Study of Recombinant Protein Vaccines With Adjuvant as a Primary Series and as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older

NCT04762680 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: VAT00002U1111-1251-46162020-003370-41
• Study Type: interventional
• Target: 3,159
• Locations: 7 countries
• Sites: 66

Brief Summary

The primary objectives of the study are: To assess the safety profile of the study vaccines in each study intervention group. To assess the neutralizing antibody profile after primary series vaccination in SARS-CoV-2-naïve adults. To demonstrate that a booster dose of monovalent or bivalent SARS-CoV-2 vaccine given to adults previously vaccinated with an authorized/approved COVID-19 vaccine induces an immune response that is non-inferior to the response induced by a twodose priming series with the monovalent vaccine, and superior to that observed immediately before booster. The secondary objectives of the study are: To assess the neutralizing and binding antibody profiles after primary series vaccination at pre-defined time points during the study. To assess the neutralizing and binding antibody responses of booster vaccination. To describe the occurrences of laboratory-confirmed symptomatic COVID19 after primary series and booster vaccination. To describe the occurrences of serologically-confirmed SARS-CoV-2 infection after primary series vaccination.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (11)

• Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Immediate Unsolicited Adverse Events (AEs)

  An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Immediate events were recorded to capture medically relevant unsolicited systemic AEs which occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form (CRF) in terms of diagnosis and onset window post-vaccination.

  Up to 30 minutes after each vaccination (Phase 2: Postdose on Days 1 and 22; Phase 3: Between 4 to 10 months after priming vaccine)

• Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions

  A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF, and were considered to be related to the study vaccine administered. An injection site reaction was an AR at and around the injection site of the study vaccine. Systemic AR were all ARs that were not injection site reactions.

  Up to 7 days after each vaccination (Phase 2: Postdose on Days 1 and 22; Phase 3: Between 4 to 10 months after priming vaccine)

• Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Unsolicited Adverse Events

  An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.

  Up to 21 days after each vaccination (Phase 2: Postdose on Days 1 and 22; Phase 3: Between 4 to 10 months after priming vaccine)

• Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)

  An SAE was defined as any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was 1 of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor could be appropriate. An MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or Emergency Department.

  Phase 2 and Phase 3 Comparator: From first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: From first dose of study vaccine administration (Day 1) up to 366 days.

• Phase 2: Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) D614G Strain at Day 1

  Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.

  Pre-vaccination on Day 1

• Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Day 36

  Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.

  Day 36

• Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Day 36

  Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers \>=2-fold and \>=4-fold increase from baseline (pre-vaccination) were analyzed.

  Day 1 (pre-vaccination) and Day 36

• Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Day 36

  Responders were participants who had baseline values below lower limit of quantification (LLOQ) with detectable neutralization titer above assay LLOQ at each pre-defined post-vaccination time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination time point.

  Day 36

• Phase 3: Cohorts 1 and 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Day 1

  Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 variant was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.

  Pre-vaccination on Day 1

• Phase 3: Cohorts 1, 2 and Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at 14 Days Post-Vaccination

  Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 variant was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.

  Cohorts 1 and 2: 14 days post-vaccination on Day 1, Day 15; Comparator: 14 days post-vaccination on Day 22, Day 36

• Phase 3: Comparator: Percentage of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Day 36

  Responders were participants who had baseline values below LLOQ with detectable neutralization titer above assay LLOQ at each pre-defined post-vaccination time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination time point. Percentages are rounded off to the tenth decimal place.

  Day 36

Secondary Outcomes (23)

• Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387

  Post-vaccination on Days 22, 78, 134, 202, 292, and 387

• Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387

  Pre-vaccination on Day 1 and Post-vaccination on Days 22, 78, 134, 202, 292, and 387

• Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387

  Post-vaccination on Days 22, 78, 134, 202, 292, and 387

• Phase 2: Geometric Mean Concentration (GMC) of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 78, 134, 202, 292, and 387

  Pre-vaccination on Day 1 and post-vaccination on Days 22, 36, 78, 134, 202, 292, and 387

• Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387

  Pre-vaccination on Day 1 and Post-vaccination on Days 22, 36, 78, 134, 202, 292, and 387

