Influenza APhase 1NCT03999554
Safety and Immunogenicity of the Bris10 M2SR and Sing2016 M2SR H3N2 Monovalent Influenza Vaccines
A Phase 1 study testing LD Sing2016 M2SR H3N2 influenza vaccine, MD Sing2016 M2SR H3N2 influenza vaccine and HD Sing2016 M2SR H3N2 influenza vaccine in people with Influenza A, run by FluGen Inc at 4 sites in United States.
Trial summary
This is a Phase I double-blind, randomized, placebo-controlled study in 250 healthy adults, 18-49 years of age, inclusive, who are in good health and meet all eligibility criteria. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza A
- What is being tested?
- LD Sing2016 M2SR H3N2 influenza vaccine, MD Sing2016 M2SR H3N2 influenza vaccine and HD Sing2016 M2SR H3N2 influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Sep 2019to 1 Jul 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Give written informed consent to participate.
- Age 18 - 49 years old.
- Judged suitable by the PI, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations.
- Willing to use oral, implantable, transdermal or injectable contraceptives, or sexual abstinence, from screening and until 28 days after second vaccine dose.
- Willing to adhere to the requirements of the study and willing and able to communicate with the Investigator and understand the requirements of the study.
Who cannot join
- Abnormal screening hematology or chemistry value per the FDA Toxicity Guidance.
- Pulse rate or blood pressure outside the reference range for this study population and considered as clinically significant by the Investigator.
- Has an acute or chronic medical condition or history of a medical condition that, in the opinion of the Investigator, would render the study procedures unsafe or would interfere with the evaluation of the responses.
- Presence or clinically significant history of lung disease, asthma, chronic obstructive pulmonary disease (COPD), or otherwise poor lung function.
- Any confirmed or suspected immunosuppressive or immunodeficient state.
- Presence of household member or close personal or professional (i.e., healthcare worker) who is a child under one year of age; is pregnant; has known immunodeficiency or is receiving immunosuppressant medication; is undergoing or soon to undergo cancer chemotherapy; has been diagnosed with emphysema, COPD, or other severe lung disease and resides in a nursing home; and/or has received a bone marrow or solid organ transplant.
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- Females who are pregnant or lactating.
- Acute febrile illness within 72 hours prior to vaccination.
- Any condition, in the opinion of the Investigator, (such as subjects who have medically high-risk conditions) that might interfere with the primary study objectives for safety of the study subject.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
RCA
Hollywood, Florida, 33024
JCCT
Lenexa, Kansas, 66219
AMR Lexington
Lexington, Kentucky, 40509
AMR Norfolk
Norfolk, Virginia, 23507
About this study
Official title: Phase 1b Clinical Study to Investigate the Safety and Immunogenicity of the Bris10 (A/Brisbane/10/2007) M2SR and Sing2016 (A/Singapore/INFIMH-16-0019/2016) M2SR H3N2 Monovalent Influenza Vaccines
This is a Phase I double-blind, randomized, placebo-controlled study in 250 healthy adults, 18-49 years of age, inclusive, who are in good health and meet all eligibility criteria. The purpose of this dose escalation clinical study is to assess the safety, tolerability/reactogenicity, and immunogenicity of H3N2 M2SR investigational vaccines for prevention of influenza, when delivered at higher dosages or in two doses . Eligible subjects will be screened and randomized to receive two administrations 28 days apart of Sing2016 M2SR at three dose levels (low, medium, high), Bris10 M2SR at one dose level (low), or placebo in a 1:1:1:1:1 ratio. Study duration will be approximately 8 months with subject participation duration approximately 7 months. The primary study objective is to assess the safety and reactogenicity of a monovalent live single replication influenza H3N2 M2SR vaccine.
