Mucosal ImmunityEarly Phase 1NCT01385215
Strategies for Enhancing Mucosal Immunity to Influenza Vaccine
A Early Phase 1 study testing Fluzone in people with Mucosal Immunity, run by John Sundy at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and effectiveness of the influenza vaccine when administered nasally and intra-muscular (a "shot" of medicine given into a muscle). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Mucosal Immunity
- What is being tested?
- Fluzone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jun 2011
- Phase
- Early Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women ages 18-50 years
- Non-smokers (defined as no tobacco use within the last 12 months and less than 10 pack-year lifetime tobacco use)
- Willing and able to provide written informed consent
- Able to speak and understand English
- Women of childbearing potential must have a negative serum pregnancy test.
Who cannot join
- Influenza vaccination within 6 months prior to screening date
- Symptoms of respiratory infection during the 14 days prior to screening
- Temperature >38.3o C during the period spanning 72 hours prior to screening and the time of immunization.
- History of allergy to egg, influenza vaccine or vaccine ingredients
- History of Guillain-Barre syndrome
- History of Bell's palsy
Show all 20Show fewer
- Tonsillectomy, adenoidectomy or prior surgery to the paranasal sinus cavity.
- Physician diagnosis of or personal history of allergic or chronic rhinitis
- Physician diagnosis of or personal history of asthma
- Acute sinusitis within 30 days prior to screening
- Use of antibiotics within 14 days prior to screening
- Requirement for use of nasal corticosteroids for the period beginning 30 days prior to screening through final study visit
- Requirement for use of antihistamines (systemic, intranasal or intraocular) for the period beginning 72 hours prior to screening through final study visit
- Use of immunomodulating drugs or systemic corticosteroids within 6 months prior to screening (includes but is not limited to azathioprine, methotrexate, mycophenolate mofetil, tumor necrosis factor inhibitors, cyclosporine, tacrolimus)
- Past or present history of allergen immunotherapy to within the last 10 years.
- Students or employees who are under direct supervision by any of the investigators in this protocol are not eligible to participate.
- Subjects who abuse alcohol or illicit substances will be excluded.
- Other medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements.
- Nursing mothers.
- Other investigational medication use within 30 days of screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
The purpose of this study is to determine the safety and effectiveness of the influenza vaccine when administered nasally and intra-muscular (a "shot" of medicine given into a muscle). The investigators will measure the systemic (through out the body) and mucosal immune responses (how your body recognizes and defends itself against bacteria) to nasally administered influenza vaccine, and determine if nasal immunization results in immunity (your body's ability to avoid infections) within multiple mucosal compartments (ocular (eye), oral and reproductive), in comparison with intramuscular administration and placebo (inactive substance given in the same form as the active drug).
- Conditions
- Mucosal Immunity
- Being tested
- Fluzone
- Keywords
- Vaccination, Mucosal Immunity, Nasal Immunization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluzoneDrug
0.5 ml/15 micrograms
FluzoneDrug
0.5 ml/60 micrograms
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Fluzone |
| Nasal Aerosol Immunization | Placebo comparator | Not described Receives: Drug: Fluzone |
| Nasal Droplet Immunization | Placebo comparator | Not described Receives: Drug: Fluzone |
| Intramuscular Immunization | Placebo comparator | Not described Receives: Drug: Fluzone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemagglutinin antibody titers from baseline to Day 28 in serum and mucosal secretions.
Assessments will include hemagglutination inhibition and antibody isotypes determination.
Measured: Baseline to Day 28
Secondary outcomes (2)
Number of subjects with adverse events.
Measured: Baseline to Day 28
Comparison of hemagglutinin antibody titers between intranasal and intramuscular route of administration, from baseline to Day 28.
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucosal ImmunityStudies 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
- Early Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Sundy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Sundy, Duke University
- Investigators
- John Sundy, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385215
- Sponsor's protocol ID
- Pro00024277
- Status last verified
- Dec 2012
- First submitted
- 25 Apr 2011
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies for Enhancing Mucosal Immunity to Influenza Vaccine
- ClinicalTrials.gov ID
- NCT01385215
- Acronym / sponsor ID
- Pro00024277
- Conditions
- Mucosal Immunity
- Keywords
- Vaccination, Mucosal Immunity, Nasal Immunization
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- John SundyUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 30 Jun 2011 (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.
The purpose of this study is to determine the safety and effectiveness of the influenza vaccine when administered nasally and intra-muscular (a "shot" of medicine given into a muscle). The investigators will measure the systemic (through out the body) and mucosal immune responses (how your body recognizes and defends itself against bacteria) to nasally administered influenza vaccine, and determine if nasal immunization results in immunity (your body's ability to avoid infections) within multiple mucosal compartments (ocular (eye), oral and reproductive), in comparison with intramuscular administration and placebo (inactive substance given in the same form as the active drug).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Fluzone |
| Nasal Aerosol Immunization | Placebo comparator | Drug: Fluzone |
| Nasal Droplet Immunization | Placebo comparator | Drug: Fluzone |
| Intramuscular Immunization | Placebo comparator | Drug: Fluzone |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy men and women ages 18-50 years
- Non-smokers (defined as no tobacco use within the last 12 months and less than 10 pack-year lifetime tobacco use)
- Willing and able to provide written informed consent
- Able to speak and understand English
- Women of childbearing potential must have a negative serum pregnancy test.
Key exclusion criteria (20 listed)
- Influenza vaccination within 6 months prior to screening date
- Symptoms of respiratory infection during the 14 days prior to screening
- Temperature >38.3o C during the period spanning 72 hours prior to screening and the time of immunization.
- History of allergy to egg, influenza vaccine or vaccine ingredients
- History of Guillain-Barre syndrome
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 |
|---|---|---|
| Fluzone0.5 ml/15 micrograms | Drug | Intramuscular Immunization |
| Fluzone0.5 ml/60 micrograms | Drug | Nasal Aerosol Immunization, Nasal Droplet Immunization, Placebo |
Primary outcome
Change in hemagglutinin antibody titers from baseline to Day 28 in serum and mucosal secretions.
Time frame: Baseline to Day 28
Assessments will include hemagglutination inhibition and antibody isotypes determination.
2 secondary outcomes
Number of subjects with adverse events.
Time frame: Baseline to Day 28
Comparison of hemagglutinin antibody titers between intranasal and intramuscular route of administration, from baseline to Day 28.
Time frame: Baseline to Day 28
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 6 Dec 2012.
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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.
John Sundy, MD, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fluzone in people with Mucosal Immunity, run by John Sundy 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 20 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 6 Dec 2012. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in hemagglutinin antibody titers from baseline to Day 28 in serum and mucosal secretions. (time frame: Baseline to Day 28). 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 6 Dec 2012.