InfluenzaPhase 1NCT02955030
Evaluation of the Safety and Immunogenicity of a Sublingual Influenza Vaccine NSV0001 in Healthy Male Volunteers
A Phase 1 study testing NSV0001 and Influenza HA vaccine "Biken HA" in people with Influenza, run by Nitto Denko Corporation at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the safety and immunogenicity of a sublingual administration of NSV0001 in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 20 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- NSV0001 and Influenza HA vaccine "Biken HA"
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2016to Sep 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 20 to 49 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is 20 to 49 years of age on the date of informed consent
- Individuals who are determined eligible healthy adult to participate clinical study from the results of medical history, medical examination and clinical estimation by principal investigator / sub-investigator.
- Written informed consent was obtained from the subject. And the subject whom principal investigator/ sub-investigator judged about the following conditions; the subject will be able to follow study instructions, subject will be able to receive medical examination and tests prescribed in the protocol and subject will be able to inform indication, etc.
- Individuals who will be able to receive telephone communication during clinical trial participations
Who cannot join
- History of administration of seasonal influenza HA vaccine within 180 days
- History of infection of influenza within 180 days
- History of receiving live attenuated vaccine within 28 days or inactivated vaccine/ toxoid within 7 days
- History of receiving any of following treatment such as medical drugs I. Within 28 days: 1. Interferon products, 2. Drugs affected to immune system (e.g., immunosuppressant), 3. Systemic or inhalant adrenocorticosteroid, 4. G-CSF and M-CSF II. Within 84 days: 1. HGG products, 2. Blood products, 3. blood transfusion (including blood component transfusion) III. Within 180 days: 1. massive dose therapy of HGG products (≥200 mg/kg)
- History of previous causing of anaphylaxis by intake of foods or drugs (including vaccine)
- History of previous finding to be suspected allergic reaction of oral cavity, pharynx or laryngeal mucosa
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- Individuals who have hypersensitivity against seasonal influenza HA vaccine or chicken egg, chicken meat and other chicken derived materials
- Individuals who have experience of fever more than 39.0℃ or finding to be suspected allergic reaction e.g. generalized rash within two days after previous preventive treatment (seasonal influenza vaccine and other vaccines)
- History of anamnestic convulsion (excluding anamnestic fever convulsion in childhood)
- History of previously diagnosis of immunodeficiency, or individuals who have close relatives (within third degree) with congenital immunodeficiency syndrome
- History of anamnestic Guillain-Barre syndrome or ADE (Acute Disseminated Encephalomyelitis)
- Individuals who have poorly controlled cardiovascular, hematological, hepatic, renal, gastrointestinal, urological or endocrine metabolic diseases, and such diseases possibly affect to the participation of clinical study or study results
- Individuals who have respiratory diseases e.g. interstitial pneumonia and bronchial asthma
- Individuals who is associated with allergic rhinitis, and have a symptom
- Individuals who have experienced whole blood donation of not less than 400 mL within 12 weeks, whole blood donation of not less than 200 mL within 4 weeks, or apheresis within 2 weeks
- Individuals who have received other study medication within 4 months
- Individuals who have inflammation, swelling or uncomfortable feeling, or mechanical problem in oral cavity, sublingual, tongue, pharynx or laryngeal mucosa, which disturbing sublingual administration or affecting absorption
- Individuals who have not recovered from injury of laryngeal mucosa caused by treatment of dental extraction etc. (excluding treatment of carious teeth)
- Individuals who is associated with disease with abnormal salivation (Sjogren's syndrome, well-defined dry mouth / xerostomia etc.)
- Individuals who have positive reaction against any of STS (serological test for syphilis) (TP antibody, lipid antibodies), HBs antigen, HCV antibody, or HIV antigen/ antibody
- History of anamnestic drug abuse (defined as illegal drug use) or alcoholism within one year before IMP dosing, or individuals who will not give up consuming excessive alcohol
- Individuals who have clinically problematic abnormality in 12-lead electrocardiogram in the examination
- Individuals who have been found abnormal value in clinical laboratory tests, which suggesting clinically problematic complications, or individuals who have been found abnormal value in the following test items: ALT and/ or AST that is more than 3 times of the upper limit of standard value.
- In addition, individuals whom principal investigator/ sub-investigator judged inappropriate as the subject of such clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study to Determine the Safety and Immunogenicity of a Sublingual Administration of NSV0001 in Healthy Male Volunteers
The purpose of this study is to evaluate the safety and immunogenicity of a sublingual administration of NSV0001 in healthy male volunteers.
