InfluenzaPhase 1/2LIfTNCT01224262
A Study Evaluating the Safety and Tolerability of a Seasonal Influenza Vaccine Containing LIQ001
A Phase 1/2 study testing Fluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine), LIQ001 (0.45mg) and LIQ001 (1.8mg) in people with Influenza, run by Liquidia Technologies, Inc. at 1 site in United States.
Trial summary
This study is designed to evaluate the safety, tolerability, and immune response of LIQ001 mixed with a commercially available seasonal influenza vaccine (Fluzone) in two populations of subjects; healthy adult subjects 18 to 49 years of age and healthy elderly subjects 65 years of age or older. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Fluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine), LIQ001 (0.45mg) and LIQ001 (1.8mg)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Dec 2011
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 49 years (Cohort 1) and age 65 or above (Cohort 2)
- For subjects 18 to 49 years of age: in good health as determined by medical history, physical examination, and the clinical judgment of the Principal Investigator (PI)
- For subjects 65 years of age and older: in stable good health as determined by medical history, physical examination, and the clinical judgment of the PI
- Live in the community (including assisted living)
- Available for duration of study (1 year)
- If female, no child-bearing potential or using appropriate measures to prevent pregnancy
Show all 10Show fewer
- Negative urine pregnancy test for women presumed to be of child-bearing potential within 24 hours of vaccination
- Be eligible for screening
- Provide informed consent
- Have working phone for contact by the study site personnel
Who cannot join
- Known allergy to eggs or any other component of Fluzone (including natural latex) or inactivated influenza vaccines or the investigational vaccine
- Received seasonal influenza or H1N1 vaccine in last 6 months
- A diagnosis of influenza within the previous 12 months
- Received any licensed vaccine within the past 1 month
- Receiving nursing home or equivalent care
- For women, breast-feeding or planning to become pregnant during the first three months post-vaccination
Show all 30Show fewer
- Chronic administration of immunosuppressant(s) or other medication that modifies immune function
- Confirmed immunodeficiency syndrome or disease
- Significant cardiovascular disease including class 3 or 4 congestive heart failure, recent history (last 6 months) of acute myocardial infarction, coronary artery bypass surgery or stent placement, unstable angina, uncontrolled arrhythmia, and for subjects 65 years of age and older, a resting heart rate greater than 100 bpm
- Hypertension that is not well controlled by medication in the judgment of the investigator or is more than 150/95 at enrollment
- Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
- Medically significant chronic lung disease, e.g., requiring chronic steroid treatment (oral doses >10 mg/day)
- Asthma that is severe, unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral, intravenous, or high dose inhaled corticosteroids (mild or intermittent asthma treated with inhaled steroids is acceptable)
- Medically significant acute or progressive hepatic disease
- Medically significant acute or progressive renal disease
- Diabetes mellitus type 2 not under pharmacological control
- A diagnosis of cancer with active treatment within the previous 5 years (except for a localized basal cell carcinoma of the skin)
- History of autoimmune/inflammatory conditions (e.g., rheumatoid arthritis and diabetes mellitus type 1)
- Medically significant acute or progressive neurological disease.
- Seizure disorder that has required treatment within the last 3 years
- History of Guillain-Barre Syndrome (GBS)
- Administration of blood products, immunoglobulin, or investigational vaccine in the 3 months prior to immunization in this study
- Use of investigational product (other than blood, immunoglobulin, or vaccine) in the past 60 days
- Seropositive for HCV, HIV or positive for HBsAg
- History of excessive alcohol use, drug abuse, or significant psychiatric illness
- Unable to complete informed consent
- Abnormal laboratory assessment meeting criteria for a mild, moderate, or severe adverse event
- Any other condition or circumstance which, in the opinion of the PI, poses an unacceptable risk for participation in the study
- Inability to operate and answer a telephone and lack of access to telephone
- Temporary Exclusion Criteria: Presence of an oral temperature ≥99.5°F, and/or signs and symptoms of an acute infectious respiratory illness within 3 days prior to vaccination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Observer-Blind, Controlled Phase 1/2a Study of the Safety, Tolerability and Immunogenicity of Fluzone Administered With and Without LIQ001 in Two Cohorts of Healthy Subjects: 18-49 Years of Age and 65 Years of Age or Older.
This study is designed to evaluate the safety, tolerability, and immune response of LIQ001 mixed with a commercially available seasonal influenza vaccine (Fluzone) in two populations of subjects; healthy adult subjects 18 to 49 years of age and healthy elderly subjects 65 years of age or older.
