Influenza, HumanPhase 1NCT06125691
Safety and Immunogenicity First-in-human Dose-ranging Study of Self-Amplifying RNA Seasonal Influenza Vaccine in Adults
A Phase 1 study testing ARCT-2138, Licensed Quadrivalent Vaccine for younger adults and Licensed Quadrivalent Vaccine for older adults in people with Influenza, Human, run by Arcturus Therapeutics, Inc. at 2 sites in Australia.
Trial summary
This is a safety and Immunogenicity first-in-human dose-ranging study of self-amplifying RNA Seasonal Influenza Vaccine (ARCT-2138) in 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?
- ARCT-2138, Licensed Quadrivalent Vaccine for younger adults and Licensed Quadrivalent Vaccine for older adults
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 2 sitesAustralia
- Study dates
- 22 Jan 2024to 7 Jan 2025
- 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 are male, female, or transgender adults 18 to 49 years of age or 65 to 85 years of age.
- Healthy participants or participants with pre-existing stable medical conditions. Pre-existing stable medical condition means a subject who: has full capacity of daily activity and no major medication modification; has not undergone surgical or minimally invasive intervention or had any hospitalization/emergency room visit for the specific medical condition within 3 months prior to Day 1.
- Participant or legally authorized representatives must freely provide documented informed consent prior to study procedures being performed.
- Individuals who have not received influenza vaccine within 6 months prior to enrollment.
- Individuals must agree to comply with all study visits and procedures (including blood tests, nasopharyngeal swabs, diary completion, receipt of telephone calls from the site, willingness to be available for Unscheduled Clinic Visits).
- Individuals of childbearing potential must be willing to adhere to contraceptive requirements.
Who cannot join
- Individuals with acute medical illness or febrile illness, including body temperature >100.4°F (>38.0°C) within 3 days prior to Randomization. These individuals may be offered the opportunity to enter the study after fever and illness has stabilized. Participants with suspected or confirmed influenza should be excluded and referred for medical care. Rescreening will be permitted for individuals who are presented with suspected influenza if another diagnosis is confirmed.
- Individuals with any medical, neurological, or psychiatric condition that, in the opinion of the investigator, could place the participant at an unacceptable risk of injury or render the participant unable to comply with all study procedures and achieve successful completion of the trial.
- Individuals with a known history of severe hypersensitivity reactions, including anaphylaxis, or other significant adverse reactions to any mRNA vaccine, influenza vaccine, or excipients.
- Individuals who have a positive pregnancy test at the Screening visit or Day 1 or who intend to become pregnant or breastfeed during the study.
- Individuals with a history of myocarditis, pericarditis, myopericarditis or cardiomyopathy.
- Individuals with a history of Guillain-Barré syndrome, encephalomyelitis, or transverse myelitis.
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- Individuals with a known bleeding disorder that would, in the opinion of the investigator, contraindicate intramuscular (I.M.) injection.
- Individuals with a history of congenital or acquired immunodeficiency.
- Individuals who have received immunomodulatory, immunostimulatory, or immunosuppressant drugs including interferon and cytotoxic drugs within 3 months of Screening/Day 1 or who plan to receive them during the study.
- Individuals requiring systemic corticosteroids exceeding 10 mg/day of prednisone equivalent for ≥10 days within 30 days of Screening. The use of topical, ophthalmic, inhaled, and intranasal steroid preparations will be permitted.
- Individuals who have received immunoglobulins and/or any blood or blood products within the 3 months before the first vaccine administration or plan to receive such products at any time during the study.
- Individuals with an immunosuppressive or immunodeficient state, asplenia, or recurrent severe infections.
- Individuals with a documented history of chronic infection including HIV, HBV, HCV, or who are currently known to have active tuberculosis.
- Individuals with chronic illness that, in the opinion of the Investigator, are at a stage where it might interfere with trial participation or interpretation of study results.
- Individuals receiving treatment with another investigational drug, biological agent, or device within 28 days of screening, or 5 half-lives of the investigational drug, whichever is longer; or are currently enrolled in or plan to participate in another clinical trial with an investigational agent during the study period.
- Individuals who received any influenza vaccine within 6 months prior to enrollment. Individuals who plan to receive an influenza vaccine during the study period*.
