IVX-A12 for Healthy Older Adults

No longer recruiting at 3 trial locations

Overseen By Icosavax Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Icosavax, Inc.

Must not be taking: Systemic corticosteroids, Immunosuppressive chemotherapy

Disqualifiers: Severe cardiopulmonary disease, Frail elderly, others

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, IVX-A12, designed to protect against two viruses: RSV and hMPV, which can cause respiratory infections. Researchers aim to ensure the vaccine is safe and triggers a strong immune response in healthy older adults. Participants will receive a low, medium, or high dose of the vaccine, or a placebo, to evaluate the effectiveness of each level. Individuals aged 60 to 75, in good health, and without severe chronic conditions may be suitable for this study. As a Phase 1 trial, this research focuses on understanding how the new vaccine works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on medications that affect the immune system, like high-dose corticosteroids or immunosuppressive drugs, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the IVX-A12 vaccine, designed to protect against respiratory syncytial virus (RSV) and human metapneumovirus (hMPV), is well-tolerated by healthy older adults aged 60 to 75. In earlier studies, participants who received the vaccine experienced no serious side effects, and it successfully activated an immune response, aiding the body in fighting infections.

For those who received the IVX-A12 vaccine with MF59®—an ingredient that enhances vaccine efficacy—similar results occurred. This combination was also well-tolerated, suggesting it is likely safe for this age group.

Overall, these studies suggest the IVX-A12 vaccine, whether administered alone or with MF59®, is safe for older adults. This early data is encouraging for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about IVX-A12 because it represents a new approach in vaccine development for older adults. Unlike traditional vaccines that typically focus on a single virus, IVX-A12 is a bivalent combination that includes virus-like particles (VLPs) from both IVX-121 and IVX-241. This dual-targeting strategy could potentially offer broader protection. Additionally, some arms of the treatment include the adjuvant MF59®, which could enhance the immune response, making the vaccine more effective. This innovative formulation and delivery could lead to improved outcomes for older adults, who often have weaker immune responses to standard vaccines.

What evidence suggests that this trial's treatments could be effective for healthy older adults?

Previous studies have shown that IVX-A12 maintains strong immune defenses against RSV and hMPV for up to a year. These studies found that recipients of the vaccine had better antibody levels than those given a placebo. Earlier research confirmed that the vaccine triggered strong immune responses, suggesting effective protection against these respiratory infections. In this trial, participants will receive different dosage levels of IVX-A12, with some receiving a version mixed with MF59, a substance that boosts the body's immune response. The version of IVX-A12 mixed with MF59 also performed well in previous studies, creating specific antibody responses in older adults. These findings suggest that IVX-A12 could help prevent lung infections caused by RSV and hMPV in people aged 60 and older. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

Screening laboratory values must be within the laboratory reference ranges or deemed not clinically significant if within Grade 1 severity on the toxicity scale

Healthy male or non-pregnant female older adults 60 to 75 years of age at the time of first vaccination

Participants with stable well-controlled chronic conditions such as hypertension without clinical exacerbation of their underlying disease within the previous 12 months

Exclusion Criteria

You have previously received an experimental vaccine for respiratory syncytial virus (RSV) or human metapneumovirus (hMPV).

You have a serious heart or lung condition that makes you more likely to have severe respiratory syncytial virus (RSV) or human metapneumovirus (hMPV) disease.

You are currently sick, with or without a fever, when you are supposed to get the vaccine.

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 injection of the IVX-A12 vaccine or placebo on Day 0

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity, with assessments of antibody titers and serum neutralization antibodies

365 days

Multiple visits over 1 year

What Are the Treatments Tested in This Trial?

Interventions

• IVX-A12

How Is the Trial Designed?

Group I: IVX-A12 Vaccine - Medium Dosage Level Experimental Treatment 2 Interventions

Participants will receive IVX-A12 vaccine (bivalent combination formulation containing IVX-121 and IVX-241 VLPs), administered IM once on Day 0.

Group II: IVX-A12 Vaccine - Low Dosage Level Experimental Treatment 2 Interventions

Participants will receive IVX-A12 vaccine (bivalent combination formulation containing IVX-121 and IVX-241 virus-like particles \[VLPs\]), administered intramuscularly (IM) once on Day 0.

Group III: IVX-A12 Vaccine - High Dosage Level Experimental Treatment 2 Interventions

Participants will receive IVX-A12 vaccine (bivalent combination formulation containing IVX-121 and IVX-241 VLPs), administered IM once on Day 0.

Group IV: IVX-A12 Vaccine + MF59® - Medium Dosage Level Experimental Treatment 3 Interventions

Participants will receive IVX-A12 vaccine (bivalent combination formulation containing IVX-121 and IVX-241 VLPs), administered IM once on Day 0.

Group V: IVX-A12 Vaccine + MF59® - Low Dosage Level Experimental Treatment 3 Interventions

Participants will receive IVX-A12 vaccine (bivalent combination formulation containing IVX-121 and IVX-241 VLPs), administered IM once on Day 0.

Group VI: Placebo Placebo Group 1 Intervention

Participants will receive placebo, administered IM once on Day 0.

Who Is Running the Clinical Trial?

Icosavax, Inc.

Lead Sponsor

Trials

3

Recruited

550+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05664334

Safety and Immunogenicity of IVX-A12 in Healthy Older ... The main purpose of this study is to evaluate the safety and immunogenicity of three dosage levels (low, medium, high) of the bivalent combination ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11977332/

A Randomized Phase 1 Clinical Trial of a Respiratory ... Neutralizing responses in IVX-A12 recipients through day 365 were maintained above or around baseline and exceeded those in placebo recipients.

3. astrazeneca.com astrazeneca.com/content/astraz/media-centre/press-releases/2024/astrazeneca-advances-science-of-infectious-disease-protection-at-idweek-2024.html

AstraZeneca advances science of infectious disease ... In the Phase II trial, IVX-A12 showed robust immune responses across RSV and hMPV antibodies, reconfirming previous immunogenicity data seen in ...

4. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-ivx-a12-vaccine-for-preventing-respiratory-infections-in-adults-aged-60-and-older/

Study on the Effectiveness and Safety of IVX-A12 Vaccine ... The purpose of the study is to see how well the IVX-A12 vaccine works in preventing lung infections caused by RSV and hMPV in adults aged 60 and ...

5. withpower.com withpower.com/trial/phase-2-healthy-subjects-hs-4-2023-6df52

IVX-A12 Vaccine for Older Adults · Info for Participants 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 ...

6. academic.oup.com academic.oup.com/ofid/article/12/4/ofaf160/8075154

Randomized Phase 1 Clinical Trial of a Respiratory Syncytial ... This first-in-human trial of an RSV/hMPV combination VLP vaccine demonstrated that IVX-A12 was well-tolerated in adults 60–75 years of age, had ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40201719/

A Randomized Phase 1 Clinical Trial of a Respiratory ... The trial showed IVX-A12 was well-tolerated, elicited antibody responses, and boosted neutralizing antibody responses against RSV and hMPV.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05903183

NCT05903183 | A Study to Evaluate the Safety and ... The primary purpose of the study is to assess the safety, tolerability and immunogenicity of a bivalent respiratory syncytial virus (RSV)/human ...