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Study of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults

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ClinicalTrials.gov Identifier: NCT04636697
Recruitment Status : Recruiting
First Posted : November 19, 2020
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Medicago

Tracking Information
First Submitted Date  ICMJE November 12, 2020
First Posted Date  ICMJE November 19, 2020
Last Update Posted Date April 13, 2021
Actual Study Start Date  ICMJE November 19, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2020)
  • Phase 2 portion: Immediate adverse event (AEs) [ Time Frame: 30 minutes ]
    Percentage, intensity, and relationship to vaccination of immediate AEs
  • Phase 2 portion: Solicited local and systemic adverse events (AEs) [ Time Frame: 7 days ]
    Percentage, intensity, and relationship to vaccination of solicited local and systemic AEs
  • Phase 2 portion: Unsolicited adverse events (AEs) [ Time Frame: 21 days ]
    Percentage, intensity, and relationship of unsolicited AEs
  • Phase 2 portion: Number of subjects with normal and abnormal clinically significant urine values [ Time Frame: 3 days ]
    Number of subjects with normal and abnormal clinically significant urine values
  • Phase 2 portion: Number of subjects with normal and abnormal clinically significant haematological values [ Time Frame: 3 days ]
    Number of subjects with normal and abnormal clinically significant haematological values
  • Phase 2 portion: Number of subjects with normal and abnormal clinically significant biochemical values [ Time Frame: 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 urine values [ Time Frame: 3 days ]
    Percentage of subjects with normal and abnormal clinically significant urine values
  • Phase 2 portion: Percentage of subjects with normal and abnormal clinically significant haematological values [ Time Frame: 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 [ Time Frame: 3 days ]
    Percentage of subjects with normal and abnormal clinically biochemical 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 [ Time Frame: 21 days ]
    Percentage of SAEs, MAAEs, AEs leading to withdrawal, AESIs (including VED), and deaths
  • Phase 2 portion: Neutralizing antibody (Nab assay) response [ Time Frame: Day 21 ]
    Nab response induced in each Study Population against the SARS-CoV-2 virus
  • Phase 2 portion: Neutralizing antibody (Nab assay) response [ Time Frame: 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 [ Time Frame: Day 21 ]
    Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 , as measured by IFN-γ ELISpot
  • Phase 2 portion:Specific Th1 cell-mediated immunity (CMI) response [ Time Frame: Day 42 ]
    Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 , as measured by IFN-γ ELISpot
  • Phase 3 portion: Laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection [ Time Frame: 14 days ]
    First occurrence, in a subject, of laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2021)
  • Phase 2 portion: Solicited local and systemic AEs [ Time Frame: 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: Solicited local and systemic AEs [ Time Frame: 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), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESI) (including vaccine-enhanced disease) and deaths [ Time Frame: Day 43 to 386 ]
    Percentage of SAEs, MAAEs, AEs leading to withdrawal, AESIs (including VED), and deaths
  • Phase 3 portion: Immediate adverse event (AEs) [ Time Frame: 30 minutes ]
    Percentage, intensity, and relationship to vaccination of immediate AEs
  • Phase 3 portion: Solicited local and systemic AEs [ Time Frame: 7 days ]
    Percentage, intensity, and relationship to vaccination of solicited local and systemic AEs
  • Phase 3 portion: Unsolicited adverse events (AEs) [ Time Frame: 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 [ Time Frame: Day 0 to 386 ]
    Percentage of SAEs, MAAEs, AEs leading to withdrawal, AESIs (including VED), and deaths
  • Phase 2 portion: Neutralizing antibody Geometric mean tiers (GMT) response [ Time Frame: 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: Neutralizing antibody Geometric mean tiers (GMT) response [ Time Frame: 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: Neutralizing antibody (Nab assay) response [ Time Frame: Day 128 ]
    Persistence of the Nab antibody response induced in each Study Population against the SARS-CoV-2 virus
  • Phase 2 portion: Neutralizing antibody (Nab assay) response [ Time Frame: Day 201 ]
    Persistence of the Nab antibody response induced in each Study Population against the SARS-CoV-2 virus
  • Phase 2 portion: Neutralizing antibody (Nab assay) response [ Time Frame: Day 386 ]
    Persistence of the Nab antibody response induced in each Study Population against the SARS-CoV-2 virus
