Clinical trial NCT06695130: Study of a Combination Vaccine Comprised of Different Recombinant Spike Antigen Levels of a Matrix-M Adjuvanted Recombinant COVID-19 Vaccine and Recombinant Influenza Vaccine in Adult Participants 50 Years of Age and Older
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 Recombinant Influenza Vaccine in Adult Participants 50 Years of Age and Older
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: COVID-19 Immunization
Influenza Immunization
Keywords: COVID-19 Vaccine
Influenza Vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-11-19
Enrollment: 980
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Study VBT00002 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 50 years and older in the United States. The purpose of the study is to assess the safety and immunogenicity of recombinant influenza vaccine (RIV) + adjuvanted recombinant COVID-19 vaccine (rC19) vaccine comprised of RIV combined with different recombinant Spike (rS) antigen levels of rC19 compared to RIV alone, rC19 (dose 1) alone, and RIV and rC19 (dose 1) (coadministered in opposite arms). Placebo will be coadministered in the RIV alone, rC19 (dose 1) alone, and RIV + rC19 study groups to control for the number of injections and to maintain observer blinding. Thus, each participant will receive two injections at enrollment, one in each deltoid muscle.

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 Day(D) 01
* Dose escalation with sequential enrollment (sentinel cohort followed by main cohort for a given dose)
* The visit frequency for participants will be D01 and D30, and D09-D366 (telephone call)

Number of Participants:

Approximately 980 participants are expected to be randomized.


Eligibility criteria: Inclusion Criteria:

Inclusion criteria to be checked at Screening Visit:

* Aged 50 years or older on the day of inclusion Informed consent
* 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 (Day \[D\]01):

* Aged 50 years or older on the day of inclusions
* 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 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 that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion .
* Any illness that, in the opinion of the investigator, would pose a health risk to the participant if enrolled.
* 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 or stroke risk factors, which may include untreated/uncontrolled hypertension, hyperlipidemia, or diabetes; active smoking; obesity, based on investigator's judgment; history of thromboembolic disease; cardiac structural abnormality; atrial fibrillation; carotid stent placement; or family history of stroke.

Prior/concomitant therapy

* 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

Primary outcomes:
measure: Number of participants with immediate adverse events (AEs)
timeFrame: Immediate adverse events are any unsolicited systemic adverse events reported in the 30 minutes after vaccination
measure: Number of participants with solicited injection site reactions
timeFrame: Up to 7 each days after vaccination
measure: Number of participants with solicited systemic reactions
timeFrame: Up to 7 days after each vaccination
measure: Number of participants with unsolicited AEs
timeFrame: Up to 28 days after each vaccination
measure: Number of participants with adverse events of special interest (AESIs)
timeFrame: Up to 180 days after each vaccination
measure: Number of participants with medical attended adverse events (MAAEs)
timeFrame: Up to 180 days after each vaccination
measure: Number of participants with MAAEs relating to predefined PIMDs
timeFrame: From Day 182 through 12 months following the last study vaccination
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 180 days after each vaccination
measure: Number of participants with related SAEs
timeFrame: From Day 182 through 12 months following the last study intervention
measure: Number of participants with MAAEs relating to predefined PIMDs that meet the criteria for SAEs
timeFrame: From Day 182 through 12 months following the last study vaccination
measure: Geometric mean (GM) of HAI titers in all participants
timeFrame: At Day 01 and Day 30
measure: Geometric mean ratio (GMR) of HAI titers in all participants
timeFrame: At Day 01 and Day 30
measure: GM of SARS-CoV-2 neutralizing titers in all participants
timeFrame: At Day 01 and Day 30
measure: GMR of SARS-CoV-2 neutralizing titers ratio D30/D01 in all participants
timeFrame: At Day 01 and Day 30
Secondary outcomes:
measure: Percentage of participants with seroconversion in all participants
timeFrame: At Day 30
measure: Percentage of participants with HAI titer ≥ 10 (1/dil) in all participants
timeFrame: At Day 01 and Day 30
measure: Percentage of participants with HAI titer ≥ 40 (1/dil) in all participants
timeFrame: At Day 01 and Day 30
measure: Percentage of participants with seroresponse to SARS-CoV-2 in all participants
timeFrame: At Day 30
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Central Phoenix Medical Clinic- Site Number : 8400009
state: Arizona
city: Cerritos
country: United States
facility: Synexus Clinical Research US, Inc. - Cerritos- Site Number : 8400002
state: California
city: Vista
country: United States
facility: Synexus Clinical Research US - Vista- Site Number : 8400010
state: California
city: Melbourne
country: United States
facility: Optimal Research - Florida- Site Number : 8400006
state: Florida
city: Orlando
country: United States
facility: Synexus Clinical Research US - Orlando- Site Number : 8400007
state: Florida
city: Peoria
country: United States
facility: Optimal Research - Illinois- Site Number : 8400008
state: Illinois
city: Evansville
country: United States
facility: Synexus Clinical Research US - Evansville- Site Number : 8400004
state: Indiana
city: Malden
country: United States
facility: Walgreens Clinical Trials-Malden- Site Number : 8400012
state: Massachusetts
city: Richfield
country: United States
facility: Synexus Clinical Research US - Minneapolis- Site Number : 8400011
state: Minnesota
city: Las Vegas
country: United States
facility: Synexus-Las Vegas- Site Number : 8400005
state: Nevada
city: Cincinnati
country: United States
facility: Synexus Clinical Research US - Cincinnati- Site Number : 8400003
state: Ohio
city: Anderson
country: United States
facility: Synexus Clinical Research US - Anderson- Site Number : 8400001
state: South Carolina
Study officials:
References: