AzTrials
AzTrials

HealthyPhase 1NCT05664334

Safety and Immunogenicity of IVX-A12 in Healthy Older Adults

A Phase 1 study testing IVX-121, IVX-241 and MF59® in people with Healthy, run by Icosavax, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main purpose of this study is to evaluate the safety and immunogenicity of three dosage levels (low, medium, high) of the bivalent combination respiratory syncytial virus (RSV)/human metapneumovirus (hMPV) virus-like particle (VLP) candidate vaccine (IVX-A12), compared to placebo, when administered as a… Read more about this study

Who is it for?
Ages 60 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
IVX-121, IVX-241 and MF59®
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
4 sitesUnited States
Study dates
21 Sep 2022to 24 Jan 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
  • Participants able to voluntarily give written informed consent and to comply with study procedures including follow-up to approximately 12 months after first dosing
  • Body mass index (BMI) 17 to 35 kilogram per square meter (kg/m^2), inclusive, at screening
  • Screening laboratory values must be within the laboratory reference ranges or deemed not clinically significant if within Grade 1 severity on the toxicity scale

Who cannot join

  • Prior receipt of any investigational RSV or hMPV vaccine
  • Prior receipt of another investigational medicinal product (study drug, biologic, or device) not authorized for use in the United States and European Union within the past year
  • Laboratory-confirmed severe RSV or hMPV infection within the past year prior to enrollment
  • Currently enrolled or plan to participate in another clinical study with an investigational agent (including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication) to be received during the study period
  • Presence of high-risk comorbidities for severe RSV or hMPV disease (example, significant cardiopulmonary disease)
  • Older adults meeting frail elderly criteria (older persons with medical, nutritional, cognitive, emotional, or activity impairments, as defined by the study site)
Show all 14Show fewer
  • Acute or chronic progressive, unstable or uncontrolled clinical conditions
  • Acute illness, with or without fever at the time of planned vaccination
  • History of hypersensitivity or serious adverse reactions to vaccines, such as anaphylaxis, Guillain-Barré, and angioedema, or any known allergies to any component of the IVX-121 and/or IVX-241 vaccine, or hypersensitivity to latex
  • Abnormal function of the immune system resulting from clinical conditions including human immunodeficiency virus, chronic administration of systemic corticosteroids (oral/intravenous/IM at a dose equivalent of greater than (>) 20 milligrams (mg) prednisone in a period of more than 14 days), or administration of immunosuppressive chemotherapy, biologics, or radiotherapy within the past 3 months before study randomization
  • Refusal to maintain contraceptive practices during the study, and (for women of childbearing potential) to be screened for pregnancy at specified times during the study
  • Receipt of licensed inactivated vaccines including influenza vaccine within 14 days prior to study vaccine administration on Study Day 0, or with live virus vaccines within 30 days of Day 0
  • Receipt of licensed vaccines is permitted after completion of the study Day 28 visit.
  • Receipt of licensed COVID-19 vaccines is permitted if dosing regimen completed within 21 days prior to study vaccine administration on Day 0 or after completion of the Day 28 visit.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • CenExcel ACMR

    Atlanta, Georgia, 30331

  • PanAmerican Clinical Research

    Brownsville, Texas, 78520

  • CenExcel RCA

    Hollywood, Florida, 33024

  • Meridien Clinical Research

    Omaha, Nebraska, 68134

Other trials in United States

About this study

Official title: A Phase 1 Randomized, Observer-blind, Placebo-controlled, Multi-center Trial to Evaluate the Safety and Immunogenicity of IVX-A12, a Respiratory Syncytial Virus and Human Metapneumovirus Bivalent Combination Virus-like Particle Protein Subunit Vaccine, in Healthy Adults, 60 to 75 Years of Age

The main purpose of this study is to evaluate the safety and immunogenicity of three dosage levels (low, medium, high) of the bivalent combination 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 75 years of age.

Read the detailed description

The Phase 1 clinical trial of IVX-A12 is a randomized, observer-blinded, placebo-controlled, multi-center study designed to evaluate the safety and immunogenicity of multiple dosage levels of IVX-A12, with and without CSL Seqirus' proprietary adjuvant MF59®.

A total of up to 120 healthy older adults aged 60 to 75 years. Participants will be administered a single shot of IVX-A12, at one of three combination dosage levels below, or placebo. The overall duration of the study is up to 1 year (365 days).

