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 range

60 Years – 85 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Solicited Local Adverse Reactions (ARs) and Systemic ARs

Timeframe: From Day 0 to Day 6

Number of Participants With Unsolicited Adverse Events

Timeframe: 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)

Timeframe: At Day 28

Model-adjusted Geometric Mean Concentrations (GMC) for RSV and hMPV Prefusion F Protein-specific IgG Antibodies (Ab)

Timeframe: 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

Timeframe: 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

Timeframe: From Day 0 (pre-vaccination) up to Day 28 post-vaccination

Trial details

NCT IDNCT05903183

SponsorIcosavax, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-05

Results submitted2025-11-24

View on ClinicalTrials.gov More Healthy trials

Plain-language summary

Who can participate

Age range

60 Years – 85 Years

Sex

ALL

See this in plain English?

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

What they're measuring

Number of Participants With Solicited Local Adverse Reactions (ARs) and Systemic ARs

Timeframe: From Day 0 to Day 6

Number of Participants With Unsolicited Adverse Events

Timeframe: 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)

Timeframe: At Day 28

Model-adjusted Geometric Mean Concentrations (GMC) for RSV and hMPV Prefusion F Protein-specific IgG Antibodies (Ab)

Timeframe: 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

Timeframe: 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

Timeframe: From Day 0 (pre-vaccination) up to Day 28 post-vaccination

A Study to Evaluate the Safety and Immunogenicity of IVX-A12 in Participants of 60 to 85 Years of Age

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

A Study to Evaluate the Safety and Immunogenicity of IVX-A12 in Participants of 60 to 85 Years of Age

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria