ClinicalTrials.gov

History of Changes for Study: NCT04636697
Study of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults
Latest version (submitted February 8, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 18, 2020 None (earliest Version on record)
2 November 27, 2020 Recruitment Status, Study Status and Contacts/Locations
3 January 13, 2021 Contacts/Locations and Study Status
4 January 15, 2021 Contacts/Locations, Outcome Measures, Oversight, Study Status, Eligibility and Study Design
5 January 26, 2021 Contacts/Locations, Study Design and Study Status
6 February 8, 2021 Contacts/Locations and Study Status
Comparison Format:

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Changes (Merged) for Study: NCT04636697
January 13, 2021 (v3) -- January 15, 2021 (v4)

Changes in: Contacts/Locations, Outcome Measures, Oversight, Study Status, Eligibility and Study Design

Study Identification
Unique Protocol ID: CP-PRO-CoVLP-021
Brief Title: Study of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults
Official Title: 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
Secondary IDs:
Study Status
Record Verification: November 2020 January 2021
Overall Status: Recruiting
Study Start: November 19, 2020
Primary Completion: December 31, 2021 [Anticipated]
Study Completion: April 30, 2022 [Anticipated]
First Submitted: November 12, 2020
First Submitted that
Met QC Criteria:
November 18, 2020
First Posted: November 19, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
January 13 15, 2021
Last Update Posted: January 14 20, 2021 [Actual]
Sponsor/Collaborators
Sponsor: Medicago
Responsible Party: Sponsor
Collaborators:
Oversight
U.S. FDA-regulated Drug: No Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Study Description
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:
Conditions
Conditions: SARS-CoV-2 Infection
Keywords:
Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 2/Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 30612 30000 [Anticipated]
Arms and Interventions
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo (0.5 mL)
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)
Experimental: 3.75 µg of CoVLP Vaccine adjuvanted
3.75 µg of CoVLP adjuvanted vaccine with AS03 adjuvant (0.5 mL)
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)
Outcome Measures
Primary Outcome Measures:
1. Phase 2 portion: Immediate adverse event (AEs)
Percentage, intensity, and relationship to vaccination of immediate AEs

[Time Frame: 30 minutes]
2. Phase 2 portion: Solicited local and systemic adverse events (AEs)
Percentage, intensity, and relationship to vaccination of solicited local and systemic AEs

[Time Frame: 7 days]
3. Phase 2 portion: Unsolicited adverse events (AEs)
Percentage, intensity, and relationship of unsolicited AEs

[Time Frame: 21 days]
4. Phase 2 portion: Number of subjects with normal and abnormal clinically significant urine values
Number of subjects with normal and abnormal clinically significant urine values

[Time Frame: 3 days]
5. Phase 2 portion: Number of subjects with normal and abnormal clinically significant haematological values
Number of subjects with normal and abnormal clinically significant haematological values

[Time Frame: 3 days]
6. Phase 2 portion: Number of subjects with normal and abnormal clinically significant biochemical values
Number of subjects with normal and abnormal clinically significant biochemical values

[Time Frame: 3 days]
7. Phase 2 portion: Percentage of subjects with normal and abnormal clinically significant urine values
Percentage of subjects with normal and abnormal clinically significant urine values

[Time Frame: 3 days]
8. Phase 2 portion: Percentage of subjects with normal and abnormal clinically significant haematological values
Percentage of subjects with normal and abnormal clinically significant haematological values

[Time Frame: 3 days]
9. Phase 2 portion: Percentage of subjects with normal and abnormal clinically biochemical values
Percentage of subjects with normal and abnormal clinically biochemical values

[Time Frame: 3 days]
10. 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
Percentage of SAEs, MAAEs, AEs leading to withdrawal, AESIs (including VED), and deaths

[Time Frame: 21 days]
11. Phase 2 portion: Neutralizing antibody (Nab assay) response
Nab response induced in each Study Population against the SARS-CoV-2 virus

[Time Frame: Day 21]
12. Phase 2 portion: Neutralizing antibody (Nab assay) response
Nab response induced in each Study Population against the SARS-CoV-2 virus

[Time Frame: Day 42]
13. Phase 2 portion:Specific Th1 cell-mediated immunity (CMI) response
Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 , as measured by IFN-γ ELISpot

[Time Frame: Day 21]
14. Phase 2 portion:Specific Th1 cell-mediated immunity (CMI) response
Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 , as measured by IFN-γ ELISpot

[Time Frame: Day 42]
15. Phase 3 portion: Laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection
First occurrence, in a subject, of laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection

[Time Frame: 14 days]
Secondary Outcome Measures:
16. Phase 2 portion: Solicited local and systemic AEs
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);

[Time Frame: 7 days]
17. Phase 2 portion: Solicited local and systemic AEs
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)

