Safety and Immunogenicity of Cam2020 M2SR H3N2 Monovalent Influenza Vaccine Alone or With Licensed IIV in Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Influenza Vaccine
• Intervention / Treatment: Biological: Cam2020 M2SR H3N2 influenza vaccine; Other: IM Placebo; Biological: Fluzone HD IIV; Other: IN Placebo

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 Type: Interventional
• Enrollment (Actual): 303
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Port Orange, Florida, United States, 32127
      • United Medical Research
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Velocity Clinical Research
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Johnson County Clin Trials
  • New York
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research
  • Ohio
    • Beechwood, Ohio, United States, 44122
      • Velocity Clinical Research
  • Texas
    • Cedar Park, Texas, United States, 78613
      • Velocity Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects must be willing and able to provide written informed consent to participate; a legally authorized representative (LAR) may not be used.
2. Males and nonchildbearing potential females 65-85 years of age at the time of consent.
3. 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.
4. 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.

Exclusion Criteria:

1. 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.
2. 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
3. Currently receiving, or planned to receive during the study, any immunosuppressive therapy.
4. Had a flu-like illness, influenza treatment, or prophylactic influenza viral drug administered in the previous 6 months before investigational product administration.
5. 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.
6. 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.
7. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: M2SR only dose; Intranasal M2SR vaccine and intramuscular placebo dose	Biological: Cam2020 M2SR H3N2 influenza vaccine; Administered intranasally on Day 1; Other: IM Placebo; Administered intramuscularly on Day 1
EXPERIMENTAL: M2SR with IIV dose; Intranasal M2SR vaccine and intramuscular IIV dose	Biological: Cam2020 M2SR H3N2 influenza vaccine; Administered intranasally on Day 1; Biological: Fluzone HD IIV; Administered intramuscularly on Day 1
ACTIVE_COMPARATOR: IIV only dose; Intranasal placebo dose and intramuscular IIV dose	Biological: Fluzone HD IIV; Administered intramuscularly on Day 1; Other: IN Placebo; Administered intranasally on Day 1
PLACEBO_COMPARATOR: Placebo only dose; Intranasal placebo dose and intramuscular placebo dose	Other: IM Placebo; Administered intramuscularly on Day 1; Other: IN Placebo; Administered intranasally on Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: FluGen Inc
• Collaborators: United States Department of Defense

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 14, 2022
• Primary Completion (ACTUAL): November 3, 2022
• Study Completion (ACTUAL): November 3, 2022

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (ACTUAL): December 20, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 11, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: FLUGEN-H3N2-V006; CDMRP-PR203559 (OTHER_GRANT: USAMRAA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No