InfluenzaNCT01673425
Evaluating Immune Response to Seasonal FluMist in Healthy Adults
A study testing Live Attenuated Influenza Vaccine in people with Influenza, run by National Center for Occupational Health and Infection Control at 1 site in United States.
Trial summary
The Live-Attenuated Influenza Vaccine (LAIV), also known as FluMist, has been shown to be effective in children but less effective in adults. Our hypothesis is that this relative failure is due to adults having enough anti-flu IgA antibody in nasal secretions to neutralize the weakened vaccine virus. Read more about this study
- Who is it for?
- Ages 20 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Live Attenuated Influenza Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 2012
- Phase
- Interventional
- 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 20 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically eligible healthy men and women between the ages of 20 to 49 years old.
Who cannot join
- A medical condition that places them at high risk for complications from influenza, including those with chronic heart or lung disease, such as asthma or reactive airway disease; people with medical conditions such as diabetes or kidney failure; or people with illnesses that weaken the immune system, or who take medications that can weaken the immune system.
- A history of Guillain-Barré Syndrome that occurred after receiving influenza vaccine
- Currently pregnant
- Have a severe allergy to chicken eggs or who are allergic to any of the nasal spray vaccine components
- Have had flu within the current flu season.
- Have had a flu vaccine within the current flu season.
- Have close contact with someone whose immune system is so weak they require care in a protected environment (such as bone marrow transplant unit).
Trial locations and contacts
1 site in 1 country.
United States1 site
Malcom Randall VA Medical Center
Gainesville, Florida, 32608
About this study
The Live-Attenuated Influenza Vaccine (LAIV), also known as FluMist, has been shown to be effective in children but less effective in adults. Our hypothesis is that this relative failure is due to adults having enough anti-flu IgA antibody in nasal secretions to neutralize the weakened vaccine virus.
Read the detailed description
This is a VA-based study to evaluate serum and nasal wash antibody responses to seasonal LAIV of healthy Veterans and VA employees between the ages of 20 and 49 years old.
Specific Aims
- The primary aim of the study is to evaluate whether people with high mucosal IgA antibodies against flu have a lower immune response to the seasonal LAIV.
- The secondary objective is to determine whether the nasal wash viral neutralization data predicts LAIV immunization failures.
- Conditions
- Influenza
- Being tested
- Live Attenuated Influenza Vaccine
- Keywords
- Influenza, Influenza Vaccines, Vaccines, Attenuated, Immunity, Mucosal
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Attenuated Influenza VaccineDrug
Also called FluMist
All participants will be given FluMist.
| Study group | Role | What they receive |
|---|---|---|
| Live Attenuated Influenza Vaccine | Experimental | Single intervention study- all participants will receive LAIV instead of injectable flu vaccine. Receives: Drug: Live Attenuated Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
IgA Antibody Titers
Measured: Change from baseline in antibody titer at 6 weeks
Secondary outcomes (1)
Serum Antibody Response to LAIV
Measured: Change from baseline in serum antibody response at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Low accrual(4 completed subjects over 2 months)\& inconclusive nasal wash assays.
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.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Occupational Health and Infection Control
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Lewis J. Radonovich, MD, Principal investigator, National Center for Occupational Health and Infection Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673425
- Sponsor's protocol ID
- IRB 604-2010
- Status last verified
- Aug 2014
- First submitted
- 21 Aug 2012
- Last updated
- 27 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Immune Response to Seasonal FluMist in Healthy Adults
- ClinicalTrials.gov ID
- NCT01673425
- Acronym / sponsor ID
- IRB 604-2010
- Conditions
- Influenza
- Keywords
- Influenza, Influenza Vaccines, Vaccines, Attenuated, Immunity, Mucosal
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual(4 completed subjects over 2 months)\& inconclusive nasal wash assays.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National Center for Occupational Health and Infection ControlUS federal agency
- Collaborators
- US Department of Veterans Affairs
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Aug 2012 (estimated)
- Results
- Posted 4 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Live-Attenuated Influenza Vaccine (LAIV), also known as FluMist, has been shown to be effective in children but less effective in adults. Our hypothesis is that this relative failure is due to adults having enough anti-flu IgA antibody in nasal secretions to neutralize the weakened vaccine virus.
Detailed description
This is a VA-based study to evaluate serum and nasal wash antibody responses to seasonal LAIV of healthy Veterans and VA employees between the ages of 20 and 49 years old.
Specific Aims
- The primary aim of the study is to evaluate whether people with high mucosal IgA antibodies against flu have a lower immune response to the seasonal LAIV.
- The secondary objective is to determine whether the nasal wash viral neutralization data predicts LAIV immunization failures.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Live Attenuated Influenza Vaccine | Experimental | Drug: Live Attenuated Influenza VaccineSingle intervention study- all participants will receive LAIV instead of injectable flu vaccine. |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Medically eligible healthy men and women between the ages of 20 to 49 years old.
Key exclusion criteria (7 listed)
- A medical condition that places them at high risk for complications from influenza, including those with chronic heart or lung disease, such as asthma or reactive airway disease; people with medical conditions such as diabetes or kidney failure; or people with illnesses that weaken the immune system, or who take medications that can weaken the immune system.
- A history of Guillain-Barré Syndrome that occurred after receiving influenza vaccine
- Currently pregnant
- Have a severe allergy to chicken eggs or who are allergic to any of the nasal spray vaccine components
- Have had flu within the current flu season.
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 |
|---|---|---|
| Live Attenuated Influenza VaccineAlso: FluMistAll participants will be given FluMist. | Drug | Live Attenuated Influenza Vaccine |
Primary outcome
IgA Antibody Titers
Time frame: Change from baseline in antibody titer at 6 weeks
1 secondary outcome
Serum Antibody Response to LAIV
Time frame: Change from baseline in serum antibody response at 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lewis J. Radonovich, MD principal investigator
National Center for Occupational Health and Infection Control
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live Attenuated Influenza Vaccine in people with Influenza, run by National Center for Occupational Health and Infection Control 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 1 inclusion and 7 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: stopped early, as of the sponsor's last update on 27 Jan 2021. 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?
Yes. Results are posted in the registry (first posted 4 Sep 2014). 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?
IgA Antibody Titers (time frame: Change from baseline in antibody titer at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2021.