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Aerosolized Adenovirus COVID-19 Vaccines for COVID-19
Study Summary
This trial will test two different experimental coronavirus vaccines to see if they are safe and if they create an immune response in the blood and lungs.
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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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Media Library
- I've had blood clots and low platelet counts after a vaccination.I have never received an experimental adenovirus vaccine through inhalation.You have breathing tests that show significant abnormalities, such as low lung capacity or difficulty moving air in and out of your lungs.You had a very bad reaction to a previous COVID vaccine, such as hives, trouble breathing, swelling, high fever, or a seizure.I am between 18 and 65 years old and healthy.I am not pregnant and will use two forms of birth control during the study.I have a lung condition like asthma or COPD that needs regular treatment.I do not have any health conditions that prevent me from undergoing a bronchoscopy.I have used inhaled drugs before but stopped smoking marijuana over a year ago and agree not to start again during the study.I have had blood clots in my brain with low platelet counts.I have had myocarditis or pericarditis in the past.You have any abnormal findings on a chest x-ray that suggest a serious lung condition.I have received three doses of an mRNA COVID vaccine over 3 months ago.I have never had COVID or had it over 6 months ago with proof.You do not have the HIV virus.I have received three doses of an mRNA COVID vaccine over 3 months ago.I currently smoke cigarettes or e-cigarettes, or I quit less than a year ago.I have a bleeding disorder or am on medication that could increase my risk of bleeding.I can follow study rules and attend all required visits.I have had Bell's Palsy in the past.You have had a condition called heparin-induced thrombocytopenia in the past.You do not have HIV.I am not pregnant and will use two forms of birth control during the study.I can follow study rules and attend all required visits.I am between 18 and 65 years old and healthy.I will use barrier contraception throughout the study.I have received an adenoviral COVID-19 vaccine like AstraZeneca.I was hospitalized due to COVID.You have allergies to ingredients in the vaccine.I am not on any treatments that weaken my immune system, including inhaled or nasal steroids.I will use barrier methods of contraception throughout the study.
- Group 1: Aerosol ChAd-tri-CoV/Mac dose level 10e5
- Group 2: Aerosol Ad5-triCoV/Mac dose level 10e7
- Group 3: Aerosol Ad5-triCoV/Mac dose level 10e5
- Group 4: Aerosol Ad5-triCoV/Mac dose level 10e6
- Group 5: Aerosol ChAd-triCoV/Mac dose level 1x10e8
- Group 6: Aerosol ChAd-triCoV/Mac dose level 10e7
- Group 7: Aerosol ChAd-triCoV/Mac dose level 10e6
- Group 8: Aerosol Ad5-triCoV/Mac dose level 3x10e7
- Group 9: Aerosol ChAd-triCoV/Mac dose level 6x10e7
- 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
Are geriatric patients being admitted to this experiment?
"The age range for enrollment in this medical study is 18-65 years old, as stipulated by the trial's inclusion criteria."
What aims does this clinical trial seek to accomplish?
"The primary objective of this 48-week trial is to assess adverse events and their intensity following ChAd-triCoV/Mac vaccination. Secondary analyses will determine correlations between antibodies in saliva, bronchioalveolar lavage (BAL) fluid, and serum, immunogenicity of the vaccine administered through aerosol delivery systems, and how pre-existing adenovirus immunity impacts immune responses after receiving Ad5-triCoV/Mac or ChAd-triCoV/Mac."
What prospective hazards does Ad5-triCoV/Mac pose to individuals?
"Due to the limited amount of safety and efficacy data available for Ad5-triCoV/Mac, our Power team assigned it a score of 1."
Are there any open opportunities for individuals to join this clinical research?
"Affirmative. Clinicaltrials.gov data reveals that the medical experiment, which was first published on March 1st 2022, is presently recruiting participants. 30 individuals are required to take part in this trial at a single research site."
What is the maximum number of participants accepted into this research project?
"Affirmative. According to clinicaltrials.gov, this test is presently recruiting participants as of October 8th, 2022. It was initially uploaded on March 1st and expected 30 patients at one facility."
Could I be included in this trial?
"This clinical trial is recruiting a cohort of 30 individuals infected with COVID-19, aged between 18 and 65. Moreover, to be eligible for the study participants must fulfill additional criteria: Women will need to take a pregnancy test and use two approved forms of contraception throughout; HIV antibody negative; Capable of understanding the protocol requirements as well as attending planned visits and completing necessary tests; Men required to utilize barrier contraception during the course of this research project.; Healthy human subjects within an age range from 18 to 65 years old., Must have completed their vaccine series with 3 doses or more at least three months prior."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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