Influenza A Virus InfectionNCT01136057
Blood and Plasma Collection For Use in Future Clinical Trials
An observational study of Influenza A Virus Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
Treatment options are limited for the treatment of influenza. This study will collect blood from people who have been exposed to the influenza virus or who have received a seasonal influenza vaccine. The blood plasma will be used in a future clinical trial to treat people hospitalized with influenza. Read more about this study
- Who is it for?
- Ages 18 to 59 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Influenza A Virus Infection
- What is being tested?
- Collection of Anti-Influenza A Immune Plasma
- Type of treatment
- Vaccines
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2010to 4 Jan 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 18 to 59 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Participants will include people who have recovered from influenza, received a seasonal influenza vaccine, or have both recovered from influenza and received a seasonal influenza vaccine.
Who may be able to join
- Currently healthy males 18 - 59 years of age with a history suggestive of having anti-influenza antibodies (either or both of the following):
- An influenza-like illness (e.g., fever, chills, malaise, cough, myalgias, nausea). Subjects must asymptomatic and must be afebrile for ≥ 7 days, and must enroll within 12 months of onset of illness.
- Vaccinated with a licensed influenza vaccine. Enrollment must occur >14 days and < 12 months from date of vaccination.
- Must be an adult male Department of Defense (DoD)/beneficiary
- Sign informed consent and Health Insurance Portability and Accountability Act (HIPAA) document
- A demonstrated H1N1 HAI titer of 1:160 or greater and H3N2 HAI titer of 1:40 or greater.
- Must also meet all Standard-of-Care inclusion criteria for donation of blood or plasma at the FDA-licensed donor center prior to every donation session. More information on this criterion can be found in the protocol.
Who cannot join
- Donors that do not meet all Standard-of-Care FDA approved requirements for the donation of blood and production of FFP as determined by the FDA-licensed donor center prior to every donation session may be excluded from further participation in this study. Study exclusion will be determined by the principal investigator (PI) or lead investigator at the study site.
- Donors that fail the Standard-of-Care screening and Blood Borne Pathogen screening for the following blood borne pathogens at the donor center will be excluded:
- Anti-HIV-I/II
- Anti-human T-lymphotropic virus (HTLV)-I/II
- Anti-hepatitis C (HCV)
- Anti-hepatitis B core antigen (HBc)
Show all 16Show fewer
- Anti-T. cruzi (enzyme immunoassay [EIA] for Chagas disease) (if required by the FDA-licensed donor center or becomes a nationwide FDA requirement)
- Hepatitis B surface antigen (HBsAg)
- Serologic test for syphilis
- HIV nucleic acid test (NAT)
- HCV NAT
- West Nile virus (WNV) NAT
- Participation in other medical research that includes:
- Studies that are currently ongoing or will start during the duration of this study that require more than 60 mL of blood to be donated in any 56-day period of time
- Administration of any unlicensed drug in the 3 months before study entry or during the duration of this study
- Administration of any unlicensed vaccine in the 12 months before study entry or during the duration of this study, with the exception of unlicensed influenza vaccine
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Naval Medical Research Center
Bethesda, Maryland, 20889
Naval Medical Center San Diego
San Diego, California, 92134
About this study
Official title: A Pilot Study for Collection of High-Titer Anti-Influenza A Plasma
Treatment options are limited for the treatment of influenza. This study will collect blood from people who have been exposed to the influenza virus or who have received a seasonal influenza vaccine. The blood plasma will be used in a future clinical trial to treat people hospitalized with influenza.
Read the detailed description
There is a concern that the influenza virus will become resistant to the standard of care, oseltamivir (commonly known as Tamiflu), as resistance to this medication has been observed in people infected with the seasonal influenza virus. Because of the possibility of drug resistance, additional treatment options for influenza are needed. The purpose of this study is to collect blood from people who have recovered from influenza or who have received a seasonal influenza vaccine. The blood will then be processed into Food and Drug Administration (FDA)-licensed fresh frozen plasma (FFP). In a future clinical trial, this plasma will be used as a treatment for people hospitalized with influenza.
This study will enroll people who have recovered from influenza or received a seasonal influenza vaccine. Participants will donate blood at FDA-licensed blood donor centers up to three times during the 240-day study period.
- Conditions
- Influenza A Virus Infection
- Being tested
- Collection of Anti-Influenza A Immune Plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of Anti-Influenza A Immune PlasmaBiological
| Study group | Role | What they receive |
|---|---|---|
| Influenza A Exposure | Participants will include people who have recovered from influenza, received a seasonal influenza vaccine, or have both recovered from influenza and received a seasonal influenza vaccine. Receives: Biological: Collection of Anti-Influenza A Immune Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of high antibody titer anti-influenza FFP
Measured: Collected at each study visit
Secondary outcomes (1)
Further define the hemagglutination inhibition (HAI) immune response in participants over time
Measured: Collected at each study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startApr 2010
- Primary completion4 Jan 2019
- Study completion4 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Influenza A Virus InfectionStudies 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
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- LCDR Nicholas Martin, USN, MSC, Principal investigator, Virology and Rickettsial Diseases Department, Naval Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136057
- Sponsor's protocol ID
- IDCRP-046
- Status last verified
- Mar 2019
- First submitted
- 14 May 2010
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Kash JC, Qi L, Dugan VG, Jagger BW, Hrabal RJ, Memoli MJ, Morens DM, Taubenberger JK. Prior infection with classical swine H1N1 influenza viruses is associated with protective immunity to the 2009 pandemic H1N1 virus. Influenza Other Respir Viruses. 2010 May 1;4(3):121-7. doi: 10.1111/j.1750-2659.2010.00132.x.
