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Intranasal COVID Vaccine for COVID-19
Study Summary
This trial evaluates the effect of a single intranasal dose of CVXGA1 to see if it can protect against SARS-CoV-2. It includes 400 healthy participants aged 18-55 who will complete 4 clinic visits & 1 follow-up call.
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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- You have a condition that affects your memory or thinking, which might make it hard for you to understand the clinical trial or follow the rules.I haven't taken immune-suppressing drugs for more than 2 weeks in the last 6 months.I haven't used any nasal medications 7 days before or plan to use them within 28 days after getting the trial vaccine.I have not received immunoglobulin or blood products in the last 3 months.I agree not to donate eggs for 90 days after getting vaccinated.I had a severe case of COVID-19 that required oxygen or ventilator support.I am not in another study and haven't received any experimental treatments in the last 28 days.I have not had any vaccines 14 days before or plan to within 14 days after the study vaccine.You live with someone who has a very weak immune system.I have had heart inflammation, Kawasaki disease, or multisystem inflammatory syndrome.I tested positive for COVID-19 less than 150 days before the planned vaccine date.I have or had a condition that weakens my immune system.You had a serious allergic reaction or needed medical help after getting a vaccine.I do not have any planned hospital stays that could interfere with the study visits.I have had severe wheezing or breathing issues that required hospitalization.I plan to use nasal irrigation, like a Neti Pot, after joining the trial.I am using or willing to use birth control or practice abstinence.I received a COVID vaccine less than 150 days ago or plan to within the next 6 months.I do not have advanced liver or kidney diseases.I have not been sick or had a fever in the last 72 hours.You are currently struggling with alcohol or illegal drug problems.I am between 18 and 80 years old.I have taken a pregnancy test and it was negative within the last 24 hours before each vaccination.I have advanced HIV, active Hepatitis B, or tested positive for Hepatitis C.I have had chemotherapy, immunotherapy, or radiation within the last 6 months.I have previously received a PIV5-based vaccine.I have a nasal condition that could affect vaccine delivery.I am a man who can father children and will use condoms for 90 days after vaccination. My female partner will also use birth control.I have a bleeding disorder or bleed easily with injections or blood draws.I agree not to donate sperm from vaccination until 90 days after.I haven't received COVID-19 antibody treatments in the last 150 days.You smoke or vape now, or have smoked or vaped regularly in the past two years.
- Group 1: CVXGA
- Group 2: Placebo
- 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
To what extent could exposure to CVXGA1 be hazardous?
"Our team at Power have assigned CVXGA1 a safety score of 2 due to the Phase 2 nature of this trial, which indicates there are some data points supporting its protection but none conclusively proving efficacy."
Are octogenarians being recruited for this trial?
"Candidates aged 18 to 55 are eligible for this clinical trial. Separately, there exist 115 studies that cater exclusively to minors and 717 trials aimed at seniors over the age of 65."
What is the size of the cohort participating in this investigation?
"Affirmative, clinicaltrials.gov data suggest this trial is now recruiting participants. This research endeavour was initially posted on June 30th 2023 and the latest update happened around the same time. 400 patients need to be recruited from a single site for successful completion of the study."
Are there any vacancies still available for enrolment in this clinical trial?
"The clinical trial, posted on June 30th 2023 and updated recently on the same date, is actively seeking participants."
Can I partake in this clinical trial?
"This clinical trial seeks to recruit 400 individuals aged 18-55 who are infected with coronavirus. The participants must meet a range of criteria, such as using at least one form of primary contraception for 28 days prior and 90 days after vaccination; male subjects being required to use condoms if in a heterosexual relationship; postmenopausal women or those surgically sterile not needing contraceptive measures; and males refraining from sperm donation during the study period. Furthermore, all potential recruits must be willing and able comply with scheduled visits, vaccinations plans, laboratory tests, etcetera."
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