Phase 1 Study to Determine the Safety and Immunogenicity of a Sublingual Administration of NSV0001 in Healthy Male Volunteers

Nitto Denko Corporation1 site in 1 country90 target enrollmentOctober 2016

ConditionsInfluenza

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Influenza
Sponsor: Nitto Denko Corporation
Enrollment: 90
Locations: 1
Primary Endpoint: Number of subjects with local and systemic reactions and subjects reporting one or more adverse events
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

October 2016

End Date

September 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Nitto Denko Corporation

Responsible Party

Sponsor

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:
•Interferon products,
•Drugs affected to immune system (e.g., immunosuppressant),
•Systemic or inhalant adrenocorticosteroid,
•G-CSF and M-CSF II. Within 84 days:
•HGG products,
•Blood products,

Outcomes

Primary Outcomes

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

Time Frame: 28 days after last vaccination

Secondary Outcomes

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)
GMT ratio of serum neutralizing antibody 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 neutralizing 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 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)