Study 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

NCT06695117 | Completed Phase 1 FDA Drug

• 2 other identifiers: VBT00001U1111-1310-5034
• Study Type: interventional
• Target: 980
• Locations: 1 country
• Sites: 12

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 50 years and older in the United States. The purpose of the study is to assess the safety and immunogenicity of IIV-HD (high-dose inactivated influenza vaccine) + rC19 (adjuvanted recombinant COVID-19 vaccine) vaccine comprised of IIV-HD combined with different recombinant Spike (rS) antigen levels of rC19 compared 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 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 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.

Conditions

COVID-19 Immunization; Influenza Immunization

Keywords

COVID-19 Vaccine and Influenza Vaccine

Outcome Measures

Primary Outcomes (14)

• Number of participants with immediate adverse events (AEs)

  Immediate adverse events are any unsolicited systemic adverse events reported in the 30 minutes after vaccination

  Within 30 minutes after each vaccination

• Number of participants with solicited injection site reactions

  Solicited injection site reactions include injection site pain, erythema and swelling

  Up to 7 each days after vaccination

• Number of participants with solicited systemic reactions

  Solicited systemic reactions include fever, headache, fatigue, myalgia and chills

  Up to 7 days after each vaccination

• Number of participants with unsolicited AEs

  Unsolicited (spontaneously reported) AEs, not fulfilling criteria for solicited adverse reactions

  Up to 28 days after each vaccination

• Number of participants with adverse events of special interest (AESIs)

  AESIs

  Up to 180 days after each vaccination

• Number of participants with medical attended adverse events (MAAEs)

  MAAEs

  Up to 180 days after each vaccination

• Number of MAAEs relating to predefined potential immune-mediated disease (PIMDs)

  MAAEs relating to predefined PIMDs

  From D182 through 12 months following the last study vaccination

• Number of participants with serious adverse events (SAEs)

  SAEs

  Up to 180 days after each vaccination

• Number of participants with related SAEs

  Related SAEs

  From D182 through 12 months following the last study vaccination

• Number of MAAEs relating to predefined PIMDs that meet the criteria for SAEs

  MAAEs relating to predefined PIMDs that meet the criteria for SAEs

  From D182 through 12 months following the last study vaccination

• Geometric mean (GM) of HAI titers in all participants

  HAI titers

  At D01 and D30

• Geometric mean ratio (GMR) HAI titers ratio D30/D01 in all participants

  Individual HAI titers ratio D30/D01

  At D01 and D30

• GM of SARS-CoV-2 neutralizing titers in all participants

  SARS-CoV-2 neutralizing titers

  At D01 and D30

• GMR of SARS-CoV-2 neutralizing titers ratio D30/D01 in all participants

  Individual SARS-CoV-2 neutralizing titers ratio D30/D01

  At D01 and D30

Secondary Outcomes (4)

• Percentage of participants with seroconversion in all participants

  At D30

• Percentage of participants with HAI titer ≥ 10 (1/dil) in all participants

  At D01 and D30

• Percentage of participants with HAI titer ≥ 40 (1/dil) in all participants

  At D01 and D30

• Percentage of participants with seroresponse to SARS-CoV-2 in all participants

  At D30

Study Arms (7)

Group 1: IIV-HD (in right or left deltoid) and placebo (in opposite deltoid)

EXPERIMENTAL

two IM injections on D01

Biological: IIV-HD; Other: Placebo (0.9% NaCl)

Group 2: rC19 (dose 1) (in right or left deltoid) and placebo (in opposite deltoid)

EXPERIMENTAL

two IM injections on D01

Biological: rC19 (dose 1); Other: Placebo (0.9% NaCl)

Group 3: IIV-HD (in right or left deltoid) and rC19 (dose1) (in opposite deltoid)

EXPERIMENTAL

two IM injections on D01

Biological: IIV-HD; Biological: rC19 (dose 1)

Group 4: IIV-HD + rC19 (dose 1) (in right or left deltoid) and placebo (in opposite deltoid)

EXPERIMENTAL

two IM injections on D01

Biological: IIV-HD + rC19 (dose 1); Other: Placebo (0.9% NaCl)

Group 5: IIV-HD + rC19 (dose 2) (in right or left deltoid) and placebo (in opposite deltoid)

EXPERIMENTAL

two IM injections on D01

Biological: IIV-HD + rC19 (dose 2); Other: Placebo (0.9% NaCl)

