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 SARS-CoV-2. The aim of the multivalent vaccine is to broaden the specific immune response against SARS-CoV-2 and to increase the probability of cross-protection against emerging variants.
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 adult participants. In the first part, the safety and immunogenicity of increasing doses of PRIME-2-CoV\_Beta will be assessed in adult healthy participants aged 18 to 55 years who have been vaccinated against COVID-19 with at least two doses of a SARS-CoV-2 mRNA vaccine (i.e. primary sequence with or without booster vaccination, subsequently referred to as "pre-vaccinated"). In addition, one dose level which has been identified as optimal will be assessed in a small cohort (12 participants) of participants 18 to 55 years of age who are SARS-CoV-2 vaccine-naïve. In addition, three dose levels identified in pre-vaccinated participants will be further evaluated for safety and immunogenicity in pre-vaccinated elderly participants aged 65-85 years (B-cohorts).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
103
Intramuscular (IM) injection
Accel Research Sites (ARS) - DeLand Clinical Research Unit
Florida City, Florida, United States
Cedar Crosse Research Center
Chicago, Illinois, United States
AMR - Center for Pharmaceutical Research - Kansas City
Kansas City, Missouri, United States
Caroline Institute for Clinical Research
Fayetteville, North Carolina, United States
Number of participants with solicited local reactions at the injection site
Solicited local reactions are described as pain, erythema/redness and induration/swelling.
Time frame: Up to 7 days after first immunization (Day 1 up to 8)
Number of participants with solicited local reactions at the injection site
Solicited local reactions are described as pain, erythema/redness and induration/swelling.
Time frame: Up to 7 days after second immunization (Day 29 up to 36)
Number of participants with solicited systemic reactions
Solicited systemic reactions are described as nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever.
Time frame: Up to 7 days after first immunization (Day 1 up to 8)
Number of participants with solicited systemic reactions
Solicited systemic reactions are described as nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever.
Time frame: Up to 7 days after second immunization (Day 29 up to 36)
Number of participants who experience at least one unsolicited Treatment-emergent Adverse Event (TEAE)
Time frame: Day 1 up to Day 57
Geometric mean of SARS-CoV-2-specific serum neutralizing titers against ancestral and variant SARS-CoV-2 strains at each time point
Time frame: Up to 6 months
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
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Cedar Health Research - DFW-East
Dallas, Texas, United States
Clinical Research Center Hannover
Hanover, Germany
Ludwig-Maximilians-University Munich (LMU)
Munich, Germany
Time frame: Up to 6 months
Number of participants who achieve ≥ 4-fold rise from baseline in SARS-CoV-2-specific serum neutralizing titers against ancestral and variant SARS-CoV-2 strains from baseline to each subsequent timepoint
Time frame: Up to 6 months
Geometric Mean Concentration (GMC) of SARS-CoV-2-spike and nucleocapsid-protein specific binding antibody levels from baseline to each subsequent time point
Time frame: Up to 6 months
Geometric Mean-fold Rise (GMFR) of SARS-CoV-2-spike and nucleocapsid-protein specific binding antibody levels from baseline to each subsequent time point
Time frame: Up to 6 months
Number of participants who achieve ≥ 4-fold rise in SARS-CoV-2-spike and nucleocapsid-protein specific binding antibody levels from baseline to each subsequent time point
Time frame: Up to 6 months
Recommended Phase 2 Dose (RP2D) of PRIME-2-CoV_Beta
RP2D based on an integrated analysis of overall safety and immunogenicity endpoints (change in SARS-CoV-2-specific serum neutralizing titers and SARS-CoV-2-spike protein-specific and -nucleocapsid protein-specific binding antibody levels.
Time frame: Up to 12 months
Safety and tolerability assessed as incidence of changes from baseline in clinical laboratory values, vital Signs, and Electrocardiograms (ECGs)
Endpoint is assessed as a composite of clinical lab values, vital signs, and ECGs.
Time frame: Up to 6 months
Number of participants with solicited local reactions at the injection site
Solicited local reactions are described as pain, erythema/redness and induration/swelling.
Time frame: Up to Day 15
Number of participants with solicited systemic reactions
Solicited systemic reactions are described as nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever.
Time frame: Up to Day 15