Clinical trial NCT04636697: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: SARS-CoV-2 Infection
Lead sponsor: Medicago
Sponsor class: INDUSTRY
First posted: 2020-11-19
Enrollment: 30918
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

   All regions except Canada: Note: Subjects with a pre-existing chronic disease will be allowed to participate if the disease is stable and, according to the Investigator's judgment that must be documented in the source documents, the condition is unlikely to confound the results of the study or pose additional risk to the subject by participating in the study. Stable disease is generally defined as no new onset or exacerbation of pre-existing chronic disease three months prior to vaccination. Based on the Investigator's judgment, a subject with more recent stabilization of a disease could also be eligible.
6. Study Populations #1 and #3: Female subjects of childbearing potential must have a negative serum pregnancy test result at Screening (Visit 1 for the Phase 2 portion) and/or a negative urine pregnancy test result at Vaccination (Visit 2 for the Phase 2 portion; Visit 1 for the Phase 3 portion):

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

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

   All regions except Canada: Note: Subjects with a pre-existing chronic disease will be allowed to participate if the disease is stable and, according to the Investigator's judgment that must be documented in the source documents, the condition is unlikely to confound the results of the study or pose additional risk to the subject by participating in the study. Stable disease is generally defined as no new onset or exacerbation of pre-existing chronic disease three months prior to vaccination. Based on the Investigator's judgment and documented in source documentation, a subject with more recent stabilization of a disease could also be eligible;
9. Study Population #3: Subjects must have one or more co-morbid conditions that puts them at higher risk for severe COVID-19 disease. These comorbidities include but are not limited to obesity, hypertension, type 1 or type 2 diabetes, chronic obstructive pulmonary disease (COPD), cardiovascular diseases, chronic kidney diseases, or be immunocompromised persons (e.g., treatment-controlled HIV infection, organ transplant recipients, or patients receiving cancer chemotherapy). Investigator discretion will be permitted with this inclusion criterion.

Exclusion criteria:

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

   Acute disease is defined as presence of any moderate or severe acute illness with or without a fever within 48 hours prior to the Screening (Visit 1) and/or Vaccination visit (Visit 2). 'Uncontrolled' is defined as:
   * Requiring a new medical or surgical treatment during the three months prior to study vaccine administration;
   * Requiring any significant change in a chronic medication (i.e. drug, dose, frequency) during the three months prior to study vaccine administration due to uncontrolled symptoms or drug toxicity unless the innocuous nature of the medication change meets the criteria outlined in inclusion criterion no. 5 (Study Population #1) or no. 8 (Study Population #2) and is appropriately justified and documented by the Investigator.

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

   * Systemic glucocorticoids at a dose exceeding 10 mg of prednisone (or equivalent) per day for more than seven consecutive days or for 10 or more days in total, within one month prior to the Vaccination visit (Visit 2). Inhaled, nasal, ophthalmic, dermatological, and other topical glucocorticoids are permitted;
   * Cytotoxic, antineoplastic, or immunosuppressant drugs - within 36 months prior to Vaccination (Visit 2);
   * Any immunoglobulin preparations or blood products, blood transfusion - within 6 months prior to Vaccination (Visit 2);
6. Study Population #3: Acute disease defined as presence of any moderate or severe acute illness with or without a fever within 48 hours prior to the Screening (Visit 1) and/or Vaccination visit (Visit 2);
7. Administration of any vaccine within 14 days prior to Vaccination (Visit 2); planned administration of any vaccine during the study (up to Day 28 of the study). Immunization on an emergency basis during the study will be evaluated on case-by-case basis by the Investigator;
8. Administration of any other SARS-CoV-2 / COVID-19, or other experimental coronavirus vaccine at any time prior to or during the study;
9. History of virologically-confirmed COVID-19;
10. Use of any investigational or non-registered product within 30 days or 5 half-lives, whichever is longer, prior to Vaccination (Visit 2) or planned use during the study period. Subjects who are in a prolonged post-administration observation period of another investigational or marketed drug clinical study, for which there is no ongoing exposure to the investigational or marketed product and all scheduled on-site visits are completed, will be allowed to take part in this study, if all other eligibility criteria are met;
11. Have a rash, dermatological condition, tattoos, muscle mass, or any other abnormalities at injection site that may interfere with injection site reaction rating. Investigator discretion will be permitted with this exclusion criterion;
12. Use of any prescription antiviral drugs with the intention of COVID-19 prophylaxis, including those that are thought to be effective for prevention of COVID-19 but have not been licensed for this indication, within one month prior to Vaccination (Visit 2);
13. For the Phase 2 portion of the study only: Use of prophylactic medications (e.g. antihistamines \[H1 receptor antagonists\], nonsteroidal anti-inflammatory drugs \[NSAIDs\], systemic and topical glucocorticoids, non-opioid and opioid analgesics) within 24 hours prior to the Vaccination (Visit 2) to prevent or pre-empt symptoms due to vaccination;
14. History of a serious allergic response to any of the constituents of CoVLP including AS03;
15. History of a documented anaphylactic reactions to plants or plant components (including tobacco, fruits and nuts);
16. Personal or family history of narcolepsy;
17. Subjects with a history of Guillain-Barré Syndrome;
18. Study Populations #1 and #3: Any female subject who has a positive or doubtful pregnancy test result prior to vaccination or who is lactating;
19. Subjects identified as an Investigator or employee of the Investigator or clinical site with direct involvement in the proposed study, or identified as an immediate family member (i.e. parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study, or any employees of Medicago.

