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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04798027




Registration number
NCT04798027
Ethics application status
Date submitted
11/03/2021
Date registered
15/03/2021

Titles & IDs
Public title
Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older
Scientific title
Immunogenicity and Safety of the First-in-Human SARS-CoV-2 mRNA Vaccine Formulation in Healthy Adults 18 Years of Age and Older
Secondary ID [1] 0 0
U1111-1251-5486
Secondary ID [2] 0 0
VAW00001
Universal Trial Number (UTN)
Trial acronym
VAW00001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - SARS-CoV-2 mRNA vaccine formulation 1
Treatment: Other - SARS-CoV-2 mRNA vaccine formulation 2
Treatment: Other - SARS-CoV-2 mRNA vaccine formulation 3
Treatment: Other - Placebo (0.9% normal saline)

Experimental: Sentinel Cohort: SARS-CoV-2 Vaccine Ultra Low dose - Participants received two intramuscular (IM) injections of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) Vaccine ultra-low dose on Day 1 and at Day 22, respectively.

Experimental: Sentinel Cohort: SARS-CoV-2 Vaccine Low dose - Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.

Experimental: Sentinel Cohort: SARS-CoV-2 Vaccine Medium dose - Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.

Experimental: FEC Cohort 1: SARS-CoV-2 Vaccine Ultra Low dose - Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.

Experimental: FEC Cohort 1: SARS-CoV-2 Vaccine Low dose - Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.

Placebo comparator: FEC Cohort 1: Placebo - Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.

Experimental: FEC Cohort 2: SARS-CoV-2 Vaccine Ultra Low dose - Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.

Experimental: FEC Cohort 2: SARS-CoV-2 Vaccine Low dose - Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.

Placebo comparator: FEC Cohort 2: Placebo - Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.


Treatment: Other: SARS-CoV-2 mRNA vaccine formulation 1
Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection

Treatment: Other: SARS-CoV-2 mRNA vaccine formulation 2
Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection

Treatment: Other: SARS-CoV-2 mRNA vaccine formulation 3
Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection

Treatment: Other: Placebo (0.9% normal saline)
Pharmaceutical form: Liquid Route of administration: Intramuscular injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)
Timepoint [1] 0 0
Within 30 minutes post any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])
Primary outcome [2] 0 0
Number of Participants With Solicited Injection Site Reactions
Timepoint [2] 0 0
Within 7 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])
Primary outcome [3] 0 0
Number of Participants With Solicited Systemic Reactions
Timepoint [3] 0 0
Within 7 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])
Primary outcome [4] 0 0
Number of Participants With Unsolicited Adverse Events
Timepoint [4] 0 0
Within 21 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])
Primary outcome [5] 0 0
Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)
Timepoint [5] 0 0
From Day 1 until 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups)
Primary outcome [6] 0 0
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance
Timepoint [6] 0 0
From Day 1 up to up to 8 days post last vaccination (i.e., up to Day 9 for Cohort 1 groups; up to Day 30 for Cohort 2 groups)
Primary outcome [7] 0 0
Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 1
Timepoint [7] 0 0
Day 1 (pre-vaccination)
Primary outcome [8] 0 0
Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 22
Timepoint [8] 0 0
Day 22 (post-vaccination)
Primary outcome [9] 0 0
Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 36
Timepoint [9] 0 0
Day 36 (post-vaccination)
Primary outcome [10] 0 0
Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22
Timepoint [10] 0 0
Day 1 (pre-vaccination) and Day 22 (post-vaccination)
Primary outcome [11] 0 0
Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36
Timepoint [11] 0 0
Day 1 (pre-vaccination) and Day 36 (post-vaccination)
Primary outcome [12] 0 0
Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22
Timepoint [12] 0 0
Day 1 (pre-vaccination) and Day 22 (post-vaccination)
Primary outcome [13] 0 0
Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36
Timepoint [13] 0 0
Day 1 (pre-vaccination) and Day 36 (post-vaccination)
Primary outcome [14] 0 0
Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22
Timepoint [14] 0 0
Day 22 (post-vaccination)
Primary outcome [15] 0 0
Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36
Timepoint [15] 0 0
Day 36 (post-vaccination)
Secondary outcome [1] 0 0
Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202
Timepoint [1] 0 0
Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 91 (only for Cohort 1), Day 112 (only for Cohort 2), Day 181 (only for Cohort 1), and Day 202 (only for Cohort 2)
Secondary outcome [2] 0 0
Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202
Timepoint [2] 0 0
Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 91 (only for Cohort 1), Day 112 (only for Cohort 2), Day 181 (only for Cohort 1), and Day 202 (only for Cohort 2)
Secondary outcome [3] 0 0
Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202
Timepoint [3] 0 0
Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 91 (only for Cohort 1), Day 112 (only for Cohort 2), Day 181 (only for Cohort 1), and Day 202 (only for Cohort 2)
Secondary outcome [4] 0 0
Geometric Mean Titers of Neutralizing Antibody Titer Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 91, 112, 181, and 202
Timepoint [4] 0 0
Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)
Secondary outcome [5] 0 0
Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202
Timepoint [5] 0 0
Day 1 (pre-vaccination), Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)
Secondary outcome [6] 0 0
Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202
Timepoint [6] 0 0
Day 1 (pre-vaccination), Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)
Secondary outcome [7] 0 0
Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens
Timepoint [7] 0 0
Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)
Secondary outcome [8] 0 0
Number of Participants With Virologically-confirmed Coronavirus Disease (COVID-19)-Like Illness
Timepoint [8] 0 0
Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)
Secondary outcome [9] 0 0
Number of Participants With Serologically-confirmed SARS-CoV-2 Infection
Timepoint [9] 0 0
Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)
Secondary outcome [10] 0 0
Correlates of Risk/Protection Based on Antibody Responses to SARS-CoV-2
Timepoint [10] 0 0
Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)

