Official Title
A Phase 1/2, Parallel, Randomized, Modified Double-blind, Multi-arm Study to Assess the Safety and Immunogenicity of a Combination Vaccine Comprised of Different Recombinant Spike Antigen Levels of a Matrix-M Adjuvanted Recombinant COVID-19 Vaccine and High-dose Inactivated Influenza Vaccine in Adult Participants 50 Years of Age and Older
Brief Summary

Study VBT00001 is planned to be a Phase 1/2, randomized, modified double-blind,active-controlled, multi-center study to be conducted in approximately 980 adults aged 50years and older in the United States.The purpose of the study is to assess the safety and immunogenicity of IIV-HD (high-doseinactivated influenza vaccine) + rC19 (adjuvanted recombinant COVID-19 vaccine) vaccinecomprised of IIV-HD combined with different recombinant Spike (rS) antigen levels of rC19compared to IIV-HD alone, rC19 (dose 1) alone, and IIV-HD and rC19 (dose 1)(coadministered in opposite arms).Placebo will be coadministered in the IIV-HD alone, rC19 (dose 1) alone, and IIV-HD +rC19 study groups to control for the number of injections and to maintainobserver-blinding.Thus, each participant will receive two injections at enrollment, one in each deltoidmuscle.Study details include: - The study duration will be approximately 12 months - Study intervention will be administered via a single intramuscular (IM) injection into the right and left deltoid muscles on D01 - Dose escalation with sequential enrollment (sentinel cohort followed by main cohort for a given dose) - The visit frequency will be D01, D09 (telephone call), D30, D182 (telephone call), and D366 (telephone call)Number of Participants:Approximately 980 participants are expected to be randomized.

Detailed Description

Not Provided

Active, not recruiting
COVID-19 Immunization
Influenza Immunization

Biological: IIV-HD

Inactivated, split-virion

Biological: rC19 (dose 1)

Protein subunit

Biological: IIV-HD + rC19 (dose 1)

IIV-HD component: Inactivated, split-virion rC19 component: Protein subunit

Biological: IIV-HD + rC19 (dose 2)

IIV-HD component: Inactivated, split-virion rC19 component: Protein subunit

Biological: IIV-HD + rC19 (dose 3)

IIV-HD component: Inactivated, split-virion rC19 component: Protein subunit

Biological: IIV-HD + rC19 (dose 4)

IIV-HD component: Inactivated, split-virion rC19 component: Protein subunit

Other: Placebo (0.9% NaCl)

Normal saline

Eligibility Criteria

Inclusion Criteria:

Inclusion criteria to be checked at Screening Visit

- Aged 50 years or older on the day of inclusion

- Informed consent form has been signed and dated.

- Able to attend all scheduled visits and to comply with all study procedures.

- Participant must be able to receive an injection in the deltoid muscle of both arms.

- Participant must have completed a primary vaccination series against SARS-CoV-2 and
at least 1 booster with a locally authorized or approved COVID-19 vaccine.

Inclusion criteria to be checked at Visit 1 (D01):

- Aged 50 years or older on the day of inclusion

- Participants who are healthy or with pre-existing stable condition (defined as
disease not requiring significant change in therapy or hospitalization for worsening
disease during the 12 weeks before enrollment), as determined by medical evaluation
including medical history and physical examination.

- A female participant is eligible to participate if she is not pregnant or
breastfeeding and one of the following conditions applies:

- Is of non-childbearing potential. To be considered of non-childbearing
potential, a female must be post-menopausal for at least 1 year, or surgically
sterile.

OR

• Is of childbearing potential and agrees to use an effective contraceptive method or
abstinence from at least 4 weeks prior to study intervention administration until at
least 4 weeks after study intervention administration.

A female participant of childbearing potential must have a negative highly sensitive
pregnancy test (urine or serum as required by local regulation) on the day of enrollment
before the first dose of study intervention.

- Informed consent form has been signed and dated.

- Able to attend all scheduled visits and to comply with all study procedures.

- Participant must be able to receive an injection in the deltoid muscle of both arms.

- Participant must have completed a primary vaccination series against SARS-CoV-2 and
at least 1 booster with a locally authorized or approved COVID-19 vaccine.

Exclusion Criteria:

Exclusion criteria to be checked at Screening Visit and at Visit 1 (D01):

- Known or suspected congenital or acquired immunodeficiency; or receipt of
immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,
within the preceding 6 months; or long-term systemic corticosteroid therapy (for
glucocorticoids, ≥ 10 milligrams/day of prednisone or equivalent for more than 2
consecutive weeks within the past 3 months).

- Known systemic hypersensitivity to any of the study intervention components, or
history of a life-threatening reaction to the study interventions used in the study
or to a product containing any of the same substances .

- Self-reported thrombocytopenia, contraindicating intramuscular injection, based on
investigator's judgment.

- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
contraindicating intramuscular injection, based on investigator's judgment.

- Chronic illness (1) that, in the opinion of the investigator, is at a stage where it
might interfere with study conduct or completion .

- Moderate or severe acute illness/infection (according to investigator judgment) or
febrile illness (temperature ≥ 100.4°F) on the day of study intervention
administration. A prospective participant should not be included in the study until
the condition has resolved or the febrile event has subsided.

- Alcohol, prescription drug, or substance abuse that, in the opinion of the
Investigator, might interfere with the study conduct or completion.

- History of serious adverse reaction to any influenza or COVID-19 vaccines.

- Personal or family history of Guillain-Barré syndrome.

- Prior history of myocarditis, pericarditis, or myopericarditis.

- Prior history of stroke, transient ischemic attack, or stroke risk factors, which
may include untreated/uncontrolled hypertension, untreated/uncontrolled
hyperlipidemia, active smoking, atrial fibrillation, and additional risk factors,
based on investigator's judgment, which may include history of thromboembolic
disease, obesity, cardiac structural or valvular abnormality, carotid stent
placement, or family history of stroke..

- Receipt of any vaccine in the 4 weeks preceding study intervention administration or
planned receipt of any vaccine prior to the second blood draw (ie, approximately in
the 28 days following study intervention administration .

- Previous vaccination against influenza (in the previous 6 months) with an
investigational or marketed vaccine.

- Previous vaccination against COVID-19 (in the previous 6 months) with an
investigational or marketed vaccine OR history of COVID-19 in the previous 6 months
.

- Receipt of immune globulins, blood or blood-derived products in the past 3 months.

- Participation at the time of study enrollment (or in the 4 weeks preceding study
intervention administration) or planned participation during the present study
period in another clinical study investigating a vaccine, drug, medical device, or
medical procedure.

- Deprived of freedom by an administrative or court order, or being in an emergency
setting, or hospitalized involuntarily.

- Identified as an Investigator or employee of the Investigator or study center with
direct involvement in the proposed study, or identified as an immediate family
member (ie, parent, spouse, natural or adopted child) of the Investigator or
employee with direct involvement in the proposed study.

1. Chronic illness may include, but is not limited to, cardiac disorders,
hypertension, pulmonary disease, renal disorders, auto-immune disorders,
diabetes mellitus, psychiatric disorders, neurologic disorders, or chronic
infection

Eligibility Gender
All
Eligibility Age
Minimum: 50 Years ~ Maximum: N/A
Countries
United States
Locations

Simon Williamson Clinic - Birmingham- Site Number : 8400003
Birmingham, Alabama, United States

AES - DRS - Optimal Research Alabama - Huntsville Site Number : 8400006
Huntsville, Alabama, United States

Orange Grove Family Practice- Site Number : 8400012
Tucson, Arizona, United States

Synexus Clinical Research US, Inc. - The Villages Site Number : 8400011
The Villages, Florida, United States

Synexus Clinical Research US - Atlanta- Site Number : 8400001
Atlanta, Georgia, United States

Synexus Clinical Research- Site Number : 8400004
Chicago, Illinois, United States

Synexus Clinical Research - St. Louis- Site Number : 8400010
Creve Coeur, Missouri, United States

Synexus New York Site Number : 8400007
New York, New York, United States

Optimal Research, LLC Site Number : 8400002
Austin, Texas, United States

Synexus Clinical Research US - Dallas- Site Number : 8400005
Dallas, Texas, United States

Synexus Clinical Research US - San Antonio- Site Number : 8400009
San Antonio, Texas, United States

Synexus Salt Lake City Site Number : 8400008
Salt Lake City, Utah, United States

Not Provided

NCT Number
Keywords
COVID-19 Vaccine and Influenza Vaccine
MeSH Terms
COVID-19
Influenza, Human