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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
Awards & highlights
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
+5 moreSecondary outcome measures
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
GMTs for RSV/A, RSV/B, hMPV/A, and hMPV/B-specific NAb
+8 moreTrial 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
1 Previous Clinical Trials
140 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the ideal qualifications for participants of this trial?
"To meet the requirements for this research, volunteers must be aged between 60-85 years and possess a good state of health. There are currently 250 participants being sought after by the clinical trial."
Answered by AI
Is this research endeavor accepting participants over 45 years of age?
"This experiment requires that participants are between 60 and 85 years of age. For those under 18, there's 55 trials available to them while 378 are open for individuals over 65."
Answered by AI
How many areas within this state are conducting the clinical trial?
"This trial is currently open at 10 sites, such as Hollywood, Stockbridge and Meridian. Select the closest location to you for reduced travelling if you choose to take part in this study."
Answered by AI
Is sign-up available for this medical experiment?
"According to current information hosted on clinicaltrials.gov, this trial continues to seek out participants for the study which was initially posted on May 15th 2023 and most recently updated June 5th, 2023."
Answered by AI
Has the first version of IVX-A12 Vaccine been given regulatory clearance by the FDA?
"Our team at Power evaluated the safety of IVX-A12 Vaccine Formulation 1 as a 2, due to Phase 2 trial results which have generated some evidence for protection but none in terms of efficacy."
Answered by AI
Who else is applying?
What site did they apply to?
AMR Phoenix
Cenexel RCA
Other
Johnson City Clin-Trials (JCCT)
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
To help with new studies. Doing studies helps create the best treatments. i am a heathy 80 year old that has a history of testing drugs at JCCT.
PatientReceived 1 prior treatment
I enjoy being on clinical trials to help further research and they also supplement my income.
PatientReceived 1 prior treatment
I was in a RSV vaccine trial a few years ago. I haven't gotten the current vaccine so I thought this was a chance to get it and help science.
PatientReceived 2+ prior treatments
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