Influenza InfectionPhase 2NCT03784885
A Phase 2, Double-blind Study to Evaluate Intranasal Trivalent Influenza Virus Vaccine in Healthy Adult
A Phase 2 study testing AD07010 and Inactivated trivalent influenza vaccine in people with Influenza Infection, run by Advagene Biopharma Co. Ltd. at 1 site in Taiwan.
Trial summary
The objectives of this phase 2 study are to evaluate immunogenicity, safety and tolerability of AD07030, a trivalent influenza virus antigens vaccine, given intranasally in 2 doses in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Infection
- What is being tested?
- AD07010 and Inactivated trivalent influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2017to 30 Oct 2018
- Phase
- Phase 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult male and female subjects aged between 20-70 (included) years.
- Should be physically and mentally healthy and free of significant medical condition as determined by Medical history, Physical examination and Clinical judgment of the Investigator.
- Negative urine β-human chorionic gonadotropin in women of childbearing potential (WOCBP; defined as women ≤ 50 years old of age or history of amenorrhea for ≤12 months) prior to administration of first dose of Investigational Product.
- WOCBP and male subjects having female partners, who are WOCBP, should be protected by effective contraceptive method (e.g. oral contraceptive and condom, intra- uterine device and condom, diaphragm with spermicide and condom) throughout the study period.
- Willing and able to give written informed consent prior to Screening and comply with study procedure.
Who cannot join
- Received vaccination against influenza within 6 months prior to Screening.
- Received any vaccination (other than influenza) within 28 days prior to Screening.
- Has previously experienced anaphylaxis or a life-threatening reaction; or has history of allergy or hypersensitivity to egg proteins, chicken proteins, any of the components of Investigational Product, or other vaccine containing same substances.
- History of influenza infection (confirmed either clinically, serologically or microbiologically) within the 6 months prior to administration of first dose of Investigational Product.
- Had active allergic rhinitis within 28 days prior to administration of first dose of Investigational Product.
- Has documented history of diarrhea within 28 days prior to administration of first dose of Investigational Product.
Show all 22Show fewer
- Have used or been administered any intranasal medication or nasal topical treatment within 7 days prior to Screening.
- Acute respiratory illness within 7 days prior to administration of first dose of Investigational Product.
- Had administration of systemic antibiotics or antivirals within 7 days prior to Screening (excluding topical/external use of antibiotics).
- Acute sinusitis or chronic sinusitis accompanying acute symptoms within 3 days prior to administration of first dose of Investigational Product.
- With acute disease (defined as fever with body temperature >38.0°C), within 3 days prior to administration of first dose of Investigational Product.
- Having any serious chronic illness, including but not limited to, cardiovascular, pulmonary, hepatic, metabolic, renal or any auto-immune disorders, at a stage that could interfere with trial conduct or completion.
- Any confirmed or suspected immunosuppressive or immune-deficient condition, based on medical history and physical examination.
- Documented history of Bell's palsy or neurological disorder.
- Receive aspirin (Salicylate) anytime in the study from screening (Visit 1)
- A positive test for HIV antibody
- Receipt of any immunoglobulins and/or blood products within 3 months of study Screening.
- Pregnant or breast-feeding women
- Require extended long-term use of steroids including parenteral steroids or high dose inhaled steroids or have used within 28 days prior to Screening
- Participated in any other clinical investigation or use of any investigational therapy other than AD07030, within 4 weeks (28 days) or 5 half-lives, whichever is longer, before Screening.
- Unable to communicate reliably with the Investigator or unlikely to cooperate with the requirements of the study procedures or schedule, or other cases judged by the Investigator to be ineligible for participation in the study.
- Other cases judged by the Investigator to be ineligible for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Double-blind, Randomized Controlled Study to Evaluate Immunogenicity and Safety of Intranasal Trivalent Influenza Virus Vaccine in Healthy Adult V Olunteers
The objectives of this phase 2 study are to evaluate immunogenicity, safety and tolerability of AD07030, a trivalent influenza virus antigens vaccine, given intranasally in 2 doses in healthy adult volunteers.
Read the detailed description
This is a Phase 2 prospective, randomized controlled, double-blind, multi-center study to evaluate the immunogenicity, safety and tolerability of AD07030, a trivalent influenza virus antigens vaccine, given intranasally in healthy adult volunteers.
