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

Influenza Vaccine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05163847
• Other study ID #: FLUGEN-H3N2-V006
• Secondary ID: CDMRP-PR203559
• Status: Completed
• Phase: Phase 1
• Start date: June 14, 2022
• Est. completion date: November 3, 2022

Study information

• Verified date: November 2022
• Source: FluGen Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 years at time of enrollment.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: November 3, 2022
• Est. primary completion date: November 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza Vaccine
• Influenza, Human

Intervention

Biological:
• Cam2020 M2SR H3N2 influenza vaccine
Administered intranasally on Day 1
• Fluzone HD IIV
Administered intramuscularly on Day 1

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

Locations

Country	Name	City	State
United States	Velocity Clinical Research	Beechwood	Ohio
United States	Velocity Clinical Research	Cedar Park	Texas
United States	Johnson County Clin Trials	Lenexa	Kansas
United States	Velocity Clinical Research	Meridian	Idaho
United States	United Medical Research	Port Orange	Florida
United States	Rochester Clinical Research	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
FluGen Inc	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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