Influenza, HumanPhase 1/2NCT01591473
Safety Study of FluMist With and Without Ampligen
A Phase 1/2 study testing Poly I:Poly C12U 50 ug, Poly I:Poly C12U 200 ug and Poly I:Poly C12U 500 ug in people with Influenza, Human, run by AIM ImmunoTech Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate FluMist with and without Ampligen in healthy volunteers. Read more about this study
- Who is it for?
- Ages 19 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- Poly I:Poly C12U 50 ug, Poly I:Poly C12U 200 ug and Poly I:Poly C12U 500 ug
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Aug 2015
- Phase
- Phase 1/2
- 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 19 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females in good general health, 19 to 49 years of age.
- Subjects must provide written informed consent.
- Subjects must be willing to participate through study completion.
- Have not been vaccinated for influenza virus in the current season or had a known influenza virus infection in the current season
- Subjects must be willing to undergo nasal washes and provide parotid saliva, urine and blood samples per protocol for safety and immunogenicity analyses.
- Females of childbearing potential must have a negative urine pregnancy test.
Show all 19Show fewer
- A female volunteer must:
- Agree to consistently use effective contraception from at least 21 days prior to enrollment through the Day 84 clinic visit for sexual activity that could lead to pregnancy;
- Effective contraception is defined as using any of the following methods:
- condoms (male or female) with or without spermicide,
- diaphragm or cervical cap with spermicide,
- intrauterine device (IUD),
- hormonal contraception, or
- successful vasectomy in the male partner (considered successful if a volunteer reports that a male partner has [1] documentation of azoospermia by microscopy or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post-vasectomy);
- Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation;
- Or be sexually abstinent;
- Volunteers who were born female must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization, until after the Day 84 clinical visit.
- Screening Laboratory Inclusion Criteria. Screening values must be within Institutional Normal Range, unless they are not clinically significant (i.e. values do not reach the threshold for mild (Grade 1) or higher toxicity as defined in Appendix D). Repeat laboratory testing may be performed at the discretion of the clinical investigators for spurious results on a case by case basis.
- Subjects must weigh at least 120 pounds at screening
Who cannot join
- Pregnant or lactating women.
- Any flu/cold, or respiratory tract symptoms and/or fever greater than 101 ºF in the 3 days prior to study enrollment and/or initial vaccination.
- Any intranasal medication administered in the 10 days prior to study enrollment and/or initial vaccination.
- History of Bell's palsy, significant cardiac history including history of arrhythmias, coagulopathy, history of cardiovascular accident, bone marrow diseases, known or suspected, autoimmune diseases (such as but not limited to psoriasis, rheumatoid arthritis, hyperthyroidism, hypothyroidism, vasculitis, Raynaud's phenomenon, rhabdomyolysis and myositis, nephritis, systemic lupus erythematosus and sarcoidosis, hemolytic anemia) and any history of malignancy.
- History of chronic rhinitis or presence of pre-existing nasal septal defect, nasal polyps or other gross abnormalities that might impact vaccine administration, or any previous nasal cautery or significant surgery for nasal septal defects.
- Any regular past or current use of intranasal illicit drugs, or a history of intravenous illicit drug use.
Show all 22Show fewer
- Asthma, or other chronic respiratory disorders, of any severity, even if mild.
- Reactive HBVsAg or reactive HCV Ab.
- HIV positive by history or by screening test.
- History of alcohol or other substance abuse, or history of depression or suicidal ideation, or a suicide attempt within two (2) years of screening. A score of 5 or greater on the PHQ-9 at Baseline indicates symptoms of depression and will exclude subject. A score of greater than zero on question nine (9) of the PHQ-9 at Baseline indicates suicidal ideation and will exclude subject.
- Immunosuppressed, altered or compromised immune status as a consequence of disease (i.e. asplenia, recurrent severe infections) or chronic treatment (more than 14 days) with systemic corticosteroids (including inhaled or intranasally-administered drugs), alkylating drugs, anti-metabolites, radiation, or other immunosuppressive therapies within the preceding 6 months.
- Administration of immunoglobulins and/or any blood products within 3 months prior to enrollment.
- Receipt of an influenza vaccine within the past 6 months.
- Receipt of any vaccine in the past 30 days.
- Receipt of any investigational drug in the past 30 days.
- Known diabetes mellitus.
- History of anaphylaxis, Guillain-Barré Syndrome, or angioedema.
- Blood pressure > 140/90 (either or both values) at screening or enrollment.
- Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a participant's ability to give informed consent.
- History of taking antiviral drugs active against influenza A and/or B in last 72 hours before FluMist® administration.
- Hypersensitivity to eggs, egg proteins, gentamicin, gelatin, or arginine, or life threatening reactions to previous influenza vaccinations.
- Clinically significant abnormality on screening EKG.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: A Phase I/II, Two-Staged, Single-Center, Randomized, Double-Blind, Antibody Titer Study to Assess Immunogenicity and Safety of FluMist® Intranasal Influenza Vaccine Administered With and Without a TLR-3 Agonist, Ampligen®.
The purpose of this study is to evaluate FluMist with and without Ampligen in healthy volunteers.
Read the detailed description
Influenza epidemics continue to represent a significant medical problem in the developed as well as the developing world. Even with existing vaccines, annual influenza epidemics typically results in 20-50 million cases, resulting in 30,000-40,000 deaths in the U.S. alone. A possible pandemic could have even more devastating consequences. Current vaccines have a number of disadvantages including slow and expensive manufacturing, and a relative lack of efficacy in elderly, children and immune-compromised populations. These disadvantages would be multiplied during a pandemic. Use of Ampligen® as an adjuvant combined with FluMist® has a number of potential advantages as compared to traditional inactivated vaccines: it is simpler to administer (intranasally), generation of a broader immunity at the natural site of entry of the influenza virus as well as systemic immunity (and hence should be more efficacious than traditional vaccines) and may stimulate cross-protection against pre-pandemic H5N1 and/or H7N9 avian influenza strains. As FluMist®, due to its intranasal administration, imitates the natural entry of the influenza virus, it will generate local 'first-line' immunity as well as the traditional systemic immunity; therefore, at least theoretically provide greater protection than injectable vaccines.
- Conditions
- Influenza, Human
- Being tested
- Poly I:Poly C12U 50 ug, Poly I:Poly C12U 200 ug, Poly I:Poly C12U 500 ug, Poly I:Poly C12U 1250 ug, Placebo
- Keywords
- Influenza, Ampligen, Poly I:Poly C12U, Rintatolimod, FluMist
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poly I:Poly C12U 50 ugDrug
Also called Ampligen, Rintatolimod
Poly I:Poly C12U 50 ug; 3 doses; nasal administration every 28 days
Poly I:Poly C12U 200 ugDrug
Also called Ampligen, Rintatolimod
Poly I:Poly C12U 200 ug; 3 doses; nasal administration every 28 days
Poly I:Poly C12U 500 ugDrug
Also called Ampligen, Rintatolimod
Poly I:Poly C12U 500 ug; 3 doses; nasal administration every 28 days
Poly I:Poly C12U 1250 ugDrug
Also called Ampligen, Rintatolimod
Poly I:Poly C12U 1250 ug; 3 doses; nasal administration every 28 days
PlaceboDrug
Placebo; 3 doses; nasal administration every 28 days
FluMistDrug
FluMist 0.2 ml; 3 doses; nasal administration every 28 days
| Study group | Role | What they receive |
|---|---|---|
| FluMist + Ampligen, Group 1 | Experimental | Nasal administration; dose group 1; FluMist + Poly I:Poly C12U 50 ug; 3 doses separated by 28 days Receives: Drug: Poly I:Poly C12U 50 ug; Drug: FluMist |
| FluMist + Ampligen, Group 2 | Experimental | Nasal administration; dose group 2; FluMist + Poly I:Poly C12U 200 ug; 3 doses separated by 28 days Receives: Drug: Poly I:Poly C12U 200 ug; Drug: FluMist |
| FluMist + Ampligen, Group 3 | Experimental | Nasal administration; dose group 3; FluMist + Poly I:Poly C12U 500 ug; 3 doses separated by 28 days Receives: Drug: Poly I:Poly C12U 500 ug; Drug: FluMist |
