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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05223179
Registration number
NCT05223179
Ethics application status
Date submitted
24/01/2022
Date registered
3/02/2022
Date last updated
31/05/2024
Titles & IDs
Public title
Intramuscular CodaVax-H1N1 in Healthy Adults
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Scientific title
Randomised, Double-blind, Placebo-controlled, Dose-escalation Study of the Safety, Tolerability, and Immunogenicity of Intramuscular CodaVax-H1N1 in Healthy Adults
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Secondary ID [1]
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CDX-FLU-103
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Influenza, Human
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - CODA-VAX H1N1
Other interventions - Flucelvax Quad
Other interventions - Saline
Experimental: CODA-VAX H1N1 - Live Attenuated Vaccine administered by Intramuscular Injection
Active Comparator: Flucelvax Quad - Licensed Injectable Seasonal Influenza Vaccine
Placebo Comparator: Saline - Normal Sterile Saline for Intramuscular Injection
Other interventions: CODA-VAX H1N1
Intramuscular Live Attenuated Influenza H1N1 Vaccine
Other interventions: Flucelvax Quad
Licensed Seasonal Injectable Influenza Vaccine
Other interventions: Saline
Saline
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety and Tolerability by Assessing Percentage of Participants with Reactogenicity Events
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Assessment method [1]
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Percentage of participants with reactogenicity events
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Timepoint [1]
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Reactogenicity events from Day 1 to Day 7
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Primary outcome [2]
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Safety and Tolerability by Assessing Percentage of Participants with Adverse Events
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Assessment method [2]
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Percentage of participants with adverse events
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Timepoint [2]
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Adverse events (AEs) from Day 1 to Day 29
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Primary outcome [3]
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Safety and Tolerability by Assessing Percentage of Participants with MAAEs, NCIs, and SAEs.
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Assessment method [3]
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Percentage of participants with MAAEs, NCIs, and SAEs.
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Timepoint [3]
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MAAEs, NCIs, SAEs from Day 1 to Day 181
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Secondary outcome [1]
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Humoral Immunogenicity
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Assessment method [1]
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To assess the humoral immunogenicity elicited by CodaVax-H1N1 at nominal doses of 5×104, 5×105, and 5×106 PFU by IM injection
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Timepoint [1]
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HAI assay titre against A/California/07/2009 and the current seasonal influenza vaccine H1N1 and H3N2 strains measured in samples collected on Days 1, 29, 91, and 181
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Eligibility
Key inclusion criteria
- Body mass index (BMI) = 18 and = 35 kg/m2
- In good health with no history, or current evidence, of clinically significant medical
conditions
- Negative SARS-CoV-2 test predose on Day 1
- For all women, negative pregnancy test
- Agreement to comply with conditions to prevent the spread of genetically modified
organisms (GMOs)
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Minimum age
18
Years
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Maximum age
49
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Pregnant or lactating women or women who plan to become pregnant through Day 29
- Inadequate venous access for repeated phlebotomy
- History of severe reaction to vaccination
- Receipt of any licenced or investigational influenza vaccine within 6 months before
Day 1
- Receipt of any live vaccine within 30 days before Day 1
- Tattoo, skin reaction, or other condition at the injection site that would interfere
with assessment of local reactogenicity
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/04/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/02/2024
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Sample size
Target
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Accrual to date
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Final
69
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Lis Gilmour, Senior Project Manager - Morayfield
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Recruitment postcode(s) [1]
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QLD 4556 - Morayfield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Codagenix, Inc
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is a Phase 1, 2-part, randomised, double-blind, controlled, clinical trial to
evaluate the safety and immune response of CodaVax-H1N1 in healthy adults aged 18 to 49
years. Participants will be enrolled in autumn 2022 (southern hemisphere) and followed
through the 2022 influenza season (Part A) or enrolled in autumn 2023 and followed through
the 2023 influenza season (Part B). Participants will be screened within 28 days of
randomization, and eligible participants in Part A will be enrolled into 1 of 3 sequential
cohorts and randomised to receive a single dose of CodaVax-H1N1, placebo (normal saline), or
licenced injectable seasonal influenza vaccine (Flucelvax Quad). Each subsequent cohort will
include a higher dose of CodaVax H1N1 than the previous cohort, in addition to placebo and
the licensed injectable seasonal influenza vaccine. In Part B, 24 eligible participants will
be enrolled into 1 of 2 sequential cohorts and randomised to receive a single IM dose of
CodaVax-H1N1 or placebo.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05223179
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Fax
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Email
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Contact person for public queries
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05223179
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