Influenza VaccinePhase 1NCT04785794

Safety and Immunogenicity of the Sing2016 M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old

A Phase 1 study testing Sing2016 M2SR H3N2 influenza vaccine in people with Influenza Vaccine, run by FluGen Inc at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 50 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Influenza Vaccine
What is being tested?: Sing2016 M2SR H3N2 influenza vaccine
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 122 participants
Where: 3 sitesUnited States
Study dates: 30 Jun 2021to 30 Nov 2021
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 50 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects must be willing and able to provide written informed consent.
Cohort 1: age 50-64 years at time of enrollment; Cohorts 2 and 3: age 65 to 85 years at time of enrollment (signing of informed consent form).
Subject 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.
Women of child-bearing potential must agree to abstain from sexual intercourse or to correctly use an acceptable method of contraception from 30 days prior to vaccination until 30 days after the last study vaccination.
Women of childbearing potential must have a negative urine pregnancy test within 24 hours prior to vaccination with investigational product.

Who cannot join

Any acute or chronic physical or mental 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.
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.
Abnormal screening hematology or chemistry value per the FDA Guidance: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials.
Currently receiving, or planned to receive during the study, any immunosuppressive therapy.
Had a flu-like illness, influenza treatment, influenza vaccination, or prophylactic influenza viral drug administered in the previous 6 months before investigational product administration.
Females who are pregnant or nursing; non-vasectomized males, with female partners of child-bearing potential, who are unwilling to use a highly effective form of contraception from the time of enrollment through at least 28 after administration of the investigational product.

Show all 10Show fewer

History of receipt of any investigational vaccine within 28 days of visit 1 or investigational drug within the past six months. An exception is made for receipt of a Covid-19 vaccine whether licensed or under emergency use authorization (EUA) as long as the second dose was given at least 28 days prior to dosing with investigational vaccine.
Acute febrile illness within 72 hours prior to investigational product vaccination
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.
Planned donation of blood or blood product of at least approximately 1 pint within 3 months after investigational product administration.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Anaheim Clinical Trials
Anaheim, California, 92801
Accel Clinical
DeLand, Florida, 32127
Johnson County Clin Trials
Lenexa, Kansas, 66219

Other trials in United States

About this study

Official title: Phase 1b Clinical Study to Investigate the Safety and Immunogenicity of the Sing2016 (A/Singapore/INFIMH-16-0019/2016) M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old.

Read the detailed description

This is a randomized, double-blind, placebo-controlled Phase 1b study to evaluate safety and immunogenicity of the investigational Sing2016 M2SR H3N2 influenza vaccine delivered intranasally to a healthy adult population age 50 to 85 years. Eligible subjects will be randomized 2:1 to receive one administration of Sing2016 M2SR or placebo followed by a dose of age-appropriate licensed inactivated influenza vaccine (IIV) at least 28 days later. Two lead-in groups of adults ages 50-64 years (Cohort 1) and 65 - 85 years (Cohort 2) will be followed by enrollment of an expansion group, ages 65 - 85 (Cohort 3). Safety data will be reviewed between enrollment of successive cohorts.

Conditions: Influenza Vaccine
Being tested: Sing2016 M2SR H3N2 influenza vaccine, 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.

Sing2016 M2SR H3N2 influenza vaccineBiological
This group will receive a dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally on Day 1 followed by IIV at least 28 days later.
PlaceboOther
This group will receive saline placebo administered intranasally on Day 1 followed by IIV at least 28 days later.

