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JYNNEOS Dosing Strategies for Monkeypox
Study Summary
This trial will compare two lower doses of the MVA-BN vaccine given intradermally to the standard dose given subcutaneously in order to see if there is a non-inferior response in terms of humoral immunity.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2014 Phase 3 trial • 4005 Patients • NCT01144637Trial Design
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Who is running the clinical trial?
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- I haven't taken any immunosuppressing drugs in the last 4 weeks.I have been vaccinated against smallpox or monkeypox.I am between 18 and 50 years old.I haven't had and won't get a live vaccine around the time of my trial participation.I am HIV positive, on ART for 6+ months, CD4 count >350, no AIDS illness in the last year.My chronic condition has been stable without needing new treatments or hospital visits in the last month.
- Group 1: Arm 1
- Group 2: Arm 2
- Group 3: Arm 3
- 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
How many subjects are participating in this experiment?
"A total of 210 compliant patients are necessary to complete the trial. Individuals can join from various sites, such as The GW Vaccine Research Unit in Washington DC and Baylor College of Medicine-Vaccine Research Center in Houston tx."
Does this trial include individuals younger than fifty years of age?
"Patients aged 18 to 50 must meet the eligibility requirements for this clinical trial. Additionally, there are 3 trials designed specifically for those under 18 years old and 6 which focus on elderly individuals over 65."
What criteria should be used to determine eligibility for this experiment?
"The requirements for eligibility in this monkeypox trial are a verified diagnosis as well as ages between 18 and 50. Currently, 210 patients have been accepted into the study."
What hazards have been observed in connection to JYNNEOS usage?
"Our analysis at Power gave JYNNEOS a score of 2, as clinical trials are only in Phase 2, indicating that while data exists to support the drug's safety there is no evidence yet affirming its efficacy."
Is this experiment presently welcomed to participants?
"Per the information provided on clinicaltrials.gov, this trial is currently enrolling patients. It was posted to the website on September 7th 2022 and updated lastly on November 23rd of the same year."
In what quantity of healthcare facilities is this clinical trial currently being conducted?
"This trial is open for recruitment at 16 different sites, such as The GW Vaccine Research Unit in Washington D.C., Baylor College of Medicine-Vaccine Research Center in Houston and the Hope Clinic of Emory University in Decatur, among others."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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