FluPhase 1NCT02188810
Safety and Reactogenicity of a PAL Combined With Seasonal Flu Vaccine in Healthy Adults
A Phase 1 study testing PAL and TIV in people with Flu, run by Folia Biotech Inc. at 1 site in Canada.
Trial summary
This is a phase 1, research study is looking at the safety and acceptability of a new vaccine adjuvant (immune booster) called PAL when combined with the seasonal flu vaccine (Fluviral) to test the safety and effectiveness of new vaccines and medications on healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Flu
- What is being tested?
- PAL and TIV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Dec 2017
- Phase
- 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
- Good general health status, as determined by history and physical examination no greater than 30 days prior to administration of the first test article.
- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of Diary Cards, return for follow-up visits).
- If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection and has a negative pregnancy test on the day of injection and has agreed to continue adequate contraception until 180 days after injection. (Please refer to the glossary for the definition of child-bearing potential and adequate contraception).
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the study product within 28 days preceding the dose of study product, or planned use during the study period.
- Planned administration/ administration of a vaccine/product not foreseen by the study protocol within the period starting 28 days before injection and ending 28 days after.
- Planned administration/ administration of the seasonal influenza vaccine recommended by local public health authorities within the period starting 120 days before injection and ending 121 days after. (Note: enrolment should be completed 120 days before the annual seasonal influenza vaccine campaigns in October and December)
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study product or planned administration during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. (Laboratory testing for HIV, Hepatitis C and Hepatitis B will be performed during the screening visit).
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drug within 6 months prior to the product dose
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- Family history of congenital or hereditary immunodeficiency.
- History of or current autoimmune disease.
- Known or suspected hypersensitivity to Fluviral, to thimerosal, or to any other ingredient in the formulation or component of the container.
- Pregnant or lactating female.
- Any hematological (hemoglobin level, white blood cell [WBC], and platelet count) and biochemical (alanine aminotransferase [ALT], aspartate aminotransferase [AST], blood urea nitrogen [BUN] and creatinine) abnormality as per local laboratory normal values considered clinically significant by the investigator.
- Any acute or chronic, clinically significant disease, as determined by physical examination or laboratory screening tests.
- Any other condition that the investigator judges may interfere with study procedures (e.g. drawing blood) or findings (e.g. immune response).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Randomized, Observer-blind, Controlled, Dose Escalation Trial of the Safety and Tolerability of a Single Intramuscular Dose of a PAL Adjuvant (FB-631) Co-administered With Seasonal TIV (2013-2014) in Healthy Adults.
This is a phase 1, research study is looking at the safety and acceptability of a new vaccine adjuvant (immune booster) called PAL when combined with the seasonal flu vaccine (Fluviral) to test the safety and effectiveness of new vaccines and medications on healthy volunteers.
The study will enroll approximately 48 healthy adult participants, and occur over 3 years. In the first six months/180 days of the study participants will have visits to the study site during which safety and immunogenicity outcomes will be measured. From Day 181 to Year 3, participants will be contacted by telephone or email to collect information on any adverse events.
Read the detailed description
This is a phase 1, dose-ranging, randomized (5:1), observer-blind, controlled study of the safety and immune response to intramuscular injection of PapMV (Papaya Mosaic Virus) rVLP (Recombinant Virus-Like Particles) which is PAL adjuvant, or "PAL" combined with Trivalent Influenza Vaccines (TIV) at one of four dose levels of PAL, combined with one of two dose levels of TIV, or active control (TIV). The study will enroll approximately 48 healthy adult participants, and occur over 3 years. In the first six months/180 days (Epoch 1) of the study participants will have visits to the study site during which safety and immunogenicity outcomes will be measured. In Epoch 2 (Day 181 to Year 3) participants will be contacted by telephone or email to collect unsolicited adverse events.
This is a controlled clinical trial. The control group will receive the standard dose of TIV, 0.5 mL, which consists of 15 μg haemagglutinin (HA) of each influenza strain recommended by the World Health Organization (WHO) for the 2013-2014 influenza season in the northern hemisphere. An active control is used so that the attributable risk of adverse events can be estimated, and so that outcome measures can be assessed in a blinded fashion. Only adults in stable health will be eligible in order to minimize participant risk. Only non-pregnant females of childbearing age are eligible, and they must agree to continue adequate contraception for 180 days after injection. Study holding rules and a safety evaluation by a Safety Review Committee (SRC) will be in place. The study will follow a staggered dose-escalation design, with each of four steps introducing a new dose of the adjuvant (30, 60, 120 and 240 μg respectively).
The first dose level of PAL adjuvant FB-631 is 0.5 X 60 µg (i.e., 30 µg), which is half the dose that was found to be most immunogenic in animal studies. The adjuvant is co-administered with 0.25 mL of TIV, which is half the dose of TIV that is routinely administered to adults (i.e. 7.5 μg of each of the three influenza subtypes contained in the vaccine). The next dose level is 60µg of FB-631 combined with 0.25 mL TIV. The third dose level is 120 μg of FB-631 with 0.25 mL TIV. In the fourth and final step the dose of adjuvant is 240 μg of PAL adjuvant combined with 0.25 mL TIV (8 participants) or 0.125 mL TIV (i.e. 3.75 μg HA of each influenza subtype contained in the vaccine) (8 participants).
Any safety signal observed in the study will lead to a hold until the decision of Safety Review Committee to continue, modify or suspend the conduct of the study.
- Conditions
- Flu
- Being tested
- PAL, TIV
- Keywords
- PAL, fluviral, healthy volunteer, adjuvant, TH1 immune response
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PALBiological
Also called PapMV Adjuvant Long lasting immune response, FB-631
Single dose administered intramuscularly.
TIVBiological
Also called Trivalent Influenza Vaccines, Fluviral
Single dose administered intramuscularly .
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Single dose of control vaccine (a single dose of 0.5 mL TIV). Receives: Biological: TIV |
| Group 2 | Experimental | Single dose of the test article (0.25 mL TIV, which is 7.5 μg of each influenza strain with 0.5x PAL, i.e. 30 μg). Receives: Biological: PAL; Biological: TIV |
| Group 3 | Experimental | Single dose of the test article (0.25 mL TIV, which is 7.5 μg of each influenza strain with 1x PAL, i.e. 60 μg). Receives: Biological: PAL; Biological: TIV |
| Group 4 | Experimental | Single dose of the test article (0.25 mL of TIV which is 7.5 μg of each influenza strain with 2x PAL (i.e., 120 μg). Receives: Biological: PAL; Biological: TIV |
| Group 5 | Experimental | Single dose of the test article (0.25 mL of TIV which is 7.5 μg of each influenza strain with 4x PAL (i.e., 240 μg). Receives: Biological: PAL; Biological: TIV |
| Group 6 | Experimental | Single dose of the test article (0.125 mL of TIV with 4x PAL i.e., 240 μg). Receives: Biological: PAL; Biological: TIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
The occurrence of adverse events from injection to Day 1095 (36 months/three years, in all participants, in all groups:
Measured: 3 years
Secondary outcomes (7)
Immunogenicity
Evaluate the immunogenicity of influenza antigens contained in TIV when combined with PAL adjuvant as measured by haemagglutination inhibition (HAI) titres, pre-injection (Day 0) and post-injection (Days 28, 120 and 180).
Measured: 6 months
Immunogenicity of TIV combined with PAL
Immunogenicity of the influenza antigens contained in TIV when combined with PAL adjuvant as measured by IgG and IgG1 antibody directed to influenza A viral nucleoproteins on Days 0, 28, 120 and 180.
Measured: 6 months
Immune responses
Describe cellular immune responses to the investigational products as assessed by antigen-secreted interferon-gamma secretion, and interferon-gamma to IL-10 ratio, pre-injection (Day 0) and post-injection (Day 28, Day 120 and Day 180).
