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

• Sponsor: FluGen Inc (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05163847
• Collaborator: United States Department of Defense (U.S. Fed)
• Enrollment: 300
• Locations: 4
• Arms: 4
• Anticipated Duration (Months): 8.5
• Patients Per Site: 75
• Patients Per Site Per Month: 8.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Influenza Vaccine	Biological: Cam2020 M2SR H3N2 influenza vaccine; Biological: Fluzone HD IIV; Other: IN Placebo; Other: IM Placebo	Phase 1

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

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Subjects assigned randomly to one of four cohorts concurrentlySubjects assigned randomly to one of four cohorts concurrently
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Syringes wrapped to obscure color of contents
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: Jun 14, 2022
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

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: IN Placebo; Administered intranasally on Day 1; Other: IM Placebo; Administered intramuscularly on Day 1

Outcome Measures

Primary Outcome Measures

1. Solicited AEs during 7 days after experimental treatment [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

2. Unsolicited AEs during 28 days after experimental treatment [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.

3. SAEs through 28 days after experimental treatment [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	United Medical Research	Port Orange	Florida	United States	32127
2	Johnson County Clin Trials	Lenexa	Kansas	United States	66219
3	Rochester Clinical Research	Rochester	New York	United States	14609
4	Velocity Clinical Research	Beechwood	Ohio	United States	44122

Sponsors and Collaborators

• FluGen Inc
• United States Department of Defense

Investigators

• Study Director: Pamuk Bilsel, FluGen Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: FluGen Inc
• ClinicalTrials.gov Identifier: NCT05163847
• Other Study ID Numbers: FLUGEN-H3N2-V006; CDMRP-PR203559
• First Posted: Dec 20, 2021
• Last Update Posted: Jun 23, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Influenza, Human

Study Results

No Results Posted as of Jun 23, 2022