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History of Changes for Study: NCT04636697
Study of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults
Latest version (submitted October 30, 2022) 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
7 March 25, 2021 Study Status, References and Contacts/Locations
8 April 2, 2021 Contacts/Locations and Study Status
9 April 12, 2021 Contacts/Locations and Study Status
10 April 20, 2021 Contacts/Locations and Study Status
11 April 23, 2021 Contacts/Locations and Study Status
12 April 30, 2021 Contacts/Locations and Study Status
13 May 10, 2021 Contacts/Locations and Study Status
14 May 14, 2021 Contacts/Locations and Study Status
15 May 21, 2021 Contacts/Locations and Study Status
16 July 15, 2021 Outcome Measures, Contacts/Locations and Study Status
17 August 9, 2021 Contacts/Locations and Study Status
18 August 17, 2021 Contacts/Locations and Study Status
19 August 23, 2021 Contacts/Locations and Study Status
20 September 7, 2021 Recruitment Status, Contacts/Locations and Study Status
21 April 4, 2022 Study Status
22 October 30, 2022
Quality Control Review has not concluded Returned: November 22, 2022
Recruitment Status, Study Status, Outcome Measures, Document Section, Results and Study Design
Comparison Format:

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Study NCT04636697
Submitted Date:  November 18, 2020 (v1)

Open or close this module 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:
Open or close this module Study Status
Record Verification: November 2020
Overall Status: Not yet 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:
November 18, 2020
Last Update Posted: November 19, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Medicago
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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:
Open or close this module Conditions
Conditions: SARS-CoV-2 Infection
Keywords:
Open or close this module 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 [Anticipated]
Open or close this module 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)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Phase 2 portion: Immediate adverse event (AEs)
[ Time Frame: 30 minutes ]

Percentage, intensity, and relationship to vaccination of immediate AEs
2. 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
3. Phase 2 portion: Unsolicited adverse events (AEs)
[ Time Frame: 21 days ]

Percentage, intensity, and relationship of unsolicited AEs
4. 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
5. 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
6. 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
7. 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
8. 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
9. 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
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
[ Time Frame: 21 days ]

Percentage of SAEs, MAAEs, AEs leading to withdrawal, AESIs (including VED), and deaths
11. 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
12. 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
13. 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
14. 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
15. 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
Secondary Outcome Measures:
1. 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);
2. 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
3. Phase 3 portion: Immediate adverse event (AEs)
[ Time Frame: 30 minutes ]

Percentage, intensity, and relationship to vaccination of immediate AEs
4. Phase 3 portion: Solicited local and systemic AEs
[ Time Frame: 7 days ]

Percentage, intensity, and relationship to vaccination of solicited local and systemic AEs
5. Phase 3 portion: Unsolicited adverse events (AEs)
[ Time Frame: 21 days ]

Percentage, intensity, and relationship of unsolicited AEs
6. 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
7. 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)
8. 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
9. 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
10. 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
11. 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
12. 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
13. 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
14. Phase 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers
[ Time Frame: Day 128 ]

The ratio of neutralizing antibody titers:IgG ELISA antibody titers
15. Phase 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers
[ Time Frame: Day 201 ]

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

The ratio of neutralizing antibody titers:IgG ELISA antibody titers
17. 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
18. 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
19. 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)
20. 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)
21. 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)
22. 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)
23. 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)
24. 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
25. 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)
26. 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)
27. 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
28. 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)
29. 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)
30. 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
31. 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)
32. 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)
33. 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)
34. 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
35. 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)
36. 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)
37. 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
38. 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
39. 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
40. 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
41. 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
42. 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
43. 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
44. 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
45. 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
46. 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
47. 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
48. 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
49. 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
50. 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
51. 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
52. 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)
53. 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)
54. 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)
55. 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)
56. 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
57. 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
58. 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
59. Phase 2 portion: Severe COVID-19 disease
[ Time Frame: Day 35 to 386 ]

Percentage of severe COVID-19 disease
60. 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
61. 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
62. Phase 3 portion: Severe COVID-19 disease
[ Time Frame: Day 35 to 386 ]

Percentage of severe COVID-19 disease
63. Phase 3 portion: COVID-19-related symptoms
[ Time Frame: 1 year ]

Percentage and intensity of COVID-19-related symptoms
Open or close this module 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;
  3. At Screening (Visit 1) and Vaccination (Visit 2), subject must have a body mass index (BMI) of ≥ 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 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;
  6. Study Populations #1: Female subjects of childbearing potential must have a negative serum pregnancy test result at Screening (Visit 1) and a negative urine pregnancy test result at Vaccination (Visit 2):

    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: 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.
  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.

Exclusion Criteria:

  1. 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. Any chronic medical condition associated with elevated risk of severe outcomes of COVID-19, including obesity, diabetes (type I/II), significant cardiovascular or respiratory disease including asthma, chronic renal failure, disorders of bleeding/coagulation, chronic inflammatory or autoimmune conditions, immunosuppressive conditions (including HIV), and hypertension;
  3. 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. 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. 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. 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;
  7. Administration of any other SARS-CoV-2 / COVID-19, or other experimental coronavirus vaccine at any time prior to or during the study;
  8. 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;
  9. 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;
  10. 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);
  11. 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;
  12. History of a serious allergic response to any of the constituents of CoVLP including AS03;
  13. History of a documented anaphylactic reactions to plants or plant components (including tobacco, fruits and nuts);
  14. Family history of narcolepsy;
  15. Subjects with a history of Guillain-Barré Syndrome;
  16. Study Populations #1: Any female subject who has a positive or doubtful pregnancy test result prior to vaccination or who is lactating;
  17. 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.
Open or close this module Contacts/Locations
Central Contact Person: Mary Hardison
Telephone: 19196660737
Email: mary.hardison@syneoshealth.com
Study Officials: Brian Ward, MD
Study Director
Medicago
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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