Primary outcomes:
measure: Phase 2 portion: Immediate adverse event (AEs)
timeFrame: 30 minutes
measure: Phase 2 portion: Solicited local and systemic adverse events (AEs)
timeFrame: 7 days
measure: Phase 2 portion: Unsolicited adverse events (AEs)
timeFrame: 21 days
measure: Phase 2 portion: Number of subjects with normal and abnormal clinically significant urine values
timeFrame: 3 days
measure: Phase 2 portion: Number of subjects with normal and abnormal clinically significant haematological values
timeFrame: 3 days
measure: Phase 2 portion: Number of subjects with normal and abnormal clinically significant biochemical values
timeFrame: 3 days
measure: Phase 2 portion: Percentage of subjects with normal and abnormal clinically significant urine values
timeFrame: 3 days
measure: Phase 2 portion: Percentage of subjects with normal and abnormal clinically significant haematological values
timeFrame: 3 days
measure: Phase 2 portion: Percentage of subjects with normal and abnormal clinically biochemical values
timeFrame: 3 days
measure: 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
timeFrame: 21 days
measure: Phase 2 portion: Neutralizing antibody (Nab assay) response
timeFrame: Day 21
measure: Phase 2 portion: Neutralizing antibody (Nab assay) response
timeFrame: Day 42
measure: Phase 2 portion:Specific Th1 cell-mediated immunity (CMI) response
timeFrame: Day 21
measure: Phase 2 portion:Specific Th1 cell-mediated immunity (CMI) response
timeFrame: Day 42
measure: Phase 3 portion: Laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection
timeFrame: Day 28 and after
Secondary outcomes:
measure: Phase 2 portion: Solicited local and systemic AEs (populations 1 and 2)
timeFrame: 7 days
measure: Phase 2 portion: Solicited local and systemic AEs (populations 1, 2 and 3)
timeFrame: 7 days
measure: 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
timeFrame: Day 43 to 386
measure: Phase 3 portion: Immediate adverse event (AEs)
timeFrame: 30 minutes
measure: Phase 3 portion: Solicited local and systemic AEs
timeFrame: 7 days
measure: Phase 3 portion: Unsolicited adverse events (AEs)
timeFrame: 21 days
measure: 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
timeFrame: Day 0 to 386
measure: Phase 2 portion: Neutralizing antibody Geometric mean tiers (GMT) response (populations 1 and 2)
timeFrame: 21 days
measure: Phase 2 portion: Neutralizing antibody Geometric mean tiers (GMT) response (populations 1, 2 and 3)
timeFrame: 21 days
measure: Phase 2 portion: Neutralizing antibody (Nab assay) response
timeFrame: Day 128
measure: Phase 2 portion: Neutralizing antibody (Nab assay) response
timeFrame: Day 201
measure: Phase 2 portion: Neutralizing antibody (Nab assay) response
timeFrame: Day 386
measure: Phase 2 portion: Specific antibody (IgG) response
timeFrame: Day 128
measure: Phase 2 portion: Specific antibody (IgG) response
timeFrame: Day 201
measure: Phase 2 portion: Specific antibody (IgG) response
timeFrame: Day 386
measure: Phase 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers
timeFrame: Day 21
measure: Phase 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers
timeFrame: Day 42
measure: Phase 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers
timeFrame: Day 128
measure: Phase 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers
timeFrame: Day 201
measure: Phase 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers
timeFrame: Day 386
measure: Phase 2 portion: Specific Th1 cell-mediated immunity (CMI) response
timeFrame: Day 201
measure: Phase 2 portion: Specific Th1 cell-mediated immunity (CMI) response
timeFrame: Day 386
measure: Phase 2 portion: Specific Th2 cell-mediated immunity (CMI) response
timeFrame: Day 21
measure: Phase 2 portion: Specific Th2 cell-mediated immunity (CMI) response
timeFrame: Day 42
measure: Phase 2 portion: Specific Th2 cell-mediated immunity (CMI) response
