Respiratory Syncytial Virus Immunization study: RSV+HMPV vaccine
Official title Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older
ClinicalTrials.gov ID: NCT07734649
What this study is testing
What is RSV+HMPV vaccine?
This is an investigational vaccine being studied to see if it can help prevent RSV and HMPV infections in adults 60 and older. It is designed to teach your immune system to recognize and fight RSV and HMPV viruses.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a new vaccine works and is safe. It checks how well it protects against RSV and HMPV.
- Who it's for
- You may be able to join if you are a healthy adult aged 60 or older.
- What's involved
- You would get a shot or a pretend treatment. You would also have blood tests to check your immune response.
- Time commitment
- The study lasts about 12 months with several visits to the clinic.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older. Healthy volunteers may be eligible.
You may be able to join if
- Aged 60 years or older on the day of inclusion
- Non-childbearing potential (ie, post-menopausal for at least 1 year or surgically sterile)
You likely can't join if
- History of laboratory-confirmed RSV and/or laboratory-confirmed HMPV infection affecting the participant and/or the participant's household in the...
- Previous history of myocarditis, pericarditis, and/or myopericarditis
- Screening electrocardiogram (ECG) that is consistent with possible myocarditis, pericarditis, and/or myopericarditis or, in the opinion of the...
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- Previous history of Guillain-Barré Syndrome
- Any vaccine given 4 weeks before or 4 weeks after study intervention
See the full eligibility criteria
- Aged 60 years or older on the day of inclusion
- Non-childbearing potential (ie, post-menopausal for at least 1 year or surgically sterile)
- History of laboratory-confirmed RSV and/or laboratory-confirmed HMPV infection affecting the participant and/or the participant's household in the previous 12 months
- Previous history of myocarditis, pericarditis, and/or myopericarditis
- Screening electrocardiogram (ECG) that is consistent with possible myocarditis, pericarditis, and/or myopericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect...
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- Previous history of Guillain-Barré Syndrome
- Any vaccine given 4 weeks before or 4 weeks after study intervention
- Previous vaccination against RSV and/or HMPV with an investigational or marketed vaccine
- Receipt of any mRNA vaccine/product in the 2 months preceding study intervention administration
- Has received a blood transfusion or blood-derived products, including immunoglobulins, in the past 3 months
- Any screening laboratory parameter with laboratory abnormality \> Grade 1 or deemed clinically significant by the investigator
The study team makes the final eligibility decision.
Where it is enrolling
- Gadsden, Alabama, United States
- Vestavia Hills, Alabama, United States
- Huntington Beach, California, United States
- La Mesa, California, United States
- Long Beach, California, United States
- San Diego, California, United States
- Washington D.C., District of Columbia, United States
- DeLand, Florida, United States
- Edgewater, Florida, United States
- Lakeland, Florida, United States
- Largo, Florida, United States
- Maitland, Florida, United States
- Palmetto Bay, Florida, United States
- Decatur, Georgia, United States
- Woodstock, Georgia, United States
- Melrose Park, Illinois, United States
- Peoria, Illinois, United States
- Indianapolis, Indiana, United States
- New Orleans, Louisiana, United States
- Boston, Massachusetts, United States
+ 26 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Gadsden, Alabama, United States; Vestavia Hills, Alabama, United States; Huntington Beach, California, United States; La Mesa, California, United States; Long Beach, California, United States; San Diego, California, United States and 40 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.