The primary purpose of the study is to assess the safety, tolerability and immunogenicity of a bivalent respiratory syncytial virus (RSV)/human metapneumovirus (hMPV) virus-like particle (VLP) candidate vaccine (IVX-A12) compared to placebo, when administered as a single-dose regimen in healthy older adults 60 to 85 years of age.
The IVX-A12 Phase 2a clinical trial is a randomized, observer-blind, placebo-controlled, dosage optimization, multi-center trial to evaluate the safety and immunogenicity of a single intramuscular (IM) dose of IVX-A12, with or without adjuvant, in adults 60 to 85 years of age. Participants will be administered a single shot of IVX-A12, at specified dosage levels, or placebo. The overall duration of the study is up to 1 year (12 months). A subset of participants will be followed for an additional 12 months for a total duration of 24 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
264
AMR Phoenix
Tempe, Arizona, United States
Cenexel RCA
Hollywood, Florida, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Velocity Clinical Research-Boise
Number of Participants With Solicited Local Adverse Reactions (ARs) and Systemic ARs
Solicited local ARs include pain, tenderness, erythema, and swelling. Solicited systemic ARs include headache, chills, fatigue, myalgia, arthralgia, vomiting, diarrhea, and fever.
Time frame: From Day 0 to Day 6
Number of Participants With Unsolicited Adverse Events
An unsolicited AE is an AE that was not solicited using the post-vaccination diary and that was spontaneously communicated by a participant.
Time frame: From Day 0 to Day 28
Model-adjusted Geometric Mean Titers (GMT) for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific Neutralizing Antibodies (NAb)
Model-adjusted GMT and corresponding 95% CI were derived from an analysis of covariance (ANCOVA) model of log2 titer at Day 28 with independent variables of log2 baseline titer, age group, and treatment group.
Time frame: At Day 28
Model-adjusted Geometric Mean Concentrations (GMC) for RSV and hMPV Prefusion F Protein-specific IgG Antibodies (Ab)
Model-adjusted GMC and corresponding 95% CI were derived from an analysis of covariance (ANCOVA) model of log2 concentration at Day 28 with independent variables of log2 baseline concentration, age group, and treatment group.
Time frame: At Day 28
Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
Proportion of participants with non-missing results at the specified visit achieving a 4-fold or greater increase in NAb titer versus baseline (Day 0).
Time frame: From Day 0 (pre-vaccination) up to Day 28 post-vaccination
Percentage of Participants With >=4-fold Increase in RSV and hMPV-specific IgG Ab Concentration
Proportion of participants with non-missing results at the specified visit achieving a 4-fold or greater increase in Ab concentration versus baseline (Day 0).
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Meridian, Idaho, United States
ASR, LLC
Nampa, Idaho, United States
Johnson City Clin-Trials (JCCT)
Lenexa, Kansas, United States
AMR Lexington
Lexington, Kentucky, United States
Velocity Clinical Research
Omaha, Nebraska, United States
Rochester Clinical Research, Inc
Rochester, New York, United States
PanAmerican Clinical Research
Brownsville, Texas, United States
Time frame: From Day 0 (pre-vaccination) up to Day 28 post-vaccination
Geometric Mean Fold Rise (GMFR) in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-Specific NAb Titers
GMFR is defined as the geometric mean of the ratio of NAb titer at specified timepoints after vaccination divided by baseline (Day 0) titer.
Time frame: From Day 0 (pre-vaccination) up to Day 28 post-vaccination
Geometric Mean Fold Rise (GMFR) in Serum for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
GMFR is defined as the geometric mean of the ratio of Ab concentration at specified timepoints after vaccination divided by baseline (Day 0) concentration.
Time frame: From Day 0 (pre-vaccination) up to Day 28 post-vaccination
Number of Participants With Serious Adverse Event (SAE), Medically-attended Adverse Events (MAAEs), and AEs Leading to Trial Withdrawal
An SAE is defined as any untoward medical occurrence that met one or more of the following: resulted in death; was immediately life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly or birth defect in the offspring of a subject; was an important and significant medical event that might have jeopardized the participant or required medical intervention to prevent one of the aforementioned outcomes. Any AESI occurring during the trial will be categorized and reported as an SAE. These AESIs include anaphylaxis, thrombocytopenia, and other potential immune-mediate conditions (including Guillain Barre syndrome). MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional, including visits to an emergency department, but not fulfilling seriousness criteria.
Time frame: From Day 0 up to the end of study (up to Day 365)
Number of Participants With Mild, Moderate, or Severe Lower Respiratory Tract Illness (LRTI) Caused by RSV and/or hMPV
Data is summarized as the number of subjects with at least one LRTI event (mild, moderate, or severe) by treatment group.
Time frame: From Day 0 up to Day 365 (end of study)
Number of Participants With Mild, Moderate, or Severe LRTI Cases Not Caused by RSV or hMPV
Data is summarized as the number of subjects with at least one LRTI event (mild, moderate, or severe) by treatment group.
Time frame: From Day 0 up to Day 365 (end of study)
Number of Participants With Clinically Significant Safety Laboratory Parameters
Time frame: At Screening, Days 0, 7 and 28
Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb
Model-adjusted GMT and corresponding 95% CI were derived from an analysis of covariance (ANCOVA) model of log2 titer at each post-baseline timepoint with independent variables of log2 baseline titer, age group, and treatment group.
Time frame: At Days 180 and 365
Model-Adjusted GMCs for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
Model-adjusted GMC and corresponding 95% CI were derived from an analysis of covariance (ANCOVA) model of log2 concentration at each post-baseline timepoint with independent variables of log2 baseline concentration, age group, and treatment group.
Time frame: At Days 180, and 365
Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
Proportion of participants with non-missing results at the specified visit achieving a 4-fold or greater increase in NAb titer versus baseline (Day 0).
Time frame: From Day 0 (pre-vaccination) up to Day 180 and Day 365 post-vaccination
Percentage of Participants With >=4-fold Increase in RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
Proportion of participants with non-missing results at the specified visit achieving a 4-fold or greater increase in Ab concentration versus baseline (Day 0).
Time frame: From Day 0 (pre-vaccination) up to Days 180, and 365 post-vaccination
Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
Proportion of participants with non-missing results at the specified visit achieving a 8-fold or greater increase in NAb titer versus baseline (Day 0).
Time frame: From Day 0 (pre-vaccination) up to Days 28, 180, and 365 post-vaccination
GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
GMFR is defined as the geometric mean of the ratio of Ab concentration at specified timepoints after vaccination divided by baseline (Day 0) concentration.
Time frame: From Day 0 (pre-vaccination) up to Day 180 and Day 365 post-vaccination
Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations
The median, as well as 25th and 75th percentiles of serum NAb titers and IgG Ab concentrations are summarized at specified timepoints.
Time frame: At Days 28, 180, and 365 post-vaccination