  • Phase 2 portion: Specific antibody (IgG) response [ Time Frame: Day 128 ]
    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: Specific antibody (IgG) response [ Time Frame: Day 201 ]
    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: Specific antibody (IgG) response [ Time Frame: 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 [ Time Frame: Day 21 ]
    The ratio of neutralizing antibody titers:IgG ELISA antibody titers
  • Phase 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers [ Time Frame: Day 42 ]
    The ratio of neutralizing antibody titers:IgG ELISA antibody titers
  • Phase 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers [ Time Frame: Day 128 ]
    The ratio of neutralizing antibody titers:IgG ELISA antibody titers
  • Phase 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers [ Time Frame: Day 201 ]
    The ratio of neutralizing antibody titers:IgG ELISA antibody titers
  • Phase 2 portion: Specific Th1 cell-mediated immunity (CMI) response [ Time Frame: Day 201 ]
    Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IFN-γ ELISpot
  • Phase 2 portion: Specific Th1 cell-mediated immunity (CMI) response [ Time Frame: Day 386 ]
    Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IFN-γ ELISpot
  • Phase 2 portion: Specific Th2 cell-mediated immunity (CMI) response [ Time Frame: Day 21 ]
    Specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)
  • Phase 2 portion: Specific Th2 cell-mediated immunity (CMI) response [ Time Frame: Day 42 ]
    Specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)
  • Phase 2 portion: Specific Th2 cell-mediated immunity (CMI) response [ Time Frame: Day 201 ]
    Specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)
  • Phase 2 portion: Specific Th2 cell-mediated immunity (CMI) response [ Time Frame: Day 386 ]
    Specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)
  • Phase 3 portion: Neutralizing antibody Geometric mean titers (GMT) response [ Time Frame: Day 21 ]
    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 Seroconversion (SC) rate response [ Time Frame: Day 21 ]
    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: Neutralizing antibody Geometric mean fold rise (GMFR) response [ Time Frame: Day 21 ]
    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 Geometric mean titers (GMT) response [ Time Frame: Day 42 ]
    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 Seroconversion (SC) rate response [ Time Frame: Day 42 ]
    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: Neutralizing antibody Geometric mean fold rise (GMFR) response [ Time Frame: Day 42 ]
    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 Geometric mean fold rise (GMFR) response [ Time Frame: 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 fold rise (GMFR)
  • Phase 3 portion: Neutralizing antibody Geometric mean titers (GMT) [ Time Frame: 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: Neutralizing antibody Seroconversion (SC) rate response [ Time Frame: 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: Seroconversion (SC) rate
  • Phase 3 portion: Neutralizing antibody Geometric mean fold rise (GMFR) response [ Time Frame: 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 Geometric mean titers (GMT) response [ Time Frame: 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 Seroconversion (SC) rate response [ Time Frame: 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: Specific antibody (IgG) response [ Time Frame: Day 21 ]
    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 3 portion: Specific antibody (IgG) response [ Time Frame: Day 42 ]
    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 3 portion: Specific antibody (IgG) response [ Time Frame: Day 201 ]
    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 3 portion: Specific antibody (IgG) response [ Time Frame: 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 3 portion: Neutralizing antibody titers: IgG ELISA antibody titers [ Time Frame: Day 21 ]
    In a subset of subjects, the ratio of neutralizing antibody titers:IgG ELISA antibody titers
  • Phase 3 portion: Neutralizing antibody titers: IgG ELISA antibody titers [ Time Frame: Day 42 ]
    In a subset of subjects, the ratio of neutralizing antibody titers:IgG ELISA antibody titers
  • Phase 3 portion: Neutralizing antibody titers: IgG ELISA antibody titers [ Time Frame: Day 201 ]
    In a subset of subjects, the ratio of neutralizing antibody titers:IgG ELISA antibody titers
  • Phase 3 portion: Neutralizing antibody titers: IgG ELISA antibody titers [ Time Frame: Day 386 ]
    In a subset of subjects, the ratio of neutralizing antibody titers:IgG ELISA antibody titers
  • Phase 3 portion: Specific Th1 cell-mediated immunity (CMI) response [ Time Frame: Day 21 ]
