Study of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults
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
1 other identifier
interventional
30,918
6 countries
91
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2020
Shorter than P25 for phase_2
91 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2020
CompletedFirst Posted
Study publicly available on registry
November 19, 2020
CompletedStudy Start
First participant enrolled
November 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedApril 6, 2022
June 1, 2021
9 months
November 12, 2020
April 4, 2022
Conditions
Outcome Measures
Primary Outcomes (15)
Phase 2 portion: Immediate adverse event (AEs)
Percentage, intensity, and relationship to vaccination of immediate AEs
30 minutes
Phase 2 portion: Solicited local and systemic adverse events (AEs)
Percentage, intensity, and relationship to vaccination of solicited local and systemic AEs
7 days
Phase 2 portion: Unsolicited adverse events (AEs)
Percentage, intensity, and relationship of unsolicited AEs
21 days
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
3 days
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
3 days
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
3 days
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
3 days
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
3 days
Phase 2 portion: Percentage of subjects with normal and abnormal clinically biochemical values
Percentage of subjects with normal and abnormal clinically biochemical values
3 days
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
21 days
Phase 2 portion: Neutralizing antibody (Nab assay) response
Nab response induced in each Study Population against the SARS-CoV-2 virus
Day 21
Phase 2 portion: Neutralizing antibody (Nab assay) response
Nab response induced in each Study Population against the SARS-CoV-2 virus
Day 42
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
Day 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 , as measured by IFN-γ ELISpot
Day 42
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
Day 28 and after
Secondary Outcomes (64)
Phase 2 portion: Solicited local and systemic AEs (populations 1 and 2)
7 days
Phase 2 portion: Solicited local and systemic AEs (populations 1, 2 and 3)
7 days
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
Day 43 to 386
Phase 3 portion: Immediate adverse event (AEs)
30 minutes
Phase 3 portion: Solicited local and systemic AEs
7 days
- +59 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo (0.5 mL)
3.75 µg of CoVLP Vaccine adjuvanted
EXPERIMENTAL3.75 µg of CoVLP adjuvanted vaccine with AS03 adjuvant (0.5 mL)
Interventions
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)
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)
Eligibility Criteria
You may qualify if:
- 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:
- 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;
- 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:
- +14 more criteria
You may not qualify if:
- 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;
- 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;
- 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;
- 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;
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medicagolead
Study Sites (91)
Achieve Clinical Research, LLC dba Accel Research Sites
Birmingham, Alabama, 35216, United States
Fiel Family and Sports Medicine/CCT
Tempe, Arizona, 85283, United States
Hope Clinical Research
Canoga Park, California, 91303, United States
CNS Network
Garden Grove, California, 92845, United States
Long Beach Clinical Trial Services Inc.
Long Beach, California, 90806-3221, United States
Pharmacology Research Institute
Newport Beach, California, 92660, United States
Wr-McCr, Llc
San Diego, California, 92108, United States
Ascension Providence Health System
Washington D.C., District of Columbia, 20017, United States
Alliance for Multispecialty Research
Coral Gables, Florida, 33134-4321, United States
Research Centers of America
Hollywood, Florida, 33024, United States
AppleMed Research Inc
Miami, Florida, 33155, United States
Elixia COVID-19
Palm Beach, Florida, 33410, United States
Precision Clinical Research
Sunrise, Florida, 33351, United States
Meridian Clinical Research
Savannah, Georgia, 31406, United States
ASR, LLC
Nampa, Idaho, 83687, United States
Affinity Health
Chicago, Illinois, 60644, United States
Meridian Clinical Research
Sioux City, Iowa, 51106, United States
Benchmark Research
Covington, Louisiana, 70433, United States
Ascension St. John Vaccine Research Unit
Grosse Pointe Woods, Michigan, 48236, United States
Methodist Physicians
Fremont, Nebraska, 68130, United States
Be Well Clinical Studies, LLC
Lincoln, Nebraska, 68516, United States
Meridian Clinical Research LLC
Norfolk, Nebraska, 68701, United States
Meridian Clinical Research LLC
Omaha, Nebraska, 68134, United States
Forte Family Practice/ CCT Research
Las Vegas, Nevada, 89103, United States
Excel Clinical Research
Las Vegas, Nevada, 89109, United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, 89030, United States
Hassman Research Institute
Berlin, New Jersey, 08009, United States
Meridian Clinical Research
Endwell, New York, 13760, United States
Carolina Institute for Clinical Research
Fayetteville, North Carolina, 28303, United States
M3 Wake Research, Inc
Raleigh, North Carolina, 27612, United States
Trial Management Associates LLC
Wilmington, North Carolina, 28403, United States
Velocity Clinical Research - Cincinnati
Cincinnati, Ohio, 45242, United States
Velocity Clinical Research
Cleveland, Ohio, 44122, United States
Aventiv Research Inc
Columbus, Ohio, 43213, United States
Velocity Clinical Research Providence
Warwick, Rhode Island, 02886, United States
Benchmark Research
Austin, Texas, 78705, United States
Tekton Research
Austin, Texas, 78745, United States
Global Medical Research
Dallas, Texas, 75224, United States
Benchmark Research
Fort Worth, Texas, 76135, United States
Research Your Health
Plano, Texas, 75093, United States
Mt. Olympus Medical Research, LLC
Sugar Land, Texas, 77479, United States
Sugar Lakes Family Practice
Sugar Land, Texas, 77479, United States
DM Clinical Research/Martin Diagnostic Clinic
Tomball, Texas, 77375, United States
South Ogden Family Medicine
Ogden, Utah, 84405, United States
Advanced Clinical Research, Inc.