- Individuals who have received any other licensed vaccines within 14 days prior to enrollment in this study or who are planning to receive any vaccine up to 14 days after the study vaccination.
- Individuals who are investigator site staff members, employees of the Sponsor or the Clinical Research Organization directly involved in the conduct of the study, or site staff members otherwise supervised by the investigator or immediate family members of any of the previously mentioned individuals.
- Participants in the older adult group (Part 3) are allowed, following their Day 29 visit, to receive the authorized influenza vaccine as per country-specific recommendations.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Nucleus Network Brisbane Clinic
Brisbane, Queensland
Emeritus Research Camberwell
Melbourne, Victoria, 3124
About this study
Official title: A Phase 1, First-in-Human, Randomized, Observer-blind, Controlled, Dose-ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of a Self-Amplifying mRNA Seasonal Influenza Vaccine (ARCT-2138), When Administered to Healthy Adults
This is a safety and Immunogenicity first-in-human dose-ranging study of self-amplifying RNA Seasonal Influenza Vaccine (ARCT-2138) in adults.
Read the detailed description
Phase 1, first-in-human, randomized, controlled, observer blind (open label Part 4 only), dose-escalation study, to assess the safety, tolerability, and immunogenicity of different dose levels of the ARCT-2138 vaccine, administered as a single dose to healthy young and older adults, in comparison with an inactivated influenza vaccine.
Study drug (ARCT-2138 or control) will be administered as an intramuscular (IM) injection. The study comprises of four parts. In Part 1, escalating dose levels of ARCT-2138 given as a single injection to younger adults will be evaluated sequentially.
Low, medium, and high dose levels of ARCT-2138 (as recommended by DSMB) will be further evaluated in younger adults in Part 2. Part 3 will evaluate low, medium, and high dose levels of ARCT-2138 (as recommended by DSMB) in older adults.
Part 4 (dose expansion phase) will administer a lower dose of ARCT-2138 in young adults.
Investigational Vaccine: ARCT-2138 (Part 1-3 only, no control vaccine for Part 4) Control Vaccines: licensed influenza vaccines (inactivated)
- For younger adults: Flucelvax® Quad, Seqirus Pty Ltd.
- For older adults: Fluad® Quad, Seqirus Pty Ltd.
- Conditions
- Influenza, Human
- Being tested
- ARCT-2138, Licensed Quadrivalent Vaccine for younger adults, Licensed Quadrivalent Vaccine for older adults
- Keywords
- Influenza, Vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARCT-2138Biological
Also called Self-Amplifying RNA seasonal Influenza vaccine
Each participant will receive one 0.5 mL intramuscular (IM) dose into the deltoid muscle.
Licensed Quadrivalent Vaccine for younger adultsBiological
Also called Influenza vaccine, surface antigen, inactivated, prepared in cell cultures
Each participant will receive one 0.5 mL intramuscular (IM) dose into the deltoid muscle.
Licensed Quadrivalent Vaccine for older adultsBiological
Also called Influenza vaccine, surface antigen, inactivated, adjuvanted
Each participant will receive one 0.5 mL intramuscular (IM) dose into the deltoid muscle.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 of ARCT-2138, younger adults | Experimental | Dose Level 1 of ARCT-2138 administered through intramuscular injection in the deltoid muscle.
Interventions:
Investigational Vaccine: ARCT-2138 Receives: Biological: ARCT-2138 |
| Cohort 2 of ARCT-2138, younger adults | Experimental | Dose Level 2 of ARCT-2138 administered through intramuscular injection in the deltoid muscle.
Interventions:
Investigational Vaccine: ARCT-2138 Receives: Biological: ARCT-2138 |
| Cohort 3 of ARCT-2138, younger adults | Experimental | Dose Level 3 of ARCT-2138 administered through intramuscular injection in the deltoid muscle.
Interventions:
Investigational Vaccine: ARCT-2138 Receives: Biological: ARCT-2138 |
| Cohort 4 of ARCT-2138, younger adults | Experimental | Dose Level 4 of ARCT-2138 administered through intramuscular injection in the deltoid muscle.
Interventions:
Investigational Vaccine: ARCT-2138 Receives: Biological: ARCT-2138 |
| Low Dose, younger and older adults | Experimental | Low dose level of ARCT-2138 administered through intramuscular injection in the deltoid muscle.
