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MVA-BN-RSV vaccine for Respiratory Syncytial Virus
Study Summary
This trial is testing a new vaccine for RSV, a respiratory virus, in adults age 60 and up. The study is comparing the new vaccine to a placebo to see if it is effective and safe.
- Respiratory Syncytial Virus (RSV)
- Respiratory Syncytial Virus
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You are not currently suffering from a life-limiting or debilitating disease.You have some long-term medical conditions such as heart disease, lung disease, high blood pressure, diabetes, high cholesterol, or underactive thyroid, but they are not causing major problems and are stable according to your doctor.You are at least 60 years of age.\nYou have been drinking too much alcohol regularly or recently (within the past 6 months).You are willing and able to use an application on a personal device (i.e., smartphone, tablet, etc.) or a provisioned device to record solicited events and record all per protocol required data during the surveillance period.You have a condition that affects your immune system, like chronic inflammatory bowel disorders.You have a history of severe allergic reactions or allergies to any of the ingredients in the vaccine, such as eggs or certain medications.
- Group 1: Group 2: Single dose Placebo
- Group 2: Group 1: Single dose MVA-BN-RSV
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What is the status of MVA-BN-RSV vaccine in terms of FDA approval?
"The MVA-BN-RSV vaccine's safety is estimated to be a 3. This is due to the fact that it is a Phase 3 trial, meaning that there is data which suggests that the vaccine is effective as well as multiple rounds of data which support the vaccine's safety."
At how many sites is this research being conducted?
"98 research sites are currently operational for this trial. A few notable locations include Accellacare - Raleigh Medical Group in Raleigh, DM Clinical Research in Philadelphia, and Tucson Neuroscience Research, LLC in Tucson."
How many individuals are taking part in this clinical research?
"That is correct. The website clinicaltrials.gov has the most recent information on this clinical trial, which as of right now is seeking 20000 participants. The trial was first posted on April 19th, 2022 and was last updated on October 8th, 2022. There are 98 locations where this trial is taking place."
Are there any available positions for patients in this clinical trial?
"That is correct, the listing on clinicaltrials.gov does show that the trial is looking for more patients. The start date for the posting was April 19th, 2022 and the most recent update was on October 28th, 2022. They are hoping to enroll 20000 people at 98 different sites."
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What portion of applicants met pre-screening criteria?
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