Read the detailed description
This is a Phase I double-blind, randomized, placebo-controlled study in 250 healthy adults, 18-49 years of age, inclusive, who are in good health and meet all eligibility criteria. This dose escalation clinical study is designed to assess the safety, tolerability/reactogenicity, and immunogenicity of H3N2 M2SR investigational vaccines for prevention of influenza, when delivered at increasing dosages or in two doses. Subjects will be enrolled in five groups in a 1:1:1:1:1 ratio. Arm 1 will receive a low dose of Sing2016 M2SR intranasally on days 1 and 29. Arm 2 will receive a medium dose of Sing2016 M2SR intranasally on days 1 and 29. Arm 3 will receive a high dose of Sing2016 M2SR intranasally on days 1 and 29. Arm 4 will receive a low dose of Bris16 M2SR intranasally on days 1 and 29. Arm 5 will receive a placebo intranasally on days 1 and 29. Study duration will be approximately 8 months with subject participation duration approximately 7 months. The primary study objective is to assess the safety and reactogenicity of a monovalent live single replication influenza H3N2 M2SR vaccine. The secondary study objectives are to evaluate systemic and mucosal immune responses induced by H3N2 M2SR vaccination.
- Conditions
- Influenza A
- Being tested
- LD Sing2016 M2SR H3N2 influenza vaccine, MD Sing2016 M2SR H3N2 influenza vaccine, HD Sing2016 M2SR H3N2 influenza vaccine, LD Bris10 M2SR H3N2 influenza vaccine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LD Sing2016 M2SR H3N2 influenza vaccineBiological
This group will receive a low dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
MD Sing2016 M2SR H3N2 influenza vaccineBiological
This group will receive a medium dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
HD Sing2016 M2SR H3N2 influenza vaccineBiological
This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
LD Bris10 M2SR H3N2 influenza vaccineBiological
This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally.
PlaceboOther
This group will receive saline placebo administered intranasally.
| Study group | Role | What they receive |
|---|---|---|
| Low dose Sing2016 M2SR | Experimental | Low dose Sing2016 M2SR will be administered intranasally on days 1 and 29 Receives: Biological: LD Sing2016 M2SR H3N2 influenza vaccine |
| Medium dose Sing2016 M2SR | Experimental | Medium dose Sing2016 M2SR will be administered intranasally on days 1 and 29 Receives: Biological: MD Sing2016 M2SR H3N2 influenza vaccine |
| High dose Sing2016 M2SR | Experimental | High dose Sing2016 M2SR will be administered intranasally on days 1 and 29 Receives: Biological: HD Sing2016 M2SR H3N2 influenza vaccine |
| Low dose Bris10 M2SR | Active comparator | Low dose Bris10 M2SR will be administered intranasally on days 1 and 29 Receives: Biological: LD Bris10 M2SR H3N2 influenza vaccine |
| Placebo | Placebo comparator | Saline will be administered intranasally on days 1 and 29 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Local and Systemic Adverse Events (AEs) Through 29 Days Post-vaccination With Bris10 M2SR and Cumulatively Through Day 209
Record adverse events following one and two administrations of the Bris10 M2SR influenza vaccine to determine the number and percentage of study participants who experience any vaccine associated adverse events (AEs) or serious adverse events (SAEs) after Bris10 M2SR or placebo administration.
Measured: From baseline through study completion (Day 209)
Number of Participants With Local and Systemic Adverse Events (AEs) Through 29 Days Post-vaccination With Sing2016 M2SR and Cumulatively Through Day 209
Record adverse events following one and two administrations of the Sing2016 M2SR influenza vaccine to determine the number and percentage of study participants who experience any vaccine associated adverse events (AEs) or serious adverse events (SAEs) after Sing2016 M2SR or placebo administration.
Measured: From baseline through study completion (Day 209)
Secondary outcomes (8)
Percentage of Bris10 M2SR Subjects Demonstrating Seroconversion to Vaccine HA
Assess the humoral immunogenicity of one administration of Bris10 M2SR vaccine to Bris 10 by HAI at day 29.
Measured: From baseline through 28 days post-dose 1 (Day 29)
Percentage of Sing2016 M2SR Subjects Demonstrating Seroconversion to Vaccine HA
Assess the humoral immunogenicity of one administration of Sing2016 M2SR vaccine to Sing2016 by HAI at day 29
Measured: From baseline through 28 days post-dose 1 (Day 29)
Percentage of Bris10 M2SR Subjects Demonstrating Seroconversion to Vaccine HA
Assess the humoral immunogenicity of two administrations of Bris10 M2SR vaccine to Bris 10 by HAI at d57.
