NCT05163847

Brief 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 years at time of enrollment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

June 14, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2022

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

December 7, 2021

Last Update Submit

November 11, 2022

Conditions

Influenza Vaccine

Outcome Measures

Primary Outcomes (3)

  • 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

    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.

    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.

    Day 1 to Day 29

Study Arms (4)

M2SR only dose

EXPERIMENTAL

Intranasal M2SR vaccine and intramuscular placebo dose

Biological: Cam2020 M2SR H3N2 influenza vaccineOther: IM Placebo

M2SR with IIV dose

EXPERIMENTAL

Intranasal M2SR vaccine and intramuscular IIV dose

Biological: Cam2020 M2SR H3N2 influenza vaccineBiological: Fluzone HD IIV

IIV only dose

ACTIVE COMPARATOR

Intranasal placebo dose and intramuscular IIV dose

Biological: Fluzone HD IIVOther: IN Placebo

Placebo only dose

PLACEBO COMPARATOR

Intranasal placebo dose and intramuscular placebo dose

Other: IN PlaceboOther: IM Placebo

Interventions

Cam2020 M2SR H3N2 influenza vaccineBIOLOGICAL

Administered intranasally on Day 1

M2SR only doseM2SR with IIV dose
Fluzone HD IIVBIOLOGICAL

Administered intramuscularly on Day 1

IIV only doseM2SR with IIV dose
IN PlaceboOTHER

Administered intranasally on Day 1

IIV only dosePlacebo only dose
IM PlaceboOTHER

Administered intramuscularly on Day 1

M2SR only dosePlacebo only dose

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

United Medical Research

Port Orange, Florida, 32127, United States

Location

Velocity Clinical Research

Meridian, Idaho, 83642, United States

Location

Johnson County Clin Trials

Lenexa, Kansas, 66219, United States

Location

Rochester Clinical Research

Rochester, New York, 14609, United States

Location

Velocity Clinical Research

Beechwood, Ohio, 44122, United States

Location

Velocity Clinical Research

Cedar Park, Texas, 78613, United States

Location

Related Publications (1)

  • 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.

    PMID: 39004096DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Pamuk Bilsel

    FluGen Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Syringes wrapped to obscure color of contents
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Subjects assigned randomly to one of four cohorts concurrently
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2021

First Posted

December 20, 2021

Study Start

June 14, 2022

Primary Completion

November 3, 2022

Study Completion

November 3, 2022

Last Updated

November 14, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

US(6)