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History of Changes for Study: NCT04762680
Study of Recombinant Protein Vaccine With Adjuvant Against COVID-19 in Adults 18 Years of Age and Older (VAT00002)
Latest version (submitted November 25, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 18, 2021 None (earliest Version on record)
2 February 23, 2021 Recruitment Status, Study Status and Contacts/Locations
3 March 2, 2021 Study Status and Contacts/Locations
4 March 10, 2021 Recruitment Status, Contacts/Locations, Study Status and Study Design
5 April 2, 2021 Study Status
6 May 19, 2021 Study Status
7 July 16, 2021 Arms and Interventions, Outcome Measures, Study Status, Study Identification, Contacts/Locations, Study Design, Study Description and Eligibility
8 August 1, 2021 Study Status
9 August 3, 2021 Study Status
10 August 24, 2021 Recruitment Status, Contacts/Locations, Study Status and Study Design
11 October 29, 2021 Study Status and Contacts/Locations
12 November 25, 2021 Study Status and Contacts/Locations
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Changes (Merged) for Study: NCT04762680
March 2, 2021 (v3) -- March 10, 2021 (v4)

Changes in: Study Status, Study Design and Contacts/Locations

Open or close this module Study Identification
Unique Protocol ID: VAT00002
Brief Title: Study of Recombinant Protein Vaccine With Adjuvant Against COVID-19 in Adults 18 Years of Age and Older (VAT00002)
Official Title: Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccine With AS03 Adjuvant in Adults 18 Years of Age and Older
Secondary IDs: U1111-1251-4616 [UTN]
Open or close this module Study Status
Record Verification: March 2021
Overall Status: Recruiting Active, not recruiting
Study Start: February 24, 2021
Primary Completion: September 2022 [Anticipated]
Study Completion: September 2022 [Anticipated]
First Submitted: February 18, 2021
First Submitted that
Met QC Criteria:
February 18, 2021
First Posted: February 21, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
March 2 10, 2021
Last Update Posted: March 3 11, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Sanofi Pasteur, a Sanofi Company
Responsible Party: Sponsor
Collaborators: GlaxoSmithKline
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary:

The primary objectives of the study are:

  • To assess the safety profile of all participants in each age group and in each study intervention group.
  • To assess the neutralizing antibody profile 14 days after the last vaccination in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-naïve adults in each study intervention group.

The secondary objectives of the study are:

  • To assess the neutralizing antibody profile in SARS-CoV-2 naïve participants at pre-defined time points during the study.
  • To assess the neutralizing antibody profile in SARS-CoV-2 non-naïve participants at pre-defined time points during the study.
  • To assess the binding antibody profile in SARS-CoV-2 naïve and non-naïve participants at pre-defined time points during the study.
  • To describe the occurrences of laboratory-confirmed symptomatic COVID-19 in all participants in each study intervention group.
  • To describe the occurrences of serologically-confirmed SARS-CoV-2 infection in each study intervention group.
Detailed Description: The duration of each participant's participation in the trial will be approximately 365 days post-injection 2 (ie, 386 days total).
Open or close this module Conditions
Conditions: COVID-19 (Healthy Volunteers)
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 720 [Anticipated] 722 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: SARS-CoV-2 vaccine Formulation 1
2 injections of SARS-CoV-2 vaccine Formulation 1 at Day 1 and Day 22
Biological: SARS-CoV-2 recombinant protein vaccine Formulation 1
Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection
Experimental: SARS-CoV-2 vaccine Formulation 2
2 injections of SARS-CoV-2 vaccine Formulation 2 at Day 1 and Day 22
Biological: SARS-CoV-2 recombinant protein vaccine Formulation 2
Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection
Experimental: SARS-CoV-2 vaccine Formulation 3
2 injections of SARS-CoV-2 vaccine Formulation 3 at Day 1 and Day 22
Biological: SARS-CoV-2 recombinant protein vaccine Formulation 3
Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Presence of immediate adverse events
[ Time Frame: Within 30 minutes after vaccination ]

