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Intranasal COVID-19 Vaccine for Coronavirus (CVXGA1-001 Trial)
CVXGA1-001 Trial Summary
This trial is testing a new, safe vaccine for adults and adolescents.
CVXGA1-001 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCVXGA1-001 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CVXGA1-001 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?
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- You are in overall good health.You have tested positive for hepatitis B, hepatitis C, or HIV.You have taken part in a research study for preventing or treating COVID-19 before, unless you are in Groups 3 or 4.You have a serious medical or mental health condition.Your oral temperature is between 97.0°F and less than 100.4°F.You have been taking certain medications for a long time that might weaken your immune system.If you are currently working in a job where you might be at high risk of being exposed to the SARS-CoV-2 virus.You have a high risk of getting very sick from COVID-19, or you have a medical condition that makes it unsafe for you to take part in the trial.You are expected to need medication that weakens your immune system in the next 6 months.You are not able to walk.You do not have the COVID-19 virus at the time of screening.You have any long-term liver disease, including fatty liver.Your body mass index (BMI) should be less than 40.0 (or less than 35.0 if you have health problems related to obesity) and you must weigh at least 31 kilograms.People between 12 and 55 years old who are not at high risk of being exposed to the SARS-CoV-2 virus and are not pregnant.Your heart beats less than 100 times per minute.Your systolic blood pressure is between 85 and 150 mmHg.Your diastolic blood pressure is lower than 95 mmHg.Your lab test results are within the normal range.You are currently taking experimental medications to prevent COVID-19.You have been in close contact with someone who has had a SARS-CoV-2 infection within 14 days before receiving the study vaccine.You are pregnant and have a positive pregnancy test.You have been drinking a lot of alcohol or using drugs for fun in the 6 months before getting the vaccine.If you are in Groups 3 or 4, you need to have received at least two doses of the COVID mRNA vaccine at least 5 months before getting the CVXGA1 vaccine, and you should not have received any other COVID vaccines.You have received immunoglobulins, blood, or blood products within the 4 months before the vaccine or at any time during the trial.You have a serious blood disorder or clotting problem.You have been diagnosed with COVID-19 in the past.You have been sick with a new illness in the three days before the vaccination.You have had or are planning to get a certain type of vaccine within 2 weeks before or after the study.You have received a COVID-19 vaccine or plan to get one within 6 months after getting the study vaccine.
- Group 1: Group 4, 1 x 10^7 PFU CVXGA1 in Ages 12-17
- Group 2: Group 3, 1 x 10^7 PFU CVXGA1 in Ages 18-55
- Group 3: Group 1, 1 x 10^6 PFU CVXGA1 in Ages 18-55
- Group 4: Group 2, 1 x 10^7 PFU CVXGA1 in Ages 18-55
- 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
Is this scientific experiment inviting participants at the moment?
"According to the information published on clinicaltrials.gov, this research is currently recruiting suitable participants. This trial was first made available for enrollment on August 6th 2021 and has been recently revised as of August 16th 2022."
Is the high dosage form of CVXGA1 approved by the FDA?
"Due to limited data on the safety and efficacy of CVXGA1 high dose, this experimental drug was assigned a score of 1."
What aims are being sought through this clinical experiment?
"This clinical trial aims to assess Solicited Adverse Events over a period of 29 days. Secondary objectives include tracking changes in IgG titers for the SARS-CoV-2 spike protein (GMFR), Serious adverse events, new chronic medical conditions, and AEs of Special Interests (AESIs). Additionally, investigators will monitor any Adverse Events that occur within 30 minutes post-dosing."
Is it possible to join this medical experiment?
"This clinical trial seeks to enrol 80 individuals aged 18-55 who have been diagnosed with COVID-19. Participation entails providing informed consent and assent, adhering to specified procedures, agreeing to the collection of blood samples, having a BMI below 40 kg/m2 (or 35 if obesity is present), being free from high risk exposure scenarios for SARS-CoV2 and weighing at least 31kg; additionally women in heterosexual relationships must use contraception or practice abstinence while males must use double barrier methods such as condoms until 90 days post vaccination. Moreover, male participants are asked not donate sperm within this timeframe whereas female participants should refrain"
How many sites are actively managing this research?
"This trial is also running in other locations such as Kentucky Pediatric/ Adult Research in Bardstown, Research Your Health in Plano and University of Rochester Medical Center."
Can subjects aged 30 or above participate in this exploration?
"For participation in this clinical trial, participants must be between the ages of 18 and 55 years old."
Did prior investigations include a high dosage of CVXGA1?
"Presently, there are 12 clinical trials being conducted to investigate the efficacy of CVXGA1 high dose. Of these, 5 are currently in Phase 3. These investigations span from Miami, Florida across 108 different sites worldwide."
How many participants have been recruited for this clinical experiment?
"The clinical trial necessitates 80 qualified individuals. Conveniently, Kentucky Pediatric/ Adult Research in Bardstown and Research Your Health in Plano are both recruiting patients for the study."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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