Study groups in NCT04785794
Study group	Role	What they receive
M2SR dose, 50-64 years of age	Experimental	Intranasal M2SR vaccine followed by standard, licensed IIV Receives: Biological: Sing2016 M2SR H3N2 influenza vaccine
Placebo dose, 50-64 years of age	Placebo comparator	Intranasal physiological saline followed by standard, licensed IIV Receives: Other: Placebo
M2SR dose, 65-85 years of age	Experimental	Intranasal M2SR vaccine followed by licensed IIV recommended for people 65 years and older Receives: Biological: Sing2016 M2SR H3N2 influenza vaccine
Placebo dose, 65-85 years of age	Placebo comparator	Intranasal physiological saline followed by licensed IIV recommended for people 65 years and older Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment Emergent AEs During 7 Days After Experimental Treatment
The number and percentage of study participants who experience local (at the dose administration site) and systemic (throughout the body) reactions during the 7 days after administration of investigational M2SR vaccine or placebo. Solicited and unsolicited signs and symptoms were reported as AEs after review by the Investigator or designee, either separately using the corresponding Medical Dictionary for Regulatory Activities (MedDRA) terminology of the sign or symptom or combined using the appropriate term.
Measured: Day 1 to Day 8
Treatment Emergent AEs During 28 Days After Experimental Treatment
The number and percentage of study participants who experience a treatment emergent AE during the 28 days after administration of investigational M2SR vaccine or placebo. Unsolicited signs and symptoms were reported as AEs after review by the Investigator or designee, either separately using the corresponding MedDRA terminology of the sign or symptom or combined using the appropriate term.
Measured: Day 1 to Day 29
SAEs Through 28 Days After Licensed IIV Treatment
The number and percentage of study participants who experience SAEs from the time of study entry through 28 days after receipt of IIV. Unsolicited signs and symptoms were reported as AEs after review by the Investigator or designee, either separately using the corresponding MedDRA terminology of the sign or symptom or combined using the appropriate term.
Measured: Time of enrollment through 28 days after receipt of IIV where the IIV was administered an average of 49 days post-IP and with an interval up to 91 days later.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 202130 Nov 2021

First posted8 Mar 2021
Study start30 Jun 2021
Primary completion30 Nov 2021
Study completion30 Nov 2021

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.
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: Sequential
Model description: Three Cohorts will be enrolled sequentially with safety data reviewed between enrollment of successive cohorts.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04785794
Sponsor's protocol ID: FLUGEN-H3N2-V005
Other IDs: DMID 20-0025
Status last verified: May 2023
First submitted: 3 Mar 2021
Last updated: 15 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Influenza Vaccine trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2023. 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 Sing2016 (A/Singapore/INFIMH-16-0019/2016) M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old.
ClinicalTrials.gov ID: NCT04785794
Acronym / sponsor ID: FLUGEN-H3N2-V005
Conditions: Influenza Vaccine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: FluGen IncIndustry (pharma, biotech, devices)
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Study start: 30 Jun 2021 (actual)
Primary completion: 30 Nov 2021 (actual)
Study completion: 30 Nov 2021 (actual)
First posted: 8 Mar 2021 (actual)
Results: Posted 15 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Three Cohorts will be enrolled sequentially with safety data reviewed between enrollment of successive cohorts.

Arm	Type	Receives
M2SR dose, 50-64 years of age	Experimental	Biological: Sing2016 M2SR H3N2 influenza vaccineIntranasal M2SR vaccine followed by standard, licensed IIV
Placebo dose, 50-64 years of age	Placebo comparator	Other: PlaceboIntranasal physiological saline followed by standard, licensed IIV
M2SR dose, 65-85 years of age	Experimental	Biological: Sing2016 M2SR H3N2 influenza vaccineIntranasal M2SR vaccine followed by licensed IIV recommended for people 65 years and older
Placebo dose, 65-85 years of age	Placebo comparator	Other: PlaceboIntranasal physiological saline followed by licensed IIV recommended for people 65 years and older

Who may qualify

Ages: 50 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Subjects must be willing and able to provide written informed consent.
Cohort 1: age 50-64 years at time of enrollment; Cohorts 2 and 3: age 65 to 85 years at time of enrollment (signing of informed consent form).
Subject 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.
Women of child-bearing potential must agree to abstain from sexual intercourse or to correctly use an acceptable method of contraception from 30 days prior to vaccination until 30 days after the last study vaccination.

Key exclusion criteria (10 listed)

Any acute or chronic physical or mental 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.
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.
Abnormal screening hematology or chemistry value per the FDA Guidance: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials.
Currently receiving, or planned to receive during the study, any immunosuppressive therapy.
Had a flu-like illness, influenza treatment, influenza vaccination, or prophylactic influenza viral drug administered in the previous 6 months before investigational product administration.