Immediate adverse events include unsolicited adverse events occurring within 30 minutes after injection.
2. Presence of solicited injection site or systemic reactions
[ Time Frame: Within 7 days after injection ]

Injection site reactions: injection site pain, erythema and swelling. Systemic reactions: fever, headache, malaise and myalgia.
3. Presence of unsolicited adverse events
[ Time Frame: Within 21 days after injection ]

Adverse events other than solicited reactions.
4. Presence of serious adverse events
[ Time Frame: From Day 1 to Day 387 ]

Serious adverse events are reported throughout the study.
5. Presence of adverse events of special interest
[ Time Frame: From Day 1 to Day 387 ]

Adverse events of special interest are reported throughout the study.
6. Presence of medically-attended adverse events
[ Time Frame: From Day 1 to Day 387 ]

Medically-attended adverse events are new onset or a worsening of a condition that prompts the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or Emergency Department.
7. Neutralizing antibody titer at Day 1
[ Time Frame: Day 1 ]

Neutralizing antibody titers are expressed as geometric mean titers.
8. Neutralizing antibody titer at Day 36
[ Time Frame: Day 36 ]

Neutralizing antibody titers are expressed as geometric mean titers.
9. Neutralizing antibody titer fold-rise post-vaccination
[ Time Frame: From Day 1 to Day 36 ]

Neutralizing antibody titer fold-rise post-vaccination.
10. 2-fold rise and 4-fold-rise in neutralization antibody titer
[ Time Frame: From Day 1 to Day 36 ]

Fold-rise in antibody neutralization titer post-vaccination relative to Day 1.
11. Responders, as determined by neutralizing antibody titers at Day 36
[ Time Frame: From Day 1 to Day 36 ]

Responders, defined as participants who had baseline values below lower limit of quantification (LLOQ) with detectable neutralization titer above assay LLOQ at each pre-defined time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titer at Day 36
Secondary Outcome Measures:
1. Neutralizing antibody titer at all pre-defined time points
[ Time Frame: Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387 ]

2. Neutralizing antibody titer fold-rise post-vaccination at all pre-defined time points
[ Time Frame: Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387 ]

Fold-rise in antibody neutralization titer post-vaccination relative to Day 1.
3. 2-fold rise and 4-fold-rise in neutralization antibody titer at all pre-defined time points
[ Time Frame: Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387 ]

Fold-rise in antibody neutralization titer post-vaccination relative to Day 1.
4. Responders, as determined by neutralizing antibody titers at each pre-defined time point
[ Time Frame: Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387 ]

Responders, defined as participants who had baseline values below LLOQ with detectable neutralization titer above assay LLOQ at each pre-defined time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titer at each pre-defined timepoint
5. Binding antibody concentrations
[ Time Frame: Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387 ]

6. Binding antibody fold-rise
[ Time Frame: Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387 ]

Fold-rise in concentration relative to Day 1.
7. 2-fold-rise and 4-fold rise in binding antibody concentration
[ Time Frame: Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387 ]

Fold-rise in concentration relative to Day 1.
8. Responders, as determined by binding antibody concentrations
[ Time Frame: Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387 ]

Responders are defined as participants who had baseline values below LLOQ with detectable anti-S antibody concentration above assay LLOQ at each pre-defined time point and participants with baseline values above LLOQ with a 4-fold increase in anti-S antibody concentration at each pre-defined time point.
9. Occurrences of laboratory-confirmed symptomatic COVID-19
[ Time Frame: From Day 1 to Day 387 ]

Symptomatic COVID-19 is defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness. Laboratory-confirmed SARS-CoV-2 infection is defined as a positive result for SARS CoV-2 by nucleic acid amplification test (NAAT), done by the central laboratory or locally, on at least one respiratory sample.
10. Occurrences of symptomatic COVID-19 episodes associated with hospitalization
[ Time Frame: From Day 1 to Day 387 ]

Symptomatic COVID-19 is defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness.
11. Occurrences of severe symptomatic COVID-19
[ Time Frame: From Day 1 to Day 387 ]

