IVX-A12 Vaccine for Older Adults

Not currently recruiting at 9 trial locations

Overseen By Icosavax Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Icosavax, Inc.

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Liver disease, Metastatic tumor, AIDS, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 29

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test the safety and immune response of a new vaccine called IVX-A12, designed to protect against two common lung viruses, RSV and hMPV. Participants will receive either a single dose of the vaccine or a placebo. The trial seeks healthy older adults aged 60 to 85 with manageable health conditions like high blood pressure or diabetes and no recent severe health issues. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

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.

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

Research has shown that the IVX-A12 vaccine is generally safe for older adults. In earlier studies, participants aged 60 to 85 received the vaccine and reported only a few side effects. Researchers tested the vaccine in different amounts, all of which proved safe. Some participants experienced mild reactions, such as a sore arm or fatigue, similar to other vaccines. Overall, the vaccine helped the body build a strong defense against RSV and hMPV viruses. These findings suggest that the IVX-A12 vaccine is safe for individuals aged 60 and older. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the IVX-A12 vaccine for older adults because it represents a novel approach to vaccination. Unlike traditional vaccines that might require multiple doses over time, IVX-A12 is designed to deliver protection with just a single intramuscular injection. This could simplify the vaccination process and improve adherence among older populations. Additionally, the vaccine's formulation may offer enhanced immune response specifically tailored for older adults, potentially providing better protection than current options.

What evidence suggests that this trial's treatments could be effective for RSV and hMPV in older adults?

Research shows that the IVX-A12 vaccine looks promising for people aged 60 to 85. Earlier studies found that it helps the body produce strong defenses against RSV and hMPV, viruses that can lead to lung infections. Older adults tolerated the vaccine well, experiencing no major side effects. In past trials, these defenses lasted up to 6 months, providing protection during that period. This trial will test two formulations of the IVX-A12 vaccine, with some participants receiving a placebo. These findings suggest that IVX-A12 could help prevent respiratory infections in older adults. ^{1 2 3 5 6}

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

Exclusion Criteria

I am considered frail based on a specific health score.

Trial personnel as an immediate family or household member

Prior receipt of another investigational medicinal product not authorized for use in the USA and European Union within the past 3 months

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?

Group I: IVX-A12 Vaccine Formulation 2 Experimental Treatment 1 Intervention

Participants will receive a single dose of IVX-A12 IM injection on Day 0.

Group II: IVX-A12 Vaccine Formulation 1 Experimental Treatment 1 Intervention

Participants will receive a single dose of IVX-A12 intramuscular (IM) injection on Day 0.

Group III: Placebo Placebo Group 1 Intervention

Participants will receive a single dose of placebo IM injection on Day 0.

Who Is Running the Clinical Trial?

Icosavax, Inc.

Lead Sponsor

Trials

3

Recruited

550+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvanted inactivated influenza Vaccine Quadrivalent for Older People. Barranco, D., Chahine, EB.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 study involving 882 adults aged 50 and older demonstrated that administering ZOSTAVAX™ (ZV) and the quadrivalent inactivated influenza vaccine (IIV4) together is safe and induces comparable immune responses to each vaccine given separately.

The immune response for varicella-zoster virus (VZV) was noninferior when ZV was given alongside IIV4, and there were no significant differences in adverse events between the groups, indicating that the combination is well tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of zoster vaccine live administered with quadrivalent influenza virus vaccine. Levin, MJ., Buchwald, UK., Gardner, J., et al.[2018]

Citations

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

A Randomized Phase 1 Clinical Trial of a Respiratory ... IVX-A12 was well-tolerated and elicited RSV- and hMPV-specific antibody responses in adults 60–75 years of age. These data support the ongoing ...

2. 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 ...

3. 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 ...

4. academic.oup.com academic.oup.com/ofid/article/12/Supplement_1/ofae631.799/7988774

P-601. Safety and Immunogenicity of a Respiratory Syncytial ... IVX-A12 containing 150μg RSV/150μg hMPV was well tolerated and immunogenic against RSV and hMPV to 6 months in older adults up to 85 years of age, regardless ...

5. 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 ...

6. 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 ...