    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 Th1 cell-mediated immunity (CMI) response [ Time Frame: Day 42 ]
    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 Th1 cell-mediated immunity (CMI) response [ Time Frame: Day 201 ]
    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 Th1 cell-mediated immunity (CMI) response [ Time Frame: 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 [ Time Frame: Day 21 ]
    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: Specific Th2 cell-mediated immunity (CMI) response [ Time Frame: Day 42 ]
    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: Specific Th2 cell-mediated immunity (CMI) response [ Time Frame: Day 201 ]
    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: Specific Th2 cell-mediated immunity (CMI) response [ Time Frame: 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: Specific cell-mediated immunity (CMI) response [ Time Frame: Day 0 to 42 ]
    In a subset of subjects, specific CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by the percentage of CD4+ T cells expressing functional markers
  • Phase 3 portion: Specific cell-mediated immunity (CMI) response [ Time Frame: Day 201 and 386 ]
    In a subset of subjects, specific CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by the percentage of CD4+ T cells expressing functional markers
  • Phase 2 portion: Laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection [ Time Frame: Day 35 to 386 ]
    First occurrence, in a subject, of laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection
  • Phase 2 portion: Severe COVID-19 disease [ Time Frame: Day 14 to 386 ]
    Percentage of severe COVID-19 disease
  • Phase 3 portion: Severe COVID-19 disease [ Time Frame: Day 14 to 386 ]
    Percentage of severe COVID-19 disease
  • Phase 3 portion: COVID-19-related symptoms [ Time Frame: 1 year ]
    Percentage and intensity of COVID-19-related symptoms
  • Phase 3 portion: Laboratory-confirmed asymptomatic SARS-CoV-2 infection [ Time Frame: Day 201 ]
    Percentage of of laboratory-confirmed asymptomatic SARS-CoV-2 infection: confirmed by the ELISA method for the N protein
  • Phase 3 portion: Laboratory-confirmed asymptomatic SARS-CoV-2 infection [ Time Frame: Day 201 ]
    Percentage of of laboratory-confirmed asymptomatic SARS-CoV-2 infection in subjects who only received a single vaccination: confirmed by the ELISA method for the N protein
  • Phase 3 portion: Laboratory-confirmed asymptomatic SARS-CoV-2 infection [ Time Frame: Day 386 ]
    Percentage of of laboratory-confirmed asymptomatic SARS-CoV-2 infection: confirmed by the ELISA method for the N protein
  • Phase 3 portion: Laboratory-confirmed asymptomatic SARS-CoV-2 infection [ Time Frame: Day 386 ]
    Percentage of of laboratory-confirmed asymptomatic SARS-CoV-2 infection in subjects who only received a single vaccination: confirmed by the ELISA method for the N protein
  • Phase 3 portion: Laboratory-confirmed symptomatic SARS-CoV-2 infection [ Time Frame: Day 14 ]
    Percentage of of laboratory-confirmed asymptomatic SARS-CoV-2 infection: virologic method
  • Phase 3 portion: Laboratory-confirmed symptomatic SARS-CoV-2 infection [ Time Frame: Day 14 to 20 ]
    Percentage of of laboratory-confirmed asymptomatic SARS-CoV-2 infection: virologic method
  • Phase 3 portion: Laboratory-confirmed symptomatic SARS-CoV-2 infection [ Time Frame: Day 21 to 28 ]
    Percentage of of laboratory-confirmed asymptomatic SARS-CoV-2 infection: virologic method
  • Phase 3 portion: Viral shedding after SARS-CoV-2 infection [ Time Frame: 1 year ]
    Duration and intensity of viral shedding after SARS-CoV-2 infection
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2020)
  • Phase 2 portion: Solicited local and systemic AEs [ Time Frame: 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: Serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESI) (including vaccine-enhanced disease) and deaths [ Time Frame: Day 43 to 386 ]
    Percentage of SAEs, MAAEs, AEs leading to withdrawal, AESIs (including VED), and deaths
  • Phase 3 portion: Immediate adverse event (AEs) [ Time Frame: 30 minutes ]
    Percentage, intensity, and relationship to vaccination of immediate AEs
  • Phase 3 portion: Solicited local and systemic AEs [ Time Frame: 7 days ]
    Percentage, intensity, and relationship to vaccination of solicited local and systemic AEs
  • Phase 3 portion: Unsolicited adverse events (AEs) [ Time Frame: 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 [ Time Frame: Day 0 to 386 ]
    Percentage of SAEs, MAAEs, AEs leading to withdrawal, AESIs (including VED), and deaths
  • Phase 2 portion: Neutralizing antibody Geometric mean tiers (GMT) response [ Time Frame: 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: Neutralizing antibody (Nab assay) response [ Time Frame: Day 128 ]
    Persistence of the Nab antibody response induced in each Study Population against the SARS-CoV-2 virus
