InfluenzaNCT02124096
Zoonotic Influenza Infections of Swine Origin at Ohio Agricultural Fairs
An observational study of Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: The flu is a very infectious and contagious virus that affects both people and pigs. Studies show that pigs can be sources of the flu virus in humans. Researchers want to know more about how the flu is transmitted from animals to people. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- How many people
- 336 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2014to 17 Jun 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 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Volunteers greater than or equal to 8 years of age
- Parental consent if a participant is less than 18 years of age
- Willing to have samples stored for future research
- Willingness to complete all study procedures
- Daily or nearly daily contact with swine during selected agricultural fairs
Who cannot join
- Any medical condition or circumstance that may make it unsafe for the participant to have nasal swab performed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University, College of Veterinary Medicine
Columbus, Ohio, 43210-1240
About this study
Background:
- The flu is a very infectious and contagious virus that affects both people and pigs. Studies show that pigs can be sources of the flu virus in humans. Researchers want to know more about how the flu is transmitted from animals to people. If they know more about it, they can find better ways to prevent the flu and treat people who get sick from it.
Read more
Objective:
- To discover if flu viruses can be found in people exposed to pigs at Ohio agricultural fairs.
Eligibility:
- Volunteers 8 years of age and older who exhibit pigs at Ohio agricultural fairs.
Design:
- Before or on the first day of the fair, participants will fill out a short demographic and medical history form. They will also complete a two-page symptom questionnaire. This is a form that asks them about any flu symptoms they might have.
- Participants will have a nasal swab performed. The inside of the participant s nose will be rubbed with a swab to collect nasal fluid.
- Researchers will see participants 2 days later and 4 days later. During these visits, participants will again fill out a symptom questionnaire and have a nasal swab.
Read the detailed description
The bidirectional transmission of influenza A viruses between animals and humans are clearly an important part of the complex dynamics of influenza evolution, however a thorough understanding of this process remains a mystery. The role of swine in overall human influenza evolution is unclear, but a long history of the study of swine origin influenza has revealed that influenza evolves in swine populations both in North America and Europe.
In 2009, a pandemic occurred with the emergence of the H1N1 pandemic (pdm) virus which was found to have originated from both a North American and European swine lineage, again reinforcing how viruses evolving in swine can lead to important human pathogens. Interestingly this virus was transmitted back into swine and birds in North America. In 2011, an H3N2 swine origin influenza virus known as the H3N2v and containing the H1N1pdm matrix genomic segment was reported causing human infections in multiple parts of the US. In 2012, these cases increased, especially during the summer months. Since 2011, 321 confirmed cases have been reported from 13 states including 107 cases in Ohio. Almost all of these cases have been linked to swine exposure on farms or at agricultural fairs.
Study of these zoonotic transmission events at agricultural fairs are necessary in order to better understand how and why these events occur, how human pathogens emerge, and how to potentially prevent events from occurring. These events could lead to new pandemics and epidemics so their prevention is crucial. The goal of this study is to examine rates of bidirectional zoonotic transmission at Ohio agricultural fairs. Through collection of viruses and host samples, we hope to begin to answer questions regarding how viruses cross species barriers, adapt to new hosts, and how these events could impact overall influenza virus evolution.
- Conditions
- Influenza
- Keywords
- Zoonotic, Influenza, Infections, Ohio, Fairs
- Medical subject headings
- Influenza, Human, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of influenza A virus infections occurring due to swinevariant influenza
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study start25 Apr 2014
- Primary completion17 Jun 2019
- Study completion17 Jun 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 InfluenzaStudies 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
- 336 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Ohio State University
- Responsible party
- Sponsor
- Investigators
- Matthew J Memoli, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124096
- Sponsor's protocol ID
- 999914092
- Other IDs
- 14-I-N092
- Status last verified
- 17 Jun 2019
- First submitted
- 25 Apr 2014
- Last updated
- 19 Jun 2019
- Results posted
- No
Publications
Webster RG. The importance of animal influenza for human disease. Vaccine. 2002 May 15;20 Suppl 2:S16-20. doi: 10.1016/s0264-410x(02)00123-8.
PubMed 12110250Reid AH, Taubenberger JK. The origin of the 1918 pandemic influenza virus: a continuing enigma. J Gen Virol. 2003 Sep;84(Pt 9):2285-2292. doi: 10.1099/vir.0.19302-0.
PubMed 12917448Gray GC, McCarthy T, Capuano AW, Setterquist SF, Olsen CW, Alavanja MC. Swine workers and swine influenza virus infections. Emerg Infect Dis. 2007 Dec;13(12):1871-8. doi: 10.3201/eid1312.061323.