West Jordan, Utah, 84088, United States
Mautalen Salud e Investigación (Expertia SA)
Buenos Aires, C1128AAF, Argentina
Fundación FunDaMos
Buenos Aires, C1405BOA, Argentina
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Buenos Aires, C1426, Argentina
Sanatorio Allende
Córdoba, 5000, Argentina
Clinica Mayo de UMCB SRL
San Miguel de Tucumán, T4000, Argentina
Instituto de Pesquisas Clinicas L2IP
Brasília, 70200-730, Brazil
Unidade Hospital do Rocio
Campo Largo, 83606-177, Brazil
Santa Casa De Misericordia De Belo Horizonte
Minas Gerais, 30150-221, Brazil
Centro de Pesquisa Clinica - Hospital Moinhos de Vento
Porto Alegre, 90035-001, Brazil
IBPClin Instituto Brasil de Pequisa Clinica
Rio de Janeiro, 20241-180, Brazil
Fundação Faculdade Regional de Medicina de Sao Jose do Rio Preto
São Paulo, 15090-000, Brazil
Azidus Brasil Pesquisa e Desenvolvimento Ltda
Valinhos, 13271-130, Brazil
CARe Clinic
Red Deer, Alberta, T4N 6V7, Canada
IWK Health Centre- Dalhousie University-Canadian Center for Vaccinology
Halifax, Nova Scotia, B3K 6R8, Canada
Aggarwal and Associates Ltd
Brampton, Ontario, L6T 0G1, Canada
Dawson Clinical Research Inc.
Guelph, Ontario, N1H 1B1, Canada
SKDS Research Inc.
Newmarket, Ontario, L3Y 5G8, Canada
LMC Clinical Research Inc. (CPU)
Toronto, Ontario, M4G 3E8, Canada
Manna Research Toronto
Toronto, Ontario, M9W 4L6, Canada
Manna Research (Quebec)
Lévis, Quebec, G6W OM5, Canada
Manna Research (Mirabel)
Mirabel, Quebec, J7J 2K8, Canada
McGill University Health Centre Vaccine Study Centre
Pierrefonds, Quebec, H9H 4Y6, Canada
CHU de Québec-Université Laval
Québec, Quebec, G1E 7G9, Canada
Diex Research Quebec Inc.
Québec, Quebec, G1N 4V3, Canada
Diex Recherche Joliette
Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
Q&T Research Sherbrooke Inc.
Sherbrooke, Quebec, J1J 2G2, Canada
Diex Recherche Sherbrooke
Sherbrooke, Quebec, J1L 0H8, Canada
Investigación Biomédica para el Desarrollo de Fármacos, S.A. de C.V.
Aguascalientes, 20010, Mexico
Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C.
Culiacán, 80230, Mexico
RM Pharma Specialists S.A. de C.V.
Mexico City, 3100, Mexico
Centro Multidisciplinario para el Desarrollo Especializado de la Investigación Clínica en Yucatan S.C.P. (CEMDEICY S.C.P.)
Mérida, 97130, Mexico
Integra RGH Centro de Investigacion, Clinica de Ozonoterapia RGH AC
Puebla City, 72410, Mexico
Sociedad de Metabolismo y Corazon S.C (SOMECO)
Veracruz, 91900, Mexico
Investigación Biomédica para el Desarrollo de Fármacos, S.A. de C.V.
Zapopan, 45070, Mexico
NHS Grampian
Aberdeen, AB25 2ZD, United Kingdom
Synexus Midlands Clinical Research Centre
Birmingham, B15 2SQ, United Kingdom
University Hospital Southampton NHS Foundation Trust (UHS)
Bournemouth, BH7 7DW, United Kingdom
Public Health Wales
Cardiff, CF10 4BZ, United Kingdom
Synexus Wales DRS
Cardiff, CF15 9SS, United Kingdom
Mid and South Essex NHS Foundation Trust
Chelmsford, CM17ET, United Kingdom
Synexus Lancashire DRS
Chorley, PR7 7 NA, United Kingdom
University Hospitals Derby and Burton
Derby, DE22 3NE, United Kingdom
London North West University Healthcare NHS Trust
Harrow, HA1 3UJ, United Kingdom
Kings College Hospital
London, SE5 9PJ, United Kingdom
Synexus Manchester DRS
Manchester, M15 6SE, United Kingdom
University of York/York Teaching Hospital
York, YO31 8HE, United Kingdom
Related Publications (1)
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.
PMID: 35507508DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Brian Ward, MD
Medicago
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Observer-blind
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2020
First Posted
November 19, 2020
Study Start
November 19, 2020
Primary Completion
August 25, 2021
Study Completion
April 30, 2022
Last Updated
April 6, 2022
Record last verified: 2021-06