AzTrials
AzTrials

SARS-CoV-2 InfectionPhase 2/3NCT04636697

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

A Phase 2/3 study testing Intramuscular injection and Intramuscular vaccine in people with SARS-CoV-2 Infection, run by Medicago at 91 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
SARS-CoV-2 Infection
What is being tested?
Intramuscular injection and Intramuscular vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30,918 participants
Where
91 sitesin 6 countries
Study dates
19 Nov 2020to 30 Apr 2022
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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;
  • 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;
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  • 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;
  • 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.);
  • 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);
  • 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);
  • 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;
  • Administration of any other SARS-CoV-2 / COVID-19, or other experimental coronavirus vaccine at any time prior to or during the study;
  • History of virologically-confirmed COVID-19;
  • 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;
  • 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;
  • 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);
  • 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;
  • History of a serious allergic response to any of the constituents of CoVLP including AS03;
  • History of a documented anaphylactic reactions to plants or plant components (including tobacco, fruits and nuts);
  • Personal or family history of narcolepsy;
  • Subjects with a history of Guillain-Barré Syndrome;
  • Study Populations #1 and #3: Any female subject who has a positive or doubtful pregnancy test result prior to vaccination or who is lactating;
  • 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.

Trial locations and contacts

91 sites in 6 countries.

91 sites in 6 countries

United States45 sites

  • Benchmark Research

    Austin, Texas, 78705

  • Tekton Research

    Austin, Texas, 78745

  • Hassman Research Institute

    Berlin, New Jersey, 08009

  • Achieve Clinical Research, LLC dba Accel Research Sites

    Birmingham, Alabama, 35216

  • Hope Clinical Research

    Canoga Park, California, 91303

  • Affinity Health

    Chicago, Illinois, 60644

  • Velocity Clinical Research - Cincinnati

    Cincinnati, Ohio, 45242

  • Velocity Clinical Research

    Cleveland, Ohio, 44122

  • Aventiv Research Inc

    Columbus, Ohio, 43213

  • Alliance for Multispecialty Research

    Coral Gables, Florida, 33134-4321

  • Benchmark Research

    Covington, Louisiana, 70433

  • Global Medical Research

    Dallas, Texas, 75224

  • Meridian Clinical Research

    Endwell, New York, 13760

  • Carolina Institute for Clinical Research

    Fayetteville, North Carolina, 28303

  • Benchmark Research

    Fort Worth, Texas, 76135

  • Methodist Physicians

    Fremont, Nebraska, 68130

  • CNS Network

    Garden Grove, California, 92845

  • Ascension St. John Vaccine Research Unit

    Grosse Pointe Woods, Michigan, 48236

  • Research Centers of America

    Hollywood, Florida, 33024

  • Forte Family Practice/ CCT Research

    Las Vegas, Nevada, 89103

  • Excel Clinical Research

    Las Vegas, Nevada, 89109

  • Be Well Clinical Studies, LLC

    Lincoln, Nebraska, 68516

  • Long Beach Clinical Trial Services Inc.

    Long Beach, California, 90806-3221

  • AppleMed Research Inc

    Miami, Florida, 33155

  • ASR, LLC

    Nampa, Idaho, 83687

  • Pharmacology Research Institute

    Newport Beach, California, 92660

  • Meridian Clinical Research LLC

    Norfolk, Nebraska, 68701

  • Las Vegas Clinical Trials

    North Las Vegas, Nevada, 89030

  • South Ogden Family Medicine

    Ogden, Utah, 84405

  • Meridian Clinical Research LLC

    Omaha, Nebraska, 68134

  • Elixia COVID-19

    Palm Beach, Florida, 33410

  • Research Your Health

    Plano, Texas, 75093

  • M3 Wake Research, Inc

    Raleigh, North Carolina, 27612

  • Wr-McCr, Llc

    San Diego, California, 92108

  • Meridian Clinical Research

    Savannah, Georgia, 31406

  • Meridian Clinical Research

    Sioux City, Iowa, 51106

  • Mt. Olympus Medical Research, LLC

    Sugar Land, Texas, 77479

  • Sugar Lakes Family Practice

    Sugar Land, Texas, 77479

  • Precision Clinical Research

    Sunrise, Florida, 33351

  • Fiel Family and Sports Medicine/CCT

    Tempe, Arizona, 85283

  • DM Clinical Research/Martin Diagnostic Clinic

    Tomball, Texas, 77375

  • Velocity Clinical Research Providence

    Warwick, Rhode Island, 02886

  • Ascension Providence Health System

    Washington D.C., District of Columbia, 20017

  • Advanced Clinical Research, Inc.

