Safety Study of Live Attenuated Influenza Vaccine, CodaVax, Delivered Via Intranasal Spray

NCT04146623 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CODA01-002
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

live-attenuated vaccine; influenza vaccine

Outcome Measures

Primary Outcomes (3)

• Reactions to vaccine

  Number of solicited local and systemic reactions for CodaVax-H1N1 and placebo

  6 days

• Adverse events (AEs)

  Number of subjects with AEs for CodaVax-H1N1 and placebo

  30 days

• Serious adverse events (SAEs)

  Number of subjects with SAEs for CodaVax-H1N1 and placebo

  180 days

Secondary Outcomes (9)

• HAI antibody titers against A/California/07/2009

  Day 0 and 30

• Increase in HAI titer against A/California/07/2009

  Day 0 and 30

• HAI sero-response

  Day 0 and 30

• Serum IgG response

  Day 0 and 30

• Increase in serum IgG

  Day 0 and 30

Study Arms (2)

Normal Saline Placebo

PLACEBO COMPARATOR

Saline (0.9%)

Biological: Normal Saline Placebo

CodaVax-H1N1

EXPERIMENTAL

Live-attenuated influenza vaccine

Biological: CodaVax-H1N1 influenza vaccine

Interventions

CodaVax-H1N1 influenza vaccine BIOLOGICAL

CodaVax-H1N1, a live attenuated vaccine (LAIV) strain based on the A/California/07/2009 (H1N1) influenza virus, administered once intranasally via a sprayer at a dose of 8 x10\^5 plaque forming units (PFU).

CodaVax-H1N1

Normal Saline Placebo BIOLOGICAL

Saline (0.9%) administered intranasally via sprayer

Normal Saline Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Must be sero-susceptible ≤10 hemagglutination inhibition (HAI) titre to CA/07/2009 Influenza virus (pre-screen).
• Laboratory Testing:
• Full blood examination and biochemistry within the laboratory defined normal range unless deemed not clinically significant by the investigator, however a small drop below the normal range for Absolute Neutrophil Count (ANC) may be acceptable as per investigator discretion;
• Urinalysis: Negative urine glucose, negative or trace urine protein, negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a microscopic urinalysis within institutional range)
• Able to communicate effectively with study personnel and considered reliable, willing and cooperative in terms of compliance with the protocol requirements

You may not qualify if:

• 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
• If female, pregnant, planning to become pregnant, or lactating, or participants is living with somebody who is pregnant or lactating.
• Participant has a history of, or current evidence at the time of screening of abuse of alcohol or any drug substance, licit or illicit, or current alcohol consumption is \> 4 standard drinks (or equivalent) per day
• History of any psychiatric illness or psychological disorder which may impair the ability to provide written informed consent or participate in the study
• Current or history of significant neurological, cardiovascular, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological, metabolic or renal disorder
• Clinically significant abnormal laboratory value at screening as determined by the Investigator
• Unusual dietary habits and excessive or unusual vitamin intake likely, in the opinion of the Investigator, to affect safety parameters

Sponsors & Collaborators

• Codagenix, Inc: lead

Study Sites (1)

Q-Pharm Pty Limited

Brisbane, Queensland, 4006, Australia

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 31, 2019
• Study Start: May 7, 2019
• Primary Completion: October 11, 2020
• Study Completion: November 11, 2020
• Last Updated: December 1, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)