[Time Frame: 7 days]
18. 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
Percentage of SAEs, MAAEs, AEs leading to withdrawal, AESIs (including VED), and deaths

[Time Frame: Day 43 to 386]
19. Phase 3 portion: Immediate adverse event (AEs)
Percentage, intensity, and relationship to vaccination of immediate AEs

[Time Frame: 30 minutes]
20. Phase 3 portion: Solicited local and systemic AEs
Percentage, intensity, and relationship to vaccination of solicited local and systemic AEs

[Time Frame: 7 days]
21. Phase 3 portion: Unsolicited adverse events (AEs)
Percentage, intensity, and relationship of unsolicited AEs

[Time Frame: 21 days]
22. 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
Percentage of SAEs, MAAEs, AEs leading to withdrawal, AESIs (including VED), and deaths

[Time Frame: Day 0 to 386]
23. Phase 2 portion: Neutralizing antibody Geometric mean tiers (GMT) response
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)

[Time Frame: 21 days]
24. Phase 3 2 portion: Neutralizing antibody Geometric mean titers tiers (GMT) response
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) • 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)

[Time Frame: 21 days 128 ]
25. Phase 2 portion: Neutralizing antibody (Nab assay) response
Persistence of the Nab antibody response induced in each Study Population against the SARS-CoV-2 virus

[Time Frame: Day 128]
26. Phase 2 portion: Neutralizing antibody (Nab assay) response
Persistence of the Nab antibody response induced in each Study Population against the SARS-CoV-2 virus

[Time Frame: Day 201]
27. Phase 2 portion: Neutralizing antibody (Nab assay) response
Persistence of the Nab antibody response induced in each Study Population against the SARS-CoV-2 virus

[Time Frame: Day 386]
28. Phase 2 portion: Specific antibody (IgG) response
Specific antibody response induced in each Study Population against the SARS-CoV-2 virus will be measured by the total IgG levels

[Time Frame: Day 128]
29. Phase 2 portion: Specific antibody (IgG) response
Specific antibody response induced in each Study Population against the SARS-CoV-2 virus will be measured by the total IgG levels

[Time Frame: Day 201]
30. Phase 2 portion: Specific antibody (IgG) response
Specific antibody response induced in each Study Population against the SARS-CoV-2 virus will be measured by the total IgG levels

[Time Frame: Day 386]
31. Phase 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers
The ratio of neutralizing antibody titers:IgG ELISA antibody titers

[Time Frame: Day 386 21]
32. Phase 3 portion: Neutralizing antibody Seroconversion (SC) rate response
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

[Time Frame: Day 128 ]
33. Phase 3 portion: Neutralizing antibody Geometric mean fold rise (GMFR) response
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)

[Time Frame: Day 128 ]
34. Phase 3 portion: Specific antibody (IgG) response
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

[Time Frame: Day 128 ]
35. Phase 3 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers
In a subset of subjects, The ratio of neutralizing antibody titers:IgG ELISA antibody titers

[Time Frame: Day 128 42]
36. Phase 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers
The ratio of neutralizing antibody titers:IgG ELISA antibody titers

[Time Frame: Day 128]
37. Phase 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers
The ratio of neutralizing antibody titers:IgG ELISA antibody titers

[Time Frame: Day 201]
38. Phase 2 portion: Specific Th1 cell-mediated immunity (CMI) response
Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IFN-γ ELISpot

[Time Frame: Day 201]
39. Phase 2 portion: Specific Th1 cell-mediated immunity (CMI) response
Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IFN-γ ELISpot

[Time Frame: Day 386]
40. Phase 2 portion: Specific Th2 cell-mediated immunity (CMI) response
Specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)

[Time Frame: Day 21]
41. Phase 2 portion: Specific Th2 cell-mediated immunity (CMI) response
Specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)

[Time Frame: Day 42]
42. Phase 2 portion: Specific Th2 cell-mediated immunity (CMI) response
Specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)

[Time Frame: Day 201]
43. Phase 2 portion: Specific Th2 cell-mediated immunity (CMI) response
Specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)

[Time Frame: Day 386]
44. Phase 3 portion: Neutralizing antibody Geometric mean titers (GMT) response
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)

[Time Frame: Day 21]
45. Phase 3 portion: Neutralizing antibody Seroconversion (SC) rate response
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

[Time Frame: Day 21]
46. Phase 3 portion: Neutralizing antibody Geometric mean fold rise (GMFR) response
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)

[Time Frame: Day 21]
47. Phase 3 portion: Neutralizing antibody Geometric mean titers (GMT) response
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)

[Time Frame: Day 42]
48. Phase 3 portion: Neutralizing antibody Seroconversion (SC) rate response
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

