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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
980
Inactivated, split-virion
Protein subunit
IIV-HD component: Inactivated, split-virion rC19 component: Protein subunit
IIV-HD component: Inactivated, split-virion rC19 component: Protein subunit
IIV-HD component: Inactivated, split-virion rC19 component: Protein subunit
IIV-HD component: Inactivated, split-virion rC19 component: Protein subunit
Normal saline
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 - 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 Clinical Research - New York- Site Number : 8400007
New York, New York, United States
Optimal Research - Texas- Site Number : 8400002
Austin, Texas, United States
Synexus Clinical Research US - Dallas- Site Number : 8400005
Dallas, Texas, United States
...and 2 more locations
Number of participants with immediate adverse events (AEs)
Immediate adverse events are any unsolicited systemic adverse events reported in the 30 minutes after vaccination
Time frame: 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
Time frame: Up to 7 each days after vaccination
Number of participants with solicited systemic reactions
Solicited systemic reactions include fever, headache, fatigue, myalgia and chills
Time frame: Up to 7 days after each vaccination
Number of participants with unsolicited AEs
Unsolicited (spontaneously reported) AEs, not fulfilling criteria for solicited adverse reactions
Time frame: Up to 28 days after each vaccination
Number of participants with adverse events of special interest (AESIs)
AESIs
Time frame: Up to 180 days after each vaccination
Number of participants with medical attended adverse events (MAAEs)
MAAEs
Time frame: Up to 180 days after each vaccination
Number of MAAEs relating to predefined potential immune-mediated disease (PIMDs)
MAAEs relating to predefined PIMDs
Time frame: From D182 through 12 months following the last study vaccination
Number of participants with serious adverse events (SAEs)
SAEs
Time frame: Up to 180 days after each vaccination
Number of participants with related SAEs
Related SAEs
Time frame: 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
Time frame: From D182 through 12 months following the last study vaccination
Geometric mean (GM) of HAI titers in all participants
HAI titers
Time frame: At D01 and D30
Geometric mean ratio (GMR) HAI titers ratio D30/D01 in all participants
Individual HAI titers ratio D30/D01
Time frame: At D01 and D30
GM of SARS-CoV-2 neutralizing titers in all participants
SARS-CoV-2 neutralizing titers
Time frame: 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
Time frame: At D01 and D30
Percentage of participants with seroconversion in all participants
Seroconversion is defined by: HAI titer \< 10 \[1/dil\] at D01 and post-injection titer ≥ 40 \[1/dil\] at D30 or HAI titer ≥ 10 \[1/dil\] and a ≥ 4-fold increase in titer \[1/dil\] at D30
Time frame: At D30
Percentage of participants with HAI titer ≥ 10 (1/dil) in all participants
detectable HAI titer ≥ 10 (1/dil)
Time frame: At D01 and D30
Percentage of participants with HAI titer ≥ 40 (1/dil) in all participants
HAI titer ≥ 40 (1/dil)
Time frame: At D01 and D30
Percentage of participants with seroresponse to SARS-CoV-2 in all participants
Seroresponse to SARS-CoV-2 is defined by SARS-CoV-2 neutralizing titers ≥ 4-fold rise in SARS-CoV-2 neutralizing titers from D01 to D30
Time frame: At D30
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