Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older
NCT ID: NCT04904549
Last Updated: 2024-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
23726 participants
INTERVENTIONAL
2020-08-20
2024-08-31
Brief Summary
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A total of approximately 21 046 participants are planned to be enrolled (5080 per study intervention group in Stage 1 and 5443 per study intervention group in Stage 2).
Initial, double-blind, primary series study design is planned for 365 days post-last Initial injection (ie, approximately 386 days total) for each participant.
Based on decisions of the Study Oversight Group, Stage 1 and Stage 2 participants will be invited to participate in an unblinded Crossover / Booster study design with duration as follows:
* For participants who initially received vaccine: 12 months post-booster (ie, approximately 18 to 24 months)
* For participants who initially received placebo: ≥ 4 months post-last dose of the primary series + 12 months post-booster (ie, approximately 28 to 34 months)
* For participants who do not consent to continue in the unblinded Crossover / Booster part of the study, all study procedures will be stopped and participants will be discontinued from the study.
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Detailed Description
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Based on decisions of the Study OG, Stage 1 and Stage 2 participants will be invited to participate in an unblinded Crossover / Booster study design with duration as follows:
* For participants who initially received vaccine: 12 months post-booster (ie, approximately 18 to 24 months)
* For participants who initially received placebo: ≥ 4 months post-last dose of the primary series + 12 months post-booster (ie, approximately 28 to 34 months)
* For participants who do not consent to continue in the unblinded Crossover / Booster part of the study, all study procedures will be stopped and participants will be discontinued from the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
For crossover / booster design of study (Stage 1 and Stage 2): unblinded
Study Groups
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Stage 1: SARS-CoV-2 vaccine
2 injections of monovalent SARS-CoV-2 vaccine at Day 1 and Day 22
SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent D614) (primary series)
Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection
SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent B.1.351) (booster dose) >= 4 months after last vaccination
Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.
Stage 1: Placebo
2 injections of placebo at Day 1 and Day 22
Placebo
Pharmaceutical form: liquid. Route of administration: intramuscular administration.
SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent D614)(primary series)& SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent B.1.351)(booster dose)>=4 months after last vaccination
Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.
Stage 2: SARS-CoV-2 vaccine
2 injections of bivalent SARS-CoV-2 vaccine at Day 1 and Day 22
SARS-CoV-2 adjuvanted recombinant protein vaccine (bivalent D614 + B.1.351) (primary series)
Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.
SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent B.1.351) (booster dose) >= 4 months after last vaccination
Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.
Stage 2: Placebo
2 injections of placebo at Day 1 and Day 22
Placebo
Pharmaceutical form: liquid. Route of administration: intramuscular administration.
SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent D614)(primary series)& SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent B.1.351)(booster dose)>=4 months after last vaccination
Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.
Interventions
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SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent D614) (primary series)
Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection
SARS-CoV-2 adjuvanted recombinant protein vaccine (bivalent D614 + B.1.351) (primary series)
Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.
Placebo
Pharmaceutical form: liquid. Route of administration: intramuscular administration.
SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent B.1.351) (booster dose) >= 4 months after last vaccination
Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.
SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent D614)(primary series)& SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent B.1.351)(booster dose)>=4 months after last vaccination
Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.
Eligibility Criteria
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Inclusion Criteria
* For persons living with human immunodeficiency virus (HIV), stable HIV infection determined by participant currently on antiretrovirals with CD4 count \> 200/mm3.
* SARS-CoV-2 rapid serodiagnostic test performed at the time of enrollment to detect presence of SARS-CoV-2 antibodies.
* Does not intend to receive an authorized/approved COVID-19 vaccine despite encouragement by the Investigator to receive the authorized vaccine available to them at the time of enrollment.
* Informed consent form has been signed and dated
* Able to attend all visits and to comply with all study procedures
* Covered by health insurance, only if required by local, regional or national regulations
* A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
* is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile, or
* is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first study intervention administration until at least 12 weeks after the second study intervention administration.
A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 25 hours before any dose of study intervention.
Exclusion Criteria
* Dementia or any other cognitive condition at a stage that could interfere with following the study procedures based on Investigator?s judgment.
* Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination based on Investigator?s judgment
* Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on Investigator?s judgment.