PubMed 18258038
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zoonotic Influenza Infections of Swine Origin at Ohio Agricultural Fairs
- ClinicalTrials.gov ID
- NCT02124096
- Acronym / sponsor ID
- 999914092
- Conditions
- Influenza
- Keywords
- Zoonotic, Influenza, Infections, Ohio, Fairs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Ohio State University
- Study start
- 25 Apr 2014
- Primary completion
- 17 Jun 2019 (actual)
- Study completion
- 17 Jun 2019 (actual)
- First posted
- 28 Apr 2014 (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:
- The flu is a very infectious and contagious virus that affects both people and pigs. Studies show that pigs can be sources of the flu virus in humans. Researchers want to know more about how the flu is transmitted from animals to people. If they know more about it, they can find better ways to prevent the flu and treat people who get sick from it.
Objective:
- To discover if flu viruses can be found in people exposed to pigs at Ohio agricultural fairs.
Eligibility:
- Volunteers 8 years of age and older who exhibit pigs at Ohio agricultural fairs.
Design:
- Before or on the first day of the fair, participants will fill out a short demographic and medical history form. They will also complete a two-page symptom questionnaire. This is a form that asks them about any flu symptoms they might have.
- Participants will have a nasal swab performed. The inside of the participant s nose will be rubbed with a swab to collect nasal fluid.
- Researchers will see participants 2 days later and 4 days later. During these visits, participants will again fill out a symptom questionnaire and have a nasal swab.
Detailed description
The bidirectional transmission of influenza A viruses between animals and humans are clearly an important part of the complex dynamics of influenza evolution, however a thorough understanding of this process remains a mystery. The role of swine in overall human influenza evolution is unclear, but a long history of the study of swine origin influenza has revealed that influenza evolves in swine populations both in North America and Europe.
In 2009, a pandemic occurred with the emergence of the H1N1 pandemic (pdm) virus which was found to have originated from both a North American and European swine lineage, again reinforcing how viruses evolving in swine can lead to important human pathogens. Interestingly this virus was transmitted back into swine and birds in North America. In 2011, an H3N2 swine origin influenza virus known as the H3N2v and containing the H1N1pdm matrix genomic segment was reported causing human infections in multiple parts of the US. In 2012, these cases increased, especially during the summer months. Since 2011, 321 confirmed cases have been reported from 13 states including 107 cases in Ohio. Almost all of these cases have been linked to swine exposure on farms or at agricultural fairs.
Study of these zoonotic transmission events at agricultural fairs are necessary in order to better understand how and why these events occur, how human pathogens emerge, and how to potentially prevent events from occurring. These events could lead to new pandemics and epidemics so their prevention is crucial. The goal of this study is to examine rates of bidirectional zoonotic transmission at Ohio agricultural fairs. Through collection of viruses and host samples, we hope to begin to answer questions regarding how viruses cross species barriers, adapt to new hosts, and how these events could impact overall influenza virus evolution.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Volunteers greater than or equal to 8 years of age
- Parental consent if a participant is less than 18 years of age
- Willing to have samples stored for future research
- Willingness to complete all study procedures
- Daily or nearly daily contact with swine during selected agricultural fairs
Key exclusion criteria (1 listed)
- Any medical condition or circumstance that may make it unsafe for the participant to have nasal swab performed.
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
Identification of influenza A virus infections occurring due to swinevariant influenza
Time frame: Ongoing
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 19 Jun 2019.
- Background: PubMed 12110250Webster RG. The importance of animal influenza for human disease. Vaccine. 2002 May 15;20 Suppl 2:S16-20. doi: 10.1016/s0264-410x(02)00123-8.
- Background: PubMed 12917448Reid AH, Taubenberger JK. The origin of the 1918 pandemic influenza virus: a continuing enigma. J Gen Virol. 2003 Sep;84(Pt 9):2285-2292. doi: 10.1099/vir.0.19302-0.
- Background: PubMed 18258038Gray GC, McCarthy T, Capuano AW, Setterquist SF, Olsen CW, Alavanja MC. Swine workers and swine influenza virus infections. Emerg Infect Dis. 2007 Dec;13(12):1871-8. doi: 10.3201/eid1312.061323.
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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.
Matthew J Memoli, 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 Influenza, 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 5 inclusion and 1 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 19 Jun 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 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?
Identification of influenza A virus infections occurring due to swinevariant influenza (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 NCT02124096, 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 19 Jun 2019.