timeFrame: Day 201
measure: Phase 2 portion: Specific Th2 cell-mediated immunity (CMI) response
timeFrame: Day 386
measure: Phase 3 portion: Neutralizing antibody Geometric mean titers (GMT) response
timeFrame: Day 21
measure: Phase 3 portion: Neutralizing antibody Seroconversion (SC) rate response
timeFrame: Day 21
measure: Phase 3 portion: Neutralizing antibody Geometric mean fold rise (GMFR) response
timeFrame: Day 21
measure: Phase 3 portion: Neutralizing antibody Geometric mean titers (GMT) response
timeFrame: Day 42
measure: Phase 3 portion: Neutralizing antibody Seroconversion (SC) rate response
timeFrame: Day 42
measure: Phase 3 portion: Neutralizing antibody Geometric mean fold rise (GMFR) response
timeFrame: Day 42
measure: Phase 3 portion: Neutralizing antibody Geometric mean fold rise (GMFR) response
timeFrame: Day 201
measure: Phase 3 portion: Neutralizing antibody Geometric mean titers (GMT)
timeFrame: Day 201
measure: Phase 3 portion: Neutralizing antibody Seroconversion (SC) rate response
timeFrame: Day 201
measure: Phase 3 portion: Neutralizing antibody Geometric mean fold rise (GMFR) response
timeFrame: Day 386
measure: Phase 3 portion: Neutralizing antibody Geometric mean titers (GMT) response
timeFrame: Day 386
measure: Phase 3 portion: Neutralizing antibody Seroconversion (SC) rate response
timeFrame: Day 386
measure: Phase 3 portion: Specific antibody (IgG) response
timeFrame: Day 21
measure: Phase 3 portion: Specific antibody (IgG) response
timeFrame: Day 42
measure: Phase 3 portion: Specific antibody (IgG) response
timeFrame: Day 201
measure: Phase 3 portion: Specific antibody (IgG) response
timeFrame: Day 386
measure: Phase 3 portion: Neutralizing antibody titers: IgG ELISA antibody titers
timeFrame: Day 21
measure: Phase 3 portion: Neutralizing antibody titers: IgG ELISA antibody titers
timeFrame: Day 42
measure: Phase 3 portion: Neutralizing antibody titers: IgG ELISA antibody titers
timeFrame: Day 201
measure: Phase 3 portion: Neutralizing antibody titers: IgG ELISA antibody titers
timeFrame: Day 386
measure: Phase 3 portion: Specific Th1 cell-mediated immunity (CMI) response
timeFrame: Day 21
measure: Phase 3 portion: Specific Th1 cell-mediated immunity (CMI) response
timeFrame: Day 42
measure: Phase 3 portion: Specific Th1 cell-mediated immunity (CMI) response
timeFrame: Day 201
measure: Phase 3 portion: Specific Th1 cell-mediated immunity (CMI) response
timeFrame: Day 386
measure: Phase 3 portion: Specific Th2 cell-mediated immunity (CMI) response
timeFrame: Day 21
measure: Phase 3 portion: Specific Th2 cell-mediated immunity (CMI) response
timeFrame: Day 42
measure: Phase 3 portion: Specific Th2 cell-mediated immunity (CMI) response
timeFrame: Day 201
measure: Phase 3 portion: Specific Th2 cell-mediated immunity (CMI) response
timeFrame: Day 386
measure: Phase 2 portion: Laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection
timeFrame: Day 28 to 386
measure: Phase 2 portion: Severe COVID-19 disease
timeFrame: Day 28 to 386
measure: Phase 3 portion: Severe COVID-19 disease
timeFrame: Day 28 to 386
measure: Phase 3 portion: COVID-19-related symptoms in virologically-confirmed cases
timeFrame: through efficacy analysis, approximately 4 months
measure: Phase 3 portion: Laboratory-confirmed asymptomatic SARS-CoV-2 infection
timeFrame: Day 201
measure: Phase 3 portion: Laboratory-confirmed symptomatic SARS-CoV-2 infection
timeFrame: through efficacy analysis, approximately 4 months
measure: Phase 3 portion: Laboratory-confirmed symptomatic SARS-CoV-2 infection
timeFrame: Day 0 to 21
measure: Phase 3 portion: Laboratory-confirmed symptomatic SARS-CoV-2 infection
timeFrame: Day 21 to 28
measure: Phase 3 portion: Viral shedding after SARS-CoV-2 infection
timeFrame: through efficacy analysis, approximately 4 months