Read the detailed description
Significant advances have been made in the design and delivery of vaccines for the prevention of influenza over the decades. However, two major hurdles remain in the global approach to influenza prevention. First, recent epidemiology research has demonstrated that immune response and protection in elderly populations are suboptimal resulting in significant seasonal influenza disease in this population every year. Second, while preparations for the emergence of pandemic influenza strains have progressed, current egg-based manufacturing methods have not provided sufficient global capacity. Furthermore, the genesis and scale-up of other manufacturing platforms will not rapidly solve this problem. Thus, safe and effective ways are needed to improve protection in the elderly as well as reduce the antigen dose in younger populations in preparation for global needs of pandemic vaccines.
Historically it is known that presentation of antigens in particulate form, for a wide range of pathogens, has clear advantages over the presentation of soluble antigen alone. A novel approach using highly uniform particles has been developed which utilizes size, shape, and composition to control the delivery and presentation of the vaccine antigen(s) to the immune system. Production of these highly uniform particles is possible because of a proprietary manufacturing approach called Pattern Replication in Non-wetting Templates (PRINT®).
The proposed approach is to use the PRINT process to make bioabsorbable particles to improve the immune response and efficacy of the seasonal influenza vaccine. It is proposed that mixing properly sized and charged particles with commercial trivalent influenza vaccine (TIV) will increase vaccine effectiveness and/or decrease the amount of antigen necessary to induce an immune response.
- Conditions
- Influenza
- Being tested
- Fluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine), LIQ001 (0.45mg), LIQ001 (1.8mg)
- Keywords
- influenza vaccine, seasonal influenza, novel vaccine, flu
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine)Biological
Also called seasonal influenza vaccination, seasonal influenza vaccine, seasonal flu vaccination, seasonal flu vaccine
A single vaccination of Fluzone alone
LIQ001 (0.45mg)Biological
A single vaccination of 0.45 mg LIQ001
LIQ001 (1.8mg)Biological
A single vaccination of 1.8 mg LIQ001
| Study group | Role | What they receive |
|---|---|---|
| Fluzone + 0.45 mg LIQ001 | Experimental | Fluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine) Administered with LIQ001 (0.45mg) Receives: Biological: Fluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine); Biological: LIQ001 (0.45mg) |
| Fluzone + 1.8 mg LIQ001 | Experimental | Fluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine) Administered with LIQ001 (1.8mg) Receives: Biological: Fluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine); Biological: LIQ001 (1.8mg) |
| Fluzone | Active comparator | Fluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine) Receives: Biological: Fluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of Adverse Events attributable to each of the doses of LIQ001 mixed with Fluzone compared to Fluzone alone.
Measured: 35 days post-vaccination
Secondary outcomes (3)
HAI response (Geometric Mean Titer) of each of the doses of LIQ001 mixed with Fluzone compared to the Fluzone alone response.
Measured: 21 days post-vaccination
HAI response (Percent with HAI titer greater than or equal to 1:40) of each of the doses of LIQ001 mixed with Fluzone compared to the Fluzone alone response.
Measured: 21 days post-vaccination
HAI response (Seroconversion rate) of each of the doses of LIQ001 mixed with Fluzone compared to the Fluzone alone response.
Measured: 21 days post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liquidia Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Accelovance, Children's Hospital Medical Center, Cincinnati
- Responsible party
- Sponsor
- Investigators
- Frank Malinoski, MD, PhD, Study director, Liquidia Technologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224262
- Sponsor's protocol ID
- LIQC10-001
- Acronym
- LIfT
- Status last verified
- Feb 2013
- First submitted
- 14 Oct 2010
- Last updated
- 1 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Observer-Blind, Controlled Phase 1/2a Study of the Safety, Tolerability and Immunogenicity of Fluzone Administered With and Without LIQ001 in Two Cohorts of Healthy Subjects: 18-49 Years of Age and 65 Years of Age or Older.
- ClinicalTrials.gov ID
- NCT01224262
- Acronym / sponsor ID
- LIfT / LIQC10-001
- Conditions
- Influenza
- Keywords
- influenza vaccine, seasonal influenza, novel vaccine, flu
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Liquidia Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Accelovance, Children's Hospital Medical Center, Cincinnati
- Study start
- Sep 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Oct 2010 (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.
This study is designed to evaluate the safety, tolerability, and immune response of LIQ001 mixed with a commercially available seasonal influenza vaccine (Fluzone) in two populations of subjects; healthy adult subjects 18 to 49 years of age and healthy elderly subjects 65 years of age or older.
