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Virus Therapy

Intranasal COVID-19 Vaccine for Coronavirus (CVXGA1-001 Trial)

Phase 1
Waitlist Available
Led By Paul Spearman, MD
Research Sponsored by CyanVac LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy male or non-pregnant female between 12 and 55 years of age inclusive at time of enrollment who are not at high risk of SARS-CoV-2 exposure
For Groups 3 and 4 only, documented receipt of at least two-doses of COVID mRNA vaccine with the last dose at least 5 months prior to planned dosing of CVXGA1, and without receipt of any other COVID vaccines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 366
Awards & highlights

CVXGA1-001 Trial Summary

This trial is testing a new, safe vaccine for adults and adolescents.

Who is the study for?
Healthy individuals aged 12-55, not at high risk for COVID-19, with normal temperature and blood pressure. Must be seronegative to SARS-CoV-2, have a BMI <40 kg/m^2 (or <35 with health conditions), and agree to use contraception. Excludes those with certain medical conditions or treatments that affect the immune system, recent drug abuse, or participation in other SARS-CoV-2 trials.Check my eligibility
What is being tested?
The trial is testing two doses of an intranasal COVID-19 vaccine called CVXGA1 for safety and immune response. Participants will receive one dose at either a low (10^6 PFU) or high (10^7 PFU) level and will be monitored for their body's defense against the virus.See study design
What are the potential side effects?
Possible side effects may include reactions where the vaccine was given, like sneezing or a runny nose; general symptoms such as headache or fatigue; allergic reactions; and potentially others as it's still being studied.

CVXGA1-001 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.
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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.

CVXGA1-001 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 366
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 366 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Solicited Adverse Events
Unsolicited Adverse Events
Secondary outcome measures
Adverse Events within 30 min of dosing
Body Weight Changes
Medically Attended Adverse Events
+3 more

CVXGA1-001 Trial Design

4Treatment groups
Experimental Treatment
Group I: Group 4, 1 x 10^7 PFU CVXGA1 in Ages 12-17Experimental Treatment1 Intervention
Group 4 (Adolescents aged 12-17 years - CVXGA1 - High Dose, prior receipt of two or more doses of COVID mRNA vaccine (Pfizer Comirnaty® or Moderna Spikevax™) at least 5 months prior to study enrollment. Prior COVID infection allowed if occuring at least 5 months prior to study enrollment.
Group II: Group 3, 1 x 10^7 PFU CVXGA1 in Ages 18-55Experimental Treatment1 Intervention
Group 3 (Young adults aged 18-55 years - CVXGA1 - High Dose, prior receipt of two or more doses of COVID mRNA vaccine (Pfizer Comirnaty® or Moderna Spikevax™) at least 5 months prior to study enrollment. Prior COVID infection allowed if occurring at least 5 months prior to study enrollment).
Group III: Group 2, 1 x 10^7 PFU CVXGA1 in Ages 18-55Experimental Treatment1 Intervention
Group 2 (Young adults aged 18 to 55 years - CVXGA1- High Dose, no prior COVID vaccine, no prior COVID vaccine or infection allowed if occurring at least 5 months prior to enrollment)
Group IV: Group 1, 1 x 10^6 PFU CVXGA1 in Ages 18-55Experimental Treatment1 Intervention
Group 1 (Young adults aged 18 to 55 years - CVXGA1- Low Dose, no prior COVID vaccine or infection)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CVXGA1 low dose
2021
Completed Phase 1
~80
CVXGA1 high dose
2021
Completed Phase 1
~80

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

CyanVac LLCLead Sponsor
1 Previous Clinical Trials
227 Total Patients Enrolled
Paul Spearman, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
4 Previous Clinical Trials
490 Total Patients Enrolled

Media Library

CVXGA1 high dose (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04954287 — Phase 1
Coronavirus Research Study Groups: Group 4, 1 x 10^7 PFU CVXGA1 in Ages 12-17, Group 3, 1 x 10^7 PFU CVXGA1 in Ages 18-55, Group 1, 1 x 10^6 PFU CVXGA1 in Ages 18-55, Group 2, 1 x 10^7 PFU CVXGA1 in Ages 18-55
Coronavirus Clinical Trial 2023: CVXGA1 high dose Highlights & Side Effects. Trial Name: NCT04954287 — Phase 1
CVXGA1 high dose (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04954287 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Cincinnati Children's Hospital Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
~20 spots leftby Mar 2025