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Virus Therapy
IVX-A12 Vaccine for Older Adults
Phase 2
Waitlist Available
Research Sponsored by Icosavax, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at days 0, 28, 180, and 365 post-vaccination
Summary
This trial tests the safety, side effects, and effectiveness of a vaccine for older adults against RSV and hMPV.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed here, common ones for vaccines include pain at injection site, fatigue, headache, muscle pain, chills or fever. Severe allergic reactions are rare but possible; this trial excludes those with known allergies to any vaccine components.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at days 0, 28, 180, and 365 post-vaccination
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at days 0, 28, 180, and 365 post-vaccination
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
GMT for RSV and hMPV Prefusion F protein-specific IgG Antibodies
Geometric Mean Fold Rise (GMFR) in Serum for Anti-RSV/A, RSV/B, hMPV/A, and hMPV/B-Specific NAb titers
Geometric Mean Fold Rise (GMFR) in Serum for RSV and hMPV Prefusion F Protein-specific IgG Antibodies
Secondary study objectives
GMFR in Serum for Anti-RSV/A, RSV/B, hMPV/A, and hMPV/B-specific NAb and RSV and hMPV Prefusion F Protein-specific IgG Antibodies
GMTs for RSV and hMPV Prefusion F Protein-specific IgG Antibody Titers
Reverse Cumulative Distribution (RCD) Curve of Serum NAb and IgG Antibody Titers
Trial Design
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.
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Who is running the clinical trial?
Icosavax, Inc.Lead Sponsor
2 Previous Clinical Trials
283 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am considered frail based on a specific health score.I can provide ID and stay in touch with the trial staff throughout the study.I haven't had any RSV or hMPV vaccine in the last year.I am currently sick, with or without a fever.I haven't had treatments like immunoglobulins or biologics in the last 3 months.I am in stable health as determined by my doctor.I have had cancer other than the specified types in the last 5 years.I am in good health as confirmed by recent medical exams.I haven't had a COVID-19 vaccine in the 3 weeks before starting or will wait until after Day 28 of the study to get one.I agree not to donate blood from the time I get vaccinated until three months after.I have moderate or severe liver disease, a spreading tumor, or AIDS.I am a woman who cannot become pregnant or do not plan to become pregnant.I haven't had any vaccines in the last 14 days, or live vaccines in the last 30 days.I can provide ID and stay in touch with the trial staff throughout the study.My immune system is weakened due to recent treatments like steroids or chemotherapy.I have received all my vaccines after the Day 28 visit.I cannot become pregnant due to menopause, surgery, or other reasons.
Research Study Groups:
This trial has the following groups:- Group 1: IVX-A12 Vaccine Formulation 1
- Group 2: IVX-A12 Vaccine Formulation 2
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.