Influenza, HumanPhase 1NCT05223179
Intramuscular CodaVax-H1N1 in Healthy Adults
A Phase 1 study testing CODA-VAX H1N1, Flucelvax Quad and Saline in people with Influenza, Human, run by Codagenix, Inc at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- CODA-VAX H1N1, Flucelvax Quad and Saline
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteAustralia
- Study dates
- 11 Apr 2022to 9 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Lis Gilmour, Senior Project Manager
Morayfield, Queensland, QLD 4556
About this study
Official title: Randomised, Double-blind, Placebo-controlled, Dose-escalation Study of the Safety, Tolerability, and Immunogenicity of Intramuscular CodaVax-H1N1 in Healthy Adults
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.
Read the detailed description
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. 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 licensed 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 additional sequential cohorts and randomised to receive a single IM dose of CodaVax-H1N1 or placebo.
Participants will record reactogenicity events (local events, systemic events, and temperature) in a daily diary for 7 days after the dose. Each participant will be contacted by telephone on the day after dosing for safety assessment and review of the diary data. Participants will return to the clinic on Days 4, 8, 29, 91, and 181 for safety and immune response assessments.
All adverse events and concomitant medications will be recorded from signing of the informed consent form (ICF) to 28 days postdose. After 28 days until the end of the study, only medically attended adverse events (MAAEs), new onset chronic illnesses (NCIs), serious adverse events (SAEs), immunosuppressive medications, blood products like transfusions or infusions, and vaccines will be recorded. A complete physical examination will be performed at Screening, and targeted and symptom-driven physical examinations will be performed predose on Day 1, 2 hours postdose, and at each postdose visit through Day 91. Vital signs will be measured at the same time points. An electrocardiogram (ECG) will be performed at Screening and on Day 29.
A serum sample will be collected predose and on Days 29, 91, and 181 for measurement of immune response.
A whole blood sample will be collected predose and on Day 8 and PBMCs isolated for measurement of T-cell response.
If a participant experiences acute symptoms compatible with viral respiratory infection, nasopharyngeal swab samples will be collected for a rapid influenza diagnostic test and respiratory virus PCR assay panel (including SARS-CoV-2) as indicated for symptomatic respiratory infection and will perform the rapid influenza diagnostic test.
The primary analysis of study data will be conducted after all participants complete the Day 29 visit. The final analysis will be conducted at the end of the study.
- Conditions
- Influenza, Human
- Being tested
- CODA-VAX H1N1, Flucelvax Quad, Saline
- Keywords
- Influenza, Human, Viral Vaccines, Vaccines, Live Attenuated
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CODA-VAX H1N1Biological
Intramuscular Live Attenuated Influenza H1N1 Vaccine
Flucelvax QuadBiological
Licensed Seasonal Injectable Influenza Vaccine
SalineOther
Saline
| Study group | Role | What they receive |
|---|---|---|
| CODA-VAX H1N1 | Experimental | Live Attenuated Vaccine administered by Intramuscular Injection Receives: Biological: CODA-VAX H1N1 |
| Flucelvax Quad | Active comparator | Licensed Injectable Seasonal Influenza Vaccine Receives: Biological: Flucelvax Quad |
| Saline | Placebo comparator | Normal Sterile Saline for Intramuscular Injection Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability by Assessing Percentage of Participants with Reactogenicity Events
Percentage of participants with reactogenicity events
Measured: Reactogenicity events from Day 1 to Day 7
Safety and Tolerability by Assessing Percentage of Participants with Adverse Events
Percentage of participants with adverse events
Measured: Adverse events (AEs) from Day 1 to Day 29
Safety and Tolerability by Assessing Percentage of Participants with MAAEs, NCIs, and SAEs.
Percentage of participants with MAAEs, NCIs, and SAEs.
