Influenza, HumanPhase 1NCT06028347
Safety, Reactogenicity, and Immunogenicity Study of a Self-Amplifying MRNA Influenza Vaccine in Healthy Adults
A Phase 1 study testing sa-mRNA vaccine Dose 1, sa-mRNA vaccine Dose 2 and sa-mRNA vaccine Dose 3 in people with Influenza, Human, run by Seqirus at 2 sites in Australia.
Trial summary
This is a Phase 1, first-in-human, randomized, placebo-controlled, observer blind study. The effect of two doses of an investigational vaccine on safety, reactogenicity, kinetics and magnitude of the post-vaccination antibody response will be evaluated at different timepoints as compared to placebo in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- sa-mRNA vaccine Dose 1, sa-mRNA vaccine Dose 2 and sa-mRNA vaccine Dose 3
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 2 sitesAustralia
- Study dates
- 5 Oct 2023to 13 Oct 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals 18 to 49 years of age OR 65 to 85 years of age, inclusive on the day of informed consent.
- Individuals with body mass index (BMI) between 18 and 32 kg/m2, inclusive, at screening .
- Individuals who can comply with study procedures including follow-up .
Who cannot join
- Female participants of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of highly effective contraceptive methods from at least 30 days prior to informed consent and who do not plan to do so for the duration of the study.
- Male participants who have not adhered to using barrier contraception such as a condom during at least 60 days after each vaccination, to prevent semen transfer to their sexual partners and prevent pregnancy of a female partner.
- Progressive, unstable, or uncontrolled clinical conditions
- Known hypersensitivity or allergy to any study vaccine component
- Known history of Guillain-Barré syndrome or other demyelinating disease
- Condition representing a contraindication to vaccination or blood draw
Show all 10Show fewer
- Abnormal function of immune system due to clinical condition, medications, or radiotherapy.
- Receipt or planning to receive blood products, non-study vaccine, influenza vaccine, mRNA-platform vaccine within different timeframes; previous or from study vaccination.
- Baseline abnormal clinically significant ECG, laboratory safety parameters or vital signs.
- Plan to donate blood products (other than for this study), sperm, ova, tissues, or organs up to 60 days following the last vaccination.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Nucleus Network Brisbane Clinic
Brisbane, Queensland, 4006
Nucleus network Melbourne Clinic
Melbourne, Victoria, 3004
About this study
Official title: Phase 1, Randomized, Placebo-Controlled, Observer Blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of an Investigational Self-Amplifying MRNA Influenza Vaccine in Healthy Adults
This is a Phase 1, first-in-human, randomized, placebo-controlled, observer blind study. The effect of two doses of an investigational vaccine on safety, reactogenicity, kinetics and magnitude of the post-vaccination antibody response will be evaluated at different timepoints as compared to placebo in healthy adults.
Approximately 96 evaluable subjects will be enrolled in this study; n=72 receiving investigational vaccine and n=24 receiving placebo.
The study has a screening period (Day -28 to Day -1), a treatment period (Day 1 to Day 43) and a follow-up period (Day 44 to Day 202).
- Conditions
- Influenza, Human
- Being tested
- sa-mRNA vaccine Dose 1, sa-mRNA vaccine Dose 2, sa-mRNA vaccine Dose 3, Placebo
- Keywords
- Influenza, Vaccine, mRNA
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sa-mRNA vaccine Dose 1Biological
self-amplifying mRNA vaccine
sa-mRNA vaccine Dose 2Biological
self-amplifying mRNA vaccine
sa-mRNA vaccine Dose 3Biological
self-amplifying mRNA vaccine
PlaceboBiological
Saline for injection
| Study group | Role | What they receive |
|---|---|---|
| sa-mRNA vaccine dose 1 | Experimental | Not described Receives: Biological: sa-mRNA vaccine Dose 1 |
| sa-mRNA vaccine dose 2 | Experimental | Not described Receives: Biological: sa-mRNA vaccine Dose 2 |
| sa-mRNA vaccine dose 3 | Experimental | Not described Receives: Biological: sa-mRNA vaccine Dose 3 |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of subjects with clinically significant abnormal vital signs and/or acute reactions
Measured: up to 60 minutes or within 6 hours post vaccination
Number and percentage of subjects reporting reactogenicity: Solicited local and systemic AEs
Measured: Day 1 to Day 14 of each post vaccination period
Number and percentage of subjects reporting unsolicited AEs
Measured: Day 1 to Day 43
Number and percentage of subjects reporting AEs leading to study withdrawal, Adverse Events of Special Interest (AESIs), medically attended AEs (MAAEs), and serious adverse events (SAEs).
