ORFEUS Clinical Study | Speransa Therapeutics

A Study evaluating the Safety, Tolerability, and Immunogenicity of PRIME-CoV-2_Beta in healthy Adults

ORFEUS is a Phase 1 dose-finding study assessing the safety, tolerability and immunogenicity of a two-dose regimen (28 days apart) of Prime-2-CoV_Beta, administered by intramuscular injection in adult participants. All participants receive two vaccinations four weeks apart and will be medically monitored after each vaccination.

Who qualifies ?

To be eligible to participate in the study :

You must

Be between 18 and 55 years OR between 65 and 85 years

Be in good, stable health

Have a body mass index between 19 and 30 kg/m2

Be unvaccinated OR vaccinated with Pfizer/BioNTech vaccine Comirnaty

Agree to use highly effective contraception during participation, if applicable

You must not

Be currently taking any medications to prevent or treat COVID-19

Have participated in another interventional clinical study within the past month

Have a current diagnosis of COVID-19 or have tested positive for SARS-CoV-2 before the first vaccination

Have known hypersensitivity against a vaccine and/or any component of the study vaccine

Pregnant and/or nursing women

For additional In- and Exclusion Critera, visit www.clinicaltrials.gov

Up to 144 Participants, three Cohorts

18-55 years old

vaccinated*

Up to 60 participants
(5 groups of 12)

65-85 years old

vaccinated*

Up to 24 participants
(2 groups of 12)

18-55 years old

not vaccinated

Up to 60 participants
(5 groups of 12)

* Have received at least 2 doses of a SARS-CoV-2 mRNA vaccine at least 3 months before

The ORFEUS Clinical Study will have three Cohorts examining different Doses of PRIME-2-Cov_Beta:

Cohort 1: participants aged 18-55 years who have previously received at least two doses of a SARS-CoV-2 mRNA vaccine (e.g. BioNTech/Comirnaty and/or Moderna/Spikevax) at least 3 months before will be assigned to groups of 12 to receive two doses (28 days apart) of the PRIME-2-CoV_Beta vaccine.
Cohort 2: participants aged 65-85 years who have previously received at least two doses of a SARS-CoV-2 mRNA vaccine (e.g. BioNTech/Comirnaty and/or Moderna/Spikevax) at least 3 months before will be assigned to groups of 12 to receive two doses (28 days apart) of the PRIME-2-CoV_Beta vaccine.
Cohort 3: participants aged 18-55 years who have not received any COVID-19 vaccine will be assigned to groups of 12 to receive two doses (28 days apart) of the PRIME-2-CoV_Beta vaccine.

Course of the study

2 vaccinations, 28 days apart

Participants will recieve two injection of PRIME-2-CoV_Beta 28 days apart (Treatment Visits on Day 1 and Day 29). Participants undego on-iste observation for 6 or 1 hour, respectively, after vaccination.

Up to 9 visits and 3 phone calls

Participants will be asked to return to the study site seven days after the first and 14 days after each injection, and then two months, three months, and 6 months after the first injection. In addition, two follow up phone calls will take place 9 and 12 months after the first injection.

Study related procedures

During these study site visits, participants will undergo study related procedures such as blood draws for safety lab and immune response

Learn more about the trial here