Interventions:
Investigational Vaccine: ARCT-2138 Receives: Biological: ARCT-2138 |
| Medium Dose, younger and older adults | Experimental | Medium dose level of ARCT-2138 administered through intramuscular injection in the deltoid muscle.
Interventions:
Investigational Vaccine: ARCT-2138 Receives: Biological: ARCT-2138 |
| High Dose, younger and older adults | Experimental | High dose level of ARCT-2138 administered through intramuscular injection in the deltoid muscle.
Interventions:
Investigational Vaccine: ARCT-2138 Receives: Biological: ARCT-2138 |
| Control Dose, younger adults | Active comparator | Licensed Quadrivalent Vaccine administered through intramuscular injection in the deltoid muscle.
Interventions:
Control Vaccine: Licensed Quadrivalent Vaccine for younger adults Receives: Biological: Licensed Quadrivalent Vaccine for younger adults |
| Control Dose, older adults | Active comparator | Licensed Quadrivalent Vaccine administered through intramuscular injection in the deltoid muscle.
Interventions:
Control Vaccine: Licensed Quadrivalent Vaccine for older adults Receives: Biological: Licensed Quadrivalent Vaccine for older adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants reporting local Adverse Events
Solicited local AEs include injection-site pain, erythema and swelling
Measured: 14 Days following study vaccination
Percentage of participants reporting systemic Adverse Events
Solicited systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills, and fever.
Measured: 14 Days following study vaccination
Percentage of participants reporting unsolicited Adverse Events
Spontaneously reported adverse events and as elicited by investigational site staff
Measured: 29 Days following study vaccination
Percentage of participants reporting laboratory or vital signs abnormalities
Abnormal clinically significant values
Measured: 29 Days following study vaccination
Percentage of participants reporting serious adverse events, medically attended adverse events adverse events of special interest and adverse events leading early termination
Spontaneously reported adverse events and as elicited by investigational site staff
Measured: 29 Days following study vaccination
Serum hemagglutination inhibition (HAI) antibody levels against the HA glycoprotein.
HAI antibody levels expressed as GMT, GMFI, SCRs and HAI titers.
Measured: 29 days following study vaccination
Serum neuraminidase enzyme-linked lectin (ELLA) assay antibody levels against the NA glycoproteins.
ELLA antibody levels expressed as GMT, GMFI, SCRs and HAI titers.
Measured: 29 days following study vaccination
Secondary outcomes (3)
Percentage of participants reporting serious adverse events, medically attended adverse events adverse events of special interest and adverse events leading early termination
Spontaneously reported adverse events and as elicited by investigational site staff
Measured: 181 days following study vaccination
Serum hemagglutination inhibition (HAI) antibody levels against the HA glycoprotein.
HAI antibody levels expressed as GMT, GMFI, SCRs and HAI titers.
Measured: 181 days following study vaccination
Serum neuraminidase enzyme-linked lectin (ELLA) assay antibody levels against the NA glycoproteins.
ELLA antibody levels expressed as GMT, GMFI, SCRs and HAI titers.
Measured: 181 days following study vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start22 Jan 2024
- Primary completion10 Aug 2024
- Study completion7 Jan 2025
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
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arcturus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seqirus, Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
- Investigators
- Clinical Program Director, Study director, Arcturus Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125691
- Sponsor's protocol ID
- ARCT-2138-01
- Status last verified
- Sep 2025
- First submitted
- 5 Nov 2023
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will only be made available to study investigators at this time.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Randomized, Observer-blind, Controlled, Dose-ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of a Self-Amplifying mRNA Seasonal Influenza Vaccine (ARCT-2138), When Administered to Healthy Adults
- ClinicalTrials.gov ID
- NCT06125691
- Acronym / sponsor ID
- ARCT-2138-01
- Conditions
- Influenza, Human
- Keywords
- Influenza, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Arcturus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Seqirus, Novotech (Australia) Pty Limited
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 10 Aug 2024 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 9 Nov 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 safety and Immunogenicity first-in-human dose-ranging study of self-amplifying RNA Seasonal Influenza Vaccine (ARCT-2138) in adults.