Read the detailed description
NSV0001 is a quadrivalent influenza vaccine with the new adjuvant (ND002) administered by sublingual route.
This study will enroll healthy male adults. Participants will receive two doses of the vaccine, 4 weeks apart, and will stay in the investigational site for 2 consecutive days after each vaccination.
Participants will keep a patient diary to record the local and systemic reactions for one week after each vaccination. In addition, the safety monitoring will be extended through 6 months from the last vaccination to detect the potential immune mediated disorders (pIMD).
- Conditions
- Influenza
- Being tested
- NSV0001, Influenza HA vaccine "Biken HA", Placebo
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSV0001Biological
sublingual
Influenza HA vaccine "Biken HA"Biological
subcutaneous
PlaceboBiological
sublingual
| Study group | Role | What they receive |
|---|---|---|
| NSV0001(Cohort1) | Experimental | 15 µg of hemagglutinin [HA] antigen per strain with 150 µg of ND002 adjuvant, administration by sublingual route Receives: Biological: NSV0001 |
| NSV0001(Cohort2) | Experimental | 30 µg of hemagglutinin[HA] antigen per strain with 300 µg of ND002 adjuvant, administration by sublingual route Receives: Biological: NSV0001 |
| NSV0001(Cohort3) | Experimental | 60 µg of hemagglutinin[HA] antigen per strain with 600 µg of ND002 adjuvant, administration by sublingual route Receives: Biological: NSV0001 |
| Placebo | Placebo comparator | 0 µg of hemagglutinin[HA] antigen per strain with 0 µg of ND002 adjuvant, administration by sublingual route Receives: Biological: Placebo |
| Influenza HA vaccine "Biken HA" | Active comparator | Seasonal quadrivalent influenza vaccine, administration by subcutaneous injection route Receives: Biological: Influenza HA vaccine "Biken HA" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with local and systemic reactions and subjects reporting one or more adverse events
Measured: 28 days after last vaccination
Secondary outcomes (7)
Seroconversion rate of serum HI antibody titer for each of four strains(A/H1N1, A/H3N2, B/Yamagata, and B/Victoria)
Measured: 28 days after last vaccination
GMT ratio of serum HI antibody titer for each of four strains(A/H1N1, A/H3N2, B/Yamagata, and B/Victoria)
Measured: 28 days after last vaccination
Reciprocal cumulative frequency distribution of serum HI antibody titer for each four strains(A/H1N1, A/H3N2, B/Yamagata, and B/Victoria)
Measured: 28 days after last vaccination
Sero-protection rate of serum HI antibody titer for each of four strains(A/H1N1, A/H3N2, B/Yamagata, and B/Victoria)
Measured: 28 days after last vaccination
Seroconversion rate of serum neutralizing antibody titer for each of four strains(A/H1N1, A/H3N2, B/Yamagata, and B/Victoria)
Measured: 28 days after last vaccination
GMT ratio of serum neutralizing antibody for each of four strains(A/H1N1, A/H3N2, B/Yamagata, and B/Victoria)
Measured: 28 days after last vaccination
Reciprocal cumulative frequency distribution of serum neutralizing antibody titer for each of four strains(A/H1N1, A/H3N2, B/Yamagata, and B/Victoria)
Measured: 28 days after last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2017
- Study completionSep 2017
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nitto Denko Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior fellow, Study chair, Nitto Denko Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955030
- Sponsor's protocol ID
- NSV0001-01
- Status last verified
- Sep 2017
- First submitted
- 2 Nov 2016
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Determine the Safety and Immunogenicity of a Sublingual Administration of NSV0001 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02955030
- Acronym / sponsor ID
- NSV0001-01
- Conditions
- Influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Nitto Denko CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 4 Nov 2016 (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 the safety and immunogenicity of a sublingual administration of NSV0001 in healthy male volunteers.
Detailed description
NSV0001 is a quadrivalent influenza vaccine with the new adjuvant (ND002) administered by sublingual route.
This study will enroll healthy male adults. Participants will receive two doses of the vaccine, 4 weeks apart, and will stay in the investigational site for 2 consecutive days after each vaccination.
Participants will keep a patient diary to record the local and systemic reactions for one week after each vaccination. In addition, the safety monitoring will be extended through 6 months from the last vaccination to detect the potential immune mediated disorders (pIMD).