  • Phase 2 portion: Neutralizing antibody (Nab assay) response [ Time Frame: Day 201 ]
    Persistence of the Nab antibody response induced in each Study Population against the SARS-CoV-2 virus
  • Phase 2 portion: Neutralizing antibody (Nab assay) response [ Time Frame: Day 386 ]
    Persistence of the Nab antibody response induced in each Study Population against the SARS-CoV-2 virus
  • Phase 2 portion: Specific antibody (IgG) response [ Time Frame: Day 128 ]
    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: Specific antibody (IgG) response [ Time Frame: Day 201 ]
    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: Specific antibody (IgG) response [ Time Frame: 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 [ Time Frame: Day 128 ]
    The ratio of neutralizing antibody titers:IgG ELISA antibody titers
  • Phase 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers [ Time Frame: Day 201 ]
    The ratio of neutralizing antibody titers:IgG ELISA antibody titers
  • Phase 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers [ Time Frame: Day 386 ]
    The ratio of neutralizing antibody titers:IgG ELISA antibody titers
  • Phase 2 portion: Specific Th1 cell-mediated immunity (CMI) response [ Time Frame: Day 201 ]
    Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IFN-γ ELISpot
  • Phase 2 portion: Specific Th1 cell-mediated immunity (CMI) response [ Time Frame: Day 386 ]
    Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IFN-γ ELISpot
  • Phase 2 portion: Specific Th2 cell-mediated immunity (CMI) response [ Time Frame: Day 21 ]
    Specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)
  • Phase 2 portion: Specific Th2 cell-mediated immunity (CMI) response [ Time Frame: Day 42 ]
    Specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)
  • Phase 2 portion: Specific Th2 cell-mediated immunity (CMI) response [ Time Frame: Day 201 ]
    Specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)
  • Phase 2 portion: Specific Th2 cell-mediated immunity (CMI) response [ Time Frame: Day 386 ]
    Specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)
  • Phase 3 portion: Neutralizing antibody Geometric mean titers (GMT) response [ Time Frame: Day 21 ]
    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 Seroconversion (SC) rate response [ Time Frame: Day 21 ]
    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: Neutralizing antibody Geometric mean fold rise (GMFR) response [ Time Frame: Day 21 ]
    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 Geometric mean titers (GMT) response [ Time Frame: Day 42 ]
    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 Seroconversion (SC) rate response [ Time Frame: Day 42 ]
    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: Neutralizing antibody Geometric mean fold rise (GMFR) response [ Time Frame: Day 42 ]
    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 Geometric mean titers (GMT) response [ Time Frame: Day 128 ]
    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 Seroconversion (SC) rate response [ Time Frame: Day 128 ]
    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: Neutralizing antibody Geometric mean fold rise (GMFR) response [ Time Frame: Day 128 ]
    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 Geometric mean fold rise (GMFR) response [ Time Frame: 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 fold rise (GMFR)
  • Phase 3 portion: Neutralizing antibody Geometric mean titers (GMT) [ Time Frame: 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: Neutralizing antibody Seroconversion (SC) rate response [ Time Frame: 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: Seroconversion (SC) rate
  • Phase 3 portion: Neutralizing antibody Geometric mean fold rise (GMFR) response [ Time Frame: 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 Geometric mean titers (GMT) response [ Time Frame: 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 Seroconversion (SC) rate response [ Time Frame: 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: Specific antibody (IgG) response [ Time Frame: Day 21 ]
    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 3 portion: Specific antibody (IgG) response [ Time Frame: Day 42 ]
    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 3 portion: Specific antibody (IgG) response [ Time Frame: Day 128 ]
    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 3 portion: Specific antibody (IgG) response [ Time Frame: Day 201 ]
    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 3 portion: Specific antibody (IgG) response [ Time Frame: 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 3 portion: Neutralizing antibody titers: IgG ELISA antibody titers [ Time Frame: Day 21 ]
    In a subset of subjects, the ratio of neutralizing antibody titers:IgG ELISA antibody titers