Detailed description
Significant advances have been made in the design and delivery of vaccines for the prevention of influenza over the decades. However, two major hurdles remain in the global approach to influenza prevention. First, recent epidemiology research has demonstrated that immune response and protection in elderly populations are suboptimal resulting in significant seasonal influenza disease in this population every year. Second, while preparations for the emergence of pandemic influenza strains have progressed, current egg-based manufacturing methods have not provided sufficient global capacity. Furthermore, the genesis and scale-up of other manufacturing platforms will not rapidly solve this problem. Thus, safe and effective ways are needed to improve protection in the elderly as well as reduce the antigen dose in younger populations in preparation for global needs of pandemic vaccines.
Historically it is known that presentation of antigens in particulate form, for a wide range of pathogens, has clear advantages over the presentation of soluble antigen alone. A novel approach using highly uniform particles has been developed which utilizes size, shape, and composition to control the delivery and presentation of the vaccine antigen(s) to the immune system. Production of these highly uniform particles is possible because of a proprietary manufacturing approach called Pattern Replication in Non-wetting Templates (PRINT®).
The proposed approach is to use the PRINT process to make bioabsorbable particles to improve the immune response and efficacy of the seasonal influenza vaccine. It is proposed that mixing properly sized and charged particles with commercial trivalent influenza vaccine (TIV) will increase vaccine effectiveness and/or decrease the amount of antigen necessary to induce an immune response.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluzone + 0.45 mg LIQ001 | Experimental | Biological: Fluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine), Biological: LIQ001 (0.45mg)Fluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine) Administered with LIQ001 (0.45mg) |
| Fluzone + 1.8 mg LIQ001 | Experimental | Biological: Fluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine), Biological: LIQ001 (1.8mg)Fluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine) Administered with LIQ001 (1.8mg) |
| Fluzone | Active comparator | Biological: Fluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine)Fluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 to 49 years (Cohort 1) and age 65 or above (Cohort 2)
- For subjects 18 to 49 years of age: in good health as determined by medical history, physical examination, and the clinical judgment of the Principal Investigator (PI)
- For subjects 65 years of age and older: in stable good health as determined by medical history, physical examination, and the clinical judgment of the PI
- Live in the community (including assisted living)
- Available for duration of study (1 year)
Key exclusion criteria (30 listed)
- Known allergy to eggs or any other component of Fluzone (including natural latex) or inactivated influenza vaccines or the investigational vaccine
- Received seasonal influenza or H1N1 vaccine in last 6 months
- A diagnosis of influenza within the previous 12 months
- Received any licensed vaccine within the past 1 month
- Receiving nursing home or equivalent care
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 |
|---|---|---|
| Fluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine)Also: seasonal influenza vaccination, seasonal influenza vaccine, seasonal flu vaccination, seasonal flu vaccineA single vaccination of Fluzone alone | Biological | Fluzone, Fluzone + 0.45 mg LIQ001, Fluzone + 1.8 mg LIQ001 |
| LIQ001 (0.45mg)A single vaccination of 0.45 mg LIQ001 | Biological | Fluzone + 0.45 mg LIQ001 |
| LIQ001 (1.8mg)A single vaccination of 1.8 mg LIQ001 | Biological | Fluzone + 1.8 mg LIQ001 |
Primary outcome
The rate of Adverse Events attributable to each of the doses of LIQ001 mixed with Fluzone compared to Fluzone alone.
Time frame: 35 days post-vaccination
3 secondary outcomes
HAI response (Geometric Mean Titer) of each of the doses of LIQ001 mixed with Fluzone compared to the Fluzone alone response.
Time frame: 21 days post-vaccination
HAI response (Percent with HAI titer greater than or equal to 1:40) of each of the doses of LIQ001 mixed with Fluzone compared to the Fluzone alone response.
Time frame: 21 days post-vaccination
HAI response (Seroconversion rate) of each of the doses of LIQ001 mixed with Fluzone compared to the Fluzone alone response.
Time frame: 21 days post-vaccination
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 1 Mar 2013.
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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.
Frank Malinoski, MD, PhD study director
Liquidia Technologies, 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 Fluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine), LIQ001 (0.45mg) and LIQ001 (1.8mg) in people with Influenza, run by Liquidia Technologies, 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 10 inclusion and 30 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 1 Mar 2013. 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 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?
The rate of Adverse Events attributable to each of the doses of LIQ001 mixed with Fluzone compared to Fluzone alone. (time frame: 35 days post-vaccination). 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 1 Mar 2013.