InfluenzaPhase 1NCT06125717
Phase 1 Evaluation of H1 Influenza Vaccine Delivered by MIMIX MAP
A Phase 1 study testing H1 influenza antigen in people with Influenza, run by Terrestrial Bio, Inc. at 3 sites in Canada.
Trial summary
A Phase 1, Randomized, Rater and Participant Blinded Placebo Controlled Study to Evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of a Standard and a Fractional Dose of H1 Influenza Vaccine Delivered by VX-103 (a MIMIX Microneedle Array Patch (MAP) System) in Healthy Adults ≥18-39 Years of Age Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- H1 influenza antigen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 3 sitesCanada
- Study dates
- 2 Jul 2022to 13 Mar 2023
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged 18 - 39 years inclusive
- Provide written informed consent to participate
- Healthy participants without acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
- o As determined by medical history, physical exam, laboratory screening
- Body Mass Index 18-35 kg/m2, inclusive, at screening
Who cannot join
- Any medical condition that in the judgement of the investigator would make subject participation in the study unsafe.
- Having cancer or received treatment for cancer within three years (persons with a history of cancer who are disease-free without treatment for three years or more are eligible), excluding basal cell carcinoma (BCC) or squamous cell carcinoma (SCC), which are allowed unless located at the vaccination site.
- Impaired immune responsiveness (of any cause), including diabetes mellitus.
- Receipt or plan to receive a non-study vaccine within 30 days prior to vaccination or 60 days after vaccination.
- Receipt of any influenza vaccine in previous 24 months and/or planned receipt of influenza vaccine for the duration of the study.
- Diagnosed influenza infection in the previous 24 months prior to screening.
Show all 14Show fewer
- Diagnosed COVID infection via medical personnel or at home test within the past 60 days prior to screening
- Allergy to influenza vaccine or components, or history of severe local or systemic reaction to any vaccination.
- History of anaphylactic type reaction to injected vaccines
- History of or current allergy to latex
- History of Guillain-Barré Syndrome.
- Positive test result for hepatitis B surface antigen (HBsAg,), hepatitis C virus antibody (HBcAb), or human immunodeficiency virus (HIV) types 1 or 2 antibodies at screening.
- History of chronic obstructive pulmonary disease or history of other lung disease.
- History of severe allergic reactions to eggs.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Centricity Research Mirabel
Mirabel, Quebec, J7J 2K8
Centricity Research Pointe-Claire
Pointe-Claire, Quebec, H9R 4S3
Centricity Research Toronto
Toronto, Ontario, M9W 4L6
About this study
Official title: A Phase 1, Randomized, Rater and Subject Blinded Placebo Controlled Study to Evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of a Standard and a Fractional Dose of H1 Influenza Vaccine Delivered by VX-103 (a MIMIX Microneedle Patch (MAP) System) in Healthy Adults ≥18-39 Years of Age
A Phase 1, Randomized, Rater and Participant Blinded Placebo Controlled Study to Evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of a Standard and a Fractional Dose of H1 Influenza Vaccine Delivered by VX-103 (a MIMIX Microneedle Array Patch (MAP) System) in Healthy Adults ≥18-39 Years of Age
- Conditions
- Influenza
- Being tested
- H1 influenza antigen
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H1 influenza antigenBiological
Either 7.5 μg or 15 μg of the H1 influenza antigen
| Study group | Role | What they receive |
|---|---|---|
| 15 μg of the H1 influenza antigen | Active comparator | Not described Receives: Biological: H1 influenza antigen |
| 7.5 μg of the H1 influenza antigen | Active comparator | Not described Receives: Biological: H1 influenza antigen |
| Placebo (no antigen) | Placebo comparator | Not described Receives: Biological: H1 influenza antigen |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety of VX-103 delivered as a single MIMIX MAP immunization
Measured: 180 Days
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 start2 Jul 2022
- Primary completion13 Mar 2023
- Study completion13 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terrestrial Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc, Q2 Solutions, Centricity Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125717
- Sponsor's protocol ID
- VX-103-01
- Status last verified
- Nov 2023
- First submitted
- 30 Oct 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garg N, Tellier G, Vale N, Kluge J, Portman JL, Markowska A, Tussey L. Phase 1, randomized, rater and participant blinded placebo-controlled study of the safety, reactogenicity, tolerability and immunogenicity of H1N1 influenza vaccine delivered by VX-103 (a MIMIX microneedle patch [MAP] system) in healthy adults. PLoS One. 2024 Jun 6;19(6):e0303450. doi: 10.1371/journal.pone.0303450. eCollection 2024.