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 |
|---|---|---|
| NSV0001(Cohort1) | Experimental | Biological: NSV000115 µg of hemagglutinin [HA] antigen per strain with 150 µg of ND002 adjuvant, administration by sublingual route |
| NSV0001(Cohort2) | Experimental | Biological: NSV000130 µg of hemagglutinin[HA] antigen per strain with 300 µg of ND002 adjuvant, administration by sublingual route |
| NSV0001(Cohort3) | Experimental | Biological: NSV000160 µg of hemagglutinin[HA] antigen per strain with 600 µg of ND002 adjuvant, administration by sublingual route |
| Placebo | Placebo comparator | Biological: Placebo0 µg of hemagglutinin[HA] antigen per strain with 0 µg of ND002 adjuvant, administration by sublingual route |
| Influenza HA vaccine "Biken HA" | Active comparator | Biological: Influenza HA vaccine "Biken HA"Seasonal quadrivalent influenza vaccine, administration by subcutaneous injection route |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject is 20 to 49 years of age on the date of informed consent
- Individuals who are determined eligible healthy adult to participate clinical study from the results of medical history, medical examination and clinical estimation by principal investigator / sub-investigator.
- Written informed consent was obtained from the subject. And the subject whom principal investigator/ sub-investigator judged about the following conditions; the subject will be able to follow study instructions, subject will be able to receive medical examination and tests prescribed in the protocol and subject will be able to inform indication, etc.
- Individuals who will be able to receive telephone communication during clinical trial participations
Key exclusion criteria (24 listed)
- History of administration of seasonal influenza HA vaccine within 180 days
- History of infection of influenza within 180 days
- History of receiving live attenuated vaccine within 28 days or inactivated vaccine/ toxoid within 7 days
- History of receiving any of following treatment such as medical drugs I. Within 28 days: 1. Interferon products, 2. Drugs affected to immune system (e.g., immunosuppressant), 3. Systemic or inhalant adrenocorticosteroid, 4. G-CSF and M-CSF II. Within 84 days: 1. HGG products, 2. Blood products, 3. blood transfusion (including blood component transfusion) III. Within 180 days: 1. massive dose therapy of HGG products (≥200 mg/kg)
- History of previous causing of anaphylaxis by intake of foods or drugs (including vaccine)
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 |
|---|---|---|
| NSV0001sublingual | Biological | NSV0001(Cohort1), NSV0001(Cohort2), NSV0001(Cohort3) |
| Influenza HA vaccine "Biken HA"subcutaneous | Biological | Influenza HA vaccine "Biken HA" |
| Placebosublingual | Biological | Placebo |
Primary outcome
Number of subjects with local and systemic reactions and subjects reporting one or more adverse events
Time frame: 28 days after last vaccination
7 secondary outcomes
Seroconversion rate of serum HI antibody titer for each of four strains(A/H1N1, A/H3N2, B/Yamagata, and B/Victoria)
Time frame: 28 days after last vaccination
GMT ratio of serum HI antibody titer for each of four strains(A/H1N1, A/H3N2, B/Yamagata, and B/Victoria)
Time frame: 28 days after last vaccination
Reciprocal cumulative frequency distribution of serum HI antibody titer for each four strains(A/H1N1, A/H3N2, B/Yamagata, and B/Victoria)
Time frame: 28 days after last vaccination
Sero-protection rate of serum HI antibody titer for each of four strains(A/H1N1, A/H3N2, B/Yamagata, and B/Victoria)
Time frame: 28 days after last vaccination
Seroconversion rate of serum neutralizing antibody titer for each of four strains(A/H1N1, A/H3N2, B/Yamagata, and B/Victoria)
Time frame: 28 days after last vaccination
GMT ratio of serum neutralizing antibody for each of four strains(A/H1N1, A/H3N2, B/Yamagata, and B/Victoria)
Time frame: 28 days after last vaccination
Reciprocal cumulative frequency distribution of serum neutralizing antibody titer for each of four strains(A/H1N1, A/H3N2, B/Yamagata, and B/Victoria)
Time frame: 28 days after last 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 18 Sep 2017.
- 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.
Senior fellow study chair
Nitto Denko Corporation
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 NSV0001 and Influenza HA vaccine "Biken HA" in people with Influenza, run by Nitto Denko Corporation at 1 site in Japan.
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 4 inclusion and 24 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 18 Sep 2017. 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 Japan. 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. Some participants in this study may receive a placebo. 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?
Number of subjects with local and systemic reactions and subjects reporting one or more adverse events (time frame: 28 days after last 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 18 Sep 2017.