  • Phase 3 portion: Neutralizing antibody titers: IgG ELISA antibody titers [ Time Frame: Day 42 ]
    In a subset of subjects, the ratio of neutralizing antibody titers:IgG ELISA antibody titers
  • Phase 3 portion: Neutralizing antibody titers: IgG ELISA antibody titers [ Time Frame: Day 128 ]
    In a subset of subjects, the ratio of neutralizing antibody titers:IgG ELISA antibody titers
  • Phase 3 portion: Neutralizing antibody titers: IgG ELISA antibody titers [ Time Frame: Day 201 ]
    In a subset of subjects, the ratio of neutralizing antibody titers:IgG ELISA antibody titers
  • Phase 3 portion: Neutralizing antibody titers: IgG ELISA antibody titers [ Time Frame: Day 386 ]
    In a subset of subjects, the ratio of neutralizing antibody titers:IgG ELISA antibody titers
  • Phase 3 portion: Specific Th1 cell-mediated immunity (CMI) response [ Time Frame: Day 21 ]
    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 Th1 cell-mediated immunity (CMI) response [ Time Frame: Day 42 ]
    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 Th1 cell-mediated immunity (CMI) response [ Time Frame: Day 201 ]
    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 Th1 cell-mediated immunity (CMI) response [ Time Frame: 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 [ Time Frame: Day 21 ]
    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: Specific Th2 cell-mediated immunity (CMI) response [ Time Frame: Day 42 ]
    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: Specific Th2 cell-mediated immunity (CMI) response [ Time Frame: Day 201 ]
    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: Specific Th2 cell-mediated immunity (CMI) response [ Time Frame: 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: Specific cell-mediated immunity (CMI) response [ Time Frame: Day 0 to 42 ]
    In a subset of subjects, specific CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by the percentage of CD4+ T cells expressing functional markers
  • Phase 3 portion: Specific cell-mediated immunity (CMI) response [ Time Frame: Day 201 and 386 ]
    In a subset of subjects, specific CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by the percentage of CD4+ T cells expressing functional markers
  • Phase 2 portion: Laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection [ Time Frame: Day 35 to 386 ]
    First occurrence, in a subject, of laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection
  • Phase 2 portion: Severe COVID-19 disease [ Time Frame: Day 35 to 386 ]
    Percentage of severe COVID-19 disease
  • Phase 3 portion: Laboratory-confirmed asymptomatic SARS-CoV-2 infection [ Time Frame: Day 201 ]
    Percentage of laboratory-confirmed (confirmed by the ELISA method for the N protein) asymptomatic SARS-CoV-2 infection
  • Phase 3 portion: Laboratory-confirmed asymptomatic SARS-CoV-2 infection [ Time Frame: Day 386 ]
    Percentage of laboratory-confirmed (confirmed by the ELISA method for the N protein) asymptomatic SARS-CoV-2 infection
  • Phase 3 portion: Severe COVID-19 disease [ Time Frame: Day 35 to 386 ]
    Percentage of severe COVID-19 disease
  • Phase 3 portion: COVID-19-related symptoms [ Time Frame: 1 year ]
    Percentage and intensity of COVID-19-related symptoms
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults
Official Title  ICMJE Randomized, Observer-Blind, Placebo-Controlled, Phase 2/3 Study to Assess the Safety, Efficacy, and Immunogenicity of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults 18 Years of Age or Older
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Observer-blind
Primary Purpose: Prevention
Condition  ICMJE SARS-CoV-2 Infection
Intervention  ICMJE
  • Drug: Intramuscular injection
    Subjects will receive two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once)
  • Biological: Intramuscular vaccine
    Subjects will receive two doses of 3.75 µg of CoVLP adjuvanted with AS03 adjuvant given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once)
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo (0.5 mL)
    Intervention: Drug: Intramuscular injection
  • Experimental: 3.75 µg of CoVLP Vaccine adjuvanted
    3.75 µg of CoVLP adjuvanted vaccine with AS03 adjuvant (0.5 mL)
    Intervention: Biological: Intramuscular vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 26, 2021)
30918
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2020)
30612
Estimated Study Completion Date  ICMJE April 30, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Subjects must have read, understood, and signed the informed consent form (ICF) prior to participating in the study; subjects must also complete study-related procedures and the subjects must communicate with the study staff at visits and by phone during the study;
  2. At the Screening visit (Visit 1), male and female subjects must be:

