Evaluation of the Safety and Immunogenicity of a Sublingual Influenza Vaccine NSV0001 in Healthy Male Volunteers
Influenza
About this trial
This is an interventional prevention trial for Influenza
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- OPHAC Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Placebo Comparator
Active Comparator
NSV0001(Cohort1)
NSV0001(Cohort2)
NSV0001(Cohort3)
Placebo
Influenza HA vaccine "Biken HA"
15 µg of hemagglutinin [HA] antigen per strain with 150 µg of ND002 adjuvant, administration by sublingual route
30 µg of hemagglutinin[HA] antigen per strain with 300 µg of ND002 adjuvant, administration by sublingual route
60 µg of hemagglutinin[HA] antigen per strain with 600 µg of ND002 adjuvant, administration by sublingual route
0 µg of hemagglutinin[HA] antigen per strain with 0 µg of ND002 adjuvant, administration by sublingual route
Seasonal quadrivalent influenza vaccine, administration by subcutaneous injection route