Safety and Immunogenicity of the Sing2016 M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old

FluGen

Status and phase: Completed; Phase 1

Conditions: Influenza Vaccine

Treatments: Biological: Sing2016 M2SR H3N2 influenza vaccine; Other: Placebo

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT04785794

FLUGEN-H3N2-V005

DMID 20-0025 (Other Grant/Funding Number)

Details and patient eligibility

About

This is a randomized, double-blind, placebo-controlled Phase 1b study to evaluate safety and immunogenicity of the investigational Sing2016 M2SR H3N2 influenza vaccine delivered intranasally to a healthy adult population age 50 to 85 years.

Full description

This is a randomized, double-blind, placebo-controlled Phase 1b study to evaluate safety and immunogenicity of the investigational Sing2016 M2SR H3N2 influenza vaccine delivered intranasally to a healthy adult population age 50 to 85 years. Eligible subjects will be randomized 2:1 to receive one administration of Sing2016 M2SR or placebo followed by a dose of age-appropriate licensed inactivated influenza vaccine (IIV) at least 28 days later. Two lead-in groups of adults ages 50-64 years (Cohort 1) and 65 - 85 years (Cohort 2) will be followed by enrollment of an expansion group, ages 65 - 85 (Cohort 3). Safety data will be reviewed between enrollment of successive cohorts.

Enrollment: 122 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subjects must be willing and able to provide written informed consent.
2. Cohort 1: age 50-64 years at time of enrollment; Cohorts 2 and 3: age 65 to 85 years at time of enrollment (signing of informed consent form).
3. Subject 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.
5. Women of child-bearing potential must agree to abstain from sexual intercourse or to correctly use an acceptable method of contraception from 30 days prior to vaccination until 30 days after the last study vaccination.
6. Women of childbearing potential must have a negative urine pregnancy test within 24 hours prior to vaccination with investigational product.

Exclusion criteria

1. Any acute or chronic physical or mental 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. Acute or chronic medical condition or history of a medical condition that, in the opinion of the Investigator, would render the study procedures unsafe or would interfere with the evaluation of the responses.
3. Abnormal screening hematology or chemistry value per the FDA Guidance: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials.
4. Currently receiving, or planned to receive during the study, any immunosuppressive therapy.
5. Had a flu-like illness, influenza treatment, influenza vaccination, or prophylactic influenza viral drug administered in the previous 6 months before investigational product administration.
6. Females who are pregnant or nursing; non-vasectomized males, with female partners of child-bearing potential, who are unwilling to use a highly effective form of contraception from the time of enrollment through at least 28 after administration of the investigational product.
7. History of receipt of any investigational vaccine within 28 days of visit 1 or investigational drug within the past six months. An exception is made for receipt of a Covid-19 vaccine whether licensed or under emergency use authorization (EUA) as long as the second dose was given at least 28 days prior to dosing with investigational vaccine.
8. Acute febrile illness within 72 hours prior to investigational product vaccination
9. 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.
10. Planned donation of blood or blood product of at least approximately 1 pint within 3 months after investigational product administration.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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122 participants in 4 patient groups, including a placebo group

M2SR dose, 50-64 years of age

Experimental group

Description:

Intranasal M2SR vaccine followed by standard, licensed IIV

Treatment:

Biological: Sing2016 M2SR H3N2 influenza vaccine

Placebo dose, 50-64 years of age

Placebo Comparator group

Description:

Intranasal physiological saline followed by standard, licensed IIV

Treatment:

Other: Placebo

M2SR dose, 65-85 years of age

Experimental group

Description:

Intranasal M2SR vaccine followed by licensed IIV recommended for people 65 years and older

Treatment:

Biological: Sing2016 M2SR H3N2 influenza vaccine

Placebo dose, 65-85 years of age

Placebo Comparator group

Description:

Intranasal physiological saline followed by licensed IIV recommended for people 65 years and older

Treatment:

Other: Placebo