Hepatitis BNCT03149874
Accelerated Vaccination Schedule Against Hepatitis B Virus With Combined Hepatitis A and B Vaccine Among Hemodialysis Patients
A study testing Hepatitis B recombinant DNA vaccine and Combined hepatitis A and B vaccine in people with Hepatitis B and Hemodialysis Complication, run by Benha University.
Trial summary
The aim of this study is to examine the result of seroprotection using the accelerated vaccination schedule in vaccination of hemodialysis patient through using combined hepatitis A and B vaccine. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hepatitis B, Hemodialysis Complication
- What is being tested?
- Hepatitis B recombinant DNA vaccine and Combined hepatitis A and B vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2014to 1 May 2017
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age was above 18 years
- Hemodialysis patient
- All patients had undetectable hepatitis B virus surface antigen and antibody
Who cannot join
- A positive serum hepatitis B virus surface antigen and antibody
- patient received a previous course of hepatitis B virus vaccine
About this study
Official title: Accelerated Vaccination Schedule Against Hepatitis B Virus With Combined Hepatitis A and B Vaccine Among Hemodialysis Patients, Does it Works?
The aim of this study is to examine the result of seroprotection using the accelerated vaccination schedule in vaccination of hemodialysis patient through using combined hepatitis A and B vaccine.
- Conditions
- Hepatitis B, Hemodialysis Complication
- Being tested
- Hepatitis B recombinant DNA vaccine, Combined hepatitis A and B vaccine
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis B recombinant DNA vaccineDrug
Hepatitis B recombinant DNA vaccine
Combined hepatitis A and B vaccineDrug
Combined hepatitis A and B vaccine given to the patients
| Study group | Role | What they receive |
|---|---|---|
| Hepatitis B recombinant DNA vaccine | Active comparator | Each Hepatitis B recombinant DNA vaccine vial contained 20 microgram of vaccine dose. Two vials will be intramuscularly injected one vial in each deltoid muscle on months zero, one, two and six. Receives: Drug: Hepatitis B recombinant DNA vaccine |
| Combined hepatitis A and B vaccine | Active comparator | Each one-milliliter dose of vaccine contains 720 ELISA units of inactivated hepatitis A virus and 20 mcg of recombinant HBsAg protein. One dose of vaccine also contains 0.45 mg of aluminum. Two vials will be intramuscularly injected one vial in each deltoid muscle on on days zero, seven, and 21. Receives: Drug: Combined hepatitis A and B vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatitis B virus Seroprotection after one month
Hepatitis B virus surface antibodies titer after one month
Measured: one month after third dose of the vaccine
Hepatitis B virus Seroprotection after three months
Hepatitis B virus surface antibodies titer after three month
Measured: three months after third dose of the vaccine
Secondary outcomes (2)
Fever
The proportion of fever among patients in both arms
Measured: 4 Days after each vaccination dose
Pain scale
Visual pain scale for pain from injection
Measured: 1 Hour after each vaccination dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start1 Dec 2014
- Primary completion30 Apr 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Patient seuentially randomized to either vaccine
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Collaborators
- New Jeddah Clinic Hospital
- Responsible party
- Principal investigator, Mahmoud Hamada imam, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149874
- Sponsor's protocol ID
- BN-0517
- Status last verified
- Feb 2023
- First submitted
- 8 May 2017
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Vaccination Schedule Against Hepatitis B Virus With Combined Hepatitis A and B Vaccine Among Hemodialysis Patients, Does it Works?
- ClinicalTrials.gov ID
- NCT03149874
- Acronym / sponsor ID
- BN-0517
- Conditions
- Hepatitis B, Hemodialysis Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Collaborators
- New Jeddah Clinic Hospital
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 11 May 2017 (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.
The aim of this study is to examine the result of seroprotection using the accelerated vaccination schedule in vaccination of hemodialysis patient through using combined hepatitis A and B vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patient seuentially randomized to either vaccine
| Arm | Type | Receives |
|---|---|---|
| Hepatitis B recombinant DNA vaccine | Active comparator | Drug: Hepatitis B recombinant DNA vaccineEach Hepatitis B recombinant DNA vaccine vial contained 20 microgram of vaccine dose. Two vials will be intramuscularly injected one vial in each deltoid muscle on months zero, one, two and six. |
| Combined hepatitis A and B vaccine | Active comparator | Drug: Combined hepatitis A and B vaccineEach one-milliliter dose of vaccine contains 720 ELISA units of inactivated hepatitis A virus and 20 mcg of recombinant HBsAg protein. One dose of vaccine also contains 0.45 mg of aluminum. Two vials will be intramuscularly injected one vial in each deltoid muscle on on days zero, seven, and 21. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age was above 18 years
- Hemodialysis patient
- All patients had undetectable hepatitis B virus surface antigen and antibody
Key exclusion criteria (2 listed)
- A positive serum hepatitis B virus surface antigen and antibody
- patient received a previous course of hepatitis B virus vaccine
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 recombinant DNA vaccineHepatitis B recombinant DNA vaccine | Drug | Hepatitis B recombinant DNA vaccine |
| Combined hepatitis A and B vaccineCombined hepatitis A and B vaccine given to the patients | Drug | Combined hepatitis A and B vaccine |
Primary outcome
Hepatitis B virus Seroprotection after one month
Time frame: one month after third dose of the vaccine
Hepatitis B virus surface antibodies titer after one month
Hepatitis B virus Seroprotection after three months
Time frame: three months after third dose of the vaccine
Hepatitis B virus surface antibodies titer after three month
2 secondary outcomes
Fever
Time frame: 4 Days after each vaccination dose
Pain scale
Time frame: 1 Hour after each vaccination dose
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 8 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Hepatitis B recombinant DNA vaccine and Combined hepatitis A and B vaccine in people with Hepatitis B and Hemodialysis Complication, run by Benha University.
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 3 inclusion and 2 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 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Seroprotection after one month (time frame: one month after third dose of the vaccine). The study lists 2 primary outcomes in all. 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 8 Feb 2023.