Measured: MAAEs, NCIs, SAEs from Day 1 to Day 181
Secondary outcomes (1)
Humoral Immunogenicity
To assess the humoral immunogenicity elicited by CodaVax-H1N1 at nominal doses of 5×104, 5×105, and 5×106 PFU by IM injection
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start11 Apr 2022
- Primary completion9 Feb 2024
- Study completion9 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Codagenix, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223179
- Sponsor's protocol ID
- CDX-FLU-103
- Status last verified
- Sep 2024
- First submitted
- 24 Jan 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Placebo-controlled, Dose-escalation Study of the Safety, Tolerability, and Immunogenicity of Intramuscular CodaVax-H1N1 in Healthy Adults
- ClinicalTrials.gov ID
- NCT05223179
- Acronym / sponsor ID
- CDX-FLU-103
- Conditions
- Influenza, Human
- Keywords
- Influenza, Human, Viral Vaccines, Vaccines, Live Attenuated
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Codagenix, IncIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 9 Feb 2024 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. 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 licensed 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 additional sequential cohorts and randomised to receive a single IM dose of CodaVax-H1N1 or placebo.
Participants will record reactogenicity events (local events, systemic events, and temperature) in a daily diary for 7 days after the dose. Each participant will be contacted by telephone on the day after dosing for safety assessment and review of the diary data. Participants will return to the clinic on Days 4, 8, 29, 91, and 181 for safety and immune response assessments.
All adverse events and concomitant medications will be recorded from signing of the informed consent form (ICF) to 28 days postdose. After 28 days until the end of the study, only medically attended adverse events (MAAEs), new onset chronic illnesses (NCIs), serious adverse events (SAEs), immunosuppressive medications, blood products like transfusions or infusions, and vaccines will be recorded. A complete physical examination will be performed at Screening, and targeted and symptom-driven physical examinations will be performed predose on Day 1, 2 hours postdose, and at each postdose visit through Day 91. Vital signs will be measured at the same time points. An electrocardiogram (ECG) will be performed at Screening and on Day 29.
A serum sample will be collected predose and on Days 29, 91, and 181 for measurement of immune response.
A whole blood sample will be collected predose and on Day 8 and PBMCs isolated for measurement of T-cell response.
If a participant experiences acute symptoms compatible with viral respiratory infection, nasopharyngeal swab samples will be collected for a rapid influenza diagnostic test and respiratory virus PCR assay panel (including SARS-CoV-2) as indicated for symptomatic respiratory infection and will perform the rapid influenza diagnostic test.
The primary analysis of study data will be conducted after all participants complete the Day 29 visit. The final analysis will be conducted at the end of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CODA-VAX H1N1 | Experimental | Biological: CODA-VAX H1N1Live Attenuated Vaccine administered by Intramuscular Injection |
| Flucelvax Quad | Active comparator | Biological: Flucelvax QuadLicensed Injectable Seasonal Influenza Vaccine |
| Saline | Placebo comparator | Other: SalineNormal Sterile Saline for Intramuscular Injection |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CODA-VAX H1N1Intramuscular Live Attenuated Influenza H1N1 Vaccine | Biological | CODA-VAX H1N1 |
| Flucelvax QuadLicensed Seasonal Injectable Influenza Vaccine | Biological | Flucelvax Quad |
| SalineSaline | Other | Saline |
Primary outcome
Safety and Tolerability by Assessing Percentage of Participants with Reactogenicity Events
Time frame: Reactogenicity events from Day 1 to Day 7
Percentage of participants with reactogenicity events
Safety and Tolerability by Assessing Percentage of Participants with Adverse Events
Time frame: Adverse events (AEs) from Day 1 to Day 29
Percentage of participants with adverse events
Safety and Tolerability by Assessing Percentage of Participants with MAAEs, NCIs, and SAEs.
Time frame: MAAEs, NCIs, SAEs from Day 1 to Day 181
Percentage of participants with MAAEs, NCIs, and SAEs.
1 secondary outcome
Humoral Immunogenicity
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CODA-VAX H1N1, Flucelvax Quad and Saline in people with Influenza, Human, run by Codagenix, Inc at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability by Assessing Percentage of Participants with Reactogenicity Events (time frame: Reactogenicity events from Day 1 to Day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.