* Unstable acute or chronic illness that in the opinion of the Investigator or designee poses additional risk as a result of participation or that could interfere with the study procedures.
* Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ? 38.0 C \[? 100.4 F\]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
* Receipt of any vaccine in the 30 days preceding or on the day of the first study vaccination or planned receipt of any vaccine between the first study vaccination and in the 30 days following the second study vaccination except for influenza vaccination, which may be received at any time in relation to study intervention.
* Prior administration of a coronavirus vaccine (SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome).
* Receipt of solid-organ or bone marrow transplants in the past 180 days.
* Receipt of anti-cancer chemotherapy in the last 90 days.
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
* Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
* Participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
18 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Locations
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AES - DRS - Simon Williamson Clinic, PC - Birmingham Site Number : 8400004
Birmingham, Alabama, United States
Optimal Research Alabama Site Number : 8400019
Huntsville, Alabama, United States
Peninsula Research Associates, Inc. Site Number : 8400021
Rolling Hills Estates, California, United States
Synexus Clinical Research US, Inc. Site Number : 8400013
Centennial, Colorado, United States
Optimal Research, LLC Site Number : 8400002
Melbourne, Florida, United States
Synexus Clinical Research US, Inc. - Orlando Site Number : 8400020
Orlando, Florida, United States
AES St. Petersburg Site Number : 8400017
Pinellas Park, Florida, United States
Synexus Clinical Research US, Inc. - Atlanta Site Number : 8400005
Atlanta, Georgia, United States
Synexus Clinical Research Chicago Site Number : 8400012
Chicago, Illinois, United States
Synexus Clinical Research Evansville Site Number : 8400008
Evansville, Indiana, United States
Synexus St. Louis Site Number : 8400006
St Louis, Missouri, United States
Synexus Clinical Research US, Inc. - Henderson Site Number : 8400018
Henderson, Nevada, United States
Rochester Clinical Research, Inc. Site Number : 8400023
Rochester, New York, United States
Synexus Akron Site Number : 8400009
Akron, Ohio, United States
Synexus Clinical Research US, Inc. - Cincinnati Site Number : 8400010
Cincinnati, Ohio, United States
Synexus US Columbus Site Number : 8400011
Columbus, Ohio, United States
Synexus Clinical Research Anderson Site Number : 8400007
Anderson, South Carolina, United States
Coastal Carolina Research Center - N Charleston Site Number : 8400022
North Charleston, South Carolina, United States
American Indian Clinical Trials Research Network Site Number : 8400025
Rapid City, South Dakota, United States
AES Austin Site Number : 8400003
Austin, Texas, United States
Synexus Dallas Site Number : 8400014
Dallas, Texas, United States
Synexus Clinical Research US, Inc. - San Antonio Site Number : 8400015
San Antonio, Texas, United States
AES Salt Lake City Site Number : 8400016
Murray, Utah, United States
Investigational Site Number : 1700010
Aguazul, , Colombia
Investigational Site Number : 1700002
Barranquilla, , Colombia
Investigational Site Number : 1700008
Barranquilla, , Colombia
Investigational Site Number : 1700001
Bogotá, , Colombia
Investigational Site Number : 1700005
Cali, , Colombia
Investigational Site Number : 1700006
Chía, , Colombia
Investigational Site Number : 1700004
Floridablanca, , Colombia
Investigational Site Number : 1700007
Girardot, , Colombia
Investigational Site Number : 1700009
Meta, , Colombia
Investigational Site Number : 1700015
Quindío, , Colombia
Investigational Site Number : 1700003
Soledad, , Colombia
Investigational Site Number : 2880002
Kintampo, , Ghana
Investigational Site Number : 2880003
Kumasi, , Ghana
Investigational Site Number : 2880001
Navrongo, , Ghana