Measured: From baseline through 28 days post-dose 2 (Day 57)
Percentage of Sing2016 M2SR Subjects Demonstrating Seroconversion to Vaccine HA
Assess the humoral immunogenicity of two administrations of Sing2016 M2SR vaccine to Sing2016 by HAI at day 57
Measured: From baseline through 28 days post-dose 2 (Day 57)
Percentage of Bris10 M2SR Subjects Demonstrating Mucosal Responses to Vaccine HA
Assess the mucosal immunogenicity of one administration of Bris10 M2SR vaccine to Bris 10 by ELISA at day 29.
Measured: From baseline through 28 days post-dose 1 (Day 29)
Percentage of Bris10 M2SR Subjects Demonstrating Mucosal Responses to Vaccine HA
Assess the mucosal immunogenicity of two administrations of Bris10 M2SR vaccine to Bris 10 by ELISA at day 57.
Measured: From baseline through 28 days post-dose 2 (Day 57)
Percentage of Sing2016 M2SR Subjects Demonstrating Mucosal Responses to Vaccine HA
Assess the mucosal immunogenicity of two administrations of Sing2016 M2SR vaccine to Sing2016 by ELISA at day 57
Measured: From baseline through 28 days post-dose 2 (Day 57)
Percentage of Sing2016 M2SR Subjects Demonstrating Mucosal Responses to Vaccine HA
Assess the mucosal immunogenicity of one administration of Sing2016 M2SR vaccine to Sing2016 by ELISA at day 29
Measured: From baseline through 28 days post-dose 1 (Day 29)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start3 Sep 2019
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza AStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blind, placebo-controlled Phase 1 study evaluating the safety and immunogenicity of the Bris10 M2SR and Sing2016 M2SR H3N2 influenza vaccines delivered intranasally to healthy adults. Eligible subjects will be screened and randomized to receive two administrations 28 days apart of Sing2016 M2SR at three dose levels, Bris10 M2SR at one dose level, or placebo in a 1:1:1:1:1 ratio.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- FluGen Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pamuk Bilsel, Study director, FluGen IncCarlos Fierro, MD, Principal investigator, JCCT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999554
- Sponsor's protocol ID
- FLUGEN-H3N2-V003
- Status last verified
- Dec 2021
- First submitted
- 18 Jun 2019
- Last updated
- 4 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Eiden J, Fierro C, Schwartz H, Adams M, Ellis KJ, Aitchison R, Herber R, Hatta Y, Marshall D, Moser MJ, Belshe R, Greenberg H, Coelingh K, Kawaoka Y, Neumann G, Bilsel P. Intranasal M2SR (M2-Deficient Single Replication) H3N2 Influenza Vaccine Provides Enhanced Mucosal and Serum Antibodies in Adults. J Infect Dis. 2022 Dec 28;227(1):103-112. doi: 10.1093/infdis/jiac433.
PubMed 36350017
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Clinical Study to Investigate the Safety and Immunogenicity of the Bris10 (A/Brisbane/10/2007) M2SR and Sing2016 (A/Singapore/INFIMH-16-0019/2016) M2SR H3N2 Monovalent Influenza Vaccines
- ClinicalTrials.gov ID
- NCT03999554
- Acronym / sponsor ID
- FLUGEN-H3N2-V003
- Conditions
- Influenza A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- FluGen IncIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 26 Jun 2019 (actual)
- Results
- Posted 4 Mar 2022
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 I double-blind, randomized, placebo-controlled study in 250 healthy adults, 18-49 years of age, inclusive, who are in good health and meet all eligibility criteria. The purpose of this dose escalation clinical study is to assess the safety, tolerability/reactogenicity, and immunogenicity of H3N2 M2SR investigational vaccines for prevention of influenza, when delivered at higher dosages or in two doses . Eligible subjects will be screened and randomized to receive two administrations 28 days apart of Sing2016 M2SR at three dose levels (low, medium, high), Bris10 M2SR at one dose level (low), or placebo in a 1:1:1:1:1 ratio. Study duration will be approximately 8 months with subject participation duration approximately 7 months. The primary study objective is to assess the safety and reactogenicity of a monovalent live single replication influenza H3N2 M2SR vaccine.
