Influenza VaccinePhase 1NCT05163847
Safety and Immunogenicity of Cam2020 M2SR H3N2 Monovalent Influenza Vaccine Alone or With Licensed IIV in Older Adults
A Phase 1 study testing Cam2020 M2SR H3N2 influenza vaccine and Fluzone HD IIV in people with Influenza Vaccine, run by FluGen Inc at 6 sites in United States.
Trial summary
This is a randomized, double-blind, double-dummy, placebo-controlled Phase 1b study evaluating the safety and immunogenicity of the investigational Cam2020 M2SR H3N2 influenza vaccine delivered IN alone or concomitantly with inactivated influenza vaccine (IIV) delivered IM to a healthy adult population age 65 to 85… Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Vaccine
- What is being tested?
- Cam2020 M2SR H3N2 influenza vaccine and Fluzone HD IIV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 303 participants
- Where
- 6 sitesUnited States
- Study dates
- 14 Jun 2022to 3 Nov 2022
- 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Subjects must be willing and able to provide written informed consent to participate; a legally authorized representative (LAR) may not be used.
- Males and nonchildbearing potential females 65-85 years of age at the time of consent.
- Subjects must be 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.
- Healthy adults and those with stable chronic conditions as determined by medical history, physical examination, vital signs, clinical safety laboratory examinations and clinical judgment of the Investigator to be eligible for study inclusion.
Who cannot join
- Any acute or chronic physical or mental health condition that would limit the subject's ability to complete the study, increase risk of study participation or participant, or may interfere with interpretation of study results as based on the assessment by the Investigator.
- Abnormal screening hematology or chemistry value per the US FDA Guidance: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
- Currently receiving, or planned to receive during the study, any immunosuppressive therapy.
- Had a flu-like illness, influenza treatment, or prophylactic influenza viral drug administered in the previous 6 months before investigational product administration.
- History of receipt of any live virus vaccine within 56 days of study entry, licensed or investigational vaccine within 28 days of Visit 01 or investigational drug within the past 6 months. An exception is made for receipt of a Covid-19 vaccine whether licensed or under EUA as long as the final dose was given at least 28 days prior to Visit 01.
- Planned receipt of licensed vaccine, other than the study-provided licensed influenza vaccine, during the 28 days following Visit 01 or another investigational vaccine or investigational drug during the study period.
- Receipt of blood/plasma products or immunoglobulin within 6 months before administration of the investigational product or planned for during the period of study participation.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Velocity Clinical Research
Beechwood, Ohio, 44122
Velocity Clinical Research
Cedar Park, Texas, 78613
Johnson County Clin Trials
Lenexa, Kansas, 66219
Velocity Clinical Research
Meridian, Idaho, 83642
United Medical Research
Port Orange, Florida, 32127
Rochester Clinical Research
Rochester, New York, 14609
About this study
Official title: Phase 1b Study to Investigate the Safety and Immunogenicity of Cam2020 (A/Cambodia/e0826360/2020) M2SR H3N2 Monovalent Influenza Vaccine Administered Alone or With Licensed, Inactivated Influenza Vaccine in Adults 65 to 85 Years Old
This is a randomized, double-blind, double-dummy, placebo-controlled Phase 1b study evaluating the safety and immunogenicity of the investigational Cam2020 M2SR H3N2 influenza vaccine delivered IN alone or concomitantly with inactivated influenza vaccine (IIV) delivered IM to a healthy adult population age 65 to 85 years at time of enrollment.
Read the detailed description
This is a randomized, double-blind, double-dummy, placebo-controlled Phase 1b study evaluating the safety and immunogenicity of the investigational Cam2020 M2SR H3N2 influenza vaccine delivered IN alone or concomitantly with IIV delivered IM to a healthy adult population age 65 to 85 years at time of enrollment. Eligible subjects will be randomized concurrently in a 3:3:3:1 ratio to receive one administration of Cam2020 M2SR alone (Cohort 1, n=90), Cam2020 M2SR along with IIV (Cohort 2, n=90), IIV alone (Cohort 3, n=90), or placebo (Cohort 4, n=30).
