A Randomized Double-Blind, Placebo Controlled, Phase I Study of the Safety, Tolerability and Immunogenicity of a Live Attenuated H1N1 Vaccine in Healthy Individuals

Codagenix, Inc1 site in 1 country33 target enrollmentMay 7, 2019

ConditionsInfluenza

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Influenza
Sponsor: Codagenix, Inc
Enrollment: 33
Locations: 1
Primary Endpoint: Reactions to vaccine
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is being conducted to assess the safety, tolerability, and immunogenicity of the live-attenuated CodaVax-H1N1 influenza vaccine as compared to normal saline placebo both administered via intranasal spray to healthy adults.

Registry

clinicaltrials.gov

Start Date

May 7, 2019

End Date

November 11, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Codagenix, Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult volunteers, aged 18 to 45 years (at the time of screening) in good general health in the opinion of the Medical Investigator or delegate, with no significant medical history and no clinically significant abnormal findings at screening.
•Participants must use highly effective, double contraception from the Screening Visit and up to the Follow-up Visit (Day 30).
•Must be willing to comply with the following conditions to prevent the spread of Genetically modified organisms (GMO) according the Office of Gene Technology Regulator (OGTR) Licence (DIR 144):
•Hygiene measures intended to prevent interpersonal transmission of study drug must be implemented, including but not limited to frequent handwashing with soap or hand disinfectant, respiratory hygiene and cough etiquette within 7 days following vaccination
•Blood, tissue or organs must not be donated within 7 days of vaccination
•Severely immunosuppressed persons who require a protective environment are not to be cared for by the participant within 7 days of vaccination
•Contact is not to be made with severely immunosuppressed persons who require a protective environment within 7 days of vaccination
•All tissues and materials used to collect respiratory secretions are to be sealed in a primary container and placed within a secondary container so that it is not accessible to children or animals for 7 days until it is returned to the study site for disposal, for 7 days within vaccination
•Contact is not to be made with infants \<6 months of age within 7 days of vaccination.
•Adequate venous access in the left or right arms to allow collection of a number of blood samples.

Exclusion Criteria

•Immunodeficiency (including HIV) or autoimmune disorder, or participant is currently taking drugs (excluding steroids, see exclusion criteria 16) or was undergoing a form of treatment within 3 months prior to study entry that affects the immune system, or participant is living with somebody with the same
•Participant is not to have had Guillain-Barre Syndrome
•Received blood or blood products in the 3 months prior to screening
•Received another vaccine within 30 days before screening
•Received another influenza vaccine from 2016 to present year
•Participants with plans to travel to the Northern Hemisphere during the Screening period
•Participated in another clinical study (involving any investigational product or device) within 60 days before screening
•Suffered previous anaphylactic reaction to foods, vaccines, drugs or hymenoptera stings, or has a history of severe allergic reactions (e.g. clinically severe urticaria, asthma)
•Participants with active asthma or a history of childhood asthma which was treated with corticosteroids.
•Participants with a known egg allergy