IVX-A12
BiologicalIVX-A12 without adjuvant
NCT Number: NCT05903183
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.
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Notify Me60 year–85 year
All sexes
Interventional
Phase 2
AMR Phoenix, Tempe, Arizona, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IVX-A12 without adjuvant
Diluent
Time frame: From Day 0 to Day 6
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 28
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: At Day 28
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 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: From Day 0 (pre-vaccination) up to Day 28 post-vaccination
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
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 Day 28 post-vaccination
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
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 up to the end of study (up to Day 365)
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 Day 365 (end of study)
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)
Data is summarized as the number of subjects with at least one LRTI event (mild, moderate, or severe) by treatment group.
Time frame: At Screening, Days 0, 7 and 28
Time frame: At Days 180 and 365
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 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: From Day 0 (pre-vaccination) up to Day 180 and Day 365 post-vaccination
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 Days 180, and 365 post-vaccination
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 28, 180, and 365 post-vaccination
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 Day 180 and Day 365 post-vaccination
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: At Days 28, 180, and 365 post-vaccination
The median, as well as 25th and 75th percentiles of serum NAb titers and IgG Ab concentrations are summarized at specified timepoints.
Icosavax, Inc.
Industry
A Phase 2a Randomized, Observer-blind, Placebo-controlled, Dosage Optimization, Multi-center Clinical Trial to Evaluate the Safety and Immunogenicity of IVX-A12, a Respiratory Syncytial Virus and Human Metapneumovirus Bivalent Combination Virus-like Particle Protein Subunit Vaccine, in Adults 60 to 85 Years of Age
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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