| FluMist + Ampligen, Group 4 | Experimental | Nasal administration; dose group 4; FluMist + Poly I:Poly C12U 50 ug; 3 doses separated by 28 days Receives: Drug: Poly I:Poly C12U 50 ug; Drug: FluMist |
| FluMist + Ampligen, Group 5 | Experimental | Nasal administration; dose group 5; FluMist + Poly I:Poly C12U 1250 ug; 3 doses separated by 28 days Receives: Drug: Poly I:Poly C12U 1250 ug; Drug: FluMist |
| FluMist + Placebo, Group 6 | Experimental | Nasal administration; dose group 6; FluMist + placebo; 3 doses separated by 28 days Receives: Drug: Placebo; Drug: FluMist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety and tolerability
Reactogenicity; other adverse events, serious adverse events, new onset of chronic illnesses, and adverse events of special interest
Measured: Every 28 days
Secondary outcomes (2)
Evaluation of immune response
Evaluated by measurements of serum antibody HI titers against the seasonal viral strains contained in vaccine and various H5N1 and/or H7N9 clades. Immunogenicity will be evaluated by comparing the titer levels in each of the treatment groups.
Measured: Every 28 days
Immunogenicity Assessments
Micro-neutralization assay and IgA (nasal wash and parotid saliva)
Measured: Every 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2014
- Study completionAug 2015
Why it stopped: The CDC indicated nasal spray flu vaccine should not be used during 2016-2017
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 Influenza, HumanStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIM ImmunoTech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David R Strayer, MD, Study director, AIM ImmunoTech Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591473
- Sponsor's protocol ID
- AMP-600
- Status last verified
- Jul 2018
- First submitted
- 2 May 2012
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Ichinohe T, Tamura S, Kawaguchi A, Ninomiya A, Imai M, Itamura S, Odagiri T, Tashiro M, Takahashi H, Sawa H, Mitchell WM, Strayer DR, Carter WA, Chiba J, Kurata T, Sata T, Hasegawa H. Cross-protection against H5N1 influenza virus infection is afforded by intranasal inoculation with seasonal trivalent inactivated influenza vaccine. J Infect Dis. 2007 Nov 1;196(9):1313-20. doi: 10.1086/521304. Epub 2007 Oct 5.
PubMed 17922395Ichinohe T, Ainai A, Ami Y, Nagata N, Iwata N, Kawaguchi A, Suzaki Y, Odagiri T, Tashiro M, Takahashi H, Strayer DR, Carter WA, Chiba J, Tamura S, Sata T, Kurata T, Hasegawa H. Intranasal administration of adjuvant-combined vaccine protects monkeys from challenge with the highly pathogenic influenza A H5N1 virus. J Med Virol. 2010 Oct;82(10):1754-61. doi: 10.1002/jmv.21824.
PubMed 20827774Overton ET, Goepfert PA, Cunningham P, Carter WA, Horvath J, Young D, Strayer DR. Intranasal seasonal influenza vaccine and a TLR-3 agonist, rintatolimod, induced cross-reactive IgA antibody formation against avian H5N1 and H7N9 influenza HA in humans. Vaccine. 2014 Sep 22;32(42):5490-5. doi: 10.1016/j.vaccine.2014.07.078. Epub 2014 Aug 13.
PubMed 25128802
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Two-Staged, Single-Center, Randomized, Double-Blind, Antibody Titer Study to Assess Immunogenicity and Safety of FluMist® Intranasal Influenza Vaccine Administered With and Without a TLR-3 Agonist, Ampligen®.
- ClinicalTrials.gov ID
- NCT01591473
- Acronym / sponsor ID
- AMP-600
- Conditions
- Influenza, Human
- Keywords
- Influenza, Ampligen, Poly I:Poly C12U, Rintatolimod, FluMist
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The CDC indicated nasal spray flu vaccine should not be used during 2016-2017
- Enrolment
- 55 participants (actual)
- Lead sponsor
- AIM ImmunoTech Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2012 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 4 May 2012 (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 evaluate FluMist with and without Ampligen in healthy volunteers.