About 358 healthy subjects, meeting all the eligibility criteria will be enrolled into the study and randomized into 3 study groups (in 2:2:1 ratio) to receive either the study vaccine at one of the dose levels of adjuvant AD07010 (30μg or 45μg LTh(αK)) in combination with hemagglutinin (HA) antigens or to receive control vaccine consisting of HA antigens alone. The 3 study groups are as follows:
- Group 1: 22.5μg HA with 30μg AD07010
- Group 2: 22.5μg HA with 45μg AD07010
- Group 3: 22.5μg HA alone Each subject will receive intranasal administration of 2 doses of IP (study or control vaccine) at same dosages, given 7 days apart on study Day 1 and Day 8. Solicited local and general AEs will be recorded after each vaccination in the subject's diary card for up to 7 days (the vaccine administration day and 6 days following it). Subjects will be followed up for monitoring of safety and immunogenicity for 180 days. AE and SAE and concomitant medication/vaccination will be collected throughout the study. There will be total of 6 study visits and a telephone call.
- Conditions
- Influenza Infection
- Being tested
- AD07010, Inactivated trivalent influenza vaccine
- Keywords
- adjuvant, vaccine, mucosa, IgA, Escherichia coli Enterotoxin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD07010Biological
Also called LTh(αK), Escherichia coli heat-labile enterotoxin
A protein based adjuvant
Inactivated trivalent influenza vaccineBiological
Inactivated trivalent seasonal influenza vaccine
| Study group | Role | What they receive |
|---|---|---|
| 30 μg of AD07010 | Experimental | All subjects in this group received 2 doses of 22.2 μg HA antigens from inactivated trivalent influenza vaccine in 30 μg of AD07010 Receives: Biological: AD07010; Biological: Inactivated trivalent influenza vaccine |
| 45 μg of AD07010 | Experimental | All subjects in this group received 2 doses of 22.2 μg HA antigens from inactivated trivalent influenza vaccine in 45 μg of AD07010 Receives: Biological: AD07010; Biological: Inactivated trivalent influenza vaccine |
| AD07010 | Active comparator | All subjects in this group received 2 doses of 22.2 μg HA antigens from inactivated trivalent influenza vaccine Receives: Biological: Inactivated trivalent influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titer changes on Day 29
Change from pre- to post-vaccination serum Geometric mean titers (GMT) of hemagglutinin inhibition (HI) antibody at Day 29(±2)
Measured: 29 days
Secondary outcomes (4)
Immunogenicity (HI titers)
Derived variables: in terms of HI titers for: Seroconversion Rate (SCR), Seroconversion Factor (SCF), and Seroprotection Rate (SPR)
Measured: 29, 90 and 180 days
Immunogenicity (IgA titers)
Change from pre- to post-vaccination GMT of mucosal anti-HA IgA antibody
Measured: 29, 90 and 180 days
Immunogenicity (anti-LTh(αK) antibodies)
Change from pre- to post-vaccination GMT of anti- LTh(αK) antibodies
Measured: 29, 90 and 180 days
Viral neutralization
Change from pre- to post-vaccination GMT of virus neutralization titer
Measured: 29, 90 and 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start1 Sep 2017
- Primary completion7 Jan 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza InfectionStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advagene Biopharma Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784885
- Sponsor's protocol ID
- 1066021486
- Status last verified
- Dec 2018
- First submitted
- 20 Dec 2018
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pan SC, Hsu WT, Lee WS, Wang NC, Chen TJ, Liu MC, Pai HC, Hsu YS, Chang M, Hsieh SM. A double-blind, randomized controlled trial to evaluate the safety and immunogenicity of an intranasally administered trivalent inactivated influenza vaccine with the adjuvant LTh(alphaK): A phase II study. Vaccine. 2020 Jan 29;38(5):1048-1056. doi: 10.1016/j.vaccine.2019.11.047. Epub 2019 Dec 4.
PubMed 31812463
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-blind, Randomized Controlled Study to Evaluate Immunogenicity and Safety of Intranasal Trivalent Influenza Virus Vaccine in Healthy Adult V Olunteers
- ClinicalTrials.gov ID
- NCT03784885
- Acronym / sponsor ID
- 1066021486
- Conditions
- Influenza Infection
- Keywords
- adjuvant, vaccine, mucosa, IgA, Escherichia coli Enterotoxin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Advagene Biopharma Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 7 Jan 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 24 Dec 2018 (actual)
- 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 objectives of this phase 2 study are to evaluate immunogenicity, safety and tolerability of AD07030, a trivalent influenza virus antigens vaccine, given intranasally in 2 doses in healthy adult volunteers.
Detailed description
This is a Phase 2 prospective, randomized controlled, double-blind, multi-center study to evaluate the immunogenicity, safety and tolerability of AD07030, a trivalent influenza virus antigens vaccine, given intranasally in healthy adult volunteers.
