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BPL-1357 Vaccine for Flu
Study Summary
This trial is testing if a new flu vaccine is safe and if it creates an immune response. Healthy adults ages 18-55 who do not smoke may be eligible. Participation involves 9 visits over 7 months and may include receiving a combination of study vaccine and/or placebo, both as a shot and as a spray, and taking daily temperature readings and completing online surveys.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
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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- I do not smoke or use vape/e-cigarette products.I am infertile due to menopause, hysterectomy, or oophorectomy.I haven't had a COVID-19 vaccine in the last 4 weeks and won't get one after the V2D28 visit.I have serious health issues or a very high or low body weight.I am between 18 and 55 years old.I agree to not have sexual intercourse.I haven't had a flu shot in the last 8 weeks and agree not to get one until after the V2D56 visit.I am between 18 and 55 years old.I haven't had a COVID-19 vaccine in the last 4 weeks and won't get one until after V2D28.I do not smoke or use vape/e-cigarette products.I haven't taken any experimental drugs recently.I am not pregnant or breastfeeding and follow specific guidelines regarding not becoming pregnant.I have had COVID-19 and still experience symptoms.I have not received any blood or blood products in the last 3 months.I haven't had a flu shot in the last 8 weeks and won't get one until after the V2D56 visit.You are allergic to lidocaine or phenylephrine.I haven't received any experimental vaccines in the last 6 months, except for COVID-19 shots.You have had issues with alcohol or drug abuse in the past six months, or have tested positive for drugs in your urine before the study.You do not have HIV and had a negative test in the past 60 days.I haven't taken certain medications in the last 14 days and agree not to use them during the study.You have a history of swelling or severe allergic reactions.
- Group 1: Group A
- Group 2: Group B
- Group 3: Group C
- 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
Does this clinical trial include individuals over the age of seventy-five in its scope?
"This research is accepting patients between the age of 18 and 55."
What risks have been associated with the administration of BPL-1357?
"Due to the limited data in regards to both safety and efficacy, BPL-1357 was given a score of 1 on Power's scale."
What are the desired outcomes of this investigation?
"This clinical trial seeks to evaluate Adverse events over the V2D28 time frame. Secondary objectives include investigating Safety: Serious Adverse Events, determined through Type of SAEs up until day V2D182, and Systemic and mucosal immune responses defined by Antibodies against N1, N3, N8, and N9 as measured by NAI or ELISA from blood/mucosa samples on day V2D28."
Are there certain criteria that make a subject especially suitable for this experiment?
"In order to qualify for this medical trial, participants must be diagnosed with the flu, abide by age restrictions (18-55), and there are only 45 openings available."
Are there open slots for participation in this trial?
"Affirmative, the information shared on clinicaltrials.gov shows that this research is actively looking for participants. The study was first published on June 27th 2022 and the last update happened on August 4th 2022; 45 patients are needed to be recruited from one medical site only."
What is the cap of participants in this clinical trial?
"Affirmative. According to the clinicaltrials.gov website, this research endeavor is currently recruiting participants and was initially posted on June 27th 2022 with a subsequent update being issued on August 4th of 2022. 45 individuals are expected to be enrolled from a single medical centre."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
What site did they apply to?
How many prior treatments have patients received?
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