Evaluation of the Safety and Immunogenicity of a Sublingual Influenza Vaccine NSV0001 in Healthy Male Volunteers

NCT02955030 | Completed Phase 1

• 1 other identifier: NSV0001-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of a sublingual administration of NSV0001 in healthy male volunteers.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Number of subjects with local and systemic reactions and subjects reporting one or more adverse events

  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)

  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)

  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)

  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)

  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)

  28 days after last vaccination

Other Outcomes (5)

• Change of immunological response of IgA ELISA specific for A/H1N1 in serum

  28 days after last vaccination

• Change of immunological response of IgA ELISA specific for A/H1N1 in the nasal wash

  28 days after last vaccination

• GMT ratio of immunological response of IgA ELISA specific for A/H1N1 in the nasal wash

  28 days after last vaccination

Study Arms (5)

NSV0001(Cohort1)

EXPERIMENTAL

15 µg of hemagglutinin \[HA\] antigen per strain with 150 µg of ND002 adjuvant, administration by sublingual route

Biological: NSV0001

NSV0001(Cohort2)

EXPERIMENTAL

30 µg of hemagglutinin\[HA\] antigen per strain with 300 µg of ND002 adjuvant, administration by sublingual route

Biological: NSV0001

NSV0001(Cohort3)

EXPERIMENTAL

60 µg of hemagglutinin\[HA\] antigen per strain with 600 µg of ND002 adjuvant, administration by sublingual route

Biological: NSV0001

Placebo

PLACEBO COMPARATOR

0 µg of hemagglutinin\[HA\] antigen per strain with 0 µg of ND002 adjuvant, administration by sublingual route

Biological: Placebo

Influenza HA vaccine "Biken HA"

ACTIVE COMPARATOR

Seasonal quadrivalent influenza vaccine, administration by subcutaneous injection route

Biological: Influenza HA vaccine "Biken HA"

Interventions

NSV0001 BIOLOGICAL

sublingual

NSV0001(Cohort1); NSV0001(Cohort2); NSV0001(Cohort3)

Influenza HA vaccine "Biken HA" BIOLOGICAL

subcutaneous

Influenza HA vaccine "Biken HA"

Placebo BIOLOGICAL

sublingual

Placebo

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nitto Denko Corporation: lead

Study Sites (1)

OPHAC Hospital

Osaka, 532-0003, Japan

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Senior fellow

  Nitto Denko Corporation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 4, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 18, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)