Hemodialysis PatientsPhase 2/3NCT01273974
The Immunogenicity of Intradermal Influenza Vaccination in Hemodialysis Patients
A Phase 2/3 study testing intradermal influenza vaccine and intramuscular influenza vaccine in people with Hemodialysis Patients, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine whether half-dose intradermal influenza vaccine is as immunogenic as standard dose intramuscular vaccine in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemodialysis Patients
- What is being tested?
- intradermal influenza vaccine and intramuscular influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteIran
- Study dates
- Oct 2009to Feb 2010
- Phase
- Phase 2/3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients under chronic hemodialysis
Who cannot join
- history of flu infection in last month
- history of flu vaccination in 2009
- hospitalization in last month
- taking immune suppressants drugs
- hemodialysis less than twice weekly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of Serum Antibody Response to Standard Intramuscular and Half Dose Intradermal Influenza Vaccine in Hemodialysis Patients in Shiraz City in 1388.
The purpose of this study is to determine whether half-dose intradermal influenza vaccine is as immunogenic as standard dose intramuscular vaccine in hemodialysis patients.
Read the detailed description
Hemodialysis patients are at high risk of influenza infection due to suppress immune status.It is recommended to immunize them against influenza annually.in intradermal vaccination antigens directly present to the large numbers of antigen-presenting cells in the skin and it may cause greater immunogenicity than in the intramuscular method. Reduced-dose intradermal influenza vaccine is immunogenic in healthy adult, patients with solid cancer and three groups of immunocompromized patients including Rheumatologic patients treated with anti-TNF, HIV-infected and stem cell transplanted patients.
In this study we compare the efficacy of influenza vaccines in half dose intradermal and standard intramuscular methods among hemodialysis patients.
- Conditions
- Hemodialysis Patients
- Being tested
- intradermal influenza vaccine, intramuscular influenza vaccine
- Keywords
- intradermal influenza vaccine, hemodialysis patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intradermal influenza vaccineBiological
0.25ml ,intradermal
intramuscular influenza vaccineBiological
0.5ml,intramuscular
| Study group | Role | What they receive |
|---|---|---|
| intradermal influenza vaccine | Experimental | Not described Receives: Biological: intradermal influenza vaccine |
| intramuscular influenza vaccine | Active comparator | Not described Receives: Biological: intramuscular influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
vaccine effectiveness
serum antibody response measured by ELIZA method time frame:1 and 3 months after vaccination
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startOct 2009
- Primary completionNov 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis PatientsStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Mohammad mahdi Sagheb, Principal investigator, Shiraz University Of Medical ScienceSamira Saeian, Principal investigator, Shiraz University Of Medical ScienceJamshid Roozbeh, Principal investigator, Shiraz University Of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273974
- Sponsor's protocol ID
- 89-5905
- Status last verified
- Aug 2010
- First submitted
- 10 Jan 2011
- Last updated
- 11 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Serum Antibody Response to Standard Intramuscular and Half Dose Intradermal Influenza Vaccine in Hemodialysis Patients in Shiraz City in 1388.
- ClinicalTrials.gov ID
- NCT01273974
- Acronym / sponsor ID
- 89-5905
- Conditions
- Hemodialysis Patients
- Keywords
- intradermal influenza vaccine, hemodialysis patients
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 11 Jan 2011 (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 half-dose intradermal influenza vaccine is as immunogenic as standard dose intramuscular vaccine in hemodialysis patients.
Detailed description
Hemodialysis patients are at high risk of influenza infection due to suppress immune status.It is recommended to immunize them against influenza annually.in intradermal vaccination antigens directly present to the large numbers of antigen-presenting cells in the skin and it may cause greater immunogenicity than in the intramuscular method. Reduced-dose intradermal influenza vaccine is immunogenic in healthy adult, patients with solid cancer and three groups of immunocompromized patients including Rheumatologic patients treated with anti-TNF, HIV-infected and stem cell transplanted patients.
In this study we compare the efficacy of influenza vaccines in half dose intradermal and standard intramuscular methods among hemodialysis patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intradermal influenza vaccine | Experimental | Biological: intradermal influenza vaccine |
| intramuscular influenza vaccine | Active comparator | Biological: intramuscular influenza vaccine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients under chronic hemodialysis
Key exclusion criteria (5 listed)
- history of flu infection in last month
- history of flu vaccination in 2009
- hospitalization in last month
- taking immune suppressants drugs
- hemodialysis less than twice weekly
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 |
|---|---|---|
| intradermal influenza vaccine0.25ml ,intradermal | Biological | intradermal influenza vaccine |
| intramuscular influenza vaccine0.5ml,intramuscular | Biological | intramuscular influenza vaccine |
Primary outcome
vaccine effectiveness
Time frame: 3 months
serum antibody response measured by ELIZA method time frame:1 and 3 months after vaccination
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 11 Jan 2011.
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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.
Mohammad mahdi Sagheb principal investigator
Shiraz University Of Medical Science
Samira Saeian principal investigator
Shiraz University Of Medical Science
Jamshid Roozbeh principal investigator
Shiraz University Of Medical Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing intradermal influenza vaccine and intramuscular influenza vaccine in people with Hemodialysis Patients, run by Shiraz University of Medical Sciences 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 1 inclusion and 5 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 11 Jan 2011. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
vaccine effectiveness (time frame: 3 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 11 Jan 2011.