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Virus Therapy

PRIME-2-CoV_Beta for COVID-19 (ORFEUS Trial)

Phase 1
Waitlist Available
Research Sponsored by Speransa Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

ORFEUS Trial Summary

This trial is testing a new vaccine that uses a weakened version of the Orf virus to help protect against the SARS-CoV-2 virus and variants.

Eligible Conditions
  • COVID-19

ORFEUS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants who experience at least one unsolicited Treatment-emergent Adverse Event (TEAE)
Secondary outcome measures
Geometric Mean Concentration (GMC) of SARS-CoV-2-spike and nucleocapsid-protein specific binding antibody levels from baseline to each subsequent time point
Geometric Mean-fold Rise (GMFR) of SARS-CoV-2-specific serum neutralizing titers against ancestral and variant SARS-CoV-2 strains from baseline to each subsequent timepoint
Geometric Mean-fold Rise (GMFR) of SARS-CoV-2-spike and nucleocapsid-protein specific binding antibody levels from baseline to each subsequent time point
+7 more

ORFEUS Trial Design

3Treatment groups
Experimental Treatment
Group I: B-Cohorts: Pre-vaccinated elderlyExperimental Treatment1 Intervention
Elderly participants aged 65-85 years who have been previously vaccinated against COVID-19 with at least two doses of a SARS-CoV-2 mRNA vaccine will be assigned to three groups to receive previously identified doses of PRIME-2-CoV_Beta (two doses, 28 days apart).
Group II: A-Cohorts: SARS-CoV-2 Vaccine-naïveExperimental Treatment1 Intervention
Participants aged 18-55 years who are SARS-CoV-2 vaccine-naïve will receive one preferred dose level of PRIME-2-CoV_Beta that has been identified as optimal in pre-vaccinated A-Cohorts (two doses, 28 days apart).
Group III: A-Cohorts: Pre-vaccinatedExperimental Treatment1 Intervention
Participants aged 18-55 years who have been pre-vaccinated against COVID-19 with at least two doses of a SARS-CoV-2 mRNA vaccine will be assigned to five groups that receive increasing doses of PRIME-2-CoV_Beta (two doses, 28 days apart).

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Speransa TherapeuticsLead Sponsor

Media Library

PRIME-2-CoV_Beta (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05367843 — Phase 1
COVID-19 Research Study Groups: A-Cohorts: Pre-vaccinated, B-Cohorts: Pre-vaccinated elderly, A-Cohorts: SARS-CoV-2 Vaccine-naïve
COVID-19 Clinical Trial 2023: PRIME-2-CoV_Beta Highlights & Side Effects. Trial Name: NCT05367843 — Phase 1
PRIME-2-CoV_Beta (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05367843 — Phase 1
COVID-19 Patient Testimony for trial: Trial Name: NCT05367843 — Phase 1

Frequently Asked Questions

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

How many health institutions are hosting this clinical trial?

"The present medical trail is being conducted across 4 different sites located in Chicago, Kansas City, Fayetteville and other locales. It is therefore imperative to choose a nearby clinic for the trial so that travel burdens can be reduced."

Answered by AI

What is the aggregate figure of participants in this experiment?

"Correct. According to records from clinicaltrials.gov, this medical trial has been recruiting since June 20th 2022 and is still searching for participants today. 144 individuals need to be enrolled across 4 different sites."

Answered by AI

Has PRIME-2-CoV_Beta received the green light from the FDA?

"The safety of PRIME-2-CoV_Beta has been tentatively assessed as a one due to its Phase 1 classification, which implies that there is very little data validating both the efficacy and security of this drug."

Answered by AI

Are researchers recruiting individuals for this research endeavor currently?

"Affirmative. Clinicaltrials.gov records indicate that this experiment, initially posted on June 20th 2022, is currently enrolling volunteers. A total of 144 participants are required from four distinct medical facilities."

Answered by AI

Does this trial permit adults to participate?

"This research project is seeking participants over the age of legal adulthood and before their 85th birthday."

Answered by AI

Am I eligible to participate in this research trial?

"This trial is seeking 144 participants between the ages of 18 and 85 who have contracted covid-19. Those enrolled must satisfy additional requirements, such as being male or female aged between 18 to 55 (A Cohort) or 65 to 85 (B Cohort), having a BMI over 19 kg/m^2 and under 32kg/m^2 with a minimum weight of 50kg at study entry, no recent hospitalization due to an existing medical condition in the 6 weeks prior to enrollment, not working in occupations deemed high risk for exposure to SARS-CoV-2 within cohort A only, no previous vaccination against SARS"

Answered by AI

Who else is applying?

What state do they live in?
Texas
Illinois
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Cedar Health Research - DFW-East
How many prior treatments have patients received?
0

Why did patients apply to this trial?

It's closer and seems to fit.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study Assessing the Safety, Tolerability, Immunogenicity of COVID-19 Vaccine Candidate PRIME-2-CoV_Beta, Orf Virus Expressing SARS-CoV_2 Spike and Nucleocapsid Proteins
2022. "A Study Assessing the Safety, Tolerability, Immunogenicity of COVID-19 Vaccine Candidate PRIME-2-CoV_Beta, Orf Virus Expressing SARS-CoV_2 Spike and Nucleocapsid Proteins". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05367843.
~36 spots leftby Apr 2025
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