Measured: Day 1 to Day 202
Number and percentage of subjects with Grade 3 or greater abnormal clinically significant hematology and chemistry laboratory values
Measured: Day 3 to Day 43
Number and percentage of subjects with grading shifts in hematology and chemistry laboratory assessments
Measured: Day 3 to Day 43
Serum antibody titer against the HA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via HI assay
Measured: Day 1, Day 22, Day 43
Number and percentage of subjects with HAI titer ≥1:10 and <1:10 (lower limit of quantification [LLOQ])
Measured: Day 1, Day 22, Day 43
Number and percentage of subjects with HAI titer ≥1:40, ≥1:80, ≥1:160 and ≥1:320
Measured: Day 1, Day 22, Day 43
Seroconversion rate (SCR) by HAI assay
SCR defined as the percentage of subjects with either a prevaccination HAI titer <1:10 and a post-vaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a ≥4-fold increase in post-vaccination
Measured: Day 1, Day 22, Day 43
Secondary outcomes (7)
Serum antibody titer against the HA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via HI assay
Measured: Day 1, Day 202
Number and percentage of subjects with ≥4-fold increase in post-vaccination HAI titer
Measured: Day 1, Day 202
Number and percentage of subjects with HAI titer ≥1:10 and <1:10 (LLOQ)
Measured: Day 202
Number and percentage of subjects with HAI titer ≥1:40, ≥1:80, ≥1:160 and ≥1:320
Measured: Day 202
Seroconversion rate (SCR) by HAI assay
Measured: Day 1, Day 202
Serum antibody titer against the NA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via ELLA assay
Measured: Day 1, Day 22, Day 43, Day 202
Number and percentage of subjects with ≥4-fold increase in post-vaccination ELLA titer
Measured: Day 1, Day 22, Day 43, Day 202
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start5 Oct 2023
- Primary completion13 Oct 2024
- Study completion13 Oct 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seqirus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Program Director, Study director, Seqirus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028347
- Sponsor's protocol ID
- V202_01
- Status last verified
- Nov 2024
- First submitted
- 31 Aug 2023
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: SEQIRUS supports the release of anonymized subject-level and study-level data in compliance with regulatory requirements, including Clinical Documents which are part of the CTD modules submitted to regulatory agencies for public release. Summary results disclosure is either in document form (e.g., ICH E3 Clinical Study Report synopsis) or structured data form (such as summary results in ClinicalTrials.gov (United States) or eudract.ema.europa.eu (EU Clinical Trial Registry \[EU CTR\])).
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Randomized, Placebo-Controlled, Observer Blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of an Investigational Self-Amplifying MRNA Influenza Vaccine in Healthy Adults
- ClinicalTrials.gov ID
- NCT06028347
- Acronym / sponsor ID
- V202_01
- Conditions
- Influenza, Human
- Keywords
- Influenza, Vaccine, mRNA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- SeqirusIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 13 Oct 2024 (actual)
- Study completion
- 13 Oct 2024 (actual)
- First posted
- 8 Sep 2023 (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 is a Phase 1, first-in-human, randomized, placebo-controlled, observer blind study. The effect of two doses of an investigational vaccine on safety, reactogenicity, kinetics and magnitude of the post-vaccination antibody response will be evaluated at different timepoints as compared to placebo in healthy adults.
Approximately 96 evaluable subjects will be enrolled in this study; n=72 receiving investigational vaccine and n=24 receiving placebo.
The study has a screening period (Day -28 to Day -1), a treatment period (Day 1 to Day 43) and a follow-up period (Day 44 to Day 202).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| sa-mRNA vaccine dose 1 | Experimental | Biological: sa-mRNA vaccine Dose 1 |
| sa-mRNA vaccine dose 2 | Experimental | Biological: sa-mRNA vaccine Dose 2 |
| sa-mRNA vaccine dose 3 | Experimental | Biological: sa-mRNA vaccine Dose 3 |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals 18 to 49 years of age OR 65 to 85 years of age, inclusive on the day of informed consent.
- Individuals with body mass index (BMI) between 18 and 32 kg/m2, inclusive, at screening .
- Individuals who can comply with study procedures including follow-up .