Detailed description
This is a Phase I double-blind, randomized, placebo-controlled study in 250 healthy adults, 18-49 years of age, inclusive, who are in good health and meet all eligibility criteria. This dose escalation clinical study is designed to assess the safety, tolerability/reactogenicity, and immunogenicity of H3N2 M2SR investigational vaccines for prevention of influenza, when delivered at increasing dosages or in two doses. Subjects will be enrolled in five groups in a 1:1:1:1:1 ratio. Arm 1 will receive a low dose of Sing2016 M2SR intranasally on days 1 and 29. Arm 2 will receive a medium dose of Sing2016 M2SR intranasally on days 1 and 29. Arm 3 will receive a high dose of Sing2016 M2SR intranasally on days 1 and 29. Arm 4 will receive a low dose of Bris16 M2SR intranasally on days 1 and 29. Arm 5 will receive a placebo intranasally on days 1 and 29. Study duration will be approximately 8 months with subject participation duration approximately 7 months. The primary study objective is to assess the safety and reactogenicity of a monovalent live single replication influenza H3N2 M2SR vaccine. The secondary study objectives are to evaluate systemic and mucosal immune responses induced by H3N2 M2SR vaccination.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- This is a randomized, double-blind, placebo-controlled Phase 1 study evaluating the safety and immunogenicity of the Bris10 M2SR and Sing2016 M2SR H3N2 influenza vaccines delivered intranasally to healthy adults. Eligible subjects will be screened and randomized to receive two administrations 28 days apart of Sing2016 M2SR at three dose levels, Bris10 M2SR at one dose level, or placebo in a 1:1:1:1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Low dose Sing2016 M2SR | Experimental | Biological: LD Sing2016 M2SR H3N2 influenza vaccineLow dose Sing2016 M2SR will be administered intranasally on days 1 and 29 |
| Medium dose Sing2016 M2SR | Experimental | Biological: MD Sing2016 M2SR H3N2 influenza vaccineMedium dose Sing2016 M2SR will be administered intranasally on days 1 and 29 |
| High dose Sing2016 M2SR | Experimental | Biological: HD Sing2016 M2SR H3N2 influenza vaccineHigh dose Sing2016 M2SR will be administered intranasally on days 1 and 29 |
| Low dose Bris10 M2SR | Active comparator | Biological: LD Bris10 M2SR H3N2 influenza vaccineLow dose Bris10 M2SR will be administered intranasally on days 1 and 29 |
| Placebo | Placebo comparator | Other: PlaceboSaline will be administered intranasally on days 1 and 29 |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Give written informed consent to participate.
- Age 18 - 49 years old.
- Judged suitable by the PI, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations.
- Willing to use oral, implantable, transdermal or injectable contraceptives, or sexual abstinence, from screening and until 28 days after second vaccine dose.
- Willing to adhere to the requirements of the study and willing and able to communicate with the Investigator and understand the requirements of the study.
Key exclusion criteria (9 listed)
- Abnormal screening hematology or chemistry value per the FDA Toxicity Guidance.
- Pulse rate or blood pressure outside the reference range for this study population and considered as clinically significant by the Investigator.
- Has an acute or chronic medical condition or history of a medical condition that, in the opinion of the Investigator, would render the study procedures unsafe or would interfere with the evaluation of the responses.
- Presence or clinically significant history of lung disease, asthma, chronic obstructive pulmonary disease (COPD), or otherwise poor lung function.
- Any confirmed or suspected immunosuppressive or immunodeficient state.