measure: Phase 3 portion: Laboratory-confirmed symptomatic SARS-CoV-2 infection (by strain)
timeFrame: through efficacy analysis, approximately 4 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC dba Accel Research Sites
state: Alabama
city: Tempe
country: United States
facility: Fiel Family and Sports Medicine/CCT
state: Arizona
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Garden Grove
country: United States
facility: CNS Network
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trial Services Inc.
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: San Diego
country: United States
facility: Wr-McCr, Llc
state: California
city: Washington
country: United States
facility: Ascension Providence Health System
state: District of Columbia
city: Coral Gables
country: United States
facility: Alliance for Multispecialty Research
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America
state: Florida
city: Miami
country: United States
facility: AppleMed Research Inc
state: Florida
city: Palm Beach
country: United States
facility: Elixia COVID-19
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research
state: Florida
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Nampa
country: United States
facility: ASR, LLC
state: Idaho
city: Chicago
country: United States
facility: Affinity Health
state: Illinois
city: Sioux City
country: United States
facility: Meridian Clinical Research
state: Iowa
city: Covington
country: United States
facility: Benchmark Research
state: Louisiana
city: Grosse Pointe Woods
country: United States
facility: Ascension St. John Vaccine Research Unit
state: Michigan
city: Fremont
country: United States
facility: Methodist Physicians
state: Nebraska
city: Lincoln
country: United States
facility: Be Well Clinical Studies, LLC
state: Nebraska
city: Norfolk
country: United States
facility: Meridian Clinical Research LLC
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Forte Family Practice/ CCT Research
state: Nevada
city: Las Vegas
country: United States
facility: Excel Clinical Research
state: Nevada
city: North Las Vegas
country: United States
facility: Las Vegas Clinical Trials
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Endwell
country: United States
facility: Meridian Clinical Research
state: New York
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research, Inc
state: North Carolina
city: Wilmington
country: United States
facility: Trial Management Associates LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Velocity Clinical Research - Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Velocity Clinical Research
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research Inc
state: Ohio
city: Warwick
country: United States
facility: Velocity Clinical Research Providence
state: Rhode Island
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Austin
country: United States
facility: Tekton Research
state: Texas
city: Dallas
country: United States
facility: Global Medical Research
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
city: Plano
country: United States
facility: Research Your Health
state: Texas
city: Sugar Land
country: United States
facility: Mt. Olympus Medical Research, LLC
state: Texas
city: Sugar Land
country: United States
facility: Sugar Lakes Family Practice
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research/Martin Diagnostic Clinic
state: Texas
city: Ogden
country: United States
facility: South Ogden Family Medicine
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research, Inc.
state: Utah
city: Buenos Aires
country: Argentina
facility: Mautalen Salud e Investigación (Expertia SA)
city: Buenos Aires
country: Argentina
facility: Fundación FunDaMos
city: Buenos Aires
country: Argentina
facility: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
city: Córdoba
country: Argentina
facility: Sanatorio Allende