Conditions
Healthy
Being tested
IVX-121, IVX-241, Placebo, MF59®
Keywords
Respiratory Syncytial Virus, Human Metapneumovirus, Bivalent Combination Virus-like Particle Protein Subunit Vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IVX-121Biological

    75 mcg of IVX-121 without MF59®

  • IVX-241Biological

    75 mcg of IVX-241 without MF59®

  • PlaceboBiological

    Diluent

  • IVX-121Biological

    75 mcg of IVX-121, without MF59®

  • IVX-241Biological

    150 mcg IVX-241, without MF59®

  • IVX-241Biological

    225 mcg of IVX-241, without MF59®

  • IVX-121Biological

    75 mcg of IVX-121, with MF59®

  • IVX-241Biological

    75 mcg of IVX-241, with MF59®

  • IVX-241Biological

    150 mcg IVX-241, with MF59®

  • MF59®Other

    MF59® as an adjuvant

Study groups in NCT05664334
Study groupRoleWhat they receive
IVX-A12 Vaccine - Low Dosage LevelExperimentalParticipants 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.
Receives: Biological: IVX-121; Biological: IVX-241
IVX-A12 Vaccine + MF59® - Low Dosage LevelExperimentalParticipants will receive IVX-A12 vaccine (bivalent combination formulation containing IVX-121 and IVX-241 VLPs), administered IM once on Day 0.
Receives: Biological: IVX-121; Biological: IVX-241; Other: MF59®
IVX-A12 Vaccine - Medium Dosage LevelExperimentalParticipants will receive IVX-A12 vaccine (bivalent combination formulation containing IVX-121 and IVX-241 VLPs), administered IM once on Day 0.
Receives: Biological: IVX-121; Biological: IVX-241
IVX-A12 Vaccine + MF59® - Medium Dosage LevelExperimentalParticipants will receive IVX-A12 vaccine (bivalent combination formulation containing IVX-121 and IVX-241 VLPs), administered IM once on Day 0.
Receives: Biological: IVX-121; Biological: IVX-241; Other: MF59®
IVX-A12 Vaccine - High Dosage LevelExperimentalParticipants will receive IVX-A12 vaccine (bivalent combination formulation containing IVX-121 and IVX-241 VLPs), administered IM once on Day 0.
Receives: Biological: IVX-121; Biological: IVX-241
PlaceboPlacebo comparatorParticipants will receive placebo, administered IM once on Day 0.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Participants With Solicited Local Reactions and Systemic AEs

    Measured: Within 7 days After the Dose (From Day 0 to Day 6)

  2. Proportion of Participants With Unsolicited AEs

    Measured: Up to 28 days After the Dose (From Day 0 to Day 28)

  3. Proportion of Participants With RSV/A, RSV/B, hMPV/A and hMPV/B Neutralizing Antibodies (NAb)

    Measured: At Day 28

  4. Proportion of Participants With RSV and hMPV Immunoglobulin G (IgG) Prefusion F Protein-specific Antibody Titers

    RSV and hMPV IgG prefusion F protein-specific antibody titers as measured by enzyme-linked immunosorbent assays (ELISAs).

    Measured: At Day 28

Secondary outcomes (5)

  1. Proportion of Participants With at Least One Serious Adverse Event (SAE), Medically-attended Adverse Events (MAAEs), AEs of Special Interest (AESIs) and AEs Leading to Study Withdrawal

    Measured: From Day 0 up to the end of study (Day 365)

  2. Proportion of Participants With Clinically Significant Safety Laboratory Abnormalities

    Measured: At screening, and after dosing, at Days 0, 7, and 28

  3. Proportion of Participants With RSV/A, RSV/B, hMPV/A and hMPV/B Specific NAbs RSV and hMPV IgG Prefusion F Protein-specific Antibody Titers, RSV and hMPV IgG prefusion F protein-specific antibody titers

    Measured: At Days 0, 7, 180, and 365

  4. Geometric Fold Rise (GMFR) in Serum for Anti-RSV/A, RSV/B, hMPV/A and hMPV/B Specific NAb

    Serum samples will be collected and the titers of serum neutralization antibodies will be assessed. GMFR is defined as the geometric mean of the ratio of concentration at specified timepoints after vaccination divided by concentration at baseline (Day 0).

    Measured: From Day 0 up to Day 180

  5. GMFR in Serum for RSV and hMPV IgG Prefusion F Protein-specific Antibody Titers

    GMFR is defined as the geometric mean of the ratio of concentration at specified timepoints after vaccination divided by concentration at baseline (Day 0).

    Measured: From Day 0 up to Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2022
  2. Study start21 Sep 2022
  3. Primary completion24 Jan 2024
  4. Study completion24 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05664334
Sponsor's protocol ID
ICVX-12-101
Status last verified
Mar 2024
First submitted
7 Dec 2022
Last updated
5 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IVX-121, IVX-241 and MF59® in people with Healthy, run by Icosavax, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants With Solicited Local Reactions and Systemic AEs (time frame: Within 7 days After the Dose (From Day 0 to Day 6)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05664334.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in