Healthy VolunteersNCT00001257
Inflammatory Responses in Normal Volunteers and Patients With Abnormal Immune Responses
An observational study of Healthy Volunteers and Abnormal Phagocyte Function, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This study will investigate the inflammatory response. People with abnormal regulation of inflammation and immune defects often have an exaggerated or depressed inflammatory response that results in poor healing of recurrent infections. Read more about this study
- Who is it for?
- Ages 6 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Abnormal Phagocyte Function
- How many people
- 169 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 1990to 2 Aug 2019
- 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 6 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients having or thought to have an immune defect between the ages of 6 and 65 years (inclusive) are eligible to participate.
- Be a healthy adult of either sex and between the ages of 18 and 65 years old.
- Weight greater than 110 pounds.
- Not have any heart, lung, or kidney disease, or bleeding disorders.
- Not have a history of viral hepatitis (B or C) since age 11.
- Not have a history of intravenous injection drug use.
- Not have a history of engaging in high-risk activities for exposure to the AIDS virus.
- Not be pregnant.
Who cannot join
- Patients less than 6 or greater than 65 years of age.
- Less than 18 years old or older than 65 years.
- Have viral hepatitis (B or C).
- HIV positive.
- Receiving chemotherapeutic agent(s), or have underlying malignancy.
- Pregnant.
- Have history of heart, lung, kidney disease, or bleeding disorders.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Comparison of Inflammatory Responses in Normal Volunteers and Patients With Abnormal Phagocyte Function Using the Suction Blister Technique
This study will investigate the inflammatory response. People with abnormal regulation of inflammation and immune defects often have an exaggerated or depressed inflammatory response that results in poor healing of recurrent infections. This study will measure and compare amounts of inflammatory mediators (chemicals involved in the inflammatory response) in healthy normal volunteers and in patients with abnormal immune responses.
Healthy normal volunteers and patients with host defense defects or excessive inflammation, as in vasculitis syndromes, may be eligible for this study. Patients must be between 6 and 65 years of age.
Read more
Participants will have eight small blisters raised on the forearm using a gentle suction device. The top of the blisters will be removed with scissors and a plastic template will be placed over the blisters. The wells of the template will be filled with a salt solution or a mixture of the subject s serum (fluid part of the blood without cells) and a salt solution. Some blisters may be covered with coverslips a small round piece of very thin sterilized glass before adding the fluid. Blister fluid will be removed from the wells at 3, 5, 8, and 24 hours with a syringe and analyzed for inflammatory mediators. A scab will form over the blisters and fall off in about 2 weeks.
Participants will have about 4 tablespoons of blood drawn in order to compare the inflammatory mediators in the blood with those in the blister fluid.
Read the detailed description
Patients with abnormal regulation of inflammation and with host defense defects often have an exaggerated or depressed inflammatory response with resultant difficulty in healing of recurrent infections. Delayed healing can be manifested by either a delay in wound healing, granuloma formation along the incision line, or dehiscence of a partially healed wound without evidence of infection. We are interested in studying the dynamics of host immune defenses during an experimentally induced inflammatory response using a well-studied suction blister device. This protocol is designed to study mediators of inflammation in patients with host defense defects as well as patients with excessive inflammation as in the vasculitis syndromes. We will measure mediators of inflammation (e.g., C5a, leukotriene B4, interleukins, chemokines, tumor necrosis factor, interferon-gamma) by ELISA, radioimmunoassay, High Performance Liquid Chromatography, multiplex cytokine assays, and/or bioactivity assays. Furthermore, molecular characterization and host defense functions (e.g., respiratory burst, chemotaxis, phagocytosis, microbicidal activity) of cells recruited to the blisters will also be examined. In addition to the analysis of cell function, RNA will be prepared and subject to DNA microarray or quantitative RT-PCR studies to measure expression and dynamics of key inflammatory mediators. Many of these factors contribute to the inflammatory process and several are thought to be important in granuloma formation. If patients are found to have abnormal amounts of these mediators when compared to healthy volunteers or patients with other abnormalities it will help us understand the basis for their disease and new therapeutic strategies. For example, this blister study allowed us to identify a patient subsequently shown to have IRAK4 deficiency.
- Conditions
- Healthy Volunteers, Abnormal Phagocyte Function
- Keywords
- Lymphokines, LTB4, Inflammation, Normal Volunteer, Abnormal Phagocyte Function
- Medical subject headings
- Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify mediators that contribute to the inflammatory process and granuloma formation by comparing mediators collected from healthy volunteers to patients with abnormal regulation of inflammation and patients with host defense defects.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start24 Apr 1990
- Study completion2 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kol A Zarember, Ph.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001257
- Sponsor's protocol ID
- 900120
- Other IDs
- 90-I-0120
- Status last verified
- 2 Aug 2019
- First submitted
- 3 Nov 1999
- Last updated
- 6 Aug 2019
- Results posted
- No
Publications
Dale DC, Wolff SM. Skin window studies of the acute inflammatory responses of neutropenic patients. Blood. 1971 Aug;38(2):138-42. No abstract available.
PubMed 4933314Hellum KB, Solberg CO. Human leucocyte migration: studies with an improved skin chamber technique. Acta Pathol Microbiol Scand C. 1977 Dec;85C(6):413-23. doi: 10.1111/j.1699-0463.1977.tb03663.x.