city: San Miguel De Tucumán
country: Argentina
facility: Clinica Mayo de UMCB SRL
city: Brasília
country: Brazil
facility: Instituto de Pesquisas Clinicas L2IP
city: Campo Largo
country: Brazil
facility: Unidade Hospital do Rocio
city: Minas Gerais
country: Brazil
facility: Santa Casa De Misericordia De Belo Horizonte
city: Porto Alegre
country: Brazil
facility: Centro de Pesquisa Clinica - Hospital Moinhos de Vento
city: Rio De Janeiro
country: Brazil
facility: IBPClin Instituto Brasil de Pequisa Clinica
city: São Paulo
country: Brazil
facility: Fundação Faculdade Regional de Medicina de Sao Jose do Rio Preto
city: Valinhos
country: Brazil
facility: Azidus Brasil Pesquisa e Desenvolvimento Ltda
city: Red Deer
country: Canada
facility: CARe Clinic
state: Alberta
city: Halifax
country: Canada
facility: IWK Health Centre- Dalhousie University-Canadian Center for Vaccinology
state: Nova Scotia
city: Brampton
country: Canada
facility: Aggarwal and Associates Ltd
state: Ontario
city: Guelph
country: Canada
facility: Dawson Clinical Research Inc.
state: Ontario
city: Newmarket
country: Canada
facility: SKDS Research Inc.
state: Ontario
city: Toronto
country: Canada
facility: LMC Clinical Research Inc. (CPU)
state: Ontario
city: Toronto
country: Canada
facility: Manna Research Toronto
state: Ontario
city: Lévis
country: Canada
facility: Manna Research (Quebec)
state: Quebec
city: Mirabel
country: Canada
facility: Manna Research (Mirabel)
state: Quebec
city: Pierrefonds
country: Canada
facility: McGill University Health Centre Vaccine Study Centre
state: Quebec
city: Québec City
country: Canada
facility: CHU de Québec-Université Laval
state: Quebec
city: Québec
country: Canada
facility: Diex Research Quebec Inc.
state: Quebec
city: Saint-Charles-Borromée
country: Canada
facility: Diex Recherche Joliette
state: Quebec
city: Sherbrooke
country: Canada
facility: Q&T Research Sherbrooke Inc.
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Recherche Sherbrooke
state: Quebec
city: Aguascalientes
country: Mexico
facility: Investigación Biomédica para el Desarrollo de Fármacos, S.A. de C.V.
city: Ciudad de México
country: Mexico
facility: RM Pharma Specialists S.A. de C.V.
city: Culiacán
country: Mexico
facility: Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C.
city: Mérida
country: Mexico
facility: Centro Multidisciplinario para el Desarrollo Especializado de la Investigación Clínica en Yucatan S.C.P. (CEMDEICY S.C.P.)
city: Puebla
country: Mexico
facility: Integra RGH Centro de Investigacion, Clinica de Ozonoterapia RGH AC
city: Veracruz
country: Mexico
facility: Sociedad de Metabolismo y Corazon S.C (SOMECO)
city: Zapopan
country: Mexico
facility: Investigación Biomédica para el Desarrollo de Fármacos, S.A. de C.V.
city: Aberdeen
country: United Kingdom
facility: NHS Grampian
city: Birmingham
country: United Kingdom
facility: Synexus Midlands Clinical Research Centre
city: Bournemouth
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust (UHS)
city: Cardiff
country: United Kingdom
facility: Public Health Wales
city: Cardiff
country: United Kingdom
facility: Synexus Wales DRS
city: Chelmsford
country: United Kingdom
facility: Mid and South Essex NHS Foundation Trust
city: Chorley
country: United Kingdom
facility: Synexus Lancashire DRS
city: Derby
country: United Kingdom
facility: University Hospitals Derby and Burton
city: Harrow
country: United Kingdom
facility: London North West University Healthcare NHS Trust
city: London
country: United Kingdom
facility: Kings College Hospital
city: Manchester
country: United Kingdom
facility: Synexus Manchester DRS
city: York
country: United Kingdom
facility: University of York/York Teaching Hospital
Study officials:
affiliation: Medicago
name: Brian Ward, MD
role: STUDY_DIRECTOR
References:
citation: 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.