Collection of Plasma From People Who Recovered From or Were Vaccinated to Emerging Infectious Dis… (NCT02338986) | Clinical Trial Compass
CompletedNot Applicable
Collection of Plasma From People Who Recovered From or Were Vaccinated to Emerging Infectious Diseases
United States10 participantsStarted 2015-03-04
Plain-language summary
Background:
\- There are more emerging infectious diseases recently. Some could affect many people. Some like Severe Acute Respiratory Syndrome (SARS) or Middle East Respiratory Syndrome (MERS) are caused by new germs. Sometimes known germs suddenly infect new and large areas, like Ebola. Many of these diseases don t have good treatments available. Researchers may be able to develop a treatment by using antibodies against these infections.
Objective:
\- To collect antibodies from people with high levels of antibodies to the diseases being studied.
Eligibility:
\- Ages 18-70 years old who weigh at least 110 pounds. They may have been infected with or vaccinated for one of the new infections researchers are studying.
Design:
* Participants will be screened with medical history and blood tests. Researchers will determine if the participant can have apheresis.
* Participants will have apheresis. First, they will be interviewed. Then, a needle will be placed in a vein. Blood will be drawn, and a machine will separate the blood cells from the antibodies and protein. The blood cells will then be returned to the participant through another vein. It takes about 60 minutes for the actual collection.
* Participants will be asked to have the procedure at least 3 times. They can participate in up to 20 sessions total as part of this study. There must be at least 7 days between sessions.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provide written informed consent before initiation of any study procedures
. Age \>=8 years old, and \<=70 years old
. History of a known infection or vaccination towards emerging infectious diseases of interest:
Exclusion criteria
. Any sign of active infection (as judged by the investigator), including but not limited
. Pregnancy
. Meets current blood establishment plasma donation exclusion criteria. A protocol amendment will not be needed to reflect updated/current blood donation exclusion criteria.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of units of plasma collected
Timeframe: 5 years after enrollment
Trial details
NCT IDNCT02338986
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Subjects that have participated in previous plasma collection or other cell component collection procedures within the last 3 months may have restrictions to participation based on the site plasma collection standard operating procedure (SOP). In this scenario, discussion should occur with the blood establishment to ensure eligibility to donate plasma.