Detailed description
Phase 1, first-in-human, randomized, controlled, observer blind (open label Part 4 only), dose-escalation study, to assess the safety, tolerability, and immunogenicity of different dose levels of the ARCT-2138 vaccine, administered as a single dose to healthy young and older adults, in comparison with an inactivated influenza vaccine.
Study drug (ARCT-2138 or control) will be administered as an intramuscular (IM) injection. The study comprises of four parts. In Part 1, escalating dose levels of ARCT-2138 given as a single injection to younger adults will be evaluated sequentially.
Low, medium, and high dose levels of ARCT-2138 (as recommended by DSMB) will be further evaluated in younger adults in Part 2. Part 3 will evaluate low, medium, and high dose levels of ARCT-2138 (as recommended by DSMB) in older adults.
Part 4 (dose expansion phase) will administer a lower dose of ARCT-2138 in young adults.
Investigational Vaccine: ARCT-2138 (Part 1-3 only, no control vaccine for Part 4) Control Vaccines: licensed influenza vaccines (inactivated)
- For younger adults: Flucelvax® Quad, Seqirus Pty Ltd.
- For older adults: Fluad® Quad, Seqirus Pty Ltd.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 of ARCT-2138, younger adults | Experimental | Biological: ARCT-2138Dose Level 1 of ARCT-2138 administered through intramuscular injection in the deltoid muscle. Interventions: Investigational Vaccine: ARCT-2138 |
| Cohort 2 of ARCT-2138, younger adults | Experimental | Biological: ARCT-2138Dose Level 2 of ARCT-2138 administered through intramuscular injection in the deltoid muscle. Interventions: Investigational Vaccine: ARCT-2138 |
| Cohort 3 of ARCT-2138, younger adults | Experimental | Biological: ARCT-2138Dose Level 3 of ARCT-2138 administered through intramuscular injection in the deltoid muscle. Interventions: Investigational Vaccine: ARCT-2138 |
| Cohort 4 of ARCT-2138, younger adults | Experimental | Biological: ARCT-2138Dose Level 4 of ARCT-2138 administered through intramuscular injection in the deltoid muscle. Interventions: Investigational Vaccine: ARCT-2138 |
| Low Dose, younger and older adults | Experimental | Biological: ARCT-2138Low dose level of ARCT-2138 administered through intramuscular injection in the deltoid muscle. Interventions: Investigational Vaccine: ARCT-2138 |
| Medium Dose, younger and older adults | Experimental | Biological: ARCT-2138Medium dose level of ARCT-2138 administered through intramuscular injection in the deltoid muscle. Interventions: Investigational Vaccine: ARCT-2138 |
| High Dose, younger and older adults | Experimental | Biological: ARCT-2138High dose level of ARCT-2138 administered through intramuscular injection in the deltoid muscle. Interventions: Investigational Vaccine: ARCT-2138 |
| Control Dose, younger adults | Active comparator | Biological: Licensed Quadrivalent Vaccine for younger adultsLicensed Quadrivalent Vaccine administered through intramuscular injection in the deltoid muscle. Interventions: Control Vaccine: Licensed Quadrivalent Vaccine for younger adults |
| Control Dose, older adults | Active comparator | Biological: Licensed Quadrivalent Vaccine for older adultsLicensed Quadrivalent Vaccine administered through intramuscular injection in the deltoid muscle. Interventions: Control Vaccine: Licensed Quadrivalent Vaccine for older adults |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals are male, female, or transgender adults 18 to 49 years of age or 65 to 85 years of age.
- Healthy participants or participants with pre-existing stable medical conditions. Pre-existing stable medical condition means a subject who: has full capacity of daily activity and no major medication modification; has not undergone surgical or minimally invasive intervention or had any hospitalization/emergency room visit for the specific medical condition within 3 months prior to Day 1.
- Participant or legally authorized representatives must freely provide documented informed consent prior to study procedures being performed.
- Individuals who have not received influenza vaccine within 6 months prior to enrollment.
- Individuals must agree to comply with all study visits and procedures (including blood tests, nasopharyngeal swabs, diary completion, receipt of telephone calls from the site, willingness to be available for Unscheduled Clinic Visits).
