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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06028347




Registration number
NCT06028347
Ethics application status
Date submitted
31/08/2023
Date registered
8/09/2023

Titles & IDs
Public title
Safety, Reactogenicity, and Immunogenicity Study of a Self-Amplifying MRNA Influenza Vaccine in Healthy Adults
Scientific 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
Secondary ID [1] 0 0
V202_01
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
Treatment: Other - sa-mRNA vaccine Dose 1
Treatment: Other - sa-mRNA vaccine Dose 2
Treatment: Other - sa-mRNA vaccine Dose 3
Treatment: Other - Placebo

Experimental: sa-mRNA vaccine dose 1 -

Experimental: sa-mRNA vaccine dose 2 -

Experimental: sa-mRNA vaccine dose 3 -

Placebo comparator: Placebo -


Treatment: Other: sa-mRNA vaccine Dose 1
self-amplifying mRNA vaccine

Treatment: Other: sa-mRNA vaccine Dose 2
self-amplifying mRNA vaccine

Treatment: Other: sa-mRNA vaccine Dose 3
self-amplifying mRNA vaccine

Treatment: Other: Placebo
Saline for injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number and percentage of subjects with clinically significant abnormal vital signs and/or acute reactions
Timepoint [1] 0 0
up to 60 minutes or within 6 hours post vaccination
Primary outcome [2] 0 0
Number and percentage of subjects reporting reactogenicity: Solicited local and systemic AEs
Timepoint [2] 0 0
Day 1 to Day 14 of each post vaccination period
Primary outcome [3] 0 0
Number and percentage of subjects reporting unsolicited AEs
Timepoint [3] 0 0
Day 1 to Day 43
Primary outcome [4] 0 0
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).
Timepoint [4] 0 0
Day 1 to Day 202
Primary outcome [5] 0 0
Number and percentage of subjects with Grade 3 or greater abnormal clinically significant hematology and chemistry laboratory values
Timepoint [5] 0 0
Day 3 to Day 43
Primary outcome [6] 0 0
Number and percentage of subjects with grading shifts in hematology and chemistry laboratory assessments
Timepoint [6] 0 0
Day 3 to Day 43
Primary outcome [7] 0 0
Serum antibody titer against the HA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via HI assay
Timepoint [7] 0 0
Day 1, Day 22, Day 43
Primary outcome [8] 0 0
Number and percentage of subjects with HAI titer =1:10 and <1:10 (lower limit of quantification [LLOQ])
Timepoint [8] 0 0
Day 1, Day 22, Day 43
Primary outcome [9] 0 0
Number and percentage of subjects with HAI titer =1:40, =1:80, =1:160 and =1:320
Timepoint [9] 0 0
Day 1, Day 22, Day 43
Primary outcome [10] 0 0
Seroconversion rate (SCR) by HAI assay
Timepoint [10] 0 0
Day 1, Day 22, Day 43
Secondary outcome [1] 0 0
Serum antibody titer against the HA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via HI assay
Timepoint [1] 0 0
Day 1, Day 202
Secondary outcome [2] 0 0
Number and percentage of subjects with =4-fold increase in post-vaccination HAI titer
Timepoint [2] 0 0
Day 1, Day 202
Secondary outcome [3] 0 0
Number and percentage of subjects with HAI titer =1:10 and <1:10 (LLOQ)
Timepoint [3] 0 0
Day 202
Secondary outcome [4] 0 0
Number and percentage of subjects with HAI titer =1:40, =1:80, =1:160 and =1:320
Timepoint [4] 0 0
Day 202
Secondary outcome [5] 0 0
Seroconversion rate (SCR) by HAI assay
Timepoint [5] 0 0
Day 1, Day 202
Secondary outcome [6] 0 0
Serum antibody titer against the NA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via ELLA assay
Timepoint [6] 0 0
Day 1, Day 22, Day 43, Day 202
Secondary outcome [7] 0 0
Number and percentage of subjects with =4-fold increase in post-vaccination ELLA titer
Timepoint [7] 0 0
Day 1, Day 22, Day 43, Day 202

Eligibility
Key inclusion criteria
1. Individuals 18 to 49 years of age OR 65 to 85 years of age, inclusive on the day of informed consent.
2. Individuals with body mass index (BMI) between 18 and 32 kg/m2, inclusive, at screening .
3. Individuals who can comply with study procedures including follow-up .
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. 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.
2. 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.
3. Progressive, unstable, or uncontrolled clinical conditions
4. Known hypersensitivity or allergy to any study vaccine component
5. Known history of Guillain-Barré syndrome or other demyelinating disease
6. Condition representing a contraindication to vaccination or blood draw
7. Abnormal function of immune system due to clinical condition, medications, or radiotherapy.
8. Receipt or planning to receive blood products, non-study vaccine, influenza vaccine, mRNA-platform vaccine within different timeframes; previous or from study vaccination.
9. Baseline abnormal clinically significant ECG, laboratory safety parameters or vital signs.
10. Plan to donate blood products (other than for this study), sperm, ova, tissues, or organs up to 60 days following the last vaccination.

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
5/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/10/2024
Sample size
Target
Accrual to date
Final
96
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Nucleus Network Brisbane Clinic - Brisbane
Recruitment hospital [2] 0 0
Nucleus network Melbourne Clinic - Melbourne
Recruitment postcode(s) [1] 0 0
4006 - Brisbane
Recruitment postcode(s) [2] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Seqirus
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Program Director
Address 0 0
Seqirus
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 \[EU CTR\])).

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
SEQIRUS discloses results from clinical studies within 12 months of last patient last visit (LPLV) unless otherwise mandated by local laws or regulations.
Available to whom?
SEQIRUS will consider requests from qualified scientific and medical researchers to disclose protocols, anonymized subject-level data and study-level data when there is medical, scientific and/or public health interest to ensure the safe use of a Seqirus product licensed on or after 1 January 2014 in the United States (US) and/or the European Union (EU). This applies to Seqirus-sponsored interventional studies initiated after 27 September 2007 and ongoing as of 26 December 2007, that have been included as part of a US or EU submission package which received approval in US and EU on or after 1 January 2014 and have been accepted for publication.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.seqirus.us/partnering


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06028347