- If a participant chooses not to consent to the review of his or her medical records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strategies for the Prevention of Hepatitis B Viral Infection Among HIV Infected Adults in Uganda
The aim of this study is to compare the effectiveness of two vaccination strategies against Hepatitis B virus (HBV) in subjects already infected with human immunodeficiency virus (HIV).
Researchers plan to determine the optimal vaccination strategy for achieving protective immunity to HBV infection in HIV-infected adults attending Mulago Hospital's HIV care clinic.
Primary objectives are to assess:
- The role of CD4-cell count and HIV viral loads on the HBV vaccine response.
- The role of highly active antiretroviral therapy (HAART) on the HBV vaccine response.
The secondary objective is to evaluate whether lack of HAART is associated with high rates of loss to follow-up.
Read the detailed description
This is an interventional study in which researchers will recruit HIV positive individuals who do not have hepatitis B (HBV negative) in order to assess the effectiveness of a hepatitis B vaccine in 2 subgroups:
- Those who have received less than 3 months treatment, or no treatment, with highly active antiretroviral drugs (HAART naive).
- Those who have received at least 3 months of treatment with highly active antiretroviral drugs (HAART exposed).
All study participants will receive vaccination against HBV.
There will be 6-12 clinic visits depending on 1) whether or not the participant responds to the standard 3-dose vaccination protocol and 2) whether he or she suffers a clinical condition or vaccine related adverse event that would call for postponement of the next vaccine dose.
The first visit will be to determine if the participant is eligible for the study. If eligible, the participant will receive one dose of vaccine at each of the following three visits. The fifth visit will be to collect blood to determine whether the participant has responded to the 3-dose vaccination protocol. The sixth visit will be to discuss the outcome of the vaccination with the participant. Participants who respond favorably to the 3-dose vaccine protocol will exit the study at this point. However, if a participant fails to respond to the initial 3-dose vaccine protocol, he or she may restart the regimen and receive another 3 doses of vaccine following the same schedule as before but off protocol.
Participants will be reimbursed for travel costs to and from the clinic for scheduled clinic visits.
- Conditions
- HIV/AIDS and Infections
- Being tested
- Hepatitis B vaccine
- Keywords
- Hepatitis B vaccine HIV infection
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis B vaccineBiological
Also called Euvax B (Sonafi)
An eligible participant will receive 3 doses of hepatitis B vaccine ( 20mcg in the deltoid intramuscular). Then their immune response will be assessed. Non responders will receive 3 additional vaccine doses off protocol
| Study group | Role | What they receive |
|---|---|---|
| HAART exposed | Other | Participants in both arms will receive the Hepatitis B vaccine as summarized in the study description Receives: Biological: Hepatitis B vaccine |
| HAART naive | Other | Participants in both arms will receive the Hepatitis B vaccine as summarized in the study description Receives: Biological: Hepatitis B vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatitis B virus (HBV) vaccine response
Measure Hepatitis B surface antibody (anti-HBs) levels and cell mediated immune response.
Measured: 18 months
Secondary outcomes (1)
Loss to follow-up (HAART naive vs. HAART exposed individuals)
Compare the number of individuals lost to follow-up among the HAART naive and HAART exposed.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startNov 2015
- Primary completion28 Apr 2017
- Study completion28 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDS and InfectionsStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University, Uganda Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Ponsiano Ocama, PhD, Principal investigator, Makerere UniversityCorey Casper, MD, Principal investigator, Fred Hutchinson Cancer CenterEmmanuel Seremba, MMED, Principal investigator, HCRI-Ug, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316444
- Sponsor's protocol ID
- U010
- Status last verified
- Jan 2019
- First submitted
- 10 Dec 2014
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies for the Prevention of Hepatitis B Viral Infection Among HIV Infected Adults in Uganda
- ClinicalTrials.gov ID
- NCT02316444
- Acronym / sponsor ID
- U010
- Conditions
- HIV/AIDS and Infections
- Keywords
- Hepatitis B vaccine HIV infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- Makerere University, Uganda Cancer Institute
- Study start
- Nov 2015
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 12 Dec 2014 (estimated)
- 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.
The aim of this study is to compare the effectiveness of two vaccination strategies against Hepatitis B virus (HBV) in subjects already infected with human immunodeficiency virus (HIV).