Measured: 6 months
Induced immune responses
Describe immune responses induced by PAL adjuvant combined with TIV as measured by Granzyme B levels in Peripheral Blood Mononuclear Cells (PBMC), pre-injection (Day 0) and post-injection (Day 28, Day 120 and Day 180).
Measured: 6 months
Solicited and General Adverse Events
The occurrence of each solicited local and general AE (adverse event), during a 7-day follow-up period after injection (i.e. the day of injection and 6 subsequent days).
Measured: up to 6 months
Hematological laboratory values
The occurrence of any hematological (hemoglobin level, WBC (white blood cells), lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (ALT, AST(angiotensin sensitivity test) and creatinine) laboratory abnormality at Day 0 and at Day 7.
Measured: up to 6 months
Unsolicited Adverse Events
The occurrence of any unsolicited AE, during a 28-day follow-up period after injection (i.e. the day of injection and 27 subsequent days), and through to Day 1095. The occurrence of any SAE through to Day 1095.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FluStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Folia Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joanne Langley, M.D., Principal investigator, Canadian Center for Vaccinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188810
- Sponsor's protocol ID
- PE1202
- Status last verified
- Feb 2016
- First submitted
- 1 Jul 2014
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized, Observer-blind, Controlled, Dose Escalation Trial of the Safety and Tolerability of a Single Intramuscular Dose of a PAL Adjuvant (FB-631) Co-administered With Seasonal TIV (2013-2014) in Healthy Adults.
- ClinicalTrials.gov ID
- NCT02188810
- Acronym / sponsor ID
- PE1202
- Conditions
- Flu
- Keywords
- PAL, fluviral, healthy volunteer, adjuvant, TH1 immune response
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Folia Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 14 Jul 2014 (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 is a phase 1, research study is looking at the safety and acceptability of a new vaccine adjuvant (immune booster) called PAL when combined with the seasonal flu vaccine (Fluviral) to test the safety and effectiveness of new vaccines and medications on healthy volunteers.
The study will enroll approximately 48 healthy adult participants, and occur over 3 years. In the first six months/180 days of the study participants will have visits to the study site during which safety and immunogenicity outcomes will be measured. From Day 181 to Year 3, participants will be contacted by telephone or email to collect information on any adverse events.
Detailed description
This is a phase 1, dose-ranging, randomized (5:1), observer-blind, controlled study of the safety and immune response to intramuscular injection of PapMV (Papaya Mosaic Virus) rVLP (Recombinant Virus-Like Particles) which is PAL adjuvant, or "PAL" combined with Trivalent Influenza Vaccines (TIV) at one of four dose levels of PAL, combined with one of two dose levels of TIV, or active control (TIV). The study will enroll approximately 48 healthy adult participants, and occur over 3 years. In the first six months/180 days (Epoch 1) of the study participants will have visits to the study site during which safety and immunogenicity outcomes will be measured. In Epoch 2 (Day 181 to Year 3) participants will be contacted by telephone or email to collect unsolicited adverse events.
This is a controlled clinical trial. The control group will receive the standard dose of TIV, 0.5 mL, which consists of 15 μg haemagglutinin (HA) of each influenza strain recommended by the World Health Organization (WHO) for the 2013-2014 influenza season in the northern hemisphere. An active control is used so that the attributable risk of adverse events can be estimated, and so that outcome measures can be assessed in a blinded fashion. Only adults in stable health will be eligible in order to minimize participant risk. Only non-pregnant females of childbearing age are eligible, and they must agree to continue adequate contraception for 180 days after injection. Study holding rules and a safety evaluation by a Safety Review Committee (SRC) will be in place. The study will follow a staggered dose-escalation design, with each of four steps introducing a new dose of the adjuvant (30, 60, 120 and 240 μg respectively).