    West Jordan, Utah, 84088

  • Trial Management Associates LLC

    Wilmington, North Carolina, 28403

Other trials in United States

Canada15 sites

  • Aggarwal and Associates Ltd

    Brampton, Ontario, L6T 0G1

  • Dawson Clinical Research Inc.

    Guelph, Ontario, N1H 1B1

  • IWK Health Centre- Dalhousie University-Canadian Center for Vaccinology

    Halifax, Nova Scotia, B3K 6R8

  • Manna Research (Quebec)

    Lévis, Quebec, G6W OM5

  • Manna Research (Mirabel)

    Mirabel, Quebec, J7J 2K8

  • SKDS Research Inc.

    Newmarket, Ontario, L3Y 5G8

  • McGill University Health Centre Vaccine Study Centre

    Pierrefonds, Quebec, H9H 4Y6

  • CHU de Québec-Université Laval

    Québec, Quebec, G1E 7G9

  • Diex Research Quebec Inc.

    Québec, Quebec, G1N 4V3

  • CARe Clinic

    Red Deer, Alberta, T4N 6V7

  • Diex Recherche Joliette

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • Q&T Research Sherbrooke Inc.

    Sherbrooke, Quebec, J1J 2G2

  • Diex Recherche Sherbrooke

    Sherbrooke, Quebec, J1L 0H8

  • LMC Clinical Research Inc. (CPU)

    Toronto, Ontario, M4G 3E8

  • Manna Research Toronto

    Toronto, Ontario, M9W 4L6

Other trials in Canada

United Kingdom12 sites

  • NHS Grampian

    Aberdeen, AB25 2ZD

  • Synexus Midlands Clinical Research Centre

    Birmingham, B15 2SQ

  • University Hospital Southampton NHS Foundation Trust (UHS)

    Bournemouth, BH7 7DW

  • Public Health Wales

    Cardiff, CF10 4BZ

  • Synexus Wales DRS

    Cardiff, CF15 9SS

  • Mid and South Essex NHS Foundation Trust

    Chelmsford, CM17ET

  • Synexus Lancashire DRS

    Chorley, PR7 7 NA

  • University Hospitals Derby and Burton

    Derby, DE22 3NE

  • London North West University Healthcare NHS Trust

    Harrow, HA1 3UJ

  • Kings College Hospital

    London, SE5 9PJ

  • Synexus Manchester DRS

    Manchester, M15 6SE

  • University of York/York Teaching Hospital

    York, YO31 8HE

Other trials in United Kingdom

Brazil7 sites

  • Instituto de Pesquisas Clinicas L2IP

    Brasília, 70200-730

  • Unidade Hospital do Rocio

    Campo Largo, 83606-177

  • Santa Casa De Misericordia De Belo Horizonte

    Minas Gerais, 30150-221

  • Centro de Pesquisa Clinica - Hospital Moinhos de Vento

    Porto Alegre, 90035-001

  • IBPClin Instituto Brasil de Pequisa Clinica

    Rio de Janeiro, 20241-180

  • Fundação Faculdade Regional de Medicina de Sao Jose do Rio Preto

    São Paulo, 15090-000

  • Azidus Brasil Pesquisa e Desenvolvimento Ltda

    Valinhos, 13271-130

Other trials in Brazil

Mexico7 sites

  • Investigación Biomédica para el Desarrollo de Fármacos, S.A. de C.V.

    Aguascalientes, 20010

  • Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C.

    Culiacán, 80230

  • Centro Multidisciplinario para el Desarrollo Especializado de la Investigación Clínica en Yucatan S.C.P. (CEMDEICY S.C.P.)

    Mérida, 97130

  • RM Pharma Specialists S.A. de C.V.

    Mexico City, 3100

  • Integra RGH Centro de Investigacion, Clinica de Ozonoterapia RGH AC

    Puebla City, 72410

  • Sociedad de Metabolismo y Corazon S.C (SOMECO)

    Veracruz, 91900

  • Investigación Biomédica para el Desarrollo de Fármacos, S.A. de C.V.