- Conditions
- Influenza Vaccine
- Being tested
- Cam2020 M2SR H3N2 influenza vaccine, Fluzone HD IIV, IN Placebo, IM Placebo
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cam2020 M2SR H3N2 influenza vaccineBiological
Administered intranasally on Day 1
Fluzone HD IIVBiological
Administered intramuscularly on Day 1
IN PlaceboOther
Administered intranasally on Day 1
IM PlaceboOther
Administered intramuscularly on Day 1
| Study group | Role | What they receive |
|---|---|---|
| M2SR only dose | Experimental | Intranasal M2SR vaccine and intramuscular placebo dose Receives: Biological: Cam2020 M2SR H3N2 influenza vaccine; Other: IM Placebo |
| M2SR with IIV dose | Experimental | Intranasal M2SR vaccine and intramuscular IIV dose Receives: Biological: Cam2020 M2SR H3N2 influenza vaccine; Biological: Fluzone HD IIV |
| IIV only dose | Active comparator | Intranasal placebo dose and intramuscular IIV dose Receives: Biological: Fluzone HD IIV; Other: IN Placebo |
| Placebo only dose | Placebo comparator | Intranasal placebo dose and intramuscular placebo dose Receives: Other: IN Placebo; Other: IM Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited AEs during 7 days after experimental treatment
The number and percentage of subjects who experience solicited local and systemic reactions during the 7 days after vaccine administration of M2SR administration alone or with IIV
Measured: Day 1 to Day 8
Unsolicited AEs during 28 days after experimental treatment
The number and percentage of subjects who experience unsolicited AEs during the 28 days after vaccine administration of M2SR alone or with IIV.
Measured: Day 1 to Day 29
SAEs through 28 days after experimental treatment
The number and percentage of subjects who experience SAEs from the time of informed consent through 28 days after vaccine administration of M2SR alone or with IIV.
Measured: Day 1 to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start14 Jun 2022
- Primary completion3 Nov 2022
- Study completion3 Nov 2022
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 Influenza VaccineStudies 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
- Subjects assigned randomly to one of four cohorts concurrently
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- FluGen Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Pamuk Bilsel, Study director, FluGen Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163847
- Sponsor's protocol ID
- FLUGEN-H3N2-V006
- Other IDs
- CDMRP-PR203559
- Status last verified
- Nov 2022
- First submitted
- 7 Dec 2021
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eiden J, Fierro C, White A, Davis M, Rhee M, Turner M, Murray B, Herber R, Aitchison R, Marshall D, Moser MJ, Belshe R, Greenberg H, Coelingh K, Kawaoka Y, Neumann G, Bilsel P. Safety and immunogenicity of the intranasal H3N2 M2-deficient single-replication influenza vaccine alone or coadministered with an inactivated influenza vaccine (Fluzone High-Dose Quadrivalent) in adults aged 65-85 years in the USA: a multicentre, randomised, double-blind, double-dummy, phase 1b trial. Lancet Infect Dis. 2024 Oct;24(10):1118-1129. doi: 10.1016/S1473-3099(24)00351-7. Epub 2024 Jul 11.
PubMed 39004096
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Study to Investigate the Safety and Immunogenicity of Cam2020 (A/Cambodia/e0826360/2020) M2SR H3N2 Monovalent Influenza Vaccine Administered Alone or With Licensed, Inactivated Influenza Vaccine in Adults 65 to 85 Years Old
- ClinicalTrials.gov ID
- NCT05163847
- Acronym / sponsor ID
- FLUGEN-H3N2-V006
- Conditions
- Influenza Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- FluGen IncIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 3 Nov 2022 (actual)
- First posted
- 20 Dec 2021 (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 randomized, double-blind, double-dummy, placebo-controlled Phase 1b study evaluating the safety and immunogenicity of the investigational Cam2020 M2SR H3N2 influenza vaccine delivered IN alone or concomitantly with inactivated influenza vaccine (IIV) delivered IM to a healthy adult population age 65 to 85 years at time of enrollment.