PubMed 343498Kuhns DB, Long Priel DA, Gallin JI. Loss of L-selectin (CD62L) on human neutrophils following exudation in vivo. Cell Immunol. 1995 Sep;164(2):306-10. doi: 10.1006/cimm.1995.1174.
PubMed 7544694
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Inflammatory Responses in Normal Volunteers and Patients With Abnormal Phagocyte Function Using the Suction Blister Technique
- ClinicalTrials.gov ID
- NCT00001257
- Acronym / sponsor ID
- 900120
- Conditions
- Healthy Volunteers, Abnormal Phagocyte Function
- Keywords
- Lymphokines, LTB4, Inflammation, Normal Volunteer, Abnormal Phagocyte Function
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 169 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 24 Apr 1990
- Study completion
- 2 Aug 2019
- First posted
- 4 Nov 1999 (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.
This study will investigate the inflammatory response. People with abnormal regulation of inflammation and immune defects often have an exaggerated or depressed inflammatory response that results in poor healing of recurrent infections. This study will measure and compare amounts of inflammatory mediators (chemicals involved in the inflammatory response) in healthy normal volunteers and in patients with abnormal immune responses.
Healthy normal volunteers and patients with host defense defects or excessive inflammation, as in vasculitis syndromes, may be eligible for this study. Patients must be between 6 and 65 years of age.
Participants will have eight small blisters raised on the forearm using a gentle suction device. The top of the blisters will be removed with scissors and a plastic template will be placed over the blisters. The wells of the template will be filled with a salt solution or a mixture of the subject s serum (fluid part of the blood without cells) and a salt solution. Some blisters may be covered with coverslips a small round piece of very thin sterilized glass before adding the fluid. Blister fluid will be removed from the wells at 3, 5, 8, and 24 hours with a syringe and analyzed for inflammatory mediators. A scab will form over the blisters and fall off in about 2 weeks.
Participants will have about 4 tablespoons of blood drawn in order to compare the inflammatory mediators in the blood with those in the blister fluid.
Detailed description
Patients with abnormal regulation of inflammation and with host defense defects often have an exaggerated or depressed inflammatory response with resultant difficulty in healing of recurrent infections. Delayed healing can be manifested by either a delay in wound healing, granuloma formation along the incision line, or dehiscence of a partially healed wound without evidence of infection. We are interested in studying the dynamics of host immune defenses during an experimentally induced inflammatory response using a well-studied suction blister device. This protocol is designed to study mediators of inflammation in patients with host defense defects as well as patients with excessive inflammation as in the vasculitis syndromes. We will measure mediators of inflammation (e.g., C5a, leukotriene B4, interleukins, chemokines, tumor necrosis factor, interferon-gamma) by ELISA, radioimmunoassay, High Performance Liquid Chromatography, multiplex cytokine assays, and/or bioactivity assays. Furthermore, molecular characterization and host defense functions (e.g., respiratory burst, chemotaxis, phagocytosis, microbicidal activity) of cells recruited to the blisters will also be examined. In addition to the analysis of cell function, RNA will be prepared and subject to DNA microarray or quantitative RT-PCR studies to measure expression and dynamics of key inflammatory mediators. Many of these factors contribute to the inflammatory process and several are thought to be important in granuloma formation. If patients are found to have abnormal amounts of these mediators when compared to healthy volunteers or patients with other abnormalities it will help us understand the basis for their disease and new therapeutic strategies. For example, this blister study allowed us to identify a patient subsequently shown to have IRAK4 deficiency.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients having or thought to have an immune defect between the ages of 6 and 65 years (inclusive) are eligible to participate.
- Be a healthy adult of either sex and between the ages of 18 and 65 years old.
- Weight greater than 110 pounds.
- Not have any heart, lung, or kidney disease, or bleeding disorders.
- Not have a history of viral hepatitis (B or C) since age 11.
Key exclusion criteria (7 listed)
- Patients less than 6 or greater than 65 years of age.
- Less than 18 years old or older than 65 years.
- Have viral hepatitis (B or C).
- HIV positive.
- Receiving chemotherapeutic agent(s), or have underlying malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To identify mediators that contribute to the inflammatory process and granuloma formation by comparing mediators collected from healthy volunteers to patients with abnormal regulation of inflammation and patients with host defense defects.
Time frame: Ongoing
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Background: PubMed 4933314Dale DC, Wolff SM. Skin window studies of the acute inflammatory responses of neutropenic patients. Blood. 1971 Aug;38(2):138-42. No abstract available.
- Background: PubMed 343498Hellum KB, Solberg CO. Human leucocyte migration: studies with an improved skin chamber technique. Acta Pathol Microbiol Scand C. 1977 Dec;85C(6):413-23. doi: 10.1111/j.1699-0463.1977.tb03663.x.
- Background: PubMed 7544694Kuhns DB, Long Priel DA, Gallin JI. Loss of L-selectin (CD62L) on human neutrophils following exudation in vivo. Cell Immunol. 1995 Sep;164(2):306-10. doi: 10.1006/cimm.1995.1174.
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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.
Kol A Zarember, Ph.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
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 Healthy Volunteers and Abnormal Phagocyte Function, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 6 Aug 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 United States. 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 was stopped early. 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?
To identify mediators that contribute to the inflammatory process and granuloma formation by comparing mediators collected from healthy volunteers to patients with abnormal regulation of inflammation and patients with host defense defects. (time frame: Ongoing). 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 NCT00001257, which also lists 3 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 6 Aug 2019.