    Zapopan, 45070

Other trials in Mexico

Argentina5 sites

  • Mautalen Salud e Investigación (Expertia SA)

    Buenos Aires, C1128AAF

  • Fundación FunDaMos

    Buenos Aires, C1405BOA

  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

    Buenos Aires, C1426

  • Sanatorio Allende

    Córdoba, 5000

  • Clinica Mayo de UMCB SRL

    San Miguel de Tucumán, T4000

Other trials in Argentina

About this study

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

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.

Being tested
Intramuscular injection, Intramuscular vaccine
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intramuscular injectionDrug

    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)

  • Intramuscular vaccineBiological

    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 groups in NCT04636697
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo (0.5 mL)
Receives: Drug: Intramuscular injection
3.75 µg of CoVLP Vaccine adjuvantedExperimental3.75 µg of CoVLP adjuvanted vaccine with AS03 adjuvant (0.5 mL)
Receives: Biological: Intramuscular vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 2 portion: Immediate adverse event (AEs)

    Percentage, intensity, and relationship to vaccination of immediate AEs

    Measured: 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

    Measured: 7 days

  3. Phase 2 portion: Unsolicited adverse events (AEs)

    Percentage, intensity, and relationship of unsolicited AEs

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 21 days

  11. Phase 2 portion: Neutralizing antibody (Nab assay) response

    Nab response induced in each Study Population against the SARS-CoV-2 virus

    Measured: Day 21

  12. Phase 2 portion: Neutralizing antibody (Nab assay) response

    Nab response induced in each Study Population against the SARS-CoV-2 virus

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Day 28 and after

Secondary outcomes (64)

  1. Phase 2 portion: Solicited local and systemic AEs (populations 1 and 2)

    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);

    Measured: 7 days

  2. Phase 2 portion: Solicited local and systemic AEs (populations 1, 2 and 3)

    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)

    Measured: 7 days

  3. Phase 2 portion: Serious adverse events (SAEs), medically attended adverse events (MAAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESI) (including vaccine-enhanced disease) and deaths

    Percentage of SAEs, MAAEs, AEs leading to withdrawal, AESIs (including VED), and deaths

    Measured: Day 43 to 386

  4. Phase 3 portion: Immediate adverse event (AEs)

    Percentage, intensity, and relationship to vaccination of immediate AEs

    Measured: 30 minutes

  5. Phase 3 portion: Solicited local and systemic AEs

    Percentage, intensity, and relationship to vaccination of solicited local and systemic AEs

    Measured: 7 days

  6. Phase 3 portion: Unsolicited adverse events (AEs)

    Percentage, intensity, and relationship of unsolicited AEs

    Measured: 21 days

  7. 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

    Measured: Day 0 to 386

  8. Phase 2 portion: Neutralizing antibody Geometric mean tiers (GMT) response (populations 1 and 2)

    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)

    Measured: 21 days

  9. Phase 2 portion: Neutralizing antibody Geometric mean tiers (GMT) response (populations 1, 2 and 3)

    • 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)

    Measured: 21 days

  10. 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

    Measured: Day 128

  11. 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

    Measured: Day 201

  12. 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

    Measured: Day 386

  13. 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

    Measured: Day 128

  14. 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

    Measured: Day 201

  15. 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

    Measured: Day 386

  16. Phase 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers

    The ratio of neutralizing antibody titers:IgG ELISA antibody titers

    Measured: Day 21

  17. Phase 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers

    The ratio of neutralizing antibody titers:IgG ELISA antibody titers

    Measured: Day 42

  18. Phase 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers

    The ratio of neutralizing antibody titers:IgG ELISA antibody titers

    Measured: Day 128

  19. Phase 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers

    The ratio of neutralizing antibody titers:IgG ELISA antibody titers

    Measured: Day 201

  20. Phase 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers

    The ratio of neutralizing antibody titers:IgG ELISA antibody titers

    Measured: Day 386

  21. 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

    Measured: Day 201

  22. 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

    Measured: Day 386

  23. 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)

    Measured: Day 21

  24. 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)

    Measured: Day 42

  25. 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)

    Measured: Day 201

  26. 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)

    Measured: Day 386

  27. 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)

    Measured: Day 21

  28. 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

    Measured: Day 21

  29. 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)

    Measured: Day 21

  30. 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)

    Measured: Day 42

  31. 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

    Measured: Day 42

  32. 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)

    Measured: Day 42

  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)

    Measured: Day 201

  34. 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)

    Measured: Day 201

  35. 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

    Measured: Day 201

  36. 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)

