Pulmonary SarcoidosisIVSNCT00828828
Antibody Response to Influenza Vaccine in Patients With Sarcoidosis
An observational study of Pulmonary Sarcoidosis, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine the efficacy of influenza vaccine (antibody response) in patients with sarcoidosis. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Sarcoidosis
- What is being tested?
- Influenza Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 49 participants
- Where
- 1 siteIran
- Study dates
- Dec 2008to May 2009
- Phase
- Observational
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Caes are defined as patients known as sarcoidosis and are under follow up at a tertiary care hospital clinic. Age and sex matched healthy healthcare workers serve as controls.
Who may be able to join
- Sarcoidosis patients:
- Patients with relevant clinical, radiologic and histologic features of sarcoidosis (all stages).
- Signed informed consent.
Who cannot join
- Organ failure (kidney, heart, liver).
- Collagen vascular diseases.
- Diabetes.
- Contraindications of vaccine (Egg allergy).
- Patients who receive high dose (> 60 mg/day) steroid therapy.
- Any acute disease.
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- Conditions accompanied by immunosuppression (like organ transplantation, HIV).
- Any psychological disease that interferes with regular follow-up.
- Inoculation with influenza vaccine within the past 5 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Controlled Trial of Serologic Efficacy of Influenza Vaccine in Patients With Sarcoidosis
The purpose of this study is to determine the efficacy of influenza vaccine (antibody response) in patients with sarcoidosis.
Read the detailed description
Sarcoidosis is a multisystem disease with unclear etiology characterized by the presence of noncaseating granuloma[1]. T helper cells response is exaggerated at the site of disease and cellular immunity depressed in peripheral blood[2]. Cutaneous anergy, lymphopenia and inversion of CD4/CD8 ratio in peripheral blood suggest T helper cells involvement[3].
The action of humeral immune system in sarcoidosis is a matter of controversy. Standard hepatitis B virus vaccination did not provoke protective antibody titer in patients with sarcoidosis[3]. Although antibody response against influenza vaccine in patients with sarcoidosis is not well described, this vaccine is highly recommended in patients with chronic pulmonary diseases such as asthma, COPD and fibrosis [4, 5, 6]. In this study we aim to evaluate the humeral response to the influenza vaccine in sarcoidosis patients and assess vaccine safety.
- Conditions
- Pulmonary Sarcoidosis
- Being tested
- Influenza Vaccine
- Keywords
- Influenza Vaccine, Sarcoidosis, Antibody
- Medical subject headings
- Sarcoidosis, Pulmonary, Influenza, Human, Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza VaccineBiological
Also called 2008-2009 vaccination campaign of influenza (Solvay Pharma)
One 0.5 ml dose of influenza vaccine injected intramuscular.
| Study group | Role | What they receive |
|---|---|---|
| Sarcoidosis | Sarcoidosis patients who are assigned to receive influenza vaccine Receives: Biological: Influenza Vaccine | |
| Healthy Controls | Healthy controls who are assigned to receive influenza vaccine Receives: Biological: Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serologic Response (equal or more than 4 fold HI titer rise) to each of the 3 antigens of the trivalent vaccine of the 2008-9 influenza vaccine
Measured: 4-6 weeks
Secondary outcomes (3)
Magnitude of change in the antibody titer against each of the 3 antigenes of the trivalent vaccine of the 2008/2009 season [A/Brisbane/59/2007(HIN1)-like virus;A/Brisbane/10/2007(H3N2)-like virus;B/Florida/4/2006-like virus]
Measured: 4-6 weeks
Protective Antibody (equal or more than 1:40) titer after vaccination
Measured: 4-6 weeks
Vaccine Safety (any major or minor side effects)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionFeb 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pulmonary SarcoidosisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Maryam Keshtkar-Jahromi, MD, MPH, Study chair, Clinical Research & Development Center, Shahid Modarres Hospital, Shahid Beheshti University (MC), Tehran, IranSasan Tavana, MD, Study chair, Clinical Research & Developement Center, Shahid Modares Hospital,Shahid Beheshti University (MC), Tehran, IranMarzieh Keshtkar-Jahromi, MD, Principal investigator, Clinical Research & Developement Center, Shahid Modares Hospital, Shahid Beheshti University (MC), Tehran, IranAmirsoheil Talebian, MD, Principal investigator, Clinical Research & Developement Center, Shahid Modares Hospital,Shahid Beheshti University (MC), Tehran, IranMohammad Rahnavardi, MD, Principal investigator, Clinical Research & Developement Center, Shahid Modares Hospital,Shahid Beheshti University (MC), Tehran, IranTalat Mokhtari-Azad, PhD, Principal investigator, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828828
- Sponsor's protocol ID
- SBMU 87-01-120-6003
- Acronym
- IVS
- Status last verified
- May 2009
- First submitted
- 23 Jan 2009
- Last updated
- 21 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Newman LS, Rose CS, Maier LA. Sarcoidosis. N Engl J Med. 1997 Apr 24;336(17):1224-34. doi: 10.1056/NEJM199704243361706. No abstract available.
