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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
~35 spots leftby May 2025
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