Study of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults
- Conditions
- SARS-CoV-2 Infection
- Interventions
- Drug: Intramuscular injectionBiological: Intramuscular vaccine
- Registration Number
- NCT04636697
- Lead Sponsor
- Medicago
- Brief Summary
This Phase 2/3 study is a multi-portion design to confirm that the chosen formulation and dosing regimen of CoVLP has an acceptable immunogenicity and safety profile.
The Phase 3 portion is an event-driven, randomized, observer blinded, placebo-controlled design that will evaluate the efficacy and safety of the CoVLP formulation compared to placebo.
Subjects will be followed for safety and immunogenicity for a period of 12 months after the last vaccination.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 30918
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Intramuscular injection Placebo (0.5 mL) 3.75 µg of CoVLP Vaccine adjuvanted Intramuscular vaccine 3.75 µg of CoVLP adjuvanted vaccine with AS03 adjuvant (0.5 mL)
- Primary Outcome Measures
Name Time Method Phase 2 portion: Percentage of subjects with normal and abnormal clinically significant urine values 3 days Percentage of subjects with normal and abnormal clinically significant urine values
Phase 3 portion: Laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection Day 28 and after First occurrence, in a subject, of laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection
Phase 2 portion: Number of subjects with normal and abnormal clinically significant urine values 3 days Number of subjects with normal and abnormal clinically significant urine values
Phase 2 portion: Immediate adverse event (AEs) 30 minutes Percentage, intensity, and relationship to vaccination of immediate AEs
Phase 2 portion: Unsolicited adverse events (AEs) 21 days Percentage, intensity, and relationship of unsolicited AEs
Phase 2 portion: Number of subjects with normal and abnormal clinically significant haematological values 3 days Number of subjects with normal and abnormal clinically significant haematological values
Phase 2 portion: Serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESI) (including vaccine-enhanced disease) and deaths 21 days Percentage of SAEs, MAAEs, AEs leading to withdrawal, AESIs (including VED), and deaths
Phase 2 portion: Neutralizing antibody (Nab assay) response Day 42 Nab response induced in each Study Population against the SARS-CoV-2 virus
Phase 2 portion:Specific Th1 cell-mediated immunity (CMI) response Day 42 Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 , as measured by IFN-γ ELISpot
Phase 2 portion: Solicited local and systemic adverse events (AEs) 7 days Percentage, intensity, and relationship to vaccination of solicited local and systemic AEs
Phase 2 portion: Number of subjects with normal and abnormal clinically significant biochemical values 3 days Number of subjects with normal and abnormal clinically significant biochemical values
Phase 2 portion: Percentage of subjects with normal and abnormal clinically significant haematological values 3 days Percentage of subjects with normal and abnormal clinically significant haematological values
Phase 2 portion: Percentage of subjects with normal and abnormal clinically biochemical values 3 days Percentage of subjects with normal and abnormal clinically biochemical values
- Secondary Outcome Measures
Name Time Method Phase 2 portion: Specific Th2 cell-mediated immunity (CMI) response Day 386 Specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)
Phase 2 portion: Neutralizing antibody Geometric mean tiers (GMT) response (populations 1 and 2) 21 days Relative neutralizing antibody response between the healthy adults (Study Population #1) and the healthy elderly population (Study Population #2; each age strata) will be analyzed using the Following parameter: Geometric mean tiers (GMT)
Phase 2 portion: Specific antibody (IgG) response Day 386 Specific antibody response induced in each Study Population against the SARS-CoV-2 virus will be measured by the total IgG levels
Phase 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers Day 386 The ratio of neutralizing antibody titers:IgG ELISA antibody titers
Phase 2 portion: Solicited local and systemic AEs (populations 1 and 2) 7 days Relative percentage of solicited local and systemic AEs following each vaccine administration between the healthy adults (Study Population #1) and the healthy elderly population (Study Population #2, each age strata);
Phase 2 portion: Neutralizing antibody Geometric mean tiers (GMT) response (populations 1, 2 and 3) 21 days • Relative neutralizing antibody response between the healthy adults (Study Population #1) and the healthy elderly adults (Study Population #2) combined and the adults with significant comorbidities (Study Population #3) will be analyzed using the Following parameter: Geometric mean tiers (GMT)
Phase 2 portion: Specific Th1 cell-mediated immunity (CMI) response Day 386 Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IFN-γ ELISpot
