Communicable DiseasesNCT02338986
Collection of Plasma From People Who Recovered From or Were Vaccinated to Emerging Infectious Diseases
An observational study of Communicable Diseases and Communicable Diseases, Emerging, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Communicable Diseases, Communicable Diseases, Emerging, Emerging Infectious Diseases
- What is being tested?
- Plasma
- Type of treatment
- Vaccines
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2015to 15 May 2025
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women who have high titer antibodies for a given emerging infectious disease.@@@
Who may be able to join
- 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:
- For convalescent subjects, the following criteria must be met:
- At least 28 days since the subject was symptomatic from the infection
- Afebrile (subjective history acceptable) for at least 28 days
Show all 15Show fewer
- Enrollment must occur within 24 months of illness.
- For vaccinated subjects, the following criteria must be met:
- Subjects must be at least 14 days after vaccination
- If vaccinated on a blinded study, the study must be unblinded and the subject received active product.
- Enrollment must occur within 24 months of the last vaccination.
- (The above represent the minimum criteria - more restrictive criteria may be listed under disease specific criteria noted in Appendix A)
- 4) Weight >=110 pounds (50 kg)
- 5) Adequate peripheral venous access for plasma donation (as judged by the examiner)
- 6) Willingness to have samples stored
Who cannot join
- Any sign of active infection (as judged by the investigator), including but not limited
- to:
- Subjective or documented fever (>38 (Infinite)C)
- Cough
- Shortness of breath
- Diarrhea
Show all 9Show fewer
- Pregnancy
- Meets current blood establishment plasma donation exclusion criteria. A protocol amendment will not be needed to reflect updated/current blood donation exclusion criteria.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Collection of Plasma From Subjects That Recovered From or Were Vaccinated To Emerging Infectious Diseases
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.
Read more
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.
Read the detailed description
The administration of convalescent plasma is often used for treatment of emerging infectious diseases. This natural history protocol will collect plasma from subjects that were vaccinated to or recovered from an emerging infectious disease of interest, in a manner that the plasma can be given to other subjects as a therapeutic. Any administration of plasma to subjects will be under a separate protocol.
- Conditions
- Communicable Diseases, Communicable Diseases, Emerging, Emerging Infectious Diseases, Infection
- Being tested
- Plasma
- Keywords
- High Titer Antibodies, Convalescent Volunteers, Apheresis, Males, Quantitative IgG, Natural History
- Medical subject headings
- Communicable Diseases, Communicable Diseases, Emerging, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlasmaDrug
Plasma
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Collection of Plasma From Subjects That Recovered From or Were Vaccinated To Emerging Infectious Diseases Receives: Drug: Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of units of plasma collected
The number of units of human plasma collected from volunteers with high titer antibodies for a given emerging infectious disease, that is potentially suitable for infusion into humans as part of a separate treatment study.
Measured: 5 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study start4 Mar 2015
- Primary completion15 May 2025
- Study completion15 May 2025
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 Communicable DiseasesStudies 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
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Richard T Davey, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338986
- Sponsor's protocol ID
- 150056
- Other IDs
- 15-I-0056
- Status last verified
- May 2025
- First submitted
- 14 Jan 2015
- Last updated
- 16 May 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Soo YO, Cheng Y, Wong R, Hui DS, Lee CK, Tsang KK, Ng MH, Chan P, Cheng G, Sung JJ. Retrospective comparison of convalescent plasma with continuing high-dose methylprednisolone treatment in SARS patients. Clin Microbiol Infect. 2004 Jul;10(7):676-8. doi: 10.1111/j.1469-0691.2004.00956.x.
PubMed 15214887Mupapa K, Massamba M, Kibadi K, Kuvula K, Bwaka A, Kipasa M, Colebunders R, Muyembe-Tamfum JJ. Treatment of Ebola hemorrhagic fever with blood transfusions from convalescent patients. International Scientific and Technical Committee. J Infect Dis. 1999 Feb;179 Suppl 1:S18-23. doi: 10.1086/514298.
PubMed 9988160Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, Liu R, Watt CL, Chan WM, Lai KY, Koo CK, Buckley T, Chow FL, Wong KK, Chan HS, Ching CK, Tang BS, Lau CC, Li IW, Liu SH, Chan KH, Lin CK, Yuen KY. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011 Feb 15;52(4):447-56. doi: 10.1093/cid/ciq106. Epub 2011 Jan 19.
PubMed 21248066
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Plasma From Subjects That Recovered From or Were Vaccinated To Emerging Infectious Diseases
- ClinicalTrials.gov ID
- NCT02338986
- Acronym / sponsor ID
- 150056
- Conditions
- Communicable Diseases, Communicable Diseases, Emerging, Emerging Infectious Diseases, Infection
- Keywords
- High Titer Antibodies, Convalescent Volunteers, Apheresis, Males, Quantitative IgG, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 4 Mar 2015 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 15 Jan 2015 (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.
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.
Detailed description
The administration of convalescent plasma is often used for treatment of emerging infectious diseases. This natural history protocol will collect plasma from subjects that were vaccinated to or recovered from an emerging infectious disease of interest, in a manner that the plasma can be given to other subjects as a therapeutic. Any administration of plasma to subjects will be under a separate protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Drug: PlasmaCollection of Plasma From Subjects That Recovered From or Were Vaccinated To Emerging Infectious Diseases |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women who have high titer antibodies for a given emerging infectious disease.@@@
Key inclusion criteria (15 listed)
- For convalescent subjects, the following criteria must be met:
- For vaccinated subjects, the following criteria must be met:
- 4) Weight >=110 pounds (50 kg)
- 5) Adequate peripheral venous access for plasma donation (as judged by the examiner)
- 6) Willingness to have samples stored
Key exclusion criteria (9 listed)
- 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.
- 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.
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 |
|---|---|---|
| PlasmaPlasma | Drug | Healthy Volunteers |
Primary outcome
Number of units of plasma collected
Time frame: 5 years after enrollment
The number of units of human plasma collected from volunteers with high titer antibodies for a given emerging infectious disease, that is potentially suitable for infusion into humans as part of a separate treatment study.
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 16 May 2025.
- Background: PubMed 15214887Soo YO, Cheng Y, Wong R, Hui DS, Lee CK, Tsang KK, Ng MH, Chan P, Cheng G, Sung JJ. Retrospective comparison of convalescent plasma with continuing high-dose methylprednisolone treatment in SARS patients. Clin Microbiol Infect. 2004 Jul;10(7):676-8. doi: 10.1111/j.1469-0691.2004.00956.x.
- Background: PubMed 9988160Mupapa K, Massamba M, Kibadi K, Kuvula K, Bwaka A, Kipasa M, Colebunders R, Muyembe-Tamfum JJ. Treatment of Ebola hemorrhagic fever with blood transfusions from convalescent patients. International Scientific and Technical Committee. J Infect Dis. 1999 Feb;179 Suppl 1:S18-23. doi: 10.1086/514298.
- Background: PubMed 21248066Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, Liu R, Watt CL, Chan WM, Lai KY, Koo CK, Buckley T, Chow FL, Wong KK, Chan HS, Ching CK, Tang BS, Lau CC, Li IW, Liu SH, Chan KH, Lin CK, Yuen KY. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011 Feb 15;52(4):447-56. doi: 10.1093/cid/ciq106. Epub 2011 Jan 19.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
Related trials for Communicable Diseases
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
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.
Richard T Davey, M.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 Communicable Diseases and Communicable Diseases, Emerging, 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 15 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 16 May 2025. 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 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?
Number of units of plasma collected (time frame: 5 years after enrollment). 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 NCT02338986, 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 16 May 2025.