[Time Frame: Day 42]
49. Phase 3 portion: Neutralizing antibody Geometric mean fold rise (GMFR) response
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)

[Time Frame: Day 42]
50. Phase 3 portion: Neutralizing antibody Geometric mean fold rise (GMFR) response
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)

[Time Frame: Day 201]
51. Phase 3 portion: Neutralizing antibody Geometric mean titers (GMT)
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)

[Time Frame: Day 201]
52. Phase 3 portion: Neutralizing antibody Seroconversion (SC) rate response
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

[Time Frame: Day 201]
53. Phase 3 portion: Neutralizing antibody Geometric mean fold rise (GMFR) response
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)

[Time Frame: Day 386]
54. Phase 3 portion: Neutralizing antibody Geometric mean titers (GMT) response
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)

[Time Frame: Day 386]
55. Phase 3 portion: Neutralizing antibody Seroconversion (SC) rate response
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

[Time Frame: Day 386]
56. Phase 3 portion: Specific antibody (IgG) response
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

[Time Frame: Day 21]
57. Phase 3 portion: Specific antibody (IgG) response
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

[Time Frame: Day 42]
58. Phase 3 portion: Specific antibody (IgG) response
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

[Time Frame: Day 201]
59. Phase 3 portion: Specific antibody (IgG) response
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

[Time Frame: Day 386]
60. Phase 3 portion: Neutralizing antibody titers: IgG ELISA antibody titers
In a subset of subjects, the ratio of neutralizing antibody titers:IgG ELISA antibody titers

[Time Frame: Day 21]
61. Phase 3 portion: Neutralizing antibody titers: IgG ELISA antibody titers
In a subset of subjects, the ratio of neutralizing antibody titers:IgG ELISA antibody titers

[Time Frame: Day 42]
62. Phase 3 portion: Neutralizing antibody titers: IgG ELISA antibody titers
In a subset of subjects, the ratio of neutralizing antibody titers:IgG ELISA antibody titers

[Time Frame: Day 201]
63. Phase 3 portion: Neutralizing antibody titers: IgG ELISA antibody titers
In a subset of subjects, the ratio of neutralizing antibody titers:IgG ELISA antibody titers

[Time Frame: Day 386]
64. Phase 3 portion: Specific Th1 cell-mediated immunity (CMI) response
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

[Time Frame: Day 21]
65. Phase 3 portion: Specific Th1 cell-mediated immunity (CMI) response
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

[Time Frame: Day 42]
66. Phase 3 portion: Specific Th1 cell-mediated immunity (CMI) response
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

[Time Frame: Day 201]
67. Phase 3 portion: Specific Th1 cell-mediated immunity (CMI) response
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

[Time Frame: Day 386]
68. Phase 3 portion: Specific Th2 cell-mediated immunity (CMI) response
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)

[Time Frame: Day 21]
69. Phase 3 portion: Specific Th2 cell-mediated immunity (CMI) response
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)

[Time Frame: Day 42]
70. Phase 3 portion: Specific Th2 cell-mediated immunity (CMI) response
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)

[Time Frame: Day 201]
71. Phase 3 portion: Specific Th2 cell-mediated immunity (CMI) response
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)

[Time Frame: Day 386]
72. Phase 3 portion: Specific cell-mediated immunity (CMI) response
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

[Time Frame: Day 0 to 42]
73. Phase 3 portion: Specific cell-mediated immunity (CMI) response
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

[Time Frame: Day 201 and 386]
74. Phase 2 portion: Laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection
First occurrence, in a subject, of laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection

[Time Frame: Day 35 to 386]
75. Phase 2 portion: Severe COVID-19 disease
Percentage of severe COVID-19 disease

[Time Frame: Day 35 14 to 386]
76. Phase 3 portion: Severe COVID-19 disease
Percentage of severe COVID-19 disease

[Time Frame: Day 35 14 to 386]
77. Phase 3 portion: COVID-19-related symptoms
Percentage and intensity of COVID-19-related symptoms

[Time Frame: 1 year]
78. Phase 3 portion: Laboratory-confirmed asymptomatic SARS-CoV-2 infection
Percentage of of laboratory-confirmed ( asymptomatic SARS-CoV-2 infection: confirmed by the ELISA method for the N protein ) asymptomatic SARS-CoV-2 infection

[Time Frame: Day 201]
79. Phase 3 portion: Laboratory-confirmed asymptomatic SARS-CoV-2 infection
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

[Time Frame: Day 201]
80. Phase 3 portion: Laboratory-confirmed asymptomatic SARS-CoV-2 infection
Percentage of of laboratory-confirmed ( asymptomatic SARS-CoV-2 infection: confirmed by the ELISA method for the N protein ) asymptomatic SARS-CoV-2 infection