    Measured: Day 386

  37. 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)

    Measured: Day 386

  38. 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

    Measured: Day 386

  39. 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

    Measured: Day 21

  40. 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

    Measured: Day 42

  41. 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

    Measured: Day 201

  42. 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

    Measured: Day 386

  43. 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

    Measured: Day 21

  44. 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

    Measured: Day 42

  45. 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

    Measured: Day 201

  46. 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

    Measured: Day 386

  47. 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

    Measured: Day 21

  48. 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

    Measured: Day 42

  49. 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

    Measured: Day 201

  50. 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

    Measured: Day 386

  51. 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)

    Measured: Day 21

  52. 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)

    Measured: Day 42

  53. 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)

    Measured: Day 201

  54. 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)

    Measured: Day 386

  55. 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

    Measured: Day 28 to 386

  56. Phase 2 portion: Severe COVID-19 disease

    Percentage of severe COVID-19 disease

    Measured: Day 28 to 386

  57. Phase 3 portion: Severe COVID-19 disease

    Percentage of severe COVID-19 disease

    Measured: Day 28 to 386

  58. Phase 3 portion: COVID-19-related symptoms in virologically-confirmed cases

    Percentage and intensity of COVID-19-related symptoms

    Measured: through efficacy analysis, approximately 4 months

  59. Phase 3 portion: Laboratory-confirmed asymptomatic SARS-CoV-2 infection

    Percentage of laboratory-confirmed asymptomatic SARS-CoV-2 infection: confirmed by the ELISA method for the N protein

    Measured: Day 201

  60. Phase 3 portion: Laboratory-confirmed symptomatic SARS-CoV-2 infection

    First occurence, in a subject, of laboratory-confirmed symptomatic SARS-CoV-2 infection: virologic method

    Measured: through efficacy analysis, approximately 4 months

  61. Phase 3 portion: Laboratory-confirmed symptomatic SARS-CoV-2 infection

    First occurence, in a subject, of laboratory-confirmed symptomatic SARS-CoV-2 infection: virologic method

    Measured: Day 0 to 21

  62. Phase 3 portion: Laboratory-confirmed symptomatic SARS-CoV-2 infection

    First occurence, in a subject, of laboratory-confirmed symptomatic SARS-CoV-2 infection: virologic method

    Measured: Day 21 to 28

  63. Phase 3 portion: Viral shedding after SARS-CoV-2 infection

    Duration and intensity of viral shedding after SARS-CoV-2 infection

    Measured: through efficacy analysis, approximately 4 months

  64. Phase 3 portion: Laboratory-confirmed symptomatic SARS-CoV-2 infection (by strain)

    First occurrence, in a subject, of laboratory-confirmed symptomatic SARS-CoV-2 infection by strain: virologic method

    Measured: through efficacy analysis, approximately 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2020
  2. Study start19 Nov 2020
  3. Primary completion25 Aug 2021
  4. Study completion30 Apr 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30,918 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04636697
Sponsor's protocol ID
CP-PRO-CoVLP-021
Status last verified
Jun 2021
First submitted
12 Nov 2020
Last updated
6 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Hager KJ, Perez Marc G, Gobeil P, Diaz RS, Heizer G, Llapur C, Makarkov AI, Vasconcellos E, Pillet S, Riera F, Saxena P, Geller Wolff P, Bhutada K, Wallace G, Aazami H, Jones CE, Polack FP, Ferrara L, Atkins J, Boulay I, Dhaliwall J, Charland N, Couture MMJ, Jiang-Wright J, Landry N, Lapointe S, Lorin A, Mahmood A, Moulton LH, Pahmer E, Parent J, Seguin A, Tran L, Breuer T, Ceregido MA, Koutsoukos M, Roman F, Namba J, D'Aoust MA, Trepanier S, Kimura Y, Ward BJ; CoVLP Study Team. Efficacy and Safety of a Recombinant Plant-Based Adjuvanted Covid-19 Vaccine. N Engl J Med. 2022 Jun 2;386(22):2084-2096. doi: 10.1056/NEJMoa2201300. Epub 2022 May 4.

    PubMed 35507508

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Intramuscular injection and Intramuscular vaccine in people with SARS-CoV-2 Infection, run by Medicago at 91 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States, Canada, United Kingdom, Brazil, Mexico and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 2 portion: Immediate adverse event (AEs) (time frame: 30 minutes). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04636697, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.

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