Investigational Site Number : 3400001
Municipio Del Distrito Central, , Honduras
Investigational Site Number : 3400002
San Pedro Sula, , Honduras
Investigational Site Number : 3560010
Ajmer, , India
Investigational Site Number : 3560002
Ambawadi, , India
Investigational Site Number : 3560007
Belagavi, , India
Investigational Site Number : 3560001
Jaipur, , India
Investigational Site Number : 3560005
Kanpur, , India
Investigational Site Number : 3560009
Nagpur, , India
Investigational Site Number : 3560011
Odisha, , India
Investigational Site Number : 3560004
Patna, , India
Investigational Site Number : 3560003
Punjagutta, , India
Investigational Site Number : 3560006
Tamilnadu, , India
Investigational Site Number : 3920005
Chiyoda-ku,, Tokyo, Japan
Investigational Site Number : 3920004
Haramachi,Shinjuku-ku, Tokyo, Japan
Investigational Site Number : 3920003
Kouenji minami,Suginami-ku, Tokyo, Japan
Investigational Site Number : 3920001
Kyobashi Chuo-ku, Tokyo, Japan
Investigational Site Number : 3920002
Ohta-ku, Tokyo, Japan
Investigational Site Number : 4040011
Butere, , Kenya
Investigational Site Number : 4040006
Eldoret, , Kenya
Investigational Site Number : 4040004
Kericho, , Kenya
Investigational Site Number : 4040002
Kisumu, , Kenya
Investigational Site Number : 4040003
Kisumu, , Kenya
Investigational Site Number : 4040012
Kisumu, , Kenya
Investigational Site Number : 4040008
Mombasa, , Kenya
Investigational Site Number : 4040001
Nairobi, , Kenya
Investigational Site Number : 4040007
Nairobi, , Kenya
Investigational Site Number : 4040009
Thika, , Kenya
Investigational Site Number : 4840005
León, Guanajuato, Mexico
Investigational Site Number : 4840004
Acapulco de Juárez, Guerrero, Mexico
Investigational Site Number : 4840003
Guadalajara, Jalisco, Mexico
Investigational Site Number : 4840009
Mexico City, Mexico City, Mexico
Investigational Site Number : 4840008
Cuernavaca, Morelos, Mexico
Investigational Site Number : 4840006
Temixco, , Mexico
Investigational Site Number : 4840002
Veracruz, , Mexico
Investigational Site Number : 5240002
Dhulikhel, , Nepal
Investigational Site Number : 5240003
Kathmandu, , Nepal
Investigational Site Number : 5240001
Nepalgunj, , Nepal
Investigational Site Number : 8000002
Entebbe, , Uganda
Investigational Site Number : 8000005
Entebbe, , Uganda
Investigational Site Number : 8000001
Kampala, , Uganda
Investigational Site Number : 8000013
Kampala, , Uganda
Investigational Site Number : 8000007
Kampala, , Uganda
Investigational Site Number : 8000003
Kampala, , Uganda
Investigational Site Number : 8000004
Kampala, , Uganda
Investigational Site Number : 8000014
Lira, , Uganda
Investigational Site Number : 8040002
Kiev, , Ukraine
Investigational Site Number : 8040004
Kyiv, , Ukraine
Investigational Site Number : 8040003
Kyiv, , Ukraine
Investigational Site Number : 8040001
Kyiv, , Ukraine
Countries
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References
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Dayan GH, Rouphael N, Walsh SR, Chen A, Grunenberg N, Allen M, Antony J, Asante KP, Bhate AS, Beresnev T, Bonaparte MI, Celle M, Ceregido MA, Corey L, Dobrianskyi D, Fu B, Grillet MH, Keshtkar-Jahromi M, Juraska M, Kee JJ, Kibuuka H, Koutsoukos M, Masotti R, Michael NL, Neuzil KM, Reynales H, Robb ML, Villagomez Martinez SM, Sawe F, Schuerman L, Tong T, Treanor J, Wartel TA, Diazgranados CA, Chicz RM, Gurunathan S, Savarino S, Sridhar S; VAT00008 Study Team. Efficacy of a bivalent (D614 + B.1.351) SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant in adults: a phase 3, parallel, randomised, modified double-blind, placebo-controlled trial. Lancet Respir Med. 2023 Nov;11(11):975-990. doi: 10.1016/S2213-2600(23)00263-1. Epub 2023 Sep 13.
Other Identifiers
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U1111-1264-3238
Identifier Type: REGISTRY
Identifier Source: secondary_id
VAT00008
Identifier Type: OTHER
Identifier Source: secondary_id
VAT00008
Identifier Type: -
Identifier Source: org_study_id
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