PubMed 38843267
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Rater and Subject Blinded Placebo Controlled Study to Evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of a Standard and a Fractional Dose of H1 Influenza Vaccine Delivered by VX-103 (a MIMIX Microneedle Patch (MAP) System) in Healthy Adults ≥18-39 Years of Age
- ClinicalTrials.gov ID
- NCT06125717
- Acronym / sponsor ID
- VX-103-01
- Conditions
- Influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Terrestrial Bio, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ICON plc, Q2 Solutions, Centricity Research
- Study start
- 2 Jul 2022 (actual)
- Primary completion
- 13 Mar 2023 (actual)
- Study completion
- 13 Mar 2023 (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.
A Phase 1, Randomized, Rater and Participant Blinded Placebo Controlled Study to Evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of a Standard and a Fractional Dose of H1 Influenza Vaccine Delivered by VX-103 (a MIMIX Microneedle Array Patch (MAP) System) in Healthy Adults ≥18-39 Years of Age
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 15 μg of the H1 influenza antigen | Active comparator | Biological: H1 influenza antigen |
| 7.5 μg of the H1 influenza antigen | Active comparator | Biological: H1 influenza antigen |
| Placebo (no antigen) | Placebo comparator | Biological: H1 influenza antigen |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female aged 18 - 39 years inclusive
- Provide written informed consent to participate
- Healthy participants without acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
- o As determined by medical history, physical exam, laboratory screening
- Body Mass Index 18-35 kg/m2, inclusive, at screening
Key exclusion criteria (14 listed)
- Any medical condition that in the judgement of the investigator would make subject participation in the study unsafe.
- Having cancer or received treatment for cancer within three years (persons with a history of cancer who are disease-free without treatment for three years or more are eligible), excluding basal cell carcinoma (BCC) or squamous cell carcinoma (SCC), which are allowed unless located at the vaccination site.
- Impaired immune responsiveness (of any cause), including diabetes mellitus.
- Receipt or plan to receive a non-study vaccine within 30 days prior to vaccination or 60 days after vaccination.
- Receipt of any influenza vaccine in previous 24 months and/or planned receipt of influenza vaccine for the duration of the study.
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 |
|---|---|---|
| H1 influenza antigenEither 7.5 μg or 15 μg of the H1 influenza antigen | Biological | 15 μg of the H1 influenza antigen, 7.5 μg of the H1 influenza antigen, Placebo (no antigen) |
Primary outcome
To determine the safety of VX-103 delivered as a single MIMIX MAP immunization
Time frame: 180 Days
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 9 Nov 2023.
- Derived from this study: PubMed 38843267Garg N, Tellier G, Vale N, Kluge J, Portman JL, Markowska A, Tussey L. Phase 1, randomized, rater and participant blinded placebo-controlled study of the safety, reactogenicity, tolerability and immunogenicity of H1N1 influenza vaccine delivered by VX-103 (a MIMIX microneedle patch [MAP] system) in healthy adults. PLoS One. 2024 Jun 6;19(6):e0303450. doi: 10.1371/journal.pone.0303450. eCollection 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.
3 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 H1 influenza antigen in people with Influenza, run by Terrestrial Bio, Inc. at 3 sites in Canada.
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 14 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 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
To determine the safety of VX-103 delivered as a single MIMIX MAP immunization (time frame: 180 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06125717, which also lists 1 linked publication.
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 9 Nov 2023.