Status:
TERMINATED
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
Lead Sponsor:
Speransa Therapeutics
Conditions:
SARS-CoV-2 Infection
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
PRIME-2-CoV\_Beta is the first clinical candidate based on the attenuated 2nd generation Orf virus (ORFV) vaccine platform which encodes for the structural spike (S)- and nucleocapsid (N) protein of S...
Detailed Description
The Phase 1 dose-finding study (ORFEUS) will assess the safety, tolerability and immunogenicity of a two-dose regimen (28-days apart) of PRIME-2-CoV\_Beta administered by intramuscular (IM) route in a...
Eligibility Criteria
Inclusion
- Male or female participants between the ages of 18 and 55 years, (A-cohorts), and 65 and 85 years (B-cohorts), inclusive at study entry.
- Body mass index (BMI) over 19 kg/m\^2 and under 32 kg/m\^2 and weight at least 50 kg at study entry.
- Healthy participants who are determined by medical history, physical examination, and clinical judgment of the Investigator to be eligible for inclusion in the study.
- Note: Healthy participants may have stable pre-existing disease defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment.
- Able to give personal signed informed consent and willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures.
- Participants must agree not to be vaccinated with any SARS-CoV-2 vaccine, starting after Visit 0 and continuously until 6 months after receiving the first study immunization.
- Participants who have previously received at least two vaccinations with a licensed SARS-CoV-2 mRNA vaccine (Spikevax/Moderna and/or Comirnaty/Pfizer administered as two-dose primary series with or without booster vaccination\[s\]) with the last vaccination having occurred at least 3 months prior.
- Participants who are SARS-CoV-2 vaccine-naïve (applies to vaccine-naïve group of Cohort A only):
- Currently not working in occupations with high risk of exposure to SARS-CoV-2 (e.g., healthcare worker, emergency response personnel) (vaccine-naïve group of Cohort A only).
- No previous vaccination with any SARS-CoV-2 vaccine (vaccine-naïve group of Cohort A only).
- If the participant is a woman of child bearing potential (WOCBP) must:
- have a negative beta-human chorionic gonadotropin (hCG)-urine test at Visit 0 and Visit 1.
- agree to practice a highly effective form of contraception for at least 14 days prior to study vaccination and continuously until a minimum of 28 days after receiving the last immunization.
- agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study, starting after Visit 0 and continuously until 28 days after receiving the last immunization.
- Note: Women that are postmenopausal or permanently sterilized will be considered as not having reproductive potential.
- Men who are sexually active with a WOCBP and have not had a vasectomy must agree to practice a highly effective form of contraception with their female partner during the study, starting from Visit 1 (pre-dose) and continuously until a minimum of 28 days after receiving the last immunization.
- Men must be willing to refrain from sperm donation, starting from Visit 1 (pre-dose) and continuously until a minimum of 28 days after receiving the last immunization.
Exclusion
- SARS-CoV-2 nucleic acid amplification test (NAAT)-positive pharyngeal swab within 24 hours before receipt of study vaccine.
- Previously NAAT-confirmed COVID-19 within the last 2 months prior to vaccination.
- Participants who are taking medications which may prevent or treat COVID-19.
- Participants who received convalescent serum or prior therapeutic antibodies against SARS-CoV-2 in a period of 6 months.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccine(s).
- Current clinical or microbiological diagnosis of COVID-19, including active respiratory or non-respiratory symptoms associated with COVID-19 disease (i.e. symptomatic COVID-19 disease).
- Any respiratory illness deemed clinically relevant by the investigator within the past month OR hospitalization \>24 hours for any reason within the past month.
- History of or current cardiac disease, including but not limited to individuals with uncontrolled hypertension (defined as grade 1 hypertension or higher as per ISH guidelines with or without antihypertensive medication), congenital structural heart diseases, myocarditis and/or pericarditis, coronary heart disease (with/without angina pectoris) or myocardial infarction.
- Individuals with myocarditis after mRNA vaccination, or individuals with AEs after mRNA-vaccination that are in nature and severity beyond the common AEs that can be expected.
- Individuals at high risk for severe COVID-19, including those with any of the following risk factors: cancer; chronic kidney disease; chronic obstructive pulmonary disease (COPD); immunocompromised state (weakened immune system) from solid organ transplant; rheumatologic or autoinflammatory conditions requiring immunosuppressive medication, malignancies; obesity (BMI of 32 or higher); serious heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies; sickle cell disease; insulin-dependent type 2 diabetes mellitus.
- Anticipating the need for immunosuppressive treatment within the next 6 months.
- Any screening hematology and/or blood chemistry laboratory value outside normal range (defined as ≥Grade 1 abnormality) and deemed clinically relevant by the investigator.
- Note: Except bilirubin, participants with any stable Grade 1 abnormalities may be considered eligible at the discretion of the Investigator.
- Chronic immunosuppressive therapy (defined as ≥14 days), including cytotoxic agents, systemic corticosteroids exceeding 10mg/d prednisone equivalent, disease-modifying antirheumatic drugs \[DMARDs\]) or any other immunomodulating agents within the last 3 months or planned receipt throughout the study.
- Note: If systemic corticosteroids have been administered short-term (\<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
- Receipt of blood/plasma products or immunoglobulin from 60 days before study vaccine administration or planned receipt throughout the study.
- Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- Individuals with a history of or active autoimmune disease requiring therapeutic intervention.
- Note: subjects with vitiligo or thyroid disease on stable dose thyroid hormone replacement may be enrolled at the discretion of the investigator.
- Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
- History of human immunodeficiency virus (HIV), known seropositivity or active infection with HIV.
- History of known seropositivity for or evidence of active viral infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Exception: Participants who are seropositive because of HBV vaccine are eligible. Participants who had HCV but have received an antiviral treatment and show no detectable HCV viral deoxyribonucleic acid (DNA) for 6 months are eligible.
- Known history of active or latent tuberculosis (bacillus tuberculosis).
- Any concomitant serious health condition or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior, which, in the opinion of the Investigator, would place the participant at undue risk from the study.
- Has received a live vaccine within 28 days of planned start of study vaccinations (i.e. 28 days before the first and after the last vaccination).
- If a participant has contraindication to IM injections according to investigator's assessment or received therapeutic-intensity anticoagulation for a thromboembolic event within a period of 60 days before vaccination.
- Note: stable long-term prophylactic-dose anticoagulation is allowed.
- Participants with prolonged exposure to sheep or goats (e.g., shepherds, sheep farmer).
- Pregnant and/or nursing women.
Key Trial Info
Start Date :
June 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2023
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT05367843
Start Date
June 20 2022
End Date
November 8 2023
Last Update
February 9 2024
Active Locations (7)
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1
Accel Research Sites (ARS) - DeLand Clinical Research Unit
Florida City, Florida, United States, 32720
2
Cedar Crosse Research Center
Chicago, Illinois, United States, 60607
3
AMR - Center for Pharmaceutical Research - Kansas City
Kansas City, Missouri, United States, 64114
4
Caroline Institute for Clinical Research
Fayetteville, North Carolina, United States, 28303