The first dose level of PAL adjuvant FB-631 is 0.5 X 60 µg (i.e., 30 µg), which is half the dose that was found to be most immunogenic in animal studies. The adjuvant is co-administered with 0.25 mL of TIV, which is half the dose of TIV that is routinely administered to adults (i.e. 7.5 μg of each of the three influenza subtypes contained in the vaccine). The next dose level is 60µg of FB-631 combined with 0.25 mL TIV. The third dose level is 120 μg of FB-631 with 0.25 mL TIV. In the fourth and final step the dose of adjuvant is 240 μg of PAL adjuvant combined with 0.25 mL TIV (8 participants) or 0.125 mL TIV (i.e. 3.75 μg HA of each influenza subtype contained in the vaccine) (8 participants).
Any safety signal observed in the study will lead to a hold until the decision of Safety Review Committee to continue, modify or suspend the conduct of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Biological: TIVSingle dose of control vaccine (a single dose of 0.5 mL TIV). |
| Group 2 | Experimental | Biological: PAL, Biological: TIVSingle dose of the test article (0.25 mL TIV, which is 7.5 μg of each influenza strain with 0.5x PAL, i.e. 30 μg). |
| Group 3 | Experimental | Biological: PAL, Biological: TIVSingle dose of the test article (0.25 mL TIV, which is 7.5 μg of each influenza strain with 1x PAL, i.e. 60 μg). |
| Group 4 | Experimental | Biological: PAL, Biological: TIVSingle dose of the test article (0.25 mL of TIV which is 7.5 μg of each influenza strain with 2x PAL (i.e., 120 μg). |
| Group 5 | Experimental | Biological: PAL, Biological: TIVSingle dose of the test article (0.25 mL of TIV which is 7.5 μg of each influenza strain with 4x PAL (i.e., 240 μg). |
| Group 6 | Experimental | Biological: PAL, Biological: TIVSingle dose of the test article (0.125 mL of TIV with 4x PAL i.e., 240 μg). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Good general health status, as determined by history and physical examination no greater than 30 days prior to administration of the first test article.
- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of Diary Cards, return for follow-up visits).
- If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection and has a negative pregnancy test on the day of injection and has agreed to continue adequate contraception until 180 days after injection. (Please refer to the glossary for the definition of child-bearing potential and adequate contraception).
Key exclusion criteria (13 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study product within 28 days preceding the dose of study product, or planned use during the study period.
- Planned administration/ administration of a vaccine/product not foreseen by the study protocol within the period starting 28 days before injection and ending 28 days after.
- Planned administration/ administration of the seasonal influenza vaccine recommended by local public health authorities within the period starting 120 days before injection and ending 121 days after. (Note: enrolment should be completed 120 days before the annual seasonal influenza vaccine campaigns in October and December)
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study product or planned administration during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. (Laboratory testing for HIV, Hepatitis C and Hepatitis B will be performed during the screening visit).
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 |
|---|---|---|
| PALAlso: PapMV Adjuvant Long lasting immune response, FB-631Single dose administered intramuscularly. | Biological | Group 2, Group 3, Group 4, Group 5, Group 6 |
| TIVAlso: Trivalent Influenza Vaccines, FluviralSingle dose administered intramuscularly . | Biological | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
Primary outcome
Safety
Time frame: 3 years
The occurrence of adverse events from injection to Day 1095 (36 months/three years, in all participants, in all groups:
7 secondary outcomes
Immunogenicity
Time frame: 6 months
Immunogenicity of TIV combined with PAL
Time frame: 6 months
Immune responses
Time frame: 6 months
Induced immune responses
Time frame: 6 months
Solicited and General Adverse Events
Time frame: up to 6 months
Hematological laboratory values
Time frame: up to 6 months
Unsolicited Adverse Events
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
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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.
Joanne Langley, M.D. principal investigator
Canadian Center for Vaccinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PAL and TIV in people with Flu, run by Folia Biotech Inc. at 1 site in Canada.
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 3 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 12 Feb 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 Canada. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Safety (time frame: 3 years). 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 12 Feb 2016.