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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
Scientific title
Randomised, Double-blind, Placebo-controlled, Dose-escalation Study of the Safety, Tolerability, and Immunogenicity of Intramuscular CodaVax-H1N1 in Healthy Adults
Secondary ID [1] 0 0
CDX-FLU-103
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Tolerability by Assessing Percentage of Participants with Reactogenicity Events
Timepoint [1] 0 0
Reactogenicity events from Day 1 to Day 7
Primary outcome [2] 0 0
Safety and Tolerability by Assessing Percentage of Participants with Adverse Events
Timepoint [2] 0 0
Adverse events (AEs) from Day 1 to Day 29
Primary outcome [3] 0 0
Safety and Tolerability by Assessing Percentage of Participants with MAAEs, NCIs, and SAEs.
Timepoint [3] 0 0
MAAEs, NCIs, SAEs from Day 1 to Day 181
Secondary outcome [1] 0 0
Humoral Immunogenicity
Timepoint [1] 0 0
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

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)
Minimum age
18 Years
Maximum age
49 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

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
The people assessing the outcomes
The people analysing the results/data
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
11/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/02/2024
Sample size
Target
Accrual to date
Final
69
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Lis Gilmour, Senior Project Manager - Morayfield
Recruitment postcode(s) [1] 0 0
QLD 4556 - Morayfield

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05223179
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