Detailed description
This is a randomized, double-blind, double-dummy, placebo-controlled Phase 1b study evaluating the safety and immunogenicity of the investigational Cam2020 M2SR H3N2 influenza vaccine delivered IN alone or concomitantly with IIV delivered IM to a healthy adult population age 65 to 85 years at time of enrollment. Eligible subjects will be randomized concurrently in a 3:3:3:1 ratio to receive one administration of Cam2020 M2SR alone (Cohort 1, n=90), Cam2020 M2SR along with IIV (Cohort 2, n=90), IIV alone (Cohort 3, n=90), or placebo (Cohort 4, n=30).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Subjects assigned randomly to one of four cohorts concurrently
| Arm | Type | Receives |
|---|---|---|
| M2SR only dose | Experimental | Biological: Cam2020 M2SR H3N2 influenza vaccine, Other: IM PlaceboIntranasal M2SR vaccine and intramuscular placebo dose |
| M2SR with IIV dose | Experimental | Biological: Cam2020 M2SR H3N2 influenza vaccine, Biological: Fluzone HD IIVIntranasal M2SR vaccine and intramuscular IIV dose |
| IIV only dose | Active comparator | Biological: Fluzone HD IIV, Other: IN PlaceboIntranasal placebo dose and intramuscular IIV dose |
| Placebo only dose | Placebo comparator | Other: IN Placebo, Other: IM PlaceboIntranasal placebo dose and intramuscular placebo dose |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Subjects must be willing and able to provide written informed consent to participate; a legally authorized representative (LAR) may not be used.
- Males and nonchildbearing potential females 65-85 years of age at the time of consent.
- Subjects must be 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.
- Healthy adults and those with stable chronic conditions as determined by medical history, physical examination, vital signs, clinical safety laboratory examinations and clinical judgment of the Investigator to be eligible for study inclusion.
Key exclusion criteria (7 listed)
- Any acute or chronic physical or mental health condition that would limit the subject's ability to complete the study, increase risk of study participation or participant, or may interfere with interpretation of study results as based on the assessment by the Investigator.
- Abnormal screening hematology or chemistry value per the US FDA Guidance: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
- Currently receiving, or planned to receive during the study, any immunosuppressive therapy.
- Had a flu-like illness, influenza treatment, or prophylactic influenza viral drug administered in the previous 6 months before investigational product administration.
- History of receipt of any live virus vaccine within 56 days of study entry, licensed or investigational vaccine within 28 days of Visit 01 or investigational drug within the past 6 months. An exception is made for receipt of a Covid-19 vaccine whether licensed or under EUA as long as the final dose was given at least 28 days prior to Visit 01.
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 |
|---|---|---|
| Cam2020 M2SR H3N2 influenza vaccineAdministered intranasally on Day 1 | Biological | M2SR only dose, M2SR with IIV dose |
| Fluzone HD IIVAdministered intramuscularly on Day 1 | Biological | IIV only dose, M2SR with IIV dose |
| IN PlaceboAdministered intranasally on Day 1 | Other | IIV only dose, Placebo only dose |
| IM PlaceboAdministered intramuscularly on Day 1 | Other | M2SR only dose, Placebo only dose |
Primary outcome
Solicited AEs during 7 days after experimental treatment
Time frame: Day 1 to Day 8
The number and percentage of subjects who experience solicited local and systemic reactions during the 7 days after vaccine administration of M2SR administration alone or with IIV
Unsolicited AEs during 28 days after experimental treatment
Time frame: Day 1 to Day 29
The number and percentage of subjects who experience unsolicited AEs during the 28 days after vaccine administration of M2SR alone or with IIV.
SAEs through 28 days after experimental treatment
Time frame: Day 1 to Day 29
The number and percentage of subjects who experience SAEs from the time of informed consent through 28 days after vaccine administration of M2SR alone or with IIV.
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 14 Nov 2022.
- Derived from this study: PubMed 39004096Eiden J, Fierro C, White A, Davis M, Rhee M, Turner M, Murray B, Herber R, Aitchison R, Marshall D, Moser MJ, Belshe R, Greenberg H, Coelingh K, Kawaoka Y, Neumann G, Bilsel P. Safety and immunogenicity of the intranasal H3N2 M2-deficient single-replication influenza vaccine alone or coadministered with an inactivated influenza vaccine (Fluzone High-Dose Quadrivalent) in adults aged 65-85 years in the USA: a multicentre, randomised, double-blind, double-dummy, phase 1b trial. Lancet Infect Dis. 2024 Oct;24(10):1118-1129. doi: 10.1016/S1473-3099(24)00351-7. Epub 2024 Jul 11.
- Individual participant dataSharing planned: No
Related trials for Influenza Vaccine
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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
6 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 Cam2020 M2SR H3N2 influenza vaccine and Fluzone HD IIV in people with Influenza Vaccine, run by FluGen Inc at 6 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 4 inclusion and 7 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 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
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?
Solicited AEs during 7 days after experimental treatment (time frame: Day 1 to Day 8). The study lists 3 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 NCT05163847, 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 14 Nov 2022.