Flu, HumanPhase 1NCT03293732
Study of the Safety, Tolerability and Immunogenicity of an Intranasal Influenza Vaccine Administered to Healthy Adults
A Phase 1 study testing DCB07010 and HA antigens in people with Flu, Human, run by Advagene Biopharma Co. Ltd. at 1 site in Taiwan.
Trial summary
The objectives of this study were to assess the safety and tolerability of DCB07010 when given intranasally at escalating dose levels of 7.5μg, 15μg, 30μg and 45μg, in combination with 22.5μg of influenza HA antigen (7.5μg HA of each of three strains) and to generate sufficient immunogenicity data to enable dose… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Flu, Human
- What is being tested?
- DCB07010 and HA antigens
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Nov 2012to 30 Sep 2013
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking adult aged between 20-40 years old;
- Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest X-rays, ophthalmoscopy, cardiac echo, and electrocardiogram;
- Body Mass Index (BMI) between 18.5 and 25, inclusive, (BMI will be calculated as weight in kilogram [kg]/height in meters2 [m2]);
- Normal hematology, biochemistry and urinalysis determinations;
- Subject is willing and able to comply with study procedures and sign informed consent
Who cannot join
- Subject with serious underlying chronic illness;
- Documented evidence of allergic rhinitis;
- Subject with acute sinusitis or chronic sinusitis accompanying acute symptoms within 3 days prior to enrollment;
- Immunosuppressed subjects as result of illness or treatment;
- Female subject of childbearing potential who:
- is lactating; or
Show all 21Show fewer
- has positive urine pregnancy test at Visit 2 or Visit 3; or
- refuse to adopt reliable method of contraception during the study;
- Subject received blood products or immunoglobulin within 3 months prior enrollment;
- Subjects with long-term use of steroids, including parenteral steroids or high dose inhaled steroids within 28 days prior to enrollment;
- Subject has received any intranasal medication or nasal topical treatment within 7 days prior to enrollment;
- Subject has received any investigational agent within 28 days or 5 half- lives, whichever is longer, prior to the first dose of investigational product;
- Subject has previously experienced anaphylaxis;
- Subject has allergy to eggs or prior influenza vaccine;
- Subject with laboratory-confirmed influenza or has been vaccinated against influenza within 6 months prior to enrollment;
- Subject with acute respiratory illness or administered antibiotics or antivirals within 7 days prior to enrollment;
- Subject with body temperature high than 38°C within 3 days prior to enrollment;
- Subject with documented history of Bell's palsy or neurological disorder.
- Subject with documented history of diarrhea within one month prior to study enrollment
- A positive test for HIV antibody.
- Subject has received Chinese medication or herbal medication within 28 days prior to enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind Phase I Trial to Evaluate the Safety, Tolerability, and Immunogenicity of DCB07010 Adjuvant Given Intranasally at Ascending Dose Levels and Co-administered With Trivalent Inactivated Influenza Virus Antigen
The objectives of this study were to assess the safety and tolerability of DCB07010 when given intranasally at escalating dose levels of 7.5μg, 15μg, 30μg and 45μg, in combination with 22.5μg of influenza HA antigen (7.5μg HA of each of three strains) and to generate sufficient immunogenicity data to enable dose selection for larger and more definitive Phase 2 studies.
This was a single center, double-blind, randomized (2:1), dose-escalation study to assess the safety, tolerability and immunogenicity of 4 different vaccine-adjuvant doses in comparison to influenza HA alone. The 4 treatment cohorts were given DCB07010 in a dose- escalating manner.
- Conditions
- Flu, Human
- Being tested
- DCB07010, HA antigens
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCB07010Biological
A protein based adjuvant originated from prokaryotic organism.