Eligibility
Key inclusion criteria
Inclusion criteria:

* Aged >= 18 years on the day of inclusion.
* A female participant was eligible to participate if she was not pregnant or breastfeeding and one of the following conditions applies:
* Was of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, or surgically sterile.

OR

* Was of childbearing potential and agreed 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.

A participant of childbearing potential must had a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours before the study intervention.

* Informed Consent Form had been signed and dated.
* Participant not eligible to receive, based on local guidance, or if eligible does not intend to receive an authorized/approved COVID-19 vaccine from first vaccination until completion of the key timepoint of Day 43 of follow-up of this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:

* History of COVID-19 disease or prior SARS-CoV-2 infection confirmed serologically.
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
* Chronic illness or condition considered to potentially increase the risk for severe COVID illness or that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion.
* Known liver disease or fatty liver.
* Positive test for chronic active Hepatitis B surface antigen, Hepatitis B core antibody, Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody from blood work collected at screening visit.
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on Investigator's judgment.
* Receipt of immunoglobulins, blood or blood-derived products in the past 3 months.
* Prior administration of a coronavirus vaccine (SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome coronavirus [MERS-CoV]).
* Receipt of any vaccine in the 30 days preceding the first study vaccination or planned receipt of any vaccine in the 30 days following the last study vaccination except for influenza vaccination, which might be received at least 2 weeks before and a minimum of 2 weeks after study vaccines.
* Receipt of any therapy known to have in-vitro antiviral activity against SARS-CoV-2 within 72 hours prior to the first blood draw or planned use of such therapy 72 hours prior to study immunogenicity blood draws at Day 22 and Day 36.
* Residence in a nursing home or long-term care facility.
* Health care workers providing direct patient care for COVID-19 participants.

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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/06/2022
Sample size
Target
Accrual to date
Final
182
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Investigational Site Number :0360003 - Morayfield
Recruitment hospital [2] 0 0
Investigational Site Number :0360005 - South Brisbane
Recruitment hospital [3] 0 0
Investigational Site Number :0360001 - Melbourne
Recruitment hospital [4] 0 0
Investigational Site Number :0360002 - Nedlands
Recruitment postcode(s) [1] 0 0
4506 - Morayfield
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
3010 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Nebraska
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
Brazil
State/province [12] 0 0
Bahia
Country [13] 0 0
Brazil
State/province [13] 0 0
Mato Grosso Do Sul
Country [14] 0 0
Brazil
State/province [14] 0 0
Minas Gerais
Country [15] 0 0
Honduras
State/province [15] 0 0
Barrio Del Centro
Country [16] 0 0
Honduras
State/province [16] 0 0
San Pedro Sula

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi Pasteur, a Sanofi Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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://vivli.org
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04798027