Study Arms (12)

Phase 2 Cohort -SARS-CoV-2 vaccine Formulation 1

EXPERIMENTAL

2 injections of SARS-CoV-2 vaccine Formulation 1 at Day 1 and Day 22

Biological: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 1

Phase 2 Cohort - SARS-CoV-2 vaccine Formulation 2

EXPERIMENTAL

2 injections of SARS-CoV-2 vaccine Formulation 2 at Day 1 and Day 22

Biological: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 2

Phase 2 Cohort - SARS-CoV-2 vaccine Formulation 3

EXPERIMENTAL

2 injections of SARS-CoV-2 vaccine Formulation 3 Day 1 and Day 22

Biological: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 3

Supplemental Cohort 1 - Booster Monovalent (D614)-AS03 SARS-CoV-2 vaccine

EXPERIMENTAL

Participants who were previously vaccinated 4 to \< 10 months prior with an authorized mRNA or adenovirus-vector COVID-19 vaccine will receive 1 booster injection of monovalent (D614)-AS03 SARS-CoV-2 vaccine

Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage A

Supplemental Cohort 2 - Booster Monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine

EXPERIMENTAL

Participants who were vaccinated 4 to \< 10 months prior with an authorized mRNA or adenovirus-vector COVID-19 vaccine or SARS-Cov-2 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine

Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03

Supplemental Cohort 2 - Booster Bivalent (D614 + B.1.351)-AS03 SARS-CoV-2 vaccine

EXPERIMENTAL

Participants who were vaccinated 4 to \< 10 months prior with an authorized mRNA or adenovirus-vector COVID-19 vaccine will receive 1 booster injection of bivalent (D614+B.1.351)-AS03 SARS-CoV-2 vaccine

Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, bivalent (D614+B.1.351)-AS03

Supplemental Cohort 2 - Booster Monovalent (D614)-AS03 SARS-CoV-2 vaccine

EXPERIMENTAL

Participants who were vaccinated 4 to \< 10 months prior with SARS-Cov-2 vaccine will receive 1 booster injection of monovalent (D614)-AS03 SARS-CoV-2 vaccine

Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage A

Supplemental Comparator for Cohort 1 and 2 Boosters - Monovalent (D614)-AS03 SARS-CoV-2 vaccine

ACTIVE COMPARATOR

2 injections of monovalent (D614)-AS03 SARS-CoV-2 vaccine at Day 1 and Day 22 in previously unvaccinated, naïve participants

Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage B

Cohort 2 - Booster Exploratory 1

EXPERIMENTAL

Participants who were vaccinated 4 to \< 10 months prior with an authorized mRNA COVID-19 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine

Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 1

Cohort 2 - Booster Exploratory 2

EXPERIMENTAL

Participants who were vaccinated 4 to \< 10 months prior with an authorized mRNA COVID-19 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine

Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 2

Cohort 2 - Booster Exploratory 3

EXPERIMENTAL

Participants who were vaccinated 4 to \< 10 months prior with an authorized mRNA COVID-19 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine

Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 3

Cohort 2 - Booster Exploratory 4

EXPERIMENTAL

Participants who were vaccinated 4 to \< 10 months prior with an authorized mRNA COVID-19 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine

Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 4

Interventions

SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 1 BIOLOGICAL

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

Also known as: rSP-COVID19

Phase 2 Cohort -SARS-CoV-2 vaccine Formulation 1

SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 2 BIOLOGICAL

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

Also known as: rSP-COVID19 Formulation 2

Phase 2 Cohort - SARS-CoV-2 vaccine Formulation 2

SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 3 BIOLOGICAL

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

Also known as: rSP-COVID19 Formulation 3

Phase 2 Cohort - SARS-CoV-2 vaccine Formulation 3

SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage A BIOLOGICAL

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

Also known as: rSP-COVID19 (D614)-AS03, Dosage A

Supplemental Cohort 1 - Booster Monovalent (D614)-AS03 SARS-CoV-2 vaccine; Supplemental Cohort 2 - Booster Monovalent (D614)-AS03 SARS-CoV-2 vaccine

SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 BIOLOGICAL

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

Also known as: rSP-COVID19 (B.1.351)-AS03

Supplemental Cohort 2 - Booster Monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine

SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage B BIOLOGICAL

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

Also known as: rSP-COVID19 (D614)-AS03, Dosage B

Supplemental Comparator for Cohort 1 and 2 Boosters - Monovalent (D614)-AS03 SARS-CoV-2 vaccine

SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 1 BIOLOGICAL

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

Also known as: rSP-COVID19 (B.1.351)-AS03 Alternative Exploratory Formulation 1

Cohort 2 - Booster Exploratory 1

SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 2 BIOLOGICAL

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

Also known as: rSP-COVID19 (B.1.351)-AS03 Alternative Exploratory Formulation 2

Cohort 2 - Booster Exploratory 2

SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 3 BIOLOGICAL

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

Also known as: rSP-COVID19 (B.1.351)-AS03 Alternative Exploratory Formulation 3

Cohort 2 - Booster Exploratory 3

SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 4 BIOLOGICAL

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

Also known as: rSP-COVID19 (B.1.351)-AS03 Alternative Exploratory Formulation 4

Cohort 2 - Booster Exploratory 4

SARS-CoV-2 adjuvanted recombinant protein vaccine, bivalent (D614+B.1.351)-AS03 BIOLOGICAL

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

Also known as: rSP-COVID19 (D614+B.1.351)-AS03

Supplemental Cohort 2 - Booster Bivalent (D614 + B.1.351)-AS03 SARS-CoV-2 vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• OR Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first vaccination until at least 12 weeks after the last vaccination (ie, second dose of primary series or booster injection). A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 4 hours before any dose of study intervention. - -Informed consent form has been signed and dated.
• Able to attend all scheduled visits and to comply with all study procedures. SARS-CoV-2 rapid serodiagnostic test performed at the time of enrollment to detect presence of SARS-CoV-2 antibodies (Original Phase 2 Cohort).
• For persons living with human immunodeficiency virus (HIV), stable HIV infection determined by participant currently on antiretrovirals with CD4 count \> 200/mm3.
• Does not intend to receive an authorized/approved COVID-19 vaccine from first vaccination to 3 weeks after the second vaccination despite encouragement by the investigator to receive the authorized vaccine available to them at the time of enrollment.
• Supplemental cohorts: for participants originally enrolled in the Phase II cohort of the study, informed consent has to be signed and dated for transitioning to Supplemental Cohort 2.

You may not qualify if:

• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances.
• Dementia or any other cognitive condition at a stage that could interfere with following the trial procedures based on Investigator or designee's judgment.
• Self-reported thrombocytopenia, contraindicating intramuscular (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.
• Receipt of solid-organ or bone marrow transplants in the past 180 days. Receipt of anti-cancer chemotherapy in the last 90 days. Receipt of immunoglobulins, blood, or blood-derived products in the past 3 months.
• 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 trial 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead
• GlaxoSmithKline: collaborator

Study Sites (66)

Synexus - Clinical Research Advantage, Inc. Site Number : 8400270

Birmingham, Alabama, 35205, United States

Location

Synexus Chandler Site Number : 8400251

Chandler, Arizona, 85225, United States

Location

Synexus - Glendale. Site Number : 8400271

Glendale, Arizona, 85306, United States

Location

Baptist Health Center for Clinical Research Site Number : 8400077

Little Rock, Arkansas, 72205, United States

Location

Charles R. Drew University of Medicine and Science Site Number : 8400220

Los Angeles, California, 90059, United States

Location

Peninsula Research Associates, Inc. Site Number : 8400094

Rolling Hills Estates, California, 90274, United States

Location

Optimal Research Site Number : 8400173

San Diego, California, 92108, United States

Location

Yale University Site Number : 8400239

New Haven, Connecticut, 06510, United States

Location

The George Washington University Site Number : 8400212

Washington D.C., District of Columbia, 20037, United States

Location

Cenexel Research Centers of America Site Number : 8400089

Hollywood, Florida, 33024, United States

Location

Optimal Research, LLC Site Number : 8400057

Melbourne, Florida, 32934, United States

Location

Synexus Clinical Research US, Inc. - Orlando Site Number : 8400179

Orlando, Florida, 32806, United States

Location

Emory University Decatur Site Number : 8400201

Decatur, Georgia, 30030, United States

Location

Chicago Clinical Research Institute, Inc. Site Number : 8400269

Chicago, Illinois, 60607, United States

Location

Optimal Research Site Number : 8400187

Peoria, Illinois, 61614, United States

Location

Synexus Clinical Research Evansville Site Number : 8400272

Evansville, Indiana, 47714, United States

Location

Research Works INC Site Number : 8400045

New Orleans, Louisiana, 70125, United States

Location

Optimal Research, LLC Rockville Site Number : 8400048

Rockville, Maryland, 20850, United States

Location

Brigham and Women's Hospital Site Number : 8400199

Boston, Massachusetts, 02115, United States

Location

Synexus St. Louis Site Number : 8400100

St Louis, Missouri, 63141, United States

Location

Velocity Clinical Research, Omaha Site Number : 8400030

Omaha, Nebraska, 68134, United States

Location

Holy Name Medical Center Site Number : 8400072

Teaneck, New Jersey, 07666, United States

Location

NYU VC-Augustana Site Number : 8400267

Brooklyn, New York, 11220, United States

Location

New York University Langone Vaccine Center Site Number : 8400230

New York, New York, 10016, United States

Location

Columbia University Irving Medical Center Site Number : 8400203

New York, New York, 10032, United States

Location

University of Rochester Site Number : 8400207

Rochester, New York, 14642, United States

Location

University of Pittsburgh Site Number : 8400233

Pittsburgh, Pennsylvania, 15213, United States

Location

Coastal Carolina Research Center Site Number : 8400097

North Charleston, South Carolina, 29405, United States

Location

American Indian Clinical Trials Research Network Site Number : 8400204

Rapid City, South Dakota, 57701, United States

Location

AES Austin Site Number : 8400191

Austin, Texas, 78744, United States

Location

Investigational Site Number : 0360001

South Brisbane, Queensland, 4101, Australia

Location

Investigational Site Number : 0360003

Norwood, 5067, Australia

Location

Investigational Site Number : 0360002

Southport, 4215, Australia

Location

Investigational Site Number : 0360005

Westmead, 2145, Australia

Location

Investigational Site Number : 0360004

Woodville, 5011, Australia

Location

Investigational Site Number : 2500013

Dijon, 21079, France

Location

Investigational Site Number : 2500008

Limoges, 87042, France

Location

Investigational Site Number : 2500014

Lyon, 69004, France

Location

Investigational Site Number : 2500015

Marseille, 13005, France

Location

Investigational Site Number : 2500016

Marseille, 13005, France

Location

Investigational Site Number : 2500006

Nantes, 44093, France

Location

Investigational Site Number : 2500005

Paris, 75679, France

Location

Investigational Site Number : 2500003

Pessac, 33600, France

Location

Investigational Site Number : 2500007

Pierre-Bénite, 69495, France

Location

Investigational Site Number : 2500004

Rennes, 35033, France

Location

Investigational Site Number : 2500002

Tours, 37044, France

Location

Investigational Site Number : 3400002

Municipio Del Distrito Central, 11101, Honduras

Location

Investigational Site Number : 3400001

San Pedro Sula, 21104, Honduras