Key exclusion criteria (10 listed)
- Female participants of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of highly effective contraceptive methods from at least 30 days prior to informed consent and who do not plan to do so for the duration of the study.
- Male participants who have not adhered to using barrier contraception such as a condom during at least 60 days after each vaccination, to prevent semen transfer to their sexual partners and prevent pregnancy of a female partner.
- Progressive, unstable, or uncontrolled clinical conditions
- Known hypersensitivity or allergy to any study vaccine component
- Known history of Guillain-Barré syndrome or other demyelinating disease
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 |
|---|---|---|
| sa-mRNA vaccine Dose 1self-amplifying mRNA vaccine | Biological | sa-mRNA vaccine dose 1 |
| sa-mRNA vaccine Dose 2self-amplifying mRNA vaccine | Biological | sa-mRNA vaccine dose 2 |
| sa-mRNA vaccine Dose 3self-amplifying mRNA vaccine | Biological | sa-mRNA vaccine dose 3 |
| PlaceboSaline for injection | Biological | Placebo |
Primary outcome
Number and percentage of subjects with clinically significant abnormal vital signs and/or acute reactions
Time frame: up to 60 minutes or within 6 hours post vaccination
Number and percentage of subjects reporting reactogenicity: Solicited local and systemic AEs
Time frame: Day 1 to Day 14 of each post vaccination period
Number and percentage of subjects reporting unsolicited AEs
Time frame: Day 1 to Day 43
Number and percentage of subjects reporting AEs leading to study withdrawal, Adverse Events of Special Interest (AESIs), medically attended AEs (MAAEs), and serious adverse events (SAEs).
Time frame: Day 1 to Day 202
Number and percentage of subjects with Grade 3 or greater abnormal clinically significant hematology and chemistry laboratory values
Time frame: Day 3 to Day 43
Number and percentage of subjects with grading shifts in hematology and chemistry laboratory assessments
Time frame: Day 3 to Day 43
Serum antibody titer against the HA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via HI assay
Time frame: Day 1, Day 22, Day 43
Number and percentage of subjects with HAI titer ≥1:10 and <1:10 (lower limit of quantification [LLOQ])
Time frame: Day 1, Day 22, Day 43
Number and percentage of subjects with HAI titer ≥1:40, ≥1:80, ≥1:160 and ≥1:320
Time frame: Day 1, Day 22, Day 43
Seroconversion rate (SCR) by HAI assay
Time frame: Day 1, Day 22, Day 43
SCR defined as the percentage of subjects with either a prevaccination HAI titer <1:10 and a post-vaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a ≥4-fold increase in post-vaccination
7 secondary outcomes
Serum antibody titer against the HA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via HI assay
Time frame: Day 1, Day 202
Number and percentage of subjects with ≥4-fold increase in post-vaccination HAI titer
Time frame: Day 1, Day 202
Number and percentage of subjects with HAI titer ≥1:10 and <1:10 (LLOQ)
Time frame: Day 202
Number and percentage of subjects with HAI titer ≥1:40, ≥1:80, ≥1:160 and ≥1:320
Time frame: Day 202
Seroconversion rate (SCR) by HAI assay
Time frame: Day 1, Day 202
Serum antibody titer against the NA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via ELLA assay
Time frame: Day 1, Day 22, Day 43, Day 202
Number and percentage of subjects with ≥4-fold increase in post-vaccination ELLA titer
Time frame: Day 1, Day 22, Day 43, Day 202
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 27 Nov 2024.
- Individual participant dataSharing planned: Yes. SEQIRUS supports the release of anonymized subject-level and study-level data in compliance with regulatory requirements, including Clinical Documents which are part of the CTD modules submitted to regulatory agencies for public release. Summary results disclosure is either in document form (e.g., ICH E3 Clinical Study Report synopsis) or structured data form (such as summary results in ClinicalTrials.gov (United States) or eudract.ema.europa.eu (EU Clinical Trial Registry [EU CTR])).
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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.
Clinical Program Director study director
Seqirus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sa-mRNA vaccine Dose 1, sa-mRNA vaccine Dose 2 and sa-mRNA vaccine Dose 3 in people with Influenza, Human, run by Seqirus at 2 sites 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 3 inclusion and 10 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 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Number and percentage of subjects with clinically significant abnormal vital signs and/or acute reactions (time frame: up to 60 minutes or within 6 hours post vaccination). The study lists 10 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 27 Nov 2024.