Phase 3 portion: Neutralizing antibody Geometric mean titers (GMT) response Day 386 In a subset of subjects, Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean titers (GMT)
Phase 3 portion: Neutralizing antibody Geometric mean titers (GMT) Day 201 In a subset of subjects, Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean titers (GMT)
Phase 3 portion: Immediate adverse event (AEs) 30 minutes Percentage, intensity, and relationship to vaccination of immediate AEs
Phase 3 portion: Unsolicited adverse events (AEs) 21 days Percentage, intensity, and relationship of unsolicited AEs
Phase 3 portion: Serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESI) (including vaccine-enhanced disease) and deaths Day 0 to 386 Percentage of SAEs, MAAEs, AEs leading to withdrawal, AESIs (including VED), and deaths
Phase 2 portion: Neutralizing antibody (Nab assay) response Day 386 Persistence of the Nab antibody response induced in each Study Population against the SARS-CoV-2 virus
Phase 3 portion: Specific antibody (IgG) response Day 386 In a subset of subjects, specific antibody response induced in each Study Population against the SARS-CoV-2 virus measured by the total IgG levels
Phase 2 portion: Laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection Day 28 to 386 First occurrence, in a subject, of laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection
Phase 2 portion: Severe COVID-19 disease Day 28 to 386 Percentage of severe COVID-19 disease
Phase 2 portion: Solicited local and systemic AEs (populations 1, 2 and 3) 7 days Relative percentage of solicited local and systemic AEs by intensity grades for seven days following each vaccine administration between the healthy adults (Study Population #1) and the healthy elderly adults (Study Population #2) combined and the adults with significant comorbidities (Study Population #3)
Phase 2 portion: Serious adverse events (SAEs), medically attended adverse events (MAAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESI) (including vaccine-enhanced disease) and deaths Day 43 to 386 Percentage of SAEs, MAAEs, AEs leading to withdrawal, AESIs (including VED), and deaths
Phase 3 portion: Solicited local and systemic AEs 7 days Percentage, intensity, and relationship to vaccination of solicited local and systemic AEs
Phase 3 portion: Neutralizing antibody Geometric mean fold rise (GMFR) response Day 386 In a subset of subjects, Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean fold rise (GMFR)
Phase 3 portion: Neutralizing antibody titers: IgG ELISA antibody titers Day 386 In a subset of subjects, the ratio of neutralizing antibody titers:IgG ELISA antibody titers
Phase 3 portion: Neutralizing antibody Seroconversion (SC) rate response Day 386 In a subset of subjects, Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Seroconversion (SC) rate
Phase 3 portion: Laboratory-confirmed symptomatic SARS-CoV-2 infection (by strain) through efficacy analysis, approximately 4 months First occurrence, in a subject, of laboratory-confirmed symptomatic SARS-CoV-2 infection by strain: virologic method
Phase 3 portion: Specific Th1 cell-mediated immunity (CMI) response Day 386 In a subset of subjects, specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IFN-γ ELISpot
Phase 3 portion: Specific Th2 cell-mediated immunity (CMI) response Day 386 In a subset of subjects, specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)
Phase 3 portion: COVID-19-related symptoms in virologically-confirmed cases through efficacy analysis, approximately 4 months Percentage and intensity of COVID-19-related symptoms
Phase 3 portion: Severe COVID-19 disease Day 28 to 386 Percentage of severe COVID-19 disease
Phase 3 portion: Viral shedding after SARS-CoV-2 infection through efficacy analysis, approximately 4 months Duration and intensity of viral shedding after SARS-CoV-2 infection
Phase 3 portion: Laboratory-confirmed asymptomatic SARS-CoV-2 infection Day 201 Percentage of laboratory-confirmed asymptomatic SARS-CoV-2 infection: confirmed by the ELISA method for the N protein
Phase 3 portion: Laboratory-confirmed symptomatic SARS-CoV-2 infection Day 21 to 28 First occurence, in a subject, of laboratory-confirmed symptomatic SARS-CoV-2 infection: virologic method
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Trial Locations
- Locations (85)
Achieve Clinical Research, LLC dba Accel Research Sites
🇺🇸Birmingham, Alabama, United States
Fiel Family and Sports Medicine/CCT
🇺🇸Tempe, Arizona, United States
Hope Clinical Research
🇺🇸Canoga Park, California, United States
CNS Network
🇺🇸Garden Grove, California, United States
Long Beach Clinical Trial Services Inc.
🇺🇸Long Beach, California, United States
Pharmacology Research Institute
🇺🇸Newport Beach, California, United States
Wr-McCr, Llc
🇺🇸San Diego, California, United States
Ascension Providence Health System
🇺🇸Washington, District of Columbia, United States
Alliance for Multispecialty Research
🇺🇸Coral Gables, Florida, United States
Research Centers of America
🇺🇸Hollywood, Florida, United States
Scroll for more (75 remaining)Achieve Clinical Research, LLC dba Accel Research Sites🇺🇸Birmingham, Alabama, United States