About 358 healthy subjects, meeting all the eligibility criteria will be enrolled into the study and randomized into 3 study groups (in 2:2:1 ratio) to receive either the study vaccine at one of the dose levels of adjuvant AD07010 (30μg or 45μg LTh(αK)) in combination with hemagglutinin (HA) antigens or to receive control vaccine consisting of HA antigens alone. The 3 study groups are as follows:
- Group 1: 22.5μg HA with 30μg AD07010
- Group 2: 22.5μg HA with 45μg AD07010
- Group 3: 22.5μg HA alone Each subject will receive intranasal administration of 2 doses of IP (study or control vaccine) at same dosages, given 7 days apart on study Day 1 and Day 8. Solicited local and general AEs will be recorded after each vaccination in the subject's diary card for up to 7 days (the vaccine administration day and 6 days following it). Subjects will be followed up for monitoring of safety and immunogenicity for 180 days. AE and SAE and concomitant medication/vaccination will be collected throughout the study. There will be total of 6 study visits and a telephone call.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 30 μg of AD07010 | Experimental | Biological: AD07010, Biological: Inactivated trivalent influenza vaccineAll subjects in this group received 2 doses of 22.2 μg HA antigens from inactivated trivalent influenza vaccine in 30 μg of AD07010 |
| 45 μg of AD07010 | Experimental | Biological: AD07010, Biological: Inactivated trivalent influenza vaccineAll subjects in this group received 2 doses of 22.2 μg HA antigens from inactivated trivalent influenza vaccine in 45 μg of AD07010 |
| AD07010 | Active comparator | Biological: Inactivated trivalent influenza vaccineAll subjects in this group received 2 doses of 22.2 μg HA antigens from inactivated trivalent influenza vaccine |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult male and female subjects aged between 20-70 (included) years.
- Should be physically and mentally healthy and free of significant medical condition as determined by Medical history, Physical examination and Clinical judgment of the Investigator.
- Negative urine β-human chorionic gonadotropin in women of childbearing potential (WOCBP; defined as women ≤ 50 years old of age or history of amenorrhea for ≤12 months) prior to administration of first dose of Investigational Product.
- WOCBP and male subjects having female partners, who are WOCBP, should be protected by effective contraceptive method (e.g. oral contraceptive and condom, intra- uterine device and condom, diaphragm with spermicide and condom) throughout the study period.
- Willing and able to give written informed consent prior to Screening and comply with study procedure.
Key exclusion criteria (22 listed)
- Received vaccination against influenza within 6 months prior to Screening.
- Received any vaccination (other than influenza) within 28 days prior to Screening.
- Has previously experienced anaphylaxis or a life-threatening reaction; or has history of allergy or hypersensitivity to egg proteins, chicken proteins, any of the components of Investigational Product, or other vaccine containing same substances.
- History of influenza infection (confirmed either clinically, serologically or microbiologically) within the 6 months prior to administration of first dose of Investigational Product.
- Had active allergic rhinitis within 28 days prior to administration of first dose of Investigational Product.
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 |
|---|---|---|
| AD07010Also: LTh(αK), Escherichia coli heat-labile enterotoxinA protein based adjuvant | Biological | 30 μg of AD07010, 45 μg of AD07010 |
| Inactivated trivalent influenza vaccineInactivated trivalent seasonal influenza vaccine | Biological | 30 μg of AD07010, 45 μg of AD07010, AD07010 |
Primary outcome
Geometric mean titer changes on Day 29
Time frame: 29 days
Change from pre- to post-vaccination serum Geometric mean titers (GMT) of hemagglutinin inhibition (HI) antibody at Day 29(±2)
4 secondary outcomes
Immunogenicity (HI titers)
Time frame: 29, 90 and 180 days
Immunogenicity (IgA titers)
Time frame: 29, 90 and 180 days
Immunogenicity (anti-LTh(αK) antibodies)
Time frame: 29, 90 and 180 days
Viral neutralization
Time frame: 29, 90 and 180 days
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 26 Dec 2018.
- Derived from this study: PubMed 31812463Pan SC, Hsu WT, Lee WS, Wang NC, Chen TJ, Liu MC, Pai HC, Hsu YS, Chang M, Hsieh SM. A double-blind, randomized controlled trial to evaluate the safety and immunogenicity of an intranasally administered trivalent inactivated influenza vaccine with the adjuvant LTh(alphaK): A phase II study. Vaccine. 2020 Jan 29;38(5):1048-1056. doi: 10.1016/j.vaccine.2019.11.047. Epub 2019 Dec 4.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AD07010 and Inactivated trivalent influenza vaccine in people with Influenza Infection, run by Advagene Biopharma Co. Ltd. at 1 site in Taiwan.
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 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: finished, as of the sponsor's last update on 26 Dec 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 Taiwan. 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 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?
Geometric mean titer changes on Day 29 (time frame: 29 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 NCT03784885, which also lists 1 linked publication.
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 Dec 2018; AzTrials last refreshed its copy on 28 Oct 2026.