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 |
|---|---|---|
| LD Sing2016 M2SR H3N2 influenza vaccineThis group will receive a low dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally. | Biological | Low dose Sing2016 M2SR |
| MD Sing2016 M2SR H3N2 influenza vaccineThis group will receive a medium dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally. | Biological | Medium dose Sing2016 M2SR |
| HD Sing2016 M2SR H3N2 influenza vaccineThis group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally. | Biological | High dose Sing2016 M2SR |
| LD Bris10 M2SR H3N2 influenza vaccineThis group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally. | Biological | Low dose Bris10 M2SR |
| PlaceboThis group will receive saline placebo administered intranasally. | Other | Placebo |
Primary outcome
Number of Participants With Local and Systemic Adverse Events (AEs) Through 29 Days Post-vaccination With Bris10 M2SR and Cumulatively Through Day 209
Time frame: From baseline through study completion (Day 209)
Record adverse events following one and two administrations of the Bris10 M2SR influenza vaccine to determine the number and percentage of study participants who experience any vaccine associated adverse events (AEs) or serious adverse events (SAEs) after Bris10 M2SR or placebo administration.
Number of Participants With Local and Systemic Adverse Events (AEs) Through 29 Days Post-vaccination With Sing2016 M2SR and Cumulatively Through Day 209
Time frame: From baseline through study completion (Day 209)
Record adverse events following one and two administrations of the Sing2016 M2SR influenza vaccine to determine the number and percentage of study participants who experience any vaccine associated adverse events (AEs) or serious adverse events (SAEs) after Sing2016 M2SR or placebo administration.
8 secondary outcomes
Percentage of Bris10 M2SR Subjects Demonstrating Seroconversion to Vaccine HA
Time frame: From baseline through 28 days post-dose 1 (Day 29)
Percentage of Sing2016 M2SR Subjects Demonstrating Seroconversion to Vaccine HA
Time frame: From baseline through 28 days post-dose 1 (Day 29)
Percentage of Bris10 M2SR Subjects Demonstrating Seroconversion to Vaccine HA
Time frame: From baseline through 28 days post-dose 2 (Day 57)
Percentage of Sing2016 M2SR Subjects Demonstrating Seroconversion to Vaccine HA
Time frame: From baseline through 28 days post-dose 2 (Day 57)
Percentage of Bris10 M2SR Subjects Demonstrating Mucosal Responses to Vaccine HA
Time frame: From baseline through 28 days post-dose 1 (Day 29)
Percentage of Bris10 M2SR Subjects Demonstrating Mucosal Responses to Vaccine HA
Time frame: From baseline through 28 days post-dose 2 (Day 57)
Percentage of Sing2016 M2SR Subjects Demonstrating Mucosal Responses to Vaccine HA
Time frame: From baseline through 28 days post-dose 2 (Day 57)
Percentage of Sing2016 M2SR Subjects Demonstrating Mucosal Responses to Vaccine HA
Time frame: From baseline through 28 days post-dose 1 (Day 29)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36350017Eiden J, Fierro C, Schwartz H, Adams M, Ellis KJ, Aitchison R, Herber R, Hatta Y, Marshall D, Moser MJ, Belshe R, Greenberg H, Coelingh K, Kawaoka Y, Neumann G, Bilsel P. Intranasal M2SR (M2-Deficient Single Replication) H3N2 Influenza Vaccine Provides Enhanced Mucosal and Serum Antibodies in Adults. J Infect Dis. 2022 Dec 28;227(1):103-112. doi: 10.1093/infdis/jiac433.
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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.
Pamuk Bilsel study director
FluGen Inc
Carlos Fierro, MD principal investigator
JCCT
4 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 LD Sing2016 M2SR H3N2 influenza vaccine, MD Sing2016 M2SR H3N2 influenza vaccine and HD Sing2016 M2SR H3N2 influenza vaccine in people with Influenza A, run by FluGen Inc at 4 sites in United States.
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 9 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 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Yes. Results are posted in the registry (first posted 4 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of Participants With Local and Systemic Adverse Events (AEs) Through 29 Days Post-vaccination With Bris10 M2SR and Cumulatively Through Day 209 (time frame: From baseline through study completion (Day 209)). The study lists 2 primary outcomes in all. 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 NCT03999554, 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 4 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.