    • Study Populations #1: 18 to 64 (has not yet had his/her 65th birthday) years of age, inclusive;
    • Study Population #2: 65 years of age or older;
    • Study Population #3: 18 years of age or older;
  3. At Screening (Visit 1) and Vaccination (Visit 2), subject must have a body mass index (BMI) of:

    • Study Populations #1 and #2: ≥ 18.5 and < 30 kg/m2;

  4. Subjects are considered by the Investigator to be reliable and likely to cooperate with the assessment procedures and be available for the duration of the study;
  5. Study Population #1: Subjects must be in good general health prior to study participation, with no clinically relevant abnormalities that could jeopardize subject safety or interfere with study assessments, as determined by medical history, physical examination, and vital signs. Investigator discretion will be permitted with this inclusion criterion;

    All regions except Canada: Note: Subjects with a pre-existing chronic disease will be allowed to participate if the disease is stable and, according to the Investigator's judgment that must be documented in the source documents, the condition is unlikely to confound the results of the study or pose additional risk to the subject by participating in the study. Stable disease is generally defined as no new onset or exacerbation of pre-existing chronic disease three months prior to vaccination. Based on the Investigator's judgment, a subject with more recent stabilization of a disease could also be eligible.

  6. Study Populations #1 and #3: Female subjects of childbearing potential must have a negative serum pregnancy test result at Screening (Visit 1 for the Phase 2 portion) and/or a negative urine pregnancy test result at Vaccination (Visit 2 for the Phase 2 portion; Visit 1 for the Phase 3 portion):

    Non-childbearing females are defined as:

    • Surgically-sterile (defined as bilateral tubal ligation, hysterectomy or bilateral oophorectomy performed more than one month prior to the first study vaccination); or
    • Post-menopausal (absence of menses for 12 consecutive months and age consistent with natural cessation of ovulation);
  7. Study Populations #1 and #3: Female subjects of childbearing potential must use an effective method of contraception for one month prior to vaccination (Visit 2) and agree to continue employing highly effective birth control measures for at least one month after the last study vaccination (or in the case of early termination, she must not plan to become pregnant for at least one month after her last study vaccination).