[Time Frame: Day 386]
81. Phase 3 portion: Laboratory-confirmed asymptomatic SARS-CoV-2 infection
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

[Time Frame: Day 386]
82. Phase 3 portion: Laboratory-confirmed symptomatic SARS-CoV-2 infection
Percentage of of laboratory-confirmed asymptomatic SARS-CoV-2 infection: virologic method

[Time Frame: Day 14]
83. Phase 3 portion: Laboratory-confirmed symptomatic SARS-CoV-2 infection
Percentage of of laboratory-confirmed asymptomatic SARS-CoV-2 infection: virologic method

[Time Frame: Day 14 to 20]
84. Phase 3 portion: Laboratory-confirmed symptomatic SARS-CoV-2 infection
Percentage of of laboratory-confirmed asymptomatic SARS-CoV-2 infection: virologic method

[Time Frame: Day 21 to 28]
85. Phase 3 portion: Viral shedding after SARS-CoV-2 infection
Duration and intensity of viral shedding after SARS-CoV-2 infection

[Time Frame: 1 year]
Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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. At Screening (Visit 1) and Vaccination (Visit 2), subject must have a body mass index (BMI) of ≥ 18.5 and < 30 kg/m2;
  5. 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;
  6. 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.

  7. Study Populations #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;
  8. 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);
  9. 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) , with the exception of the following subjects: .

    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.
  10. 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;

  11. 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.
  12. 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.

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 I/II 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.
Contacts/Locations
Central Contact: Mary Hardison
Telephone: 19196660737
Email: mary.hardison@syneoshealth.com
Medicago Trial Inquiries
Telephone: 581-700-1977 Ext. 1111
Email: clinicalTrialInquiries@medicago.com
Study Officials: Brian Ward, MD
Study Director
Medicago
Locations: United States, Florida
Alliance for Multispecialty Research
[Recruiting]
Coral Gables, Florida, United States, 33134-4321
Contact: Maribel Hernandez 305-445-5637 maribel.hernandez@amrllc.com
Research Centers of America
[Recruiting]
Hollywood, Florida, United States, 33024
Contact: Katherine Ali 954-588-4500 Katherine.ali@rcatrials.com
United States, Nebraska
Meridian Clinical Research LLC
[Recruiting]
Norfolk, Nebraska, United States, 68701
Contact: Keith Vrbicky 402-933-6501 kvrbicky@mcrmed.com
Meridian Clinical Research LLC
[Recruiting]
Omaha, Nebraska, United States, 68134
Contact: Carissa Schejbal 402-934-7563 cschejbal@mcrmed.com
United States, Texas
DM Clinical Research/Martin Diagnostic Clinic
[Recruiting]
Tomball, Texas, United States, 77375
Contact: Earl Martin 281-517-0550 drearlfmartin@dmclinicalresearch.com
Canada, New Brunswick
IWK Health Centre- Dalhousie University-Canadian Center for Vaccinology
[Recruiting]
Halifax, New Brunswick, Canada, B3K 6R8
Contact: Jill Mutch 902-470-8141 jill.mutch@iwk.nshealth.ca
Canada, Ontario
Dawson Clinical Research Inc.
[Recruiting]
Guelph, Ontario, Canada, N1H 1B1
Contact: Marianne Roth (519) 222-8251 mroth@dawsonclinicalresearch.com
Canada, Quebec
Manna Research (Mirabel)
[Recruiting]
Mirabel, Quebec, Canada, J7J 2K8
Contact: Raphaël Brochu 438-399-0435 raphael.brochu@lmcmanna.com
McGill University Health Centre Vaccine Study Centre
[Recruiting]
Pierrefonds, Quebec, Canada, H9H 4Y6
Contact: Giuliana Aflonso 514 934 1934 Ext. 22832 giuliana.alfonso@muhc.mcgill.ca
CHU de Québec-Université Laval
[Recruiting]
Québec City, Quebec, Canada, G1E 7G9
Contact: Marc Dionne 418-666-7000 Ext. 10224 marc.dionne@crchudequebec.ulaval.ca
Diex Research Quebec Inc.
[Recruiting]
Québec, Quebec, Canada, G1N 4V3
Contact: Andre Frechette afrechette@diex.ca
Diex Recherche Joliette
[Recruiting]
Saint-Charles-Borromée, Quebec, Canada, J6E 2B4
Contact: Jean-Sebastien Paquette 579 841 0571 Jspaquette@diex.ca
Q&T Research Sherbrooke Inc.
[Recruiting]
Sherbrooke, Quebec, Canada, J1J 2G2
Contact: Audrey Jean 819-562-0777 Ext. 126 audrey.jean@qtresearch.com
IPDSharing
Plan to Share IPD:
References
Citations:
Links:
Available IPD/Information:

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