Group 6: IIV-HD + rC19 (dose 3) (in right or left deltoid) and placebo (in opposite deltoid)

EXPERIMENTAL

two IM injections on D01

Biological: IIV-HD + rC19 (dose 3); Other: Placebo (0.9% NaCl)

Group 7: IIV-HD + rC19 (dose 4) (in right or left deltoid) and placebo (in opposite deltoid)

EXPERIMENTAL

two IM injections on D01

Biological: IIV-HD + rC19 (dose 4); Other: Placebo (0.9% NaCl)

Interventions

IIV-HD BIOLOGICAL

Inactivated, split-virion

Group 1: IIV-HD (in right or left deltoid) and placebo (in opposite deltoid); Group 3: IIV-HD (in right or left deltoid) and rC19 (dose1) (in opposite deltoid)

rC19 (dose 1) BIOLOGICAL

Protein subunit

Group 2: rC19 (dose 1) (in right or left deltoid) and placebo (in opposite deltoid); Group 3: IIV-HD (in right or left deltoid) and rC19 (dose1) (in opposite deltoid)

IIV-HD + rC19 (dose 1) BIOLOGICAL

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

Group 4: IIV-HD + rC19 (dose 1) (in right or left deltoid) and placebo (in opposite deltoid)

IIV-HD + rC19 (dose 2) BIOLOGICAL

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

Group 5: IIV-HD + rC19 (dose 2) (in right or left deltoid) and placebo (in opposite deltoid)

IIV-HD + rC19 (dose 3) BIOLOGICAL

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

Group 6: IIV-HD + rC19 (dose 3) (in right or left deltoid) and placebo (in opposite deltoid)

IIV-HD + rC19 (dose 4) BIOLOGICAL

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

Group 7: IIV-HD + rC19 (dose 4) (in right or left deltoid) and placebo (in opposite deltoid)

Placebo (0.9% NaCl) OTHER

Normal saline

Group 1: IIV-HD (in right or left deltoid) and placebo (in opposite deltoid); Group 2: rC19 (dose 1) (in right or left deltoid) and placebo (in opposite deltoid); Group 4: IIV-HD + rC19 (dose 1) (in right or left deltoid) and placebo (in opposite deltoid); Group 5: IIV-HD + rC19 (dose 2) (in right or left deltoid) and placebo (in opposite deltoid); Group 6: IIV-HD + rC19 (dose 3) (in right or left deltoid) and placebo (in opposite deltoid); Group 7: IIV-HD + rC19 (dose 4) (in right or left deltoid) and placebo (in opposite deltoid)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (12)

Simon Williamson Clinic - Birmingham- Site Number : 8400003

Birmingham, Alabama, 35211, United States

Location

AES - DRS - Optimal Research Alabama - Huntsville Site Number : 8400006

Huntsville, Alabama, 35802-2568, United States

Location

Orange Grove Family Practice- Site Number : 8400012

Tucson, Arizona, 85741, United States

Location

Synexus Clinical Research US - The Villages- Site Number : 8400011

The Villages, Florida, 32162, United States

Location

Synexus Clinical Research US - Atlanta- Site Number : 8400001

Atlanta, Georgia, 30328, United States

Location

Synexus Clinical Research- Site Number : 8400004

Chicago, Illinois, 60602, United States

Location

Synexus Clinical Research - St. Louis- Site Number : 8400010

Creve Coeur, Missouri, 63141, United States

Location

Synexus Clinical Research - New York- Site Number : 8400007

New York, New York, 10017, United States

Location

Optimal Research - Texas- Site Number : 8400002

Austin, Texas, 78705, United States

Location

Synexus Clinical Research US - Dallas- Site Number : 8400005

Dallas, Texas, 75234, United States

Location

Synexus Clinical Research US - San Antonio- Site Number : 8400009

San Antonio, Texas, 78229, United States

Location

Synexus Salt Lake City Site Number : 8400008

Salt Lake City, Utah, 84106, United States

Location

Related Links

• VBT00001 Plain Language Results Summary

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will be performed in a modified double-blind fashion. Modified double-blind: * Investigator, participants, and laboratory personnel will be blinded * Clinical site staff preparing/administering the study vaccines will be unblinded * Sponsor study staff will be blinded, except for dedicated staff involved in interim analysis, who will be unblinded at the time of interim analysis, and for dedicated staff involved in assessing criteria for safety surveillance
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 19, 2024
• Study Start: November 19, 2024
• Primary Completion: April 16, 2026
• Study Completion: April 16, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (12)