    The following relationship or methods of contraception are considered to be highly effective:

    • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
    • Oral;
    • Intravaginal;
    • Transdermal;
    • Progestogen-only hormonal contraception associated with inhibition of ovulation:
    • Oral;
    • Injectable;
    • Implantable;
    • Intra-uterine device with or without hormonal release;
    • Credible self-reported history of heterosexual vaginal intercourse abstinence prior to and for at least one month after the last study vaccination. Abstinent subjects who are ovulating should be asked what method(s) they would use should their circumstances change, and subjects without a well-defined plan should be excluded;
    • Female partner;
    • All regions except the US: Vasectomised partner, provided that this partner is the sole sexual partner of the study participant and that the vasectomised partner has received a medical assessment of the surgical success;
    • Bilateral tubal ligation.
  8. Study Population #2: Subjects must be non-institutionalized (e.g. not living in rehabilitation centres or old-age homes; living in an elderly community is acceptable) and have no acute or evolving medical problems prior to study participation and no clinically relevant abnormalities that could jeopardize subject safety or interfere with study assessments, as assessed by the Principal Investigator or sub-Investigator (thereafter referred as Investigator) and determined by medical history, physical examination, serology (only for the Phase 2 portion), clinical chemistry and haematology tests (only for the Phase 2 portion), urinalysis (only for the Phase 2 portion), and vital signs. Investigator discretion will be permitted with this inclusion criterion.

    All regions except Canada: Note: Subjects with a pre-existing chronic disease will be allowed to participate if the disease is stable and, according to the Investigator's judgment that must be documented in the source documents, the condition is unlikely to confound the results of the study or pose additional risk to the subject by participating in the study. Stable disease is generally defined as no new onset or exacerbation of pre-existing chronic disease three months prior to vaccination. Based on the Investigator's judgment and documented in source documentation, a subject with more recent stabilization of a disease could also be eligible;

  9. Study Population #3: Subjects must have one or more co-morbid conditions that puts them at higher risk for severe COVID-19 disease. These comorbidities include but are not limited to obesity, hypertension, type 1 or type 2 diabetes, chronic obstructive pulmonary disease (COPD), cardiovascular diseases, chronic kidney diseases, or be immunocompromised persons (e.g., treatment-controlled HIV infection, organ transplant recipients, or patients receiving cancer chemotherapy). Investigator discretion will be permitted with this inclusion criterion.

Exclusion criteria:

  1. Study Populations #1 and #2: According to the Investigator's opinion, significant acute or chronic, uncontrolled medical or neuropsychiatric illness.

    Acute disease is defined as presence of any moderate or severe acute illness with or without a fever within 48 hours prior to the Screening (Visit 1) and/or Vaccination visit (Visit 2). 'Uncontrolled' is defined as:

    • Requiring a new medical or surgical treatment during the three months prior to study vaccine administration;
    • Requiring any significant change in a chronic medication (i.e. drug, dose, frequency) during the three months prior to study vaccine administration due to uncontrolled symptoms or drug toxicity unless the innocuous nature of the medication change meets the criteria outlined in inclusion criterion no. 5 (Study Population #1) or no. 8 (Study Population #2) and is appropriately justified and documented by the Investigator.

    Investigator discretion is permitted with this exclusion criterion and must be carefully and fully documented in the source documents;