Symptomatic COVID-19 is defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness with pre-defined criteria of severity.
12. Occurrences of death associated with symptomatic COVID-19
[ Time Frame: From Day 1 to Day 387 ]

Symptomatic COVID-19 is defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness.
13. Occurrences of serologically-confirmed SARS-CoV-2 infection
[ Time Frame: From Day 1 to Day 387 ]

Serologically-confirmed SARS-CoV-2 infection is defined as a positive result in a serum sample for antibodies against SARS-CoV-2.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion criteria :

  • Aged 18 years or older on the day of inclusion.
  • 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 mut 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 vaccination until at least 12 weeks after the second vaccination. A subject 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 trial procedures.
  • SARS-CoV-2 rapid serodiagnostic test performed at the time of enrollment to detect presence of SARS-CoV-2 antibodies.
  • 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

Exclusion criteria:

  • 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 or designee's judgment.
  • Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on Investigator or designee'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 trial procedures.
  • Receipt of solid-organ or bone marrow transplants in the past 180 days.
  • Receipt of anti-cancer chemotherapy in the last 90 days.
  • 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 trial vaccination or planned receipt of any vaccine in the 30 days following the second trial vaccination except for influenza vaccination, which may be received at any time in relation to trial intervention.
  • Prior administration of a coronavirus vaccine (SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome [MERS-CoV]).
  • Participation at the time of trial enrollment (or in the 30 days preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Open or close this module Contacts/Locations
Central Contact Person: Trial Transparency email recommended (Toll free number for US & Canada)
Telephone: 800-633-1610 Ext. option 6
Email: Contact-US@sanofi.com
Study Officials: Clinical Sciences & Operations
Study Director
Sanofi
Locations: United States, Arizona
Investigational Site Number 8400251
[Recruiting]
Chandler, Arizona, United States, 85225
United States, California
Investigational Site Number 8400220
[Recruiting]
Los Angeles, California, United States, 90059
Investigational Site Number 8400094
[Recruiting]
Rolling Hills Estates, California, United States, 90274
Investigational Site Number 8400173
[Recruiting]
San Diego, California, United States, 92108
United States, Connecticut
Investigational Site Number 8400239
[Recruiting]
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Investigational Site Number 8400212
[Recruiting]
Washington, District of Columbia, United States, 20037
United States, Florida
Investigational Site Number 8400089
Hollywood, Florida, United States, 33024
United States, Florida
Investigational Site Number 8400057
[Recruiting]
Melbourne, Florida, United States, 32934
Investigational Site Number 8400179
[Recruiting]
Orlando, Florida, United States, 32806
United States, Georgia
Investigational Site Number 8400201
[Recruiting]
Decatur, Georgia, United States, 30030
United States, Illinois
Investigational Site Number 8400187
[Recruiting]
Peoria, Illinois, United States, 61614
United States, Maryland
Investigational Site Number 8400048
[Recruiting]
Rockville, Maryland, United States, 20850
United States, Massachusetts
Investigational Site Number 8400199
[Recruiting]
Boston, Massachusetts, United States, 02115
United States, Nebraska
Investigational Site Number 8400030
[Recruiting]
Omaha, Nebraska, United States, 68134
United States, New York
Investigational Site Number 8400230
[Recruiting]
New York, New York, United States, 10016
Investigational Site Number 8400203
[Recruiting]
New York, New York, United States, 10032
Investigational Site Number 8400207
[Recruiting]
Rochester, New York, United States, 14642
United States, Pennsylvania
Investigational Site Number 8400233
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Investigational Site Number 8400097
[Recruiting]
North Charleston, South Carolina, United States, 29405
United States, Texas
Investigational Site Number 8400191
[Recruiting]
Austin, Texas, United States, 78705
Honduras
Investigational Site Number 3400002
Municipio Del Distrito Central, Honduras, 11101
Investigational Site Number 3400001
San Pedro Sula, Honduras, 21101
Open or close this module IPDSharing
Plan to Share IPD: Yes
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/
Supporting Information:
Time Frame:
Access Criteria:
URL:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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