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CVXGA1 low dose for Coronavirus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
CoronavirusCVXGA1 low dose - Biological
Eligibility
18 - 55
All Sexes
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Study Summary

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

Eligible Conditions
  • Coronavirus

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Adaptive Dose-finding/Optimization
1
PHV02
1
GAd20-209-FSP, RP2D

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Day 1 to Day 366

Day 1
Adverse Events within 30 min of dosing
Day 1 - 181
Medically Attended Adverse Events
Day 366
Serious adverse events, new-onset chronic medical conditions, and adverse events of special interest
Day 1-29
Unsolicited Adverse Events
Day 1-8
Solicited Adverse Events
Day 29
Body Weight Changes
Percentage of subjects who seroconverted
Serum IgG titers to SARS-CoV-2 S protein

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Adaptive Dose-finding/Optimization
1
PHV02
1
GAd20-209-FSP, RP2D

Trial Design

11 Treatment Groups

Group 2, 1 x 10^7 PFU CVXGA1 in Ages 18-55
1 of 11
Young adult cohort (age 18-55), high dose, no prior COVID vaccine or infection
1 of 11
Group 3, 1 x 10^7 PFU CVXGA1 in Ages 18-55
1 of 11
Group 4, 1 x 10^7 PFU CVXGA1 in Ages 12-17
1 of 11
Group 1, 1 x 10^6 PFU CVXGA1 in Ages 18-55
1 of 11
Young adult cohort (age 18-55), low dose
1 of 11
Older adult cohort (age 56-75), low dose
1 of 11
Young adult cohort (age 18-55), high dose
1 of 11
Older adult cohort (age 56-75), high dose
1 of 11
Young adult cohort (age 18-55), high dose, receipt of prior COVID Pfizer vaccine
1 of 11
Young adult cohort (age 18-55), low dose, no prior COVID vaccine or infection
1 of 11

Experimental Treatment

80 Total Participants · 11 Treatment Groups

Primary Treatment: CVXGA1 low dose · No Placebo Group · Phase 1

Group 2, 1 x 10^7 PFU CVXGA1 in Ages 18-55
Biological
Experimental Group · 1 Intervention: CVXGA1 high dose · Intervention Types: Biological
Young adult cohort (age 18-55), high dose, no prior COVID vaccine or infection
Biological
Experimental Group · 1 Intervention: CVXGA1 high dose · Intervention Types: Biological
Group 3, 1 x 10^7 PFU CVXGA1 in Ages 18-55
Biological
Experimental Group · 1 Intervention: CVXGA1 high dose · Intervention Types: Biological
Group 4, 1 x 10^7 PFU CVXGA1 in Ages 12-17
Biological
Experimental Group · 1 Intervention: CVXGA1 high dose · Intervention Types: Biological
Group 1, 1 x 10^6 PFU CVXGA1 in Ages 18-55
Biological
Experimental Group · 1 Intervention: CVXGA1 low dose · Intervention Types: Biological
Young adult cohort (age 18-55), low dose
Biological
Experimental Group · 1 Intervention: CVXGA1 low dose · Intervention Types: Biological
Older adult cohort (age 56-75), low dose
Biological
Experimental Group · 1 Intervention: CVXGA1 low dose · Intervention Types: Biological
Young adult cohort (age 18-55), high dose
Biological
Experimental Group · 1 Intervention: CVXGA1 high dose · Intervention Types: Biological
Older adult cohort (age 56-75), high dose
Biological
Experimental Group · 1 Intervention: CVXGA1 high dose · Intervention Types: Biological
Young adult cohort (age 18-55), high dose, receipt of prior COVID Pfizer vaccine
Biological
Experimental Group · 1 Intervention: CVXGA1 high dose · Intervention Types: Biological
Young adult cohort (age 18-55), low dose, no prior COVID vaccine or infection
Biological
Experimental Group · 1 Intervention: CVXGA1 low dose · Intervention Types: Biological

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 to day 366

Who is running the clinical trial?

CyanVac LLCLead Sponsor
Paul Spearman, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
3 Previous Clinical Trials
276 Total Patients Enrolled

Eligibility Criteria

Age 18 - 55 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must provide informed consent and assent as applicable prior to initiation of any trial procedures.
You are willing to comply with the trial procedures and be available for all trial visits.
You are between 12 and 55 years of age inclusive at time of enrollment.
You are of childbearing potential and you have not used or have used one or more acceptable forms of contraception.**, ***, **** Note: These criteria are applicable to females in a heterosexual relationship and child-bearing potential (i.e.
Male subjects of childbearing potential: use of condoms to ensure effective contraception with a female partner of childbearing potential from vaccination until 90 days after vaccination
Male subjects agree to refrain from sperm donation from the time of vaccination until 90 days after vaccination.
You are female and agree to refrain from egg donation from time of vaccination until 90 days after vaccination.
References

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