  2. Study Populations #1 and #2: Any chronic medical condition associated with elevated risk of severe outcomes of COVID-19, including obesity, diabetes (type 1 or type 2), significant cardiovascular or respiratory diseases including asthma, chronic renal failure, disorders of bleeding/coagulation, chronic inflammatory or autoimmune conditions, immunosuppressive conditions (including HIV), and hypertension;
  3. Study Populations #1 and #2: Any confirmed or suspected current immunosuppressive condition or immunodeficiency, including cancer, human immunodeficiency virus (HIV), hepatitis B or C infection (subjects with a history of cured hepatitis B or C infection without any signs of immunodeficiency at present time are allowed). Investigator discretion is permitted with this exclusion criterion;
  4. Study Populations #1 and #2: Current autoimmune disease (such as rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis or narcolepsy). Investigator discretion is permitted with this exclusion criterion, and subjects may be eligible to participate with appropriate written justification in the source document (i.e. subjects with a history of autoimmune disease who are disease-free without treatment for three years or more, or on stable thyroid replacement therapy, mild psoriasis [i.e. a small number of minor plaques requiring no systemic treatment], etc.);
  5. Study Populations #1 and #2: Administration of any medication or treatment that may alter the vaccine immune responses, such as:

    • Systemic glucocorticoids at a dose exceeding 10 mg of prednisone (or equivalent) per day for more than seven consecutive days or for 10 or more days in total, within one month prior to the Vaccination visit (Visit 2). Inhaled, nasal, ophthalmic, dermatological, and other topical glucocorticoids are permitted;
    • Cytotoxic, antineoplastic, or immunosuppressant drugs - within 36 months prior to Vaccination (Visit 2);
    • Any immunoglobulin preparations or blood products, blood transfusion - within 6 months prior to Vaccination (Visit 2);
  6. Study Population #3: Acute disease defined as presence of any moderate or severe acute illness with or without a fever within 48 hours prior to the Screening (Visit 1) and/or Vaccination visit (Visit 2);
  7. Administration of any vaccine within 14 days prior to Vaccination (Visit 2); planned administration of any vaccine during the study (up to Day 28 of the study). Immunization on an emergency basis during the study will be evaluated on case-by-case basis by the Investigator;
  8. Administration of any other SARS-CoV-2 / COVID-19, or other experimental coronavirus vaccine at any time prior to or during the study;
  9. History of virologically-confirmed COVID-19;
  10. Use of any investigational or non-registered product within 30 days or 5 half-lives, whichever is longer, prior to Vaccination (Visit 2) or planned use during the study period. Subjects who are in a prolonged post-administration observation period of another investigational or marketed drug clinical study, for which there is no ongoing exposure to the investigational or marketed product and all scheduled on-site visits are completed, will be allowed to take part in this study, if all other eligibility criteria are met;
  11. Have a rash, dermatological condition, tattoos, muscle mass, or any other abnormalities at injection site that may interfere with injection site reaction rating. Investigator discretion will be permitted with this exclusion criterion;
  12. Use of any prescription antiviral drugs with the intention of COVID-19 prophylaxis, including those that are thought to be effective for prevention of COVID-19 but have not been licensed for this indication, within one month prior to Vaccination (Visit 2);
  13. For the Phase 2 portion of the study only: Use of prophylactic medications (e.g. antihistamines [H1 receptor antagonists], nonsteroidal anti-inflammatory drugs [NSAIDs], systemic and topical glucocorticoids, non-opioid and opioid analgesics) within 24 hours prior to the Vaccination (Visit 2) to prevent or pre-empt symptoms due to vaccination;
  14. History of a serious allergic response to any of the constituents of CoVLP including AS03;
  15. History of a documented anaphylactic reactions to plants or plant components (including tobacco, fruits and nuts);
  16. Personal or family history of narcolepsy;
  17. Subjects with a history of Guillain-Barré Syndrome;
  18. Study Populations #1 and #3: Any female subject who has a positive or doubtful pregnancy test result prior to vaccination or who is lactating;
  19. Subjects identified as an Investigator or employee of the Investigator or clinical site with direct involvement in the proposed study, or identified as an immediate family member (i.e. parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study, or any employees of Medicago.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Medicago Trial Inquiries 581-700-1977 ext 1111 clinicalTrialInquiries@medicago.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04636697
Other Study ID Numbers  ICMJE CP-PRO-CoVLP-021
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medicago
Study Sponsor  ICMJE Medicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Brian Ward, MD Medicago
PRS Account Medicago
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP