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

FluGen

Status and phase: Completed; Phase 1

Conditions: Influenza Vaccine

Treatments: Biological: Fluzone HD IIV; Other: IN Placebo; Other: IM Placebo; Biological: Cam2020 M2SR H3N2 influenza vaccine

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT05163847

CDMRP-PR203559 (Other Grant/Funding Number)

FLUGEN-H3N2-V006

Details and patient eligibility

About

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.

Full 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).

Enrollment: 303 patients

Sex: All

Ages: 65 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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303 participants in 4 patient groups, including a placebo group

M2SR only dose

Experimental group

Description:

Intranasal M2SR vaccine and intramuscular placebo dose

Treatment:

Biological: Cam2020 M2SR H3N2 influenza vaccine

Other: IM Placebo

M2SR with IIV dose

Experimental group

Description:

Intranasal M2SR vaccine and intramuscular IIV dose

Treatment:

Biological: Fluzone HD IIV

Biological: Cam2020 M2SR H3N2 influenza vaccine

IIV only dose

Active Comparator group

Description:

Intranasal placebo dose and intramuscular IIV dose

Treatment:

Other: IN Placebo

Biological: Fluzone HD IIV

Placebo only dose

Placebo Comparator group

Description:

Intranasal placebo dose and intramuscular placebo dose

Treatment:

Other: IN Placebo

Other: IM Placebo