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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04146623




Registration number
NCT04146623
Ethics application status
Date submitted
28/10/2019
Date registered
31/10/2019

Titles & IDs
Public title
Safety Study of Live Attenuated Influenza Vaccine, CodaVax, Delivered Via Intranasal Spray
Scientific title
A Randomized Double-Blind, Placebo Controlled, Phase I Study of the Safety, Tolerability and Immunogenicity of a Live Attenuated H1N1 Vaccine in Healthy Individuals
Secondary ID [1] 0 0
CODA01-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - CodaVax-H1N1 influenza vaccine
Treatment: Other - Normal Saline Placebo

Placebo comparator: Normal Saline Placebo - Saline (0.9%)

Experimental: CodaVax-H1N1 - Live-attenuated influenza vaccine


Treatment: Other: CodaVax-H1N1 influenza vaccine
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).

Treatment: Other: Normal Saline Placebo
Saline (0.9%) administered intranasally via sprayer
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reactions to vaccine
Timepoint [1] 0 0
6 days
Primary outcome [2] 0 0
Adverse events (AEs)
Timepoint [2] 0 0
30 days
Primary outcome [3] 0 0
Serious adverse events (SAEs)
Timepoint [3] 0 0
180 days
Secondary outcome [1] 0 0
HAI antibody titers against A/California/07/2009
Timepoint [1] 0 0
Day 0 and 30
Secondary outcome [2] 0 0
Increase in HAI titer against A/California/07/2009
Timepoint [2] 0 0
Day 0 and 30
Secondary outcome [3] 0 0
HAI sero-response
Timepoint [3] 0 0
Day 0 and 30
Secondary outcome [4] 0 0
Serum IgG response
Timepoint [4] 0 0
Day 0 and 30
Secondary outcome [5] 0 0
Increase in serum IgG
Timepoint [5] 0 0
Day 0 and 30
Secondary outcome [6] 0 0
Serum IgA response
Timepoint [6] 0 0
Day 0 and 30
Secondary outcome [7] 0 0
Increase in serum IgA
Timepoint [7] 0 0
Day 0 and 30
Secondary outcome [8] 0 0
Salivary IgA Response
Timepoint [8] 0 0
Day 0 and 30
Secondary outcome [9] 0 0
Increase in salivary IgA
Timepoint [9] 0 0
Day 0 and 30

Eligibility
Key inclusion criteria
1. 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.
2. Participants must use highly effective, double contraception from the Screening Visit and up to the Follow-up Visit (Day 30).
3. 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):

1. 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
2. Blood, tissue or organs must not be donated within 7 days of vaccination
3. Severely immunosuppressed persons who require a protective environment are not to be cared for by the participant within 7 days of vaccination
4. Contact is not to be made with severely immunosuppressed persons who require a protective environment within 7 days of vaccination
5. 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
4. Contact is not to be made with infants <6 months of age within 7 days of vaccination.
5. Adequate venous access in the left or right arms to allow collection of a number of blood samples.
6. Must be sero-susceptible =10 hemagglutination inhibition (HAI) titre to CA/07/2009 Influenza virus (pre-screen).
7. Laboratory Testing:

1. 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;
2. 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)
8. Able to communicate effectively with study personnel and considered reliable, willing and cooperative in terms of compliance with the protocol requirements
9. Participant does not intend to start or change an existing physical conditioning regimen prior to or during the study period
10. Participant has voluntarily given written informed consent to participate in the study (prior study entry)
11. Participant is available for the duration of the study
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. 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
2. Participant is not to have had Guillain-Barre Syndrome
3. Received blood or blood products in the 3 months prior to screening
4. Received another vaccine within 30 days before screening
5. Received another influenza vaccine from 2016 to present year
6. Participants with plans to travel to the Northern Hemisphere during the Screening period
7. Participated in another clinical study (involving any investigational product or device) within 60 days before screening
8. 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)
9. Participants with active asthma or a history of childhood asthma which was treated with corticosteroids.
10. Participants with a known egg allergy
11. If female, pregnant, planning to become pregnant, or lactating, or participants is living with somebody who is pregnant or lactating.
12. 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
13. History of any psychiatric illness or psychological disorder which may impair the ability to provide written informed consent or participate in the study
14. Current or history of significant neurological, cardiovascular, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological, metabolic or renal disorder
15. Clinically significant abnormal laboratory value at screening as determined by the Investigator
16. Known or suspected impairment/alteration of immune function, including: Chronic use of oral steroids (equivalent to 20 mg/day prednisone =12 weeks /=2 mg/kg body weight / day prednisone =2 weeks) within 60 days prior to Day 0 (use of inhaled, IN, or topical corticosteroids is allowed, unless used for the management of asthma - see exclusion criteria 9). Receipt of parenteral steroids (equivalent to 20 mg/day prednisone =12 weeks /=2 mg/kg body weight/day prednisone = 2 weeks) within 60 days prior to Day 0. Or participant is living with somebody with the same
17. Unusual dietary habits and excessive or unusual vitamin intake likely, in the opinion of the Investigator, to affect safety parameters
18. Participant is sero-positive to hepatitis C virus or hepatitis B virus.
19. Body temperature (oral) =38.0ºC or acute illness within 5 days prior to vaccination
20. Any other significant finding that, in the opinion of the Investigator, would increase the risk of the individual having an adverse outcome from participating in this study
21. Participant is a member of the team or is related or in a dependent relationship with a member of the study team, as defined as the Sponsor or study site personnel

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/11/2020
Sample size
Target
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm Pty Limited - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Codagenix, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04146623