PubMed 9110911Muller-Quernheim J. Sarcoidosis: immunopathogenetic concepts and their clinical application. Eur Respir J. 1998 Sep;12(3):716-38. doi: 10.1183/09031936.98.12030716.
PubMed 9762805Mert A, Bilir M, Ozaras R, Tabak F, Karayel T, Senturk H. Results of hepatitis B vaccination in sarcoidosis. Respiration. 2000;67(5):543-5. doi: 10.1159/000067471.
PubMed 11070460Kmiecik T, Arnoux S, Kobryn A, Gorski P. Influenza vaccination in adults with asthma: safety of an inactivated trivalent influenza vaccine. J Asthma. 2007 Dec;44(10):817-22. doi: 10.1080/02770900701539723.
PubMed 18097856Ayabe E, Kaneko N, Ohkuni Y, Misawa M, Inoue K, Tanabe Y, Yasui D, Sato C, Mitsuishi Y, Nakashita T, Motojima S. [The efficacy of influenza vaccine for acute exacerbation of chronic obstructive lung disease in elderly patients]. Nihon Kokyuki Gakkai Zasshi. 2008 Jul;46(7):511-5. Japanese.
PubMed 18700566Wat D, Gelder C, Hibbitts S, Bowler I, Pierrepoint M, Evans R, Doull I. Is there a role for influenza vaccination in cystic fibrosis? J Cyst Fibros. 2008 Jan;7(1):85-8. doi: 10.1016/j.jcf.2007.05.002. Epub 2007 Jul 5.
PubMed 17616444
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Trial of Serologic Efficacy of Influenza Vaccine in Patients With Sarcoidosis
- ClinicalTrials.gov ID
- NCT00828828
- Acronym / sponsor ID
- IVS / SBMU 87-01-120-6003
- Conditions
- Pulmonary Sarcoidosis
- Keywords
- Influenza Vaccine, Sarcoidosis, Antibody
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 26 Jan 2009 (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 the efficacy of influenza vaccine (antibody response) in patients with sarcoidosis.
Detailed description
Sarcoidosis is a multisystem disease with unclear etiology characterized by the presence of noncaseating granuloma[1]. T helper cells response is exaggerated at the site of disease and cellular immunity depressed in peripheral blood[2]. Cutaneous anergy, lymphopenia and inversion of CD4/CD8 ratio in peripheral blood suggest T helper cells involvement[3].
The action of humeral immune system in sarcoidosis is a matter of controversy. Standard hepatitis B virus vaccination did not provoke protective antibody titer in patients with sarcoidosis[3]. Although antibody response against influenza vaccine in patients with sarcoidosis is not well described, this vaccine is highly recommended in patients with chronic pulmonary diseases such as asthma, COPD and fibrosis [4, 5, 6]. In this study we aim to evaluate the humeral response to the influenza vaccine in sarcoidosis patients and assess vaccine safety.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarcoidosis | – | Biological: Influenza VaccineSarcoidosis patients who are assigned to receive influenza vaccine |
| Healthy Controls | – | Biological: Influenza VaccineHealthy controls who are assigned to receive influenza vaccine |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Caes are defined as patients known as sarcoidosis and are under follow up at a tertiary care hospital clinic. Age and sex matched healthy healthcare workers serve as controls.
