The main purpose of this study is to evaluate the safety and immunogenicity of three dosage levels (low, medium, high) of the bivalent combination 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 75 years of age.
The Phase 1 clinical trial of IVX-A12 is a randomized, observer-blinded, placebo-controlled, multi-center study designed to evaluate the safety and immunogenicity of multiple dosage levels of IVX-A12, with and without CSL Seqirus' proprietary adjuvant MF59®. A total of up to 120 healthy older adults aged 60 to 75 years. Participants will be administered a single shot of IVX-A12, at one of three combination dosage levels below, or placebo. The overall duration of the study is up to 1 year (365 days).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
140
CenExcel RCA
Hollywood, Florida, United States
CenExcel ACMR
Atlanta, Georgia, United States
Meridien Clinical Research
Omaha, Nebraska, United States
PanAmerican Clinical Research
Brownsville, Texas, United States
Proportion of Participants With Solicited Local Reactions and Systemic AEs
Time frame: Within 7 days After the Dose (From Day 0 to Day 6)
Proportion of Participants With Unsolicited AEs
Time frame: Up to 28 days After the Dose (From Day 0 to Day 28)
Proportion of Participants With RSV/A, RSV/B, hMPV/A and hMPV/B Neutralizing Antibodies (NAb)
Time frame: At Day 28
Proportion of Participants With RSV and hMPV Immunoglobulin G (IgG) Prefusion F Protein-specific Antibody Titers
RSV and hMPV IgG prefusion F protein-specific antibody titers as measured by enzyme-linked immunosorbent assays (ELISAs).
Time frame: At Day 28
Proportion of Participants With at Least One Serious Adverse Event (SAE), Medically-attended Adverse Events (MAAEs), AEs of Special Interest (AESIs) and AEs Leading to Study Withdrawal
Time frame: From Day 0 up to the end of study (Day 365)
Proportion of Participants With Clinically Significant Safety Laboratory Abnormalities
Time frame: At screening, and after dosing, at Days 0, 7, and 28
Proportion of Participants With RSV/A, RSV/B, hMPV/A and hMPV/B Specific NAbs RSV and hMPV IgG Prefusion F Protein-specific Antibody Titers, RSV and hMPV IgG prefusion F protein-specific antibody titers
Time frame: At Days 0, 7, 180, and 365
Geometric Fold Rise (GMFR) in Serum for Anti-RSV/A, RSV/B, hMPV/A and hMPV/B Specific NAb
Serum samples will be collected and the titers of serum neutralization antibodies will be assessed. GMFR is defined as the geometric mean of the ratio of concentration at specified timepoints after vaccination divided by concentration at baseline (Day 0).
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75 mcg of IVX-121, without MF59®
150 mcg IVX-241, without MF59®
225 mcg of IVX-241, without MF59®
75 mcg of IVX-121, with MF59®
75 mcg of IVX-241, with MF59®
150 mcg IVX-241, with MF59®
MF59® as an adjuvant
Time frame: From Day 0 up to Day 180
GMFR in Serum for RSV and hMPV IgG Prefusion F Protein-specific Antibody Titers
GMFR is defined as the geometric mean of the ratio of concentration at specified timepoints after vaccination divided by concentration at baseline (Day 0).
Time frame: From Day 0 up to Day 180