Location

Investigational Site Number : 5540005

New Lynn, Auckland, 0600, New Zealand

Location

Investigational Site Number : 5540002

Christchurch, 8013, New Zealand

Location

Investigational Site Number : 5540007

Nawton, 3243, New Zealand

Location

Investigational Site Number : 5540010

Nelson, 7011, New Zealand

Location

Investigational Site Number : 5540001

Rotorua, 3010, New Zealand

Location

Investigational Site Number : 7240013

Santiago de Compostela, Galicia [Galicia], 15706, Spain

Location

Investigational Site Number : 7240016

Majadahonda, Madrid, 28222, Spain

Location

Investigational Site Number : 7240009

Madrid, 28041, Spain

Location

Investigational Site Number : 7240008

Valencia, 46020, Spain

Location

Investigational Site Number : 7240003

Vigo, 36312, Spain

Location

Investigational Site Number : 8260011

Runcorn, Halton, WA7 2DA, United Kingdom

Location

Investigational Site Number : 8260017

Bath, Somerset, BA1 3NG, United Kingdom

Location

Investigational Site Number : 8260013

Surrey, Sutton, SM2 5PT, United Kingdom

Location

Investigational Site Number : 8260014

Doncaster, DN4 8QN, United Kingdom

Location

Investigational Site Number : 8260016

Gloucester, GL1 3NN, United Kingdom

Location

Investigational Site Number : 8260010

Harrow, HA1 3UJ, United Kingdom

Location

Investigational Site Number : 8260015

London, SW10 0LR, United Kingdom

Location

Investigational Site Number : 8260012

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (2)

• de Bruyn G, Wang J, Purvis A, Ruiz MS, Adhikarla H, Alvi S, Bonaparte MI, Brune D, Bueso A, Canter RM, Ceregido MA, Deshmukh S, Diemert D, Finn A, Forrat R, Fu B, Gallais J, Griffin P, Grillet MH, Haney O, Henderson JA, Koutsoukos M, Launay O, Torres FM, Masotti R, Michael NL, Park J, Rivera-Medina DM, Romanyak N, Rook C, Schuerman L, Sher LD, Tavares-Da-Silva F, Whittington A, Chicz RM, Gurunathan S, Savarino S, Sridhar S; VAT00002 booster cohorts study team. Safety and immunogenicity of a variant-adapted SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant as a booster in adults primed with authorized vaccines: a phase 3, parallel-group study. EClinicalMedicine. 2023 Jul 22;62:102109. doi: 10.1016/j.eclinm.2023.102109. eCollection 2023 Aug.

  PMID: 37533419 DERIVED

• Sridhar S, Joaquin A, Bonaparte MI, Bueso A, Chabanon AL, Chen A, Chicz RM, Diemert D, Essink BJ, Fu B, Grunenberg NA, Janosczyk H, Keefer MC, Rivera M DM, Meng Y, Michael NL, Munsiff SS, Ogbuagu O, Raabe VN, Severance R, Rivas E, Romanyak N, Rouphael NG, Schuerman L, Sher LD, Walsh SR, White J, von Barbier D, de Bruyn G, Canter R, Grillet MH, Keshtkar-Jahromi M, Koutsoukos M, Lopez D, Masotti R, Mendoza S, Moreau C, Ceregido MA, Ramirez S, Said A, Tavares-Da-Silva F, Shi J, Tong T, Treanor J, Diazgranados CA, Savarino S. Safety and immunogenicity of an AS03-adjuvanted SARS-CoV-2 recombinant protein vaccine (CoV2 preS dTM) in healthy adults: interim findings from a phase 2, randomised, dose-finding, multicentre study. Lancet Infect Dis. 2022 May;22(5):636-648. doi: 10.1016/S1473-3099(21)00764-7. Epub 2022 Jan 25.

  PMID: 35090638 DERIVED

Related Links

• VAT00002 Plain language Results Summary

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi Pasteur

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In the original Phase 2 part, participants, outcome assessors, Investigators, laboratory personnel, and sponsor study staff are blinded to intervention group; and those preparing the study interventions are unblinded to vaccine assignment group. The supplemental Cohort 1 intervention group and Supplemental Cohorts Comparator Group will be open-label. Supplemental Cohort 2 will involve sequential randomization to main arms then exploratory arms, and the intervention will be modified double-blind (observer-blinded, as described).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: To address the emergence of variant strains, Sanofi Pasteur is developing monovalent and bivalent vaccines for use as universal late booster vaccines which will be studied in additional Phase 3 study cohorts that are added to the initial Phase 2 protocol cohorts. Supplemental Cohorts 1 and 2 will evaluate booster vaccine candidates.

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: February 24, 2021
• Primary Completion: June 29, 2023
• Study Completion: June 29, 2023
• Last Updated: September 18, 2025
• Results First Posted: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

AU (5); NZ (5); ES (5); HO (2); GB (8); US (30); FR (11)