HA antigensBiological
HA antigens from three strains of influenza virus ( 7.5 μg of HA each strain).
| Study group | Role | What they receive |
|---|---|---|
| HA antigen only | Active comparator | All subjects in this group received 2 doses of 22.2 μg HA antigens Receives: Biological: HA antigens |
| 7.5 μg of DCB07010 | Experimental | All subjects in this group received 7.5 μg of DCB07010 in 22.2 μg HA antigens twice. Receives: Biological: DCB07010; Biological: HA antigens |
| 15 μg of DCB07010 | Experimental | All subjects in this group received 15 μg of DCB07010 in 22.2 μg HA antigens twice. Receives: Biological: DCB07010; Biological: HA antigens |
| 30 μg of DCB07010 | Experimental | All subjects in this group received 30 μg of DCB07010 in 22.2 μg HA antigens twice. Receives: Biological: DCB07010; Biological: HA antigens |
| 45 μg of DCB07010 | Experimental | All subjects in this group received 45 μg of DCB07010 in 22.2 μg HA antigens twice. Receives: Biological: DCB07010; Biological: HA antigens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titers (GMT) against all three strains of viral antigen
Geometric Mean Titers (GMT) against all three strains of viral antigen after 2 doses of DCB07010 adjuvanted egg-derived vaccines or egg-derived vaccine. The geometric mean titers against all three-vaccine strains were assessed by egg-derived antigen haemagglutination inhibition (HI) assay.
Statistic tests were two-sided and were set for alpha = 0.05. The purpose of this study was exploratory in safety and the formal statistical analysis was not necessary.
Measured: Day=0, 28
Secondary outcomes (2)
Geometric Mean Ratio (GMR) after 2 dose of vaccines
Geometric Mean Ratio (GMR) after 2 dose of egg-based vaccine and DCB07010-adjuvanted vaccines. Statistic tests were two-sided and were set for alpha = 0.05. The purpose of this study was exploratory in safety and the formal statistical analysis was not necessary.
Measured: Day=0, 28
Seroconversion Rates (SCR) measurements
Seroconversion Rates (SCR) is defined the percentage of subjects with pre-vaccination HI titers < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer to each of the three vaccine components on Day 28.
Measured: Day=0, 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start28 Nov 2012
- Primary completion30 Mar 2013
- Study completion30 Sep 2013
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 Flu, 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advagene Biopharma Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Taiwan University Hospital
- Responsible party
- Sponsor
- Investigators
- Shaun-Chwen Chang, Ph.D., Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293732
- Sponsor's protocol ID
- DCB07030-CT-01
- Status last verified
- Jan 2020
- First submitted
- 19 Sep 2017
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pan SC, Hsieh SM, Lin CF, Hsu YS, Chang M, Chang SC. A randomized, double-blind, controlled clinical trial to evaluate the safety and immunogenicity of an intranasally administered trivalent inactivated influenza vaccine with adjuvant LTh(alphaK): A phase I study. Vaccine. 2019 Mar 28;37(14):1994-2003. doi: 10.1016/j.vaccine.2019.02.006. Epub 2019 Mar 2.
PubMed 30837170
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Phase I Trial to Evaluate the Safety, Tolerability, and Immunogenicity of DCB07010 Adjuvant Given Intranasally at Ascending Dose Levels and Co-administered With Trivalent Inactivated Influenza Virus Antigen
- ClinicalTrials.gov ID
- NCT03293732
- Acronym / sponsor ID
- DCB07030-CT-01
- Conditions
- Flu, Human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Advagene Biopharma Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- National Taiwan University Hospital
- Study start
- 28 Nov 2012 (actual)
- Primary completion
- 30 Mar 2013 (actual)
- Study completion
- 30 Sep 2013 (actual)
- First posted
- 26 Sep 2017 (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 study were to assess the safety and tolerability of DCB07010 when given intranasally at escalating dose levels of 7.5μg, 15μg, 30μg and 45μg, in combination with 22.5μg of influenza HA antigen (7.5μg HA of each of three strains) and to generate sufficient immunogenicity data to enable dose selection for larger and more definitive Phase 2 studies.
