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

No Placebo-Only Group

Summary

This trial tests a new COVID-19 vaccine that uses a weakened virus to help the body recognize and fight the coronavirus. It targets healthy adults who have been vaccinated, a small group of unvaccinated adults, and elderly adults who have been vaccinated. The vaccine works by teaching the immune system to recognize and fight the coronavirus.

Eligible Conditions

COVID-19

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Number of participants with solicited local reactions at the injection site

Number of participants with solicited systemic reactions

Recommended Phase 2 Dose (RP2D) of PRIME-2-CoV_Beta

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

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