A Study to Evaluate the Safety and Immunogenicity of IVX-A12 in Participants of 60 to 85 Years of… (NCT05903183) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Safety and Immunogenicity of IVX-A12 in Participants of 60 to 85 Years of Age
United States264 participantsStarted 2023-05-15
Plain-language summary
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.
Who can participate
Age range60 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female participants, who must be in stable health based on medical history, vital signs, physical examination, and laboratory evaluation prior to vaccination, in the investigator's clinical judgment
✓. Participants may have ongoing chronic conditions (comorbidities such as hypertension, congestive heart failure, chronic obstructive pulmonary disease, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism) who are, in the investigator's opinion, medically compensated and without recent exacerbation within the prior 3 months
✓. Participants able to voluntarily give written informed consent and can comply with trial procedures including follow-up for approximately 12 months after vaccination
✓. Body mass index 17 to less than (\<) 40 kilograms per square meter (kg/m\^2) at screening
✓. Before randomization, female participants must be unable to conceive (example, menopausal, that is, 12 consecutive months without menstruation, hysterectomy, oophorectomy, etc.) and not intending to conceive by any method
✓. Participants must agree not to donate blood from the time of vaccination through 3 months after vaccination
✓. Participants must be willing to provide verifiable identification and have the means to be contacted and to contact the investigator or the site's staff during the entire clinical trial
Exclusion criteria
✕. Participants with moderate or severe liver disease, metastatic solid tumor, and acquired immunodeficiency syndrome (AIDS) are to be excluded. In addition, participants with underlying significant illness or condition(s) or ongoing treatment that, in the opinion of the investigator, could (i) interfere with the conduct of the trial, (ii) pose an unacceptable risk to the participant in this trial, (iii) interfere with the participant's ability to comply with the trial procedures or abide by the procedures
What they're measuring
1
Number of Participants With Solicited Local Adverse Reactions (ARs) and Systemic ARs
Timeframe: From Day 0 to Day 6
2
Number of Participants With Unsolicited Adverse Events
Timeframe: From Day 0 to Day 28
3
Model-adjusted Geometric Mean Titers (GMT) for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific Neutralizing Antibodies (NAb)
Timeframe: At Day 28
4
Model-adjusted Geometric Mean Concentrations (GMC) for RSV and hMPV Prefusion F Protein-specific IgG Antibodies (Ab)
Timeframe: At Day 28
5
Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
Timeframe: From Day 0 (pre-vaccination) up to Day 28 post-vaccination
6
Percentage of Participants With >=4-fold Increase in RSV and hMPV-specific IgG Ab Concentration
Timeframe: From Day 0 (pre-vaccination) up to Day 28 post-vaccination
7
Geometric Mean Fold Rise (GMFR) in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-Specific NAb Titers
Timeframe: From Day 0 (pre-vaccination) up to Day 28 post-vaccination
✕. Older adults who meet frail elderly criteria (older persons with medical, nutritional, cognitive, emotional, or activity impairments, as defined by the Dalhousie Clinical Frailty Score greater than or equal to \[\>=\]4)
✕. Prior receipt of any licensed or investigational RSV or hMPV vaccine within the past 12 months
✕. Prior receipt of another investigational medicinal product (IMP; trial drug, biologic, or device) not authorized for use in the United States of America (USA) and European Union within the past 3 months
✕. Laboratory-confirmed RSV or hMPV infection within 12 months prior to enrollment
✕. Currently enrolled or plan to participate in another clinical trial with an investigational agent (including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication) to be received during the trial period
✕. History of malignancy within 5 years before screening not in the following categories: (i) participants with squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix may be enrolled at the discretion of the investigator, (ii) participants with a history of malignancy within 5 years before screening, with minimal risk of recurrence per investigator's judgment, can be enrolled
✕. Acute illness, with or without fever at the time of planned vaccination
8
Geometric Mean Fold Rise (GMFR) in Serum for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
Timeframe: From Day 0 (pre-vaccination) up to Day 28 post-vaccination