Researchers plan to determine the optimal vaccination strategy for achieving protective immunity to HBV infection in HIV-infected adults attending Mulago Hospital's HIV care clinic.
Primary objectives are to assess:
- The role of CD4-cell count and HIV viral loads on the HBV vaccine response.
- The role of highly active antiretroviral therapy (HAART) on the HBV vaccine response.
The secondary objective is to evaluate whether lack of HAART is associated with high rates of loss to follow-up.
Detailed description
This is an interventional study in which researchers will recruit HIV positive individuals who do not have hepatitis B (HBV negative) in order to assess the effectiveness of a hepatitis B vaccine in 2 subgroups:
- Those who have received less than 3 months treatment, or no treatment, with highly active antiretroviral drugs (HAART naive).
- Those who have received at least 3 months of treatment with highly active antiretroviral drugs (HAART exposed).
All study participants will receive vaccination against HBV.
There will be 6-12 clinic visits depending on 1) whether or not the participant responds to the standard 3-dose vaccination protocol and 2) whether he or she suffers a clinical condition or vaccine related adverse event that would call for postponement of the next vaccine dose.
The first visit will be to determine if the participant is eligible for the study. If eligible, the participant will receive one dose of vaccine at each of the following three visits. The fifth visit will be to collect blood to determine whether the participant has responded to the 3-dose vaccination protocol. The sixth visit will be to discuss the outcome of the vaccination with the participant. Participants who respond favorably to the 3-dose vaccine protocol will exit the study at this point. However, if a participant fails to respond to the initial 3-dose vaccine protocol, he or she may restart the regimen and receive another 3 doses of vaccine following the same schedule as before but off protocol.
Participants will be reimbursed for travel costs to and from the clinic for scheduled clinic visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAART exposed | Other | Biological: Hepatitis B vaccineParticipants in both arms will receive the Hepatitis B vaccine as summarized in the study description |
| HAART naive | Other | Biological: Hepatitis B vaccineParticipants in both arms will receive the Hepatitis B vaccine as summarized in the study description |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hepatitis B core antibody (anti-HBc) and anti-HBs negative
- Age ≥18 years
- HIV infected persons (HAART naïve and HAART exposed). HAART enrollees will be considered to be HAART exposed if they have been taking these medications for at least 3 months. Participants that have never been on HAART and those that have been on HAART for <3months will be considered to be HAART naïve. HAART exposed enrollees will have an adherence of at least 95%.
- Ambulatory
- Intention to attend the Mulago HIV/AIDS clinic for the 18 months
Key exclusion criteria (6 listed)
- History of hypersensitivity to vaccines or intolerance to any of the HBV vaccine components
- Previously-confirmed diagnosis of decompensated liver disease or HCC
- Serological evidence of prior receipt of the HBV vaccine (anti-HBS positive, anti-HBc negative) or documented (clinical) evidence of having been vaccinated.
- Known history of HBV infection (HBsAg and/or anti-HBc positive).
- Inability to follow study procedures
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 |
|---|---|---|
| Hepatitis B vaccineAlso: Euvax B (Sonafi)An eligible participant will receive 3 doses of hepatitis B vaccine ( 20mcg in the deltoid intramuscular). Then their immune response will be assessed. Non responders will receive 3 additional vaccine doses off protocol | Biological | HAART exposed, HAART naive |
Primary outcome
Hepatitis B virus (HBV) vaccine response
Time frame: 18 months
Measure Hepatitis B surface antibody (anti-HBs) levels and cell mediated immune response.
1 secondary outcome
Loss to follow-up (HAART naive vs. HAART exposed individuals)
Time frame: 18 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 25 Jan 2019.
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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.
Ponsiano Ocama, PhD principal investigator
Makerere University
Corey Casper, MD principal investigator
Fred Hutchinson Cancer Center
Emmanuel Seremba, MMED principal investigator
HCRI-Ug, Makerere University
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 Hepatitis B vaccine in people with HIV/AIDS and Infections, run by Fred Hutchinson Cancer Center at 1 site in Uganda.
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 6 inclusion and 6 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 25 Jan 2019. 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 Uganda. 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?
Hepatitis B virus (HBV) vaccine response (time frame: 18 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 25 Jan 2019.