PubMed 20409208Tang JW, Shetty N, Lam TT. Features of the new pandemic influenza A/H1N1/2009 virus: virology, epidemiology, clinical and public health aspects. Curr Opin Pulm Med. 2010 May;16(3):235-41. doi: 10.1097/MCP.0b013e3283375727.
PubMed 20375785
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for Collection of High-Titer Anti-Influenza A Plasma
- ClinicalTrials.gov ID
- NCT01136057
- Acronym / sponsor ID
- IDCRP-046
- Conditions
- Influenza A Virus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Apr 2010
- Primary completion
- 4 Jan 2019 (actual)
- Study completion
- 4 Jan 2019 (actual)
- First posted
- 3 Jun 2010 (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.
Treatment options are limited for the treatment of influenza. This study will collect blood from people who have been exposed to the influenza virus or who have received a seasonal influenza vaccine. The blood plasma will be used in a future clinical trial to treat people hospitalized with influenza.
Detailed description
There is a concern that the influenza virus will become resistant to the standard of care, oseltamivir (commonly known as Tamiflu), as resistance to this medication has been observed in people infected with the seasonal influenza virus. Because of the possibility of drug resistance, additional treatment options for influenza are needed. The purpose of this study is to collect blood from people who have recovered from influenza or who have received a seasonal influenza vaccine. The blood will then be processed into Food and Drug Administration (FDA)-licensed fresh frozen plasma (FFP). In a future clinical trial, this plasma will be used as a treatment for people hospitalized with influenza.
This study will enroll people who have recovered from influenza or received a seasonal influenza vaccine. Participants will donate blood at FDA-licensed blood donor centers up to three times during the 240-day study period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Influenza A Exposure | – | Biological: Collection of Anti-Influenza A Immune PlasmaParticipants will include people who have recovered from influenza, received a seasonal influenza vaccine, or have both recovered from influenza and received a seasonal influenza vaccine. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants will include people who have recovered from influenza, received a seasonal influenza vaccine, or have both recovered from influenza and received a seasonal influenza vaccine.
Key inclusion criteria (7 listed)
- Currently healthy males 18 - 59 years of age with a history suggestive of having anti-influenza antibodies (either or both of the following):
- Must be an adult male Department of Defense (DoD)/beneficiary
- Sign informed consent and Health Insurance Portability and Accountability Act (HIPAA) document
- A demonstrated H1N1 HAI titer of 1:160 or greater and H3N2 HAI titer of 1:40 or greater.
- Must also meet all Standard-of-Care inclusion criteria for donation of blood or plasma at the FDA-licensed donor center prior to every donation session. More information on this criterion can be found in the protocol.
Key exclusion criteria (16 listed)
- Donors that do not meet all Standard-of-Care FDA approved requirements for the donation of blood and production of FFP as determined by the FDA-licensed donor center prior to every donation session may be excluded from further participation in this study. Study exclusion will be determined by the principal investigator (PI) or lead investigator at the study site.
- Donors that fail the Standard-of-Care screening and Blood Borne Pathogen screening for the following blood borne pathogens at the donor center will be excluded:
- Participation in other medical research that includes:
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 |
|---|---|---|
| Collection of Anti-Influenza A Immune Plasma | Biological | Influenza A Exposure |
Primary outcome
Collection of high antibody titer anti-influenza FFP
Time frame: Collected at each study visit
1 secondary outcome
Further define the hemagglutination inhibition (HAI) immune response in participants over time
Time frame: Collected at each study visit
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 13 Mar 2019.
- Background: PubMed 20409208Kash JC, Qi L, Dugan VG, Jagger BW, Hrabal RJ, Memoli MJ, Morens DM, Taubenberger JK. Prior infection with classical swine H1N1 influenza viruses is associated with protective immunity to the 2009 pandemic H1N1 virus. Influenza Other Respir Viruses. 2010 May 1;4(3):121-7. doi: 10.1111/j.1750-2659.2010.00132.x.
- Background: PubMed 20375785Tang JW, Shetty N, Lam TT. Features of the new pandemic influenza A/H1N1/2009 virus: virology, epidemiology, clinical and public health aspects. Curr Opin Pulm Med. 2010 May;16(3):235-41. doi: 10.1097/MCP.0b013e3283375727.
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Healthy Participants
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.
LCDR Nicholas Martin, USN, MSC principal investigator
Virology and Rickettsial Diseases Department, Naval Medical Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza A Virus Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites 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 7 inclusion and 16 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 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Collection of high antibody titer anti-influenza FFP (time frame: Collected at each study visit). 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 NCT01136057, which also lists 2 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 13 Mar 2019.