Covid-19 MedDRA version: 23.1 Level: LLT Classification code 10084465 Term: COVID-19 vaccination System Organ Class: 100000004865
Conditions
Interventions
Product Name: Coronavirus-Like Particle COVID-19 Vaccine
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: SARS-COV-2, VIRUS-LIKE-PARTICLES
Current Sponsor code: CoVLP
Other descripti
Sponsors
Medicago R&D Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria at the Screening (Visit 1) and/or Vaccination (Visit 2) visits to be eligible for participation in this study; no protocol waivers are allowed. All Investigator assessment-based judgements must be carefully and fully documented in the source documents: 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), study populations #1 and #2 must have a body mass index (BMI) of = 18.5 and < 30 kg/m2 for the Phase 2 portion of the study and a BMI of = 18.5 and < 35 kg/m2 for the Phase 3 portion of the study; 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 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
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria at the Screening (Visit 1) and/or Vaccination (Visit 2) visits will not be eligible for participation in this study; no protocol waivers are allowed. All Investigator assessment-based judgements must be thoroughly documented in the source documents: 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), 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. 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 diseasefree 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase 3 portion The primary objective of the Phase 3 portion of the study is: Efficacy: • To evaluate the efficacy of the CoVLP formulation, compared to placebo, in the prevention of laboratory confirmed symptomatic SARS-CoV-2 infection (virologic method) starting 7 days after the second vaccination in Period 1 and prior to the cross-over.;Secondary Objective: Phase 3 portion The secondary objectives of the Phase 3 portion of the study are: Efficacy: • To evaluate the efficacy of the CoVLP formulation, compared to placebo, in the prevention of laboratory confirmed asymptomatic SARS-CoV-2 infection (serologic method) starting 7 days after the second vaccination in Period 1 and prior to the cross-over; • To evaluate the efficacy of the CoVLP formulation, compared to placebo, in the prevention of severe COVID-19 disease starting 7 days after the second vaccination in Period 1 and prior to the cross-over; Please refer the protocol for further details. Immunogenicity: • To assess the immunogenicity of the CoVLP formulation, compared to placebo, in a subset of subjects, as determined by the protocol Safety: • To assess the safety and tolerability of the CoVLP formulation, compared to placebo, up to the end of the study.;Primary end point(s): Phase 2 portion In the Phase 2 portion, the primary endpoints are: Safety: • Occurrence, intensity, and relationship to vaccination of immediate AEs (30 minutes after each vaccination); • Occurrence and intensity of solicited local and systemic AEs (for seven days following each vaccine administration); • Occurrence, intensity, and relationship of unsolicited AEs for 21 days following each vaccine administration; • Number and percentage of subjects with normal and abnormal clinically significant urine, haematological and biochemical values prior to and three days following each vaccination; • Occurrences of SAEs, MAAEs, AEs leading to withdrawal, AESIs (including VED), and deaths up to 21 days following each vaccine | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase 2 portion In the Phase 2 portion, the secondary endpoints are: Immunogenicity: • Relative neutralizing antibody response between the healthy adults (Study Population #1) and the healthy elderly populations (Study Population #2; each age strata) induced at 21 days after the second vaccination will be analyzed using the following parameter: GMT; • Relative neutralizing antibody response for the combination of healthy adults (Study Population #1) and healthy elderly adults (Study Population #2) compared to adults and elderly adults with significant comorbidities (Study Population #3) induced at 21 days after the second vaccination will be analyzed using the following parameter: GMT; • Persistence of the Nab antibody response induced in each Study Population against the SARS-CoV-2 virus at Day 128, Day 201, and Day 386 will be analyzed using the following parameters: GMT, SC rate, and GMFR; • Specific antibody response induced in each Study Population against the SARS-CoV-2 virus will be measured by the total IgG levels on Days 0, 21, and 42, and the persistence of these antibodies at Days 128, 201, and 386 and analyzed using the following parameters: GMT, SC rate, and GMFR; • The ratio of neutralizing antibody titers: IgG (ELISA) antibody titers at Day 21, Day 42, Day 128, Day 201, and Day 386; • Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 virus on Day 201 and Day 386, as measured by IFN-? ELISpot; • Specific T helper 2 (Th2) CMI response induced in each Study Population against the SARS-CoV-2 virus on Days 0, 21, 42, 201, and 386, as measured by IL-4 ELISpot; Safety: • Relative occurrence of solicited local and systemic AEs by intensity grades for seven days following each vaccine administration between the healthy adults (Study Population #1) and each healthy elderly population (Study Population #2); • Relative occurrence of solicited local and systemic AEs by intensity grades for seven days followi | — |
Countries
Argentina, Brazil, Canada, Colombia, Hungary, Mexico, Peru, Poland, Spain, United Kingdom, United States
Contacts
Public ContactMedicago Trial Inquiries
Medicago R&D Inc.
Outcome results
None listed