264 Participants Needed

IVX-A12 Vaccine for Older Adults

Recruiting at 9 trial locations
IC
Overseen ByIcosavax Clinical Operations
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on treatments that affect the immune system, like certain steroids or immunosuppressive therapies, you might need to stop them 3 months before the vaccination. It's best to discuss your specific medications with the trial team.

How is the IVX-A12 vaccine different from other vaccines for older adults?

The IVX-A12 vaccine is unique because it is specifically designed for older adults, potentially offering a novel approach compared to traditional vaccines that may not elicit a strong immune response in this age group. While the research does not provide direct comparisons, it suggests that IVX-A12 could be an innovative option for enhancing immunity in older populations.12345

What data supports the effectiveness of the IVX-A12 treatment for older adults?

The research on MVA-NP+M1, a similar vaccine designed to boost immune responses in older adults, suggests that targeting specific immune cells can improve vaccine effectiveness in this age group. This approach may provide insights into the potential effectiveness of the IVX-A12 treatment.678910

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 60 to 85 who can follow the study procedures for about a year. They should have a stable health condition, even with chronic issues like hypertension or diabetes if well-managed. Women must be unable to conceive. Participants cannot join if they've had recent RSV/hMPV vaccines or infections, are in other trials, have severe liver disease/AIDS/certain cancers, serious vaccine reactions, immune system problems from treatments within the last 3 months.

Inclusion Criteria

Participants able to voluntarily give written informed consent and comply with trial procedures including follow-up for approximately 12 months after vaccination
Participants with ongoing chronic conditions (comorbidities such as hypertension, congestive heart failure, chronic obstructive pulmonary disease, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism) that are medically compensated and without recent exacerbation within the prior 3 months, as per investigator's opinion
Body mass index 17 to less than 40 kilograms per square meter (kg/m^2) at screening
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Exclusion Criteria

I am considered frail based on a specific health score.
Trial personnel as an immediate family or household member
I haven't had any RSV or hMPV vaccine in the last year.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intramuscular dose of IVX-A12 or placebo

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity post-vaccination

12 months
Visits at Days 28, 180, and 365

Extended Follow-up

A subset of participants will be followed for an additional 12 months

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • IVX-A12
  • Placebo
Trial Overview The study tests IVX-A12, an experimental vaccine aimed at preventing respiratory syncytial virus (RSV) and human metapneumovirus (hMPV), against a placebo in older adults. It's given as one dose and participants will be monitored to see how safe it is and how their bodies respond to it immunologically.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: IVX-A12 Vaccine Formulation 2Experimental Treatment1 Intervention
Participants will receive a single dose of IVX-A12 IM injection on Day 0.
Group II: IVX-A12 Vaccine Formulation 1Experimental Treatment1 Intervention
Participants will receive a single dose of IVX-A12 intramuscular (IM) injection on Day 0.
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive a single dose of placebo IM injection on Day 0.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icosavax, Inc.

Lead Sponsor

Trials
3
Recruited
550+

Published Research Related to This Trial

The MVA-NP+M1 influenza vaccine was found to be safe and well-tolerated in a study involving 30 older adults (ages 50-85), with significant boosts in T cell responses observed after vaccination.
Unlike traditional seasonal influenza vaccines, MVA-NP+M1 generated similar immune responses in both older and younger individuals, suggesting it may effectively address the reduced immune response often seen in older adults.
A T cell-inducing influenza vaccine for the elderly: safety and immunogenicity of MVA-NP+M1 in adults aged over 50 years.Antrobus, RD., Lillie, PJ., Berthoud, TK., et al.[2022]
The novel vaccine MVA-NP+M1 aims to enhance immune responses against influenza by targeting conserved proteins, potentially offering broader and longer-lasting protection, especially for older adults who currently have poor vaccine responses.
The INVICTUS study, involving 2030 participants aged 65 and older, will assess the safety and efficacy of MVA-NP+M1 when given alongside a standard influenza vaccine, with the goal of reducing the duration of moderate to severe influenza-like illness.
A phase IIb study to determine the safety and efficacy of candidate INfluenza Vaccine MVA-NP+M1 in combination with licensed Ina CTivated infl Uenza vaccine in adult S aged 65 years and above (INVICTUS): a study protocol.Swayze, H., Allen, J., Folegatti, P., et al.[2020]
The adjuvanted inactivated influenza vaccine quadrivalent (aIIV4) is specifically designed to enhance the immune response in older adults (65 years and older), who typically have a weaker response to standard influenza vaccines.
While aIIV4 is effective in protecting against influenza, it does carry a warning for potential Guillain-Barré syndrome and common side effects include injection site pain, fatigue, headache, and muscle aches.
Adjuvanted inactivated influenza Vaccine Quadrivalent for Older People.Barranco, D., Chahine, EB.[2021]

Citations

A T cell-inducing influenza vaccine for the elderly: safety and immunogenicity of MVA-NP+M1 in adults aged over 50 years. [2022]
Estimating influenza vaccine effectiveness: Evolution of methods to better understand effects of confounding in older adults. [2018]
Influenza vaccine effectiveness estimates in the Dutch population from 2003 to 2014: The test-negative design case-control study with different control groups. [2023]
Coverage and Estimated Effectiveness of mRNA COVID-19 Vaccines Among US Veterans. [2023]
A phase IIb study to determine the safety and efficacy of candidate INfluenza Vaccine MVA-NP+M1 in combination with licensed Ina CTivated infl Uenza vaccine in adult S aged 65 years and above (INVICTUS): a study protocol. [2020]
Adjuvanted inactivated influenza Vaccine Quadrivalent for Older People. [2021]
Case-control vaccine effectiveness studies: Preparation, design, and enrollment of cases and controls. [2022]
Immunogenicity and safety of zoster vaccine live administered with quadrivalent influenza virus vaccine. [2018]
Immunogenicity and safety of a quadrivalent high-dose inactivated influenza vaccine compared with a standard-dose quadrivalent influenza vaccine in healthy people aged 60 years or older: a randomized Phase III trial. [2022]
Immunogenicity and safety of three commercial influenza vaccines in institutionalized elderly. [2019]
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