2009 H1N1 Influenza VirusPhase 1/2NCT01055184
Effects of Age on Response to the 2009 H1N1 Virus Vaccine
A Phase 1/2 study testing 2009 H1N1 Virus Vaccine in people with 2009 H1N1 Influenza Virus, run by University of Rochester at 1 site in United States.
Trial summary
Unlike most influenza viruses, the 2009 H1N1 virus has affected people between 5 and 40 years old more often than people 60 years old or older. It may be that older people have had greater exposure to previous strains of H1N1 influenza, and this previous exposure protects them from infection. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- 2009 H1N1 Influenza Virus
- What is being tested?
- 2009 H1N1 Virus Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Apr 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No prior history of infection with novel H1N1 virus or immunization with novel H1N1 vaccine documented by a laboratory
- Female participants must not be capable of becoming pregnant or take steps to prevent pregnancy from 30 days before enrollment to 30 days after receiving the study vaccine
- In good health, as determined by medical history and targeted physical examination
- Able to understand and comply with the planned study procedures, including being available for all study visits
Who cannot join
- Pregnancy
- Previous history of vaccination against novel H1N1 virus or a laboratory documented history of previous novel H1N1 infection
- Immunosuppressed as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs or use of anticancer chemotherapy or radiation therapy within the preceding 36 months
- Active neoplastic disease (excluding nonmelanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematological malignancy. For this criterion, "active" is defined as having received treatment within the past 5 years.
- Long-term (greater than 2 weeks) use of oral or parenteral steroids or high-dose inhaled steroids (greater than 800 mcg/day of beclomethasone dipropionate or equivalent) within the 6 months prior to study enrollment (nasal and topical steroids are allowed)
- Received immunoglobulin or another blood product within the 3 months prior to enrollment in this study
Show all 15Show fewer
- Received an inactivated vaccine within 2 weeks or a live vaccine within 4 weeks prior to enrollment in this study or plans to receive another vaccine within the next 28 days
- Has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses.
- Has had an acute illness or an oral temperature greater than 99.9°F (37.7°C) within 3 days prior to enrollment or vaccination. Subjects who had an acute illness that was treated with symptoms resolved are eligible to enroll as long as treatment is completed and symptoms are resolved more than 3 days prior to enrollment.
- Currently participating or plans to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication), has received an experimental agent within 1 month prior to enrollment in this study, expects to receive another experimental agent during participation in this study, or intends to donate blood during the study period
- History of alcohol or drug abuse in the 5 years prior to enrollment
- Has a known human immunodeficiency virus (HIV) or hepatitis B or C infection
- Has a previous history of Guillain-Barré syndrome
- Allergic to eggs or egg proteins, gentamicin, gelatin, or arginine or has experienced life-threatening reactions to previous influenza vaccination
- Has any other condition that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center, Vaccine Research Unit
Rochester, New York, 14642
About this study
Official title: Assessment of the Effect of Age on the Immunological and Virological Response to a Live Attenuated Influenza Vaccine for the 2009 H1N1 Virus
Unlike most influenza viruses, the 2009 H1N1 virus has affected people between 5 and 40 years old more often than people 60 years old or older. It may be that older people have had greater exposure to previous strains of H1N1 influenza, and this previous exposure protects them from infection. This study will examine how older people respond to a version of the H1N1 virus vaccine that includes a live, noninfectious version of the virus.
Read the detailed description
Unlike most influenza viruses, the 2009 H1N1 virus affects many individuals between 5 and 40 years old, but very few 60 years old or older. It is not completely understood why, but scientists believe it may be because older people may have been exposed to other H1N1 viruses in their lives. H1N1 viruses were common until 1957, when they were eclipsed by H2N2 viruses.
In order to test susceptibility to the 2009 H1N1 virus, this study will examine how often people older than 60 get infected by the 2009 H1N1 live attenuated influenza vaccine (LAIV). The LAIV is made from a live virus that has been weakened, so the ability of the immune system to combat this weakened form is likely to mimic its ability to combat the normal form. Additionally, this study will examine how LAIVs work in older people; inactivated virus vaccines are used more often than LAIVs in older people, so little is known of LAIV's effects on this population.
Participation in this study will last 6 months. Participants will be people older than 60, divided into equal groups of people between the ages of 60 and 70 and people older than 70. Both groups will receive one dose of LAIV for 2009 H1N1 vaccine.
There will be six study visits, occurring at baseline and 2, 5, 7, 28, and 180 days after vaccination. Nasal wicks and throat swabs will be taken on Days 2, 5, and 7; a nasal wick alone will be taken at baseline and on Day 28. Blood samples will be taken at baseline and on Days 7 and 28. Participants will undergo physical exams at each visit.
- Conditions
- 2009 H1N1 Influenza Virus
- Being tested
- 2009 H1N1 Virus Vaccine
- Keywords
- Influenza, H1N1
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2009 H1N1 Virus VaccineBiological
Also called Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal
Single 0.2 mL dose of live monovalent vaccine, delivered through nasal spray
| Study group | Role | What they receive |
|---|---|---|
| 2009 H1N1 Vaccine | Experimental | Participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine. Receives: Biological: 2009 H1N1 Virus Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Shed Virus
number of participants who shed virus above the limit of detection at any timepoint after vaccine. The limit of detection is 0.5 tissue culture infectious doses per mL of nasal wash.
Measured: day 0 to day 7 post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 2009 H1N1 Influenza VirusStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, John Treanor, University of Rochester
- Investigators
- John Treanor, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055184
- Sponsor's protocol ID
- URMC 09-009
- Status last verified
- Apr 2016
- First submitted
- 5 Jan 2010
- Last updated
- 30 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Greenberg ME, Lai MH, Hartel GF, Wichems CH, Gittleson C, Bennet J, Dawson G, Hu W, Leggio C, Washington D, Basser RL. Response to a monovalent 2009 influenza A (H1N1) vaccine. N Engl J Med. 2009 Dec 17;361(25):2405-13. doi: 10.1056/NEJMoa0907413. Epub 2009 Sep 10.
PubMed 19745216Cutler J, Schleihauf E, Hatchette TF, Billard B, Watson-Creed G, Davidson R, Li Y, Bastien N, Sarwal S; Nova Scotia Human Swine Influenza Investigation Team. Investigation of the first cases of human-to-human infection with the new swine-origin influenza A (H1N1) virus in Canada. CMAJ. 2009 Aug 4;181(3-4):159-63. doi: 10.1503/cmaj.090859. Epub 2009 Jul 20.
PubMed 19620268
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Age on the Immunological and Virological Response to a Live Attenuated Influenza Vaccine for the 2009 H1N1 Virus
- ClinicalTrials.gov ID
- NCT01055184
- Acronym / sponsor ID
- URMC 09-009
- Conditions
- 2009 H1N1 Influenza Virus
- Keywords
- Influenza, H1N1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Mar 2010
- Primary completion
- Apr 2011 (actual)
- First posted
- 25 Jan 2010 (estimated)
- Results
- Posted 30 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Unlike most influenza viruses, the 2009 H1N1 virus has affected people between 5 and 40 years old more often than people 60 years old or older. It may be that older people have had greater exposure to previous strains of H1N1 influenza, and this previous exposure protects them from infection. This study will examine how older people respond to a version of the H1N1 virus vaccine that includes a live, noninfectious version of the virus.
Detailed description
Unlike most influenza viruses, the 2009 H1N1 virus affects many individuals between 5 and 40 years old, but very few 60 years old or older. It is not completely understood why, but scientists believe it may be because older people may have been exposed to other H1N1 viruses in their lives. H1N1 viruses were common until 1957, when they were eclipsed by H2N2 viruses.
In order to test susceptibility to the 2009 H1N1 virus, this study will examine how often people older than 60 get infected by the 2009 H1N1 live attenuated influenza vaccine (LAIV). The LAIV is made from a live virus that has been weakened, so the ability of the immune system to combat this weakened form is likely to mimic its ability to combat the normal form. Additionally, this study will examine how LAIVs work in older people; inactivated virus vaccines are used more often than LAIVs in older people, so little is known of LAIV's effects on this population.
Participation in this study will last 6 months. Participants will be people older than 60, divided into equal groups of people between the ages of 60 and 70 and people older than 70. Both groups will receive one dose of LAIV for 2009 H1N1 vaccine.
There will be six study visits, occurring at baseline and 2, 5, 7, 28, and 180 days after vaccination. Nasal wicks and throat swabs will be taken on Days 2, 5, and 7; a nasal wick alone will be taken at baseline and on Day 28. Blood samples will be taken at baseline and on Days 7 and 28. Participants will undergo physical exams at each visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2009 H1N1 Vaccine | Experimental | Biological: 2009 H1N1 Virus VaccineParticipants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- No prior history of infection with novel H1N1 virus or immunization with novel H1N1 vaccine documented by a laboratory
- Female participants must not be capable of becoming pregnant or take steps to prevent pregnancy from 30 days before enrollment to 30 days after receiving the study vaccine
- In good health, as determined by medical history and targeted physical examination
- Able to understand and comply with the planned study procedures, including being available for all study visits
Key exclusion criteria (15 listed)
- Pregnancy
- Previous history of vaccination against novel H1N1 virus or a laboratory documented history of previous novel H1N1 infection
- Immunosuppressed as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs or use of anticancer chemotherapy or radiation therapy within the preceding 36 months
- Active neoplastic disease (excluding nonmelanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematological malignancy. For this criterion, "active" is defined as having received treatment within the past 5 years.
- Long-term (greater than 2 weeks) use of oral or parenteral steroids or high-dose inhaled steroids (greater than 800 mcg/day of beclomethasone dipropionate or equivalent) within the 6 months prior to study enrollment (nasal and topical steroids are allowed)
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 |
|---|---|---|
| 2009 H1N1 Virus VaccineAlso: Influenza A (H1N1) 2009 Monovalent Vaccine Live, IntranasalSingle 0.2 mL dose of live monovalent vaccine, delivered through nasal spray | Biological | 2009 H1N1 Vaccine |
Primary outcome
Number of Participants Who Shed Virus
Time frame: day 0 to day 7 post vaccination
number of participants who shed virus above the limit of detection at any timepoint after vaccine. The limit of detection is 0.5 tissue culture infectious doses per mL of nasal wash.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19745216Greenberg ME, Lai MH, Hartel GF, Wichems CH, Gittleson C, Bennet J, Dawson G, Hu W, Leggio C, Washington D, Basser RL. Response to a monovalent 2009 influenza A (H1N1) vaccine. N Engl J Med. 2009 Dec 17;361(25):2405-13. doi: 10.1056/NEJMoa0907413. Epub 2009 Sep 10.
- Background: PubMed 19620268Cutler J, Schleihauf E, Hatchette TF, Billard B, Watson-Creed G, Davidson R, Li Y, Bastien N, Sarwal S; Nova Scotia Human Swine Influenza Investigation Team. Investigation of the first cases of human-to-human infection with the new swine-origin influenza A (H1N1) virus in Canada. CMAJ. 2009 Aug 4;181(3-4):159-63. doi: 10.1503/cmaj.090859. Epub 2009 Jul 20.
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.
John Treanor, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 2009 H1N1 Virus Vaccine in people with 2009 H1N1 Influenza Virus, run by University of Rochester 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 4 inclusion and 15 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 30 May 2016. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants Who Shed Virus (time frame: day 0 to day 7 post vaccination). 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 NCT01055184, 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 30 May 2016.