This was a single center, double-blind, randomized (2:1), dose-escalation study to assess the safety, tolerability and immunogenicity of 4 different vaccine-adjuvant doses in comparison to influenza HA alone. The 4 treatment cohorts were given DCB07010 in a dose- escalating manner.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| HA antigen only | Active comparator | Biological: HA antigensAll subjects in this group received 2 doses of 22.2 μg HA antigens |
| 7.5 μg of DCB07010 | Experimental | Biological: DCB07010, Biological: HA antigensAll subjects in this group received 7.5 μg of DCB07010 in 22.2 μg HA antigens twice. |
| 15 μg of DCB07010 | Experimental | Biological: DCB07010, Biological: HA antigensAll subjects in this group received 15 μg of DCB07010 in 22.2 μg HA antigens twice. |
| 30 μg of DCB07010 | Experimental | Biological: DCB07010, Biological: HA antigensAll subjects in this group received 30 μg of DCB07010 in 22.2 μg HA antigens twice. |
| 45 μg of DCB07010 | Experimental | Biological: DCB07010, Biological: HA antigensAll subjects in this group received 45 μg of DCB07010 in 22.2 μg HA antigens twice. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Non-smoking adult aged between 20-40 years old;
- Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest X-rays, ophthalmoscopy, cardiac echo, and electrocardiogram;
- Body Mass Index (BMI) between 18.5 and 25, inclusive, (BMI will be calculated as weight in kilogram [kg]/height in meters2 [m2]);
- Normal hematology, biochemistry and urinalysis determinations;
- Subject is willing and able to comply with study procedures and sign informed consent
Key exclusion criteria (21 listed)
- Subject with serious underlying chronic illness;
- Documented evidence of allergic rhinitis;
- Subject with acute sinusitis or chronic sinusitis accompanying acute symptoms within 3 days prior to enrollment;
- Immunosuppressed subjects as result of illness or treatment;
- Female subject of childbearing potential who:
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 |
|---|---|---|
| DCB07010A protein based adjuvant originated from prokaryotic organism. | Biological | 15 μg of DCB07010, 30 μg of DCB07010, 45 μg of DCB07010, 7.5 μg of DCB07010 |
| HA antigensHA antigens from three strains of influenza virus ( 7.5 μg of HA each strain). | Biological | 15 μg of DCB07010, 30 μg of DCB07010, 45 μg of DCB07010, 7.5 μg of DCB07010, HA antigen only |
Primary outcome
Geometric Mean Titers (GMT) against all three strains of viral antigen
Time frame: Day=0, 28
Geometric Mean Titers (GMT) against all three strains of viral antigen after 2 doses of DCB07010 adjuvanted egg-derived vaccines or egg-derived vaccine. The geometric mean titers against all three-vaccine strains were assessed by egg-derived antigen haemagglutination inhibition (HI) assay. Statistic tests were two-sided and were set for alpha = 0.05. The purpose of this study was exploratory in safety and the formal statistical analysis was not necessary.
2 secondary outcomes
Geometric Mean Ratio (GMR) after 2 dose of vaccines
Time frame: Day=0, 28
Seroconversion Rates (SCR) measurements
Time frame: Day=0, 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Derived from this study: PubMed 30837170Pan SC, Hsieh SM, Lin CF, Hsu YS, Chang M, Chang SC. A randomized, double-blind, controlled clinical trial to evaluate the safety and immunogenicity of an intranasally administered trivalent inactivated influenza vaccine with adjuvant LTh(alphaK): A phase I study. Vaccine. 2019 Mar 28;37(14):1994-2003. doi: 10.1016/j.vaccine.2019.02.006. Epub 2019 Mar 2.
- Individual participant dataSharing planned: No
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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.
Shaun-Chwen Chang, Ph.D. study chair
National Taiwan University Hospital
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 DCB07010 and HA antigens in people with Flu, Human, 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 21 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 7 Jan 2020. 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 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?
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 Titers (GMT) against all three strains of viral antigen (time frame: Day=0, 28). 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 NCT03293732, 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 7 Jan 2020.