Intramuscular CodaVax-H1N1 in Healthy Adults (NCT05223179) | Clinical Trial Compass
CompletedPhase 1
Intramuscular CodaVax-H1N1 in Healthy Adults
Australia69 participantsStarted 2022-04-11
Plain-language 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.
Who can participate
Age range
18 Years – 49 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and Tolerability by Assessing Percentage of Participants with Reactogenicity Events
Timeframe: Reactogenicity events from Day 1 to Day 7
2
Safety and Tolerability by Assessing Percentage of Participants with Adverse Events
Timeframe: Adverse events (AEs) from Day 1 to Day 29
3
Safety and Tolerability by Assessing Percentage of Participants with MAAEs, NCIs, and SAEs.
Timeframe: MAAEs, NCIs, SAEs from Day 1 to Day 181