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
Sing2016 M2SR H3N2 influenza vaccineThis group will receive a dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally on Day 1 followed by IIV at least 28 days later.	Biological	M2SR dose, 50-64 years of age, M2SR dose, 65-85 years of age
PlaceboThis group will receive saline placebo administered intranasally on Day 1 followed by IIV at least 28 days later.	Other	Placebo dose, 50-64 years of age, Placebo dose, 65-85 years of age

Primary outcome

Treatment Emergent AEs During 7 Days After Experimental Treatment
Time frame: Day 1 to Day 8
The number and percentage of study participants who experience local (at the dose administration site) and systemic (throughout the body) reactions during the 7 days after administration of investigational M2SR vaccine or placebo. Solicited and unsolicited signs and symptoms were reported as AEs after review by the Investigator or designee, either separately using the corresponding Medical Dictionary for Regulatory Activities (MedDRA) terminology of the sign or symptom or combined using the appropriate term.
Treatment Emergent AEs During 28 Days After Experimental Treatment
Time frame: Day 1 to Day 29
The number and percentage of study participants who experience a treatment emergent AE during the 28 days after administration of investigational M2SR vaccine or placebo. Unsolicited signs and symptoms were reported as AEs after review by the Investigator or designee, either separately using the corresponding MedDRA terminology of the sign or symptom or combined using the appropriate term.
SAEs Through 28 Days After Licensed IIV Treatment
Time frame: Time of enrollment through 28 days after receipt of IIV where the IIV was administered an average of 49 days post-IP and with an interval up to 91 days later.
The number and percentage of study participants who experience SAEs from the time of study entry through 28 days after receipt of IIV. Unsolicited signs and symptoms were reported as AEs after review by the Investigator or designee, either separately using the corresponding MedDRA terminology of the sign or symptom or combined using the appropriate term.

Results and safety

Results posted to the registry on 15 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
M2SR Dose, 50-64 Years of Age	10	9
Placebo Dose, 50-64 Years of Age	5	5
M2SR Dose, 65-85 Years of Age	70	67
Placebo Dose, 65-85 Years of Age	37	37

Primary outcome: Treatment Emergent AEs During 7 Days After Experimental Treatment

Time frame: Day 1 to Day 8. Count of participants. Unit: Participants

Measure	M2SR Dose, 50-64 Years of Age n = 10	Placebo Dose, 50-64 Years of Age n = 5	M2SR Dose, 65-85 Years of Age n = 70	Placebo Dose, 65-85 Years of Age n = 37
Value	1	0	12	3

Population analysed: All subjects who received an IP dose

Primary outcome: Treatment Emergent AEs During 28 Days After Experimental Treatment

Time frame: Day 1 to Day 29. Count of participants. Unit: Participants

Measure	M2SR Dose, 50-64 Years of Age n = 10	Placebo Dose, 50-64 Years of Age n = 5	M2SR Dose, 65-85 Years of Age n = 70	Placebo Dose, 65-85 Years of Age n = 37
Value	1	1	16	8

Primary outcome: SAEs Through 28 Days After Licensed IIV Treatment

Time frame: Time of enrollment through 28 days after receipt of IIV where the IIV was administered an average of 49 days post-IP and with an interval up to 91 days later.. Count of participants. Unit: Participants

Measure	M2SR Dose, 50-64 Years of Age n = 10	Placebo Dose, 50-64 Years of Age n = 5	M2SR Dose, 65-85 Years of Age n = 68	Placebo Dose, 65-85 Years of Age n = 37
Value	0	0	0	0

Population analysed: Numbers of subjects analyzed for SAEs includes 2 subjects who were administered IIV but who did not have biological samples collected and therefore were not considered to have completed trial. Thus, the participant flow shows 9 subjects completed while safety shows 10 subjects for the M2SR dose 50-64 years of age. Similarly, the participant flow shows 67 subjects completed while safety shows 68 subjects for the M2SR dose 65-85 years of age.

Adverse events

Time frame: IP administration until 28 days post-IIV (where interval between IP and IIV was up to 91 days with an average span of 49 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
M2SR Dose, 50-64 Years of Age	0 of 10 (0%)	1 of 10 (10%)	0 of 10
Placebo Dose, 50-64 Years of Age	0 of 5 (0%)	1 of 5 (20%)	0 of 5
M2SR Dose, 65-85 Years of Age	0 of 70 (0%)	2 of 70 (2.9%)	0 of 70
Placebo Dose, 65-85 Years of Age	0 of 37 (0%)	3 of 37 (8.1%)	0 of 37

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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

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 Sing2016 M2SR H3N2 influenza vaccine in people with Influenza Vaccine, run by FluGen Inc at 3 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 6 inclusion and 10 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 15 Jun 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 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 15 Jun 2023). 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?

Treatment Emergent 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 NCT04785794.

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 15 Jun 2023.