Hepatitis BPhase 4NCT01548326
Effects of Short-term Atorvastatin Treatment on Vaccination Efficacy in Nonresponder Persons to Hepatitis B Vaccine
A Phase 4 study testing Atorvastatin in people with Hepatitis B and Vaccination Failure, run by Nematollah Jonaidi Jafari at 1 site in Iran.
Trial summary
The purpose of this study is to determine whether short-term Atorvastatin can increase the immunity response to hepatitis B vaccination in vaccine Nonresponders. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Vaccination Failure
- What is being tested?
- Atorvastatin
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteIran
- Study dates
- Sep 2011to Jul 2012
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Previous 3 dose hepatitis B vaccination
- Negative HBc Ab
- Negative HBs Ag
- HBs Ab less than 10 in ELIZA
Who cannot join
- positive serologic evidence of Hepatitis B infection
- Chronic use of Atorvastatin
- Immunosuppressive Disease
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether short-term Atorvastatin can increase the immunity response to hepatitis B vaccination in vaccine Nonresponders.
Read the detailed description
20 person of vaccinated individuals who have HBsAb<10 after 3 dose hepatitis B vaccination who called Nonresponders will be randomly allocated in 2 groups. one group receive short-term Atorvastatin and other group receive placebo.both group will be vaccinated with hepatitis B vaccine and then immunity response will be measured.
- Conditions
- Hepatitis B, Vaccination Failure
- Being tested
- Atorvastatin, placebo
- Keywords
- Vaccination Failure, Nonresponder, Hepatitis B virus, Atorvastatin, Immunization against viral Hepatitis
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
one 40 mg Atorvastatin tablet orally per day for 10 days
placeboDrug
one Placebo tablet orally per day for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Active comparator | will receive one 40 mg Atorvastatin tablet orally per day for 10 days and in 5th day 1 dose of recombinant yeast-derived Hepatitis B vaccine intramuscular in left Deltoid muscle Receives: Drug: Atorvastatin |
| Placebo | Placebo comparator | will receive one Placebo tablet orally per day for 10 days and in 5th day 1 dose of recombinant yeast-derived Hepatitis B vaccine intramuscular in left Deltoid muscle Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in serum HBsAb level
HBsAb level in serum measurement with quantitative ELIZA method
Measured: 1 month after vaccination
Secondary outcomes (4)
IL-4 level in WBC culture
IL-4 level measurement with polymerase chain reaction method
Measured: 1 month after vaccination
IL 17 level in WBC culture
IL 17 level measurement with polymerase chain reaction method
Measured: 1 month after vaccination
TGF-beta level in WBC culture
TGF-beta level measurement with polymerase chain reaction method
Measured: 1 month after vaccination
IFN-gamma level in WBC culture
IFN-gamma level measurement with polymerase chain reaction method
Measured: 1 month after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startSep 2011
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nematollah Jonaidi Jafari
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nematollah Jonaidi Jafari, Baqiyatallah Medical Sciences University
- Investigators
- Nematollah Jonaidi Jafari, MD, Study chair, Baqiyatallah University of Medical Sciencesc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548326
- Sponsor's protocol ID
- behdasht-90-6-16
- Other IDs
- IRCT201109147556N1
- Status last verified
- Mar 2012
- First submitted
- 27 Feb 2012
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Short-term Atorvastatin Treatment on Vaccination Efficacy in Nonresponder Persons to Hepatitis B Vaccine
- ClinicalTrials.gov ID
- NCT01548326
- Acronym / sponsor ID
- behdasht-90-6-16
- Conditions
- Hepatitis B, Vaccination Failure
- Keywords
- Vaccination Failure, Nonresponder, Hepatitis B virus, Atorvastatin, Immunization against viral Hepatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Nematollah Jonaidi JafariUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 8 Mar 2012 (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 purpose of this study is to determine whether short-term Atorvastatin can increase the immunity response to hepatitis B vaccination in vaccine Nonresponders.
Detailed description
20 person of vaccinated individuals who have HBsAb<10 after 3 dose hepatitis B vaccination who called Nonresponders will be randomly allocated in 2 groups. one group receive short-term Atorvastatin and other group receive placebo.both group will be vaccinated with hepatitis B vaccine and then immunity response will be measured.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Active comparator | Drug: Atorvastatinwill receive one 40 mg Atorvastatin tablet orally per day for 10 days and in 5th day 1 dose of recombinant yeast-derived Hepatitis B vaccine intramuscular in left Deltoid muscle |
| Placebo | Placebo comparator | Drug: placebowill receive one Placebo tablet orally per day for 10 days and in 5th day 1 dose of recombinant yeast-derived Hepatitis B vaccine intramuscular in left Deltoid muscle |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Previous 3 dose hepatitis B vaccination
- Negative HBc Ab
- Negative HBs Ag
- HBs Ab less than 10 in ELIZA
Key exclusion criteria (3 listed)
- positive serologic evidence of Hepatitis B infection
- Chronic use of Atorvastatin
- Immunosuppressive Disease
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 |
|---|---|---|
| Atorvastatinone 40 mg Atorvastatin tablet orally per day for 10 days | Drug | Atorvastatin |
| placeboone Placebo tablet orally per day for 10 days | Drug | Placebo |
Primary outcome
Change from baseline in serum HBsAb level
Time frame: 1 month after vaccination
HBsAb level in serum measurement with quantitative ELIZA method
4 secondary outcomes
IL-4 level in WBC culture
Time frame: 1 month after vaccination
IL 17 level in WBC culture
Time frame: 1 month after vaccination
TGF-beta level in WBC culture
Time frame: 1 month after vaccination
IFN-gamma level in WBC culture
Time frame: 1 month after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
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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.
Nematollah Jonaidi Jafari, MD study chair
Baqiyatallah University of Medical Sciencesc
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 Atorvastatin in people with Hepatitis B and Vaccination Failure, run by Nematollah Jonaidi Jafari at 1 site in Iran.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Mar 2012. 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 Iran. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Change from baseline in serum HBsAb level (time frame: 1 month after vaccination). 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 Mar 2012.