Key exclusion criteria (19 listed)
- Individuals with acute medical illness or febrile illness, including body temperature >100.4°F (>38.0°C) within 3 days prior to Randomization. These individuals may be offered the opportunity to enter the study after fever and illness has stabilized. Participants with suspected or confirmed influenza should be excluded and referred for medical care. Rescreening will be permitted for individuals who are presented with suspected influenza if another diagnosis is confirmed.
- Individuals with any medical, neurological, or psychiatric condition that, in the opinion of the investigator, could place the participant at an unacceptable risk of injury or render the participant unable to comply with all study procedures and achieve successful completion of the trial.
- Individuals with a known history of severe hypersensitivity reactions, including anaphylaxis, or other significant adverse reactions to any mRNA vaccine, influenza vaccine, or excipients.
- Individuals who have a positive pregnancy test at the Screening visit or Day 1 or who intend to become pregnant or breastfeed during the study.
- Individuals with a history of myocarditis, pericarditis, myopericarditis or cardiomyopathy.
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 |
|---|---|---|
| ARCT-2138Also: Self-Amplifying RNA seasonal Influenza vaccineEach participant will receive one 0.5 mL intramuscular (IM) dose into the deltoid muscle. | Biological | Cohort 1 of ARCT-2138, younger adults, Cohort 2 of ARCT-2138, younger adults, Cohort 3 of ARCT-2138, younger adults, Cohort 4 of ARCT-2138, younger adults, High Dose, younger and older adults, Low Dose, younger and older adults, Medium Dose, younger and older adults |
| Licensed Quadrivalent Vaccine for younger adultsAlso: Influenza vaccine, surface antigen, inactivated, prepared in cell culturesEach participant will receive one 0.5 mL intramuscular (IM) dose into the deltoid muscle. | Biological | Control Dose, younger adults |
| Licensed Quadrivalent Vaccine for older adultsAlso: Influenza vaccine, surface antigen, inactivated, adjuvantedEach participant will receive one 0.5 mL intramuscular (IM) dose into the deltoid muscle. | Biological | Control Dose, older adults |
Primary outcome
Percentage of participants reporting local Adverse Events
Time frame: 14 Days following study vaccination
Solicited local AEs include injection-site pain, erythema and swelling
Percentage of participants reporting systemic Adverse Events
Time frame: 14 Days following study vaccination
Solicited systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills, and fever.
Percentage of participants reporting unsolicited Adverse Events
Time frame: 29 Days following study vaccination
Spontaneously reported adverse events and as elicited by investigational site staff
Percentage of participants reporting laboratory or vital signs abnormalities
Time frame: 29 Days following study vaccination
Abnormal clinically significant values
Percentage of participants reporting serious adverse events, medically attended adverse events adverse events of special interest and adverse events leading early termination
Time frame: 29 Days following study vaccination
Spontaneously reported adverse events and as elicited by investigational site staff
Serum hemagglutination inhibition (HAI) antibody levels against the HA glycoprotein.
Time frame: 29 days following study vaccination
HAI antibody levels expressed as GMT, GMFI, SCRs and HAI titers.
Serum neuraminidase enzyme-linked lectin (ELLA) assay antibody levels against the NA glycoproteins.
Time frame: 29 days following study vaccination
ELLA antibody levels expressed as GMT, GMFI, SCRs and HAI titers.
3 secondary outcomes
Percentage of participants reporting serious adverse events, medically attended adverse events adverse events of special interest and adverse events leading early termination
Time frame: 181 days following study vaccination
Serum hemagglutination inhibition (HAI) antibody levels against the HA glycoprotein.
Time frame: 181 days following study vaccination
Serum neuraminidase enzyme-linked lectin (ELLA) assay antibody levels against the NA glycoproteins.
Time frame: 181 days following study vaccination
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 3 Oct 2025.
- Individual participant dataSharing planned: No. Individual participant data will only be made available to study investigators at this time.
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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
Arcturus Therapeutics
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 ARCT-2138, Licensed Quadrivalent Vaccine for younger adults and Licensed Quadrivalent Vaccine for older adults in people with Influenza, Human, run by Arcturus Therapeutics, Inc. 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 6 inclusion and 19 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 3 Oct 2025. 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. 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?
Percentage of participants reporting local Adverse Events (time frame: 14 Days following study vaccination). The study lists 7 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 3 Oct 2025.