Detailed description
Influenza epidemics continue to represent a significant medical problem in the developed as well as the developing world. Even with existing vaccines, annual influenza epidemics typically results in 20-50 million cases, resulting in 30,000-40,000 deaths in the U.S. alone. A possible pandemic could have even more devastating consequences. Current vaccines have a number of disadvantages including slow and expensive manufacturing, and a relative lack of efficacy in elderly, children and immune-compromised populations. These disadvantages would be multiplied during a pandemic. Use of Ampligen® as an adjuvant combined with FluMist® has a number of potential advantages as compared to traditional inactivated vaccines: it is simpler to administer (intranasally), generation of a broader immunity at the natural site of entry of the influenza virus as well as systemic immunity (and hence should be more efficacious than traditional vaccines) and may stimulate cross-protection against pre-pandemic H5N1 and/or H7N9 avian influenza strains. As FluMist®, due to its intranasal administration, imitates the natural entry of the influenza virus, it will generate local 'first-line' immunity as well as the traditional systemic immunity; therefore, at least theoretically provide greater protection than injectable vaccines.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| FluMist + Ampligen, Group 1 | Experimental | Drug: Poly I:Poly C12U 50 ug, Drug: FluMistNasal administration; dose group 1; FluMist + Poly I:Poly C12U 50 ug; 3 doses separated by 28 days |
| FluMist + Ampligen, Group 2 | Experimental | Drug: Poly I:Poly C12U 200 ug, Drug: FluMistNasal administration; dose group 2; FluMist + Poly I:Poly C12U 200 ug; 3 doses separated by 28 days |
| FluMist + Ampligen, Group 3 | Experimental | Drug: Poly I:Poly C12U 500 ug, Drug: FluMistNasal administration; dose group 3; FluMist + Poly I:Poly C12U 500 ug; 3 doses separated by 28 days |
| FluMist + Ampligen, Group 4 | Experimental | Drug: Poly I:Poly C12U 50 ug, Drug: FluMistNasal administration; dose group 4; FluMist + Poly I:Poly C12U 50 ug; 3 doses separated by 28 days |
| FluMist + Ampligen, Group 5 | Experimental | Drug: Poly I:Poly C12U 1250 ug, Drug: FluMistNasal administration; dose group 5; FluMist + Poly I:Poly C12U 1250 ug; 3 doses separated by 28 days |
| FluMist + Placebo, Group 6 | Experimental | Drug: Placebo, Drug: FluMistNasal administration; dose group 6; FluMist + placebo; 3 doses separated by 28 days |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Males and females in good general health, 19 to 49 years of age.
- Subjects must provide written informed consent.
- Subjects must be willing to participate through study completion.
- Have not been vaccinated for influenza virus in the current season or had a known influenza virus infection in the current season
- Subjects must be willing to undergo nasal washes and provide parotid saliva, urine and blood samples per protocol for safety and immunogenicity analyses.
Key exclusion criteria (22 listed)
- Pregnant or lactating women.
- Any flu/cold, or respiratory tract symptoms and/or fever greater than 101 ºF in the 3 days prior to study enrollment and/or initial vaccination.
- Any intranasal medication administered in the 10 days prior to study enrollment and/or initial vaccination.
- History of Bell's palsy, significant cardiac history including history of arrhythmias, coagulopathy, history of cardiovascular accident, bone marrow diseases, known or suspected, autoimmune diseases (such as but not limited to psoriasis, rheumatoid arthritis, hyperthyroidism, hypothyroidism, vasculitis, Raynaud's phenomenon, rhabdomyolysis and myositis, nephritis, systemic lupus erythematosus and sarcoidosis, hemolytic anemia) and any history of malignancy.
- History of chronic rhinitis or presence of pre-existing nasal septal defect, nasal polyps or other gross abnormalities that might impact vaccine administration, or any previous nasal cautery or significant surgery for nasal septal defects.