Key inclusion criteria (3 listed)
- Patients with relevant clinical, radiologic and histologic features of sarcoidosis (all stages).
- Signed informed consent.
Key exclusion criteria (9 listed)
- Organ failure (kidney, heart, liver).
- Collagen vascular diseases.
- Diabetes.
- Contraindications of vaccine (Egg allergy).
- Patients who receive high dose (> 60 mg/day) steroid therapy.
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 |
|---|---|---|
| Influenza VaccineAlso: 2008-2009 vaccination campaign of influenza (Solvay Pharma)One 0.5 ml dose of influenza vaccine injected intramuscular. | Biological | Healthy Controls, Sarcoidosis |
Primary outcome
Serologic Response (equal or more than 4 fold HI titer rise) to each of the 3 antigens of the trivalent vaccine of the 2008-9 influenza vaccine
Time frame: 4-6 weeks
3 secondary outcomes
Magnitude of change in the antibody titer against each of the 3 antigenes of the trivalent vaccine of the 2008/2009 season [A/Brisbane/59/2007(HIN1)-like virus;A/Brisbane/10/2007(H3N2)-like virus;B/Florida/4/2006-like virus]
Time frame: 4-6 weeks
Protective Antibody (equal or more than 1:40) titer after vaccination
Time frame: 4-6 weeks
Vaccine Safety (any major or minor side effects)
Time frame: 2 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 21 May 2009.
- Background: PubMed 9110911Newman LS, Rose CS, Maier LA. Sarcoidosis. N Engl J Med. 1997 Apr 24;336(17):1224-34. doi: 10.1056/NEJM199704243361706. No abstract available.
- Background: PubMed 9762805Muller-Quernheim J. Sarcoidosis: immunopathogenetic concepts and their clinical application. Eur Respir J. 1998 Sep;12(3):716-38. doi: 10.1183/09031936.98.12030716.
- Background: PubMed 11070460Mert A, Bilir M, Ozaras R, Tabak F, Karayel T, Senturk H. Results of hepatitis B vaccination in sarcoidosis. Respiration. 2000;67(5):543-5. doi: 10.1159/000067471.
- Background: PubMed 18097856Kmiecik T, Arnoux S, Kobryn A, Gorski P. Influenza vaccination in adults with asthma: safety of an inactivated trivalent influenza vaccine. J Asthma. 2007 Dec;44(10):817-22. doi: 10.1080/02770900701539723.
- Background: PubMed 18700566Ayabe E, Kaneko N, Ohkuni Y, Misawa M, Inoue K, Tanabe Y, Yasui D, Sato C, Mitsuishi Y, Nakashita T, Motojima S. [The efficacy of influenza vaccine for acute exacerbation of chronic obstructive lung disease in elderly patients]. Nihon Kokyuki Gakkai Zasshi. 2008 Jul;46(7):511-5. Japanese.
- Background: PubMed 17616444Wat D, Gelder C, Hibbitts S, Bowler I, Pierrepoint M, Evans R, Doull I. Is there a role for influenza vaccination in cystic fibrosis? J Cyst Fibros. 2008 Jan;7(1):85-8. doi: 10.1016/j.jcf.2007.05.002. Epub 2007 Jul 5.
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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.
Maryam Keshtkar-Jahromi, MD, MPH study chair
Clinical Research & Development Center, Shahid Modarres Hospital, Shahid Beheshti University (MC), Tehran, Iran
Sasan Tavana, MD study chair
Clinical Research & Developement Center, Shahid Modares Hospital,Shahid Beheshti University (MC), Tehran, Iran
Marzieh Keshtkar-Jahromi, MD principal investigator
Clinical Research & Developement Center, Shahid Modares Hospital, Shahid Beheshti University (MC), Tehran, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Sarcoidosis, run by Shahid Beheshti 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 3 inclusion and 9 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 21 May 2009. 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.
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?
Serologic Response (equal or more than 4 fold HI titer rise) to each of the 3 antigens of the trivalent vaccine of the 2008-9 influenza vaccine (time frame: 4-6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00828828, which also lists 6 linked publications.
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 21 May 2009.