Clinical trial NCT05163847: Safety and Immunogenicity of Cam2020 M2SR H3N2 Monovalent Influenza Vaccine Alone or With Licensed IIV in Older Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza Vaccine
Lead sponsor: FluGen Inc
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
First posted: 2021-12-20
Enrollment: 303
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects assigned randomly to one of four cohorts concurrently
Primary purpose: BASIC_SCIENCE

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Solicited AEs during 7 days after experimental treatment
timeFrame: Day 1 to Day 8
measure: Unsolicited AEs during 28 days after experimental treatment
timeFrame: Day 1 to Day 29
measure: SAEs through 28 days after experimental treatment
timeFrame: Day 1 to Day 29
Secondary outcomes:
Other outcomes:
Locations:
city: Port Orange
country: United States
facility: United Medical Research
state: Florida
city: Meridian
country: United States
facility: Velocity Clinical Research
state: Idaho
city: Lenexa
country: United States
facility: Johnson County Clin Trials
state: Kansas
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: Beechwood
country: United States
facility: Velocity Clinical Research
state: Ohio
city: Cedar Park
country: United States
facility: Velocity Clinical Research
state: Texas
Study officials:
affiliation: FluGen Inc
name: Pamuk Bilsel
role: STUDY_DIRECTOR
References: