HealthyNCT00320164
Anti-Pseudomonas Immune Status and Dendritic Cell Preparation in Normal Individuals
An observational study of Healthy, run by Weill Medical College of Cornell University.
Trial summary
This protocol aims to collect human peripheral blood mononuclear cells for the production of dendritic cells (DC). There are two ways to collect human peripheral blood mononuclear cells in this protocol. One is by using the method of leukapheresis from normal healthy adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Jan 2008
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group A is for leukapheresis and Group B is for buffy coats collection. We will use either Group A or Group B or both to collect mononuclear cells. The source of potential subjects in both groups will be normal individuals recruited from the population of healthy individuals. Accrual will be random with no bias as to gender or racial/ethnic group. Nevertheless, because the accrual process will be random, it is possible that there may be differences in the proportion of males and females, and racial/ethnic groups. The study volunteers will be recruited through IRB approved advertisements placed in local newspapers and fliers. All efforts will be made to recruit women and minorities.
Who may be able to join
- All study subjects must be capable of providing informed consent.
- Normal male or female, age 18 and older.
- Not taking corticosteroids
- Not taking any prescription or over-the-counter medication, except acetaminophen (tylenol)
- Participants of Group A must have adequate peripheral veins for leukapheresis
- Study subjects should not be taking experimental medications.
- Females cannot be pregnant.
Who cannot join
- Individuals who do not meet the inclusion criteria will be unable to participate in the protocol.
- Individuals with active infection in the 3 weeks prior to beginning the protocol will not be able to participate.
- Individuals with evidence of significant cardiac, pulmonary, renal, endocrine, central nervous system, major psychiatric disorder that would prevent compliance or substance abuse, musculoskeletal disease or immunodeficiency disease, (including evidence of human immunodeficiency virus infection, HIV) will be unable to participate in the protocol.
- Individuals participating in any other experimental clinical studies.
- Women who are pregnant or nursing.
- Active or recent drug users
About this study
This protocol aims to collect human peripheral blood mononuclear cells for the production of dendritic cells (DC). There are two ways to collect human peripheral blood mononuclear cells in this protocol. One is by using the method of leukapheresis from normal healthy adults. The other is by drawing the blood from normal healthy adults and then getting the buffy coats from the blood.
Read the detailed description
One objective of these studies on DC is to complete a preclinical development for a human study of a candidate anti-Pseudomonas aeruginosa vaccine consisting of autologous dendritic cells primed with heat-inactivated P. aeruginosa (PA) strain POA1 and expressing the T-cell costimulatory molecule CD40 ligand (CD40L). The other objective is to complete a preclinical development for a human study of a candidate anti-anthrax vaccine. Prior to testing the vaccine in humans, the Food and Drug Administration will require preclinical and Good Manufacturing Practice (GMP) practice batches of dendritic cells. The intent of the leukapheresis or collecting the buffy coats is to provide the biological materials for this purpose.
- Conditions
- Healthy
- Keywords
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Leukapheresis | Subject's peripheral blood mononuclear cells are collected via leukapheresis. | |
| Group B: Buffy Coats Collection | Subject's peripheral blood mononuclear cells are collected via the buffy coats from blood. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startJan 2006
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil R. Hackett, Ph.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00320164
- Sponsor's protocol ID
- Dendritic Cells
- Status last verified
- May 2017
- First submitted
- 27 Apr 2006
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Pseudomonas Immune Status and Dendritic Cell Preparation in Normal Individuals
- ClinicalTrials.gov ID
- NCT00320164
- Acronym / sponsor ID
- Dendritic Cells
- Conditions
- Healthy
- Keywords
- Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 3 May 2006 (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 protocol aims to collect human peripheral blood mononuclear cells for the production of dendritic cells (DC). There are two ways to collect human peripheral blood mononuclear cells in this protocol. One is by using the method of leukapheresis from normal healthy adults. The other is by drawing the blood from normal healthy adults and then getting the buffy coats from the blood.
Detailed description
One objective of these studies on DC is to complete a preclinical development for a human study of a candidate anti-Pseudomonas aeruginosa vaccine consisting of autologous dendritic cells primed with heat-inactivated P. aeruginosa (PA) strain POA1 and expressing the T-cell costimulatory molecule CD40 ligand (CD40L). The other objective is to complete a preclinical development for a human study of a candidate anti-anthrax vaccine. Prior to testing the vaccine in humans, the Food and Drug Administration will require preclinical and Good Manufacturing Practice (GMP) practice batches of dendritic cells. The intent of the leukapheresis or collecting the buffy coats is to provide the biological materials for this purpose.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Leukapheresis | – | –Subject's peripheral blood mononuclear cells are collected via leukapheresis. |
| Group B: Buffy Coats Collection | – | –Subject's peripheral blood mononuclear cells are collected via the buffy coats from blood. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group A is for leukapheresis and Group B is for buffy coats collection. We will use either Group A or Group B or both to collect mononuclear cells. The source of potential subjects in both groups will be normal individuals recruited from the population of healthy individuals. Accrual will be random with no bias as to gender or racial/ethnic group. Nevertheless, because the accrual process will be random, it is possible that there may be differences in the proportion of males and females, and racial/ethnic groups. The study volunteers will be recruited through IRB approved advertisements placed in local newspapers and fliers. All efforts will be made to recruit women and minorities.
Key inclusion criteria (7 listed)
- All study subjects must be capable of providing informed consent.
- Normal male or female, age 18 and older.
- Not taking corticosteroids
- Not taking any prescription or over-the-counter medication, except acetaminophen (tylenol)
- Participants of Group A must have adequate peripheral veins for leukapheresis
Key exclusion criteria (6 listed)
- Individuals who do not meet the inclusion criteria will be unable to participate in the protocol.
- Individuals with active infection in the 3 weeks prior to beginning the protocol will not be able to participate.
- Individuals with evidence of significant cardiac, pulmonary, renal, endocrine, central nervous system, major psychiatric disorder that would prevent compliance or substance abuse, musculoskeletal disease or immunodeficiency disease, (including evidence of human immunodeficiency virus infection, HIV) will be unable to participate in the protocol.
- Individuals participating in any other experimental clinical studies.
- Women who are pregnant or nursing.
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
Not reported in the source record.
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 24 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
Neil R. Hackett, Ph.D. principal investigator
Weill Medical College of Cornell University
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Weill Medical College of Cornell 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 7 inclusion and 6 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 24 May 2017. 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.
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 24 May 2017.