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 |
|---|---|---|
| Poly I:Poly C12U 50 ugAlso: Ampligen, RintatolimodPoly I:Poly C12U 50 ug; 3 doses; nasal administration every 28 days | Drug | FluMist + Ampligen, Group 1, FluMist + Ampligen, Group 4 |
| Poly I:Poly C12U 200 ugAlso: Ampligen, RintatolimodPoly I:Poly C12U 200 ug; 3 doses; nasal administration every 28 days | Drug | FluMist + Ampligen, Group 2 |
| Poly I:Poly C12U 500 ugAlso: Ampligen, RintatolimodPoly I:Poly C12U 500 ug; 3 doses; nasal administration every 28 days | Drug | FluMist + Ampligen, Group 3 |
| Poly I:Poly C12U 1250 ugAlso: Ampligen, RintatolimodPoly I:Poly C12U 1250 ug; 3 doses; nasal administration every 28 days | Drug | FluMist + Ampligen, Group 5 |
| PlaceboPlacebo; 3 doses; nasal administration every 28 days | Drug | FluMist + Placebo, Group 6 |
| FluMistFluMist 0.2 ml; 3 doses; nasal administration every 28 days | Drug | FluMist + Ampligen, Group 1, FluMist + Ampligen, Group 2, FluMist + Ampligen, Group 3, FluMist + Ampligen, Group 4, FluMist + Ampligen, Group 5, FluMist + Placebo, Group 6 |
Primary outcome
Evaluate safety and tolerability
Time frame: Every 28 days
Reactogenicity; other adverse events, serious adverse events, new onset of chronic illnesses, and adverse events of special interest
2 secondary outcomes
Evaluation of immune response
Time frame: Every 28 days
Immunogenicity Assessments
Time frame: Every 28 days
Results and safety
The study was stopped early (reason given: The CDC indicated nasal spray flu vaccine should not be used during 2016-2017). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Background: PubMed 17922395Ichinohe T, Tamura S, Kawaguchi A, Ninomiya A, Imai M, Itamura S, Odagiri T, Tashiro M, Takahashi H, Sawa H, Mitchell WM, Strayer DR, Carter WA, Chiba J, Kurata T, Sata T, Hasegawa H. Cross-protection against H5N1 influenza virus infection is afforded by intranasal inoculation with seasonal trivalent inactivated influenza vaccine. J Infect Dis. 2007 Nov 1;196(9):1313-20. doi: 10.1086/521304. Epub 2007 Oct 5.
- Background: PubMed 20827774Ichinohe T, Ainai A, Ami Y, Nagata N, Iwata N, Kawaguchi A, Suzaki Y, Odagiri T, Tashiro M, Takahashi H, Strayer DR, Carter WA, Chiba J, Tamura S, Sata T, Kurata T, Hasegawa H. Intranasal administration of adjuvant-combined vaccine protects monkeys from challenge with the highly pathogenic influenza A H5N1 virus. J Med Virol. 2010 Oct;82(10):1754-61. doi: 10.1002/jmv.21824.
- Results publication: PubMed 25128802Overton ET, Goepfert PA, Cunningham P, Carter WA, Horvath J, Young D, Strayer DR. Intranasal seasonal influenza vaccine and a TLR-3 agonist, rintatolimod, induced cross-reactive IgA antibody formation against avian H5N1 and H7N9 influenza HA in humans. Vaccine. 2014 Sep 22;32(42):5490-5. doi: 10.1016/j.vaccine.2014.07.078. Epub 2014 Aug 13.
- Individual participant dataSharing planned: Undecided
Related trials for Influenza, Human
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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.
David R Strayer, MD study director
AIM ImmunoTech Inc.
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 Poly I:Poly C12U 50 ug, Poly I:Poly C12U 200 ug and Poly I:Poly C12U 500 ug in people with Influenza, Human, run by AIM ImmunoTech Inc. 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 19 inclusion and 22 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 26 Jul 2018. 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?
The study was stopped early (reason given: The CDC indicated nasal spray flu vaccine should not be used during 2016-2017). Results are not available in the source record.
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?
Evaluate safety and